Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices. Committees that consider the ethical dimensions of patient care are ETHICS COMMITTEES, CLINICAL; committees established to protect the welfare of research subjects are ETHICS COMMITTEES, RESEARCH.
Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.
Hospital or other institutional ethics committees established to consider the ethical dimensions of patient care. Distinguish from ETHICS COMMITTEES, RESEARCH, which are established to monitor the welfare of patients or healthy volunteers participating in research studies.
A formal process of examination of patient care or research proposals for conformity with ethical standards. The review is usually conducted by an organized clinical or research ethics committee (CLINICAL ETHICS COMMITTEES or RESEARCH ETHICS COMMITTEES), sometimes by a subset of such a committee, an ad hoc group, or an individual ethicist (ETHICISTS).
The composition of a committee; the state or status of being a member of a committee.
The principles of professional conduct concerning the rights and duties of the physician, relations with patients and fellow practitioners, as well as actions of the physician in patient care and interpersonal relations with patient families.
The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.
Services provided by an individual ethicist (ETHICISTS) or an ethics team or committee (ETHICS COMMITTEES, CLINICAL) to address the ethical issues involved in a specific clinical case. The central purpose is to improve the process and outcomes of patients' care by helping to identify, analyze, and resolve ethical problems.
The use of humans as investigational subjects.
The identification, analysis, and resolution of moral problems that arise in the care of patients. (Bioethics Thesaurus)
The moral and ethical obligations or responsibilities of institutions.
Committees of professional personnel who have responsibility for determining policies, procedures, and controls related to professional matters in health facilities.
Persons trained in philosophical or theological ethics who work in clinical, research, public policy, or other settings where they bring their expertise to bear on the analysis of ethical dilemmas in policies or cases. (Bioethics Thesaurus)
Chemical compounds which yield hydrogen ions or protons when dissolved in water, whose hydrogen can be replaced by metals or basic radicals, or which react with bases to form salts and water (neutralization). An extension of the term includes substances dissolved in media other than water. (Grant & Hackh's Chemical Dictionary, 5th ed)
Critical and exhaustive investigation or experimentation, having for its aim the discovery of new facts and their correct interpretation, the revision of accepted conclusions, theories, or laws in the light of newly discovered facts, or the practical application of such new or revised conclusions, theories, or laws. (Webster, 3d ed)
Clusters of topics that fall within the domain of BIOETHICS, the field of study concerned with value questions that arise in biomedicine and health care delivery.
Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.
Persons who are enrolled in research studies or who are otherwise the subjects of research.
The principles of proper professional conduct concerning the rights and duties of nurses themselves, their patients, and their fellow practitioners, as well as their actions in the care of patients and in relations with their families.
Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.
The principles of proper conduct concerning the rights and duties of the professional, relations with patients or consumers and fellow practitioners, as well as actions of the professional and interpersonal relations with patient or consumer families. (From Stedman, 25th ed)
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Institutional committees established to protect the welfare of animals used in research and education. The 1971 NIH Guide for the Care and Use of Laboratory Animals introduced the policy that institutions using warm-blooded animals in projects supported by NIH grants either be accredited by a recognized professional laboratory animal accrediting body or establish its own committee to evaluate animal care; the Public Health Service adopted a policy in 1979 requiring such committees; and the 1985 amendments to the Animal Welfare Act mandate review and approval of federally funded research with animals by a formally designated Institutional Animal Care and Use Committee (IACUC).
The use of systematic methods of ethical examination, such as CASUISTRY or ETHICAL THEORY, in reasoning about moral problems.
Fundamental claims of patients, as expressed in statutes, declarations, or generally accepted moral principles. (Bioethics Thesaurus) The term is used for discussions of patient rights as a group of many rights, as in a hospital's posting of a list of patient rights.
The use of animals as investigational subjects.
Human experimentation that is intended to benefit the subjects on whom it is performed.
The state or quality of being kind, charitable, or beneficial. (from American Heritage Dictionary of the English Language, 4th ed). The ethical principle of BENEFICENCE requires producing net benefit over harm. (Bioethics Thesaurus)
Research that involves the application of the behavioral and social sciences to the study of the actions or reactions of persons or animals in response to external or internal stimuli. (from American Heritage Dictionary, 4th ed)
An approach to ethics that focuses on theories of the importance of general principles such as respect for autonomy, beneficence/nonmaleficence, and justice.
A branch of applied ethics that studies the value implications of practices and developments in life sciences, medicine, and health care.
Groups set up to advise governmental bodies, societies, or other institutions on policy. (Bioethics Thesaurus)
A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.
Self-directing freedom and especially moral independence. An ethical principle holds that the autonomy of persons ought to be respected. (Bioethics Thesaurus)
A philosophically coherent set of propositions (for example, utilitarianism) which attempts to provide general norms for the guidance and evaluation of moral conduct. (from Beauchamp and Childress, Principles of Biomedical Ethics, 4th ed)
Documents describing a medical treatment or research project, including proposed procedures, risks, and alternatives, that are to be signed by an individual, or the individual's proxy, to indicate his/her understanding of the document and a willingness to undergo the treatment or to participate in the research.
The obligations and accountability assumed in carrying out actions or ideas on behalf of others.
The informal or formal organization of a group of people based on a network of personal relationships which is influenced by the size and composition, etc., of the group.
Research that involves the application of the natural sciences, especially biology and physiology, to medicine.
Financial support of research activities.
Those individuals engaged in research.
The privacy of information and its protection against unauthorized disclosure.
Exercise of governmental authority to control conduct.
The principles of proper professional conduct concerning the rights and duties of the dentist, relations with patients and fellow practitioners, as well as actions of the dentist in patient care and interpersonal relations with patient families. (From Stedman, 25th ed)
Duties that are based in ETHICS, rather than in law.
A legal concept for individuals who are designated to act on behalf of persons who are considered incapable of acting in their own behalf, e.g., minors and persons found to be not mentally competent.
Differences of opinion or disagreements that may arise, for example, between health professionals and patients or their families, or against a political regime.
Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally.
The guidelines and policy statements set forth by the editor(s) or editorial board of a publication.
The evaluation by experts of the quality and pertinence of research or research proposals of other experts in the same field. Peer review is used by editors in deciding which submissions warrant publication, by granting agencies to determine which proposals should be funded, and by academic institutions in tenure decisions.
A situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict.
A systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. The text may be cursive or in outline form but is generally a comprehensive guide to problems and approaches in any field of activity. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available.
An international agreement of the World Medical Association which offers guidelines for conducting experiments using human subjects. It was adopted in 1962 and revised by the 18th World Medical Assembly at Helsinki, Finland in 1964. Subsequent revisions were made in 1975, 1983, 1989, and 1996. (From Encyclopedia of Bioethics, rev ed, 1995)
Members of a religious denomination founded in the United States during the late 19th century in which active evangelism is practiced, the imminent approach of the millennium is preached, and war and organized government authority in matters of conscience are strongly opposed (from American Heritage Dictionary of the English Language, 4th ed). Jehovah's Witnesses generally refuse blood transfusions and other blood-based treatments based on religious belief.
Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Control which is exerted by the more stable organizations of society, such as established institutions and the law. They are ordinarily embodied in definite codes, usually written.
Informed consent given by a parent on behalf of a minor or otherwise incompetent child.
Research into the cause, transmission, amelioration, elimination, or enhancement of inherited disorders and traits.
Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children.
Revealing of information, by oral or written communication.
A self-governing territory formed from the central and eastern portions of the Northwest Territories. It was officially established April 1, 1999. The capital is Iqaluit.
The rights of the individual to cultural, social, economic, and educational opportunities as provided by society, e.g., right to work, right to education, and right to social security.
The act or practice of killing or allowing death from natural causes, for reasons of mercy, i.e., in order to release a person from incurable disease, intolerable suffering, or undignified death. (from Beauchamp and Walters, Contemporary Issues in Bioethics, 5th ed)
Testing in which the source of the specimen or the person being tested is not individually identified.
Standards of conduct that distinguish right from wrong.
Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.
Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
A person who has not attained the age at which full civil rights are accorded.
Accountability and responsibility to another, enforceable by civil or criminal sanctions.
An advisory group composed primarily of staff physicians and the pharmacist which serves as the communication link between the medical staff and the pharmacy department.
The process by which decisions are made in an institution or other organization.
A rare developmental defect in which the heart is abnormally located partially or totally outside the THORAX. It is the result of defective fusion of the anterior chest wall. Depending on the location of the heart, ectopia cordis can be thoracic, thoracoabdominal, abdominal, and cervical.
Persons whose profession is to give legal advice and assistance to clients and represent them in legal matters. (American Heritage Dictionary, 3d ed)
A course or method of action selected, usually by an organization, institution, university, society, etc., from among alternatives to guide and determine present and future decisions and positions on matters of public interest or social concern. It does not include internal policy relating to organization and administration within the corporate body, for which ORGANIZATION AND ADMINISTRATION is available.
The circulation or wide dispersal of information.
The commitment in writing, as authentic evidence, of something having legal importance. The concept includes certificates of birth, death, etc., as well as hospital, medical, and other institutional records.
"The business or profession of the commercial production and issuance of literature" (Webster's 3d). It includes the publisher, publication processes, editing and editors. Production may be by conventional printing methods or by electronic publishing.
The level of governmental organization and function at the national or country-wide level.
The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed)
The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.
The interaction of persons or groups of persons representing various nations in the pursuit of a common goal or interest.
Research carried out by nurses, generally in clinical settings, in the areas of clinical practice, evaluation, nursing education, nursing administration, and methodology.
Predetermined sets of questions used to collect data - clinical data, social status, occupational group, etc. The term is often applied to a self-completed survey instrument.
Character traits that are considered to be morally praiseworthy. (Bioethics Thesaurus)
Payment, or other means of making amends, for a wrong or injury.
An organized procedure carried out by a select committee of professionals in evaluating the performance of other professionals in meeting the standards of their specialty. Review by peers is used by editors in the evaluation of articles and other papers submitted for publication. Peer review is used also in the evaluation of grant applications. It is applied also in evaluating the quality of health care provided to patients.
The process by which individuals internalize standards of right and wrong conduct.
Management of the internal organization of the hospital.
That segment of commercial enterprise devoted to the design, development, and manufacture of chemical products for use in the diagnosis and treatment of disease, disability, or other dysfunction, or to improve function.
Abstract standards or empirical variables in social life which are believed to be important and/or desirable.
The study of religion and religious belief, or a particular system or school of religious beliefs and teachings (from online Cambridge Dictionary of American English, 2000 and WordNet: An Electronic Lexical Database, 1997)
Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.
Large hospitals with a resident medical staff which provides continuous care to maternity, surgical and medical patients.
The integration of epidemiologic, sociological, economic, and other analytic sciences in the study of health services. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services. The aim of the research is evaluation, particularly in terms of structure, process, output, and outcome. (From Last, Dictionary of Epidemiology, 2d ed)
A publication issued at stated, more or less regular, intervals.
The application of discoveries generated by laboratory research and preclinical studies to the development of clinical trials and studies in humans. A second area of translational research concerns enhancing the adoption of best practices.
Societies whose membership is limited to physicians.
Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data.
Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.
The expected and characteristic pattern of behavior exhibited by an individual as a member of a particular social group.
The state or condition of being a human individual accorded moral and/or legal rights. Criteria to be used to determine this status are subject to debate, and range from the requirement of simply being a human organism to such requirements as that the individual be self-aware and capable of rational thought and moral agency.
Attitudes of personnel toward their patients, other professionals, toward the medical care system, etc.
A love or pursuit of wisdom. A search for the underlying causes and principles of reality. (Webster, 3d ed)
The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
An interactive process whereby members of a community are concerned for the equality and rights of all.
The study, based on direct observation, use of statistical records, interviews, or experimental methods, of actual practices or the actual impact of practices or policies.
Apparatus, devices, or supplies intended for one-time or temporary use.
The science or philosophy of law. Also, the application of the principles of law and justice to health and medicine.
Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Elements of limited time intervals, contributing to particular results or situations.
A system of medical care regulated, controlled and financed by the government, in which the government assumes responsibility for the health needs of the population.
Countries in the process of change with economic growth, that is, an increase in production, per capita consumption, and income. The process of economic growth involves better utilization of natural and human resources, which results in a change in the social, political, and economic structures.
The philosophical view that conceptions of truth and moral values are not absolute but are relative to the persons or groups holding them. (from American Heritage Dictionary of the English Language, 4th ed)
The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)
Interaction between research personnel and research subjects.
Violation of laws, regulations, or professional standards.
Collaborative process of research involving researchers and community representatives.
The intrinsic moral worth ascribed to a living being. (Bioethics Thesaurus)
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.
Time period from 1901 through 2000 of the common era.
Groups of persons whose range of options is severely limited, who are frequently subjected to COERCION in their DECISION MAKING, or who may be compromised in their ability to give INFORMED CONSENT.
A course of study offered by an educational institution.
Created 7 April 1992 as a result of the division of Yugoslavia.
Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.
Societal or individual decisions about the equitable distribution of available resources.
The principles of proper professional conduct concerning the rights and duties of the pharmacist, relations with patients and fellow practitioners, as well as actions of the pharmacist in health care and interpersonal relations with patient families. (From Stedman, 25th ed)
Communication, in the sense of cross-fertilization of ideas, involving two or more academic disciplines (such as the disciplines that comprise the cross-disciplinary field of bioethics, including the health and biological sciences, the humanities, and the social sciences and law). Also includes problems in communication stemming from differences in patterns of language usage in different academic or medical disciplines.
Failing to prevent death from natural causes, for reasons of mercy by the withdrawal or withholding of life-prolonging treatment.
The study of laws, theories, and hypotheses through a systematic examination of pertinent facts and their interpretation in the field of dentistry. (From Jablonski, Illustrated Dictionary of Dentistry, 1982, p674)
Intentional falsification of scientific data by presentation of fraudulent or incomplete or uncorroborated findings as scientific fact.
Organizations representing specialized fields which are accepted as authoritative; may be non-governmental, university or an independent research organization, e.g., National Academy of Sciences, Brookings Institution, etc.
Any type of research that employs nonnumeric information to explore individual or group characteristics, producing findings not arrived at by statistical procedures or other quantitative means. (Qualitative Inquiry: A Dictionary of Terms Thousand Oaks, CA: Sage Publications, 1997)
The protection of animals in laboratories or other specific environments by promoting their health through better nutrition, housing, and care.
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
A specialized agency of the United Nations designed as a coordinating authority on international health work; its aim is to promote the attainment of the highest possible level of health by all peoples.
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
Research carried out by nurses in the clinical setting and designed to provide information that will help improve patient care. Other professional staff may also participate in the research.
Experimentation on, or using the organs or tissues from, a human or other mammalian conceptus during the prenatal stage of development that is characterized by rapid morphological changes and the differentiation of basic structures. In humans, this includes the period from the time of fertilization to the end of the eighth week after fertilization.
Conversations with an individual or individuals held in order to obtain information about their background and other personal biographical data, their attitudes and opinions, etc. It includes school admission or job interviews.
Organizations composed of members with common interests and whose professions may be similar.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
The branch of philosophy that treats of first principles, including ontology (the nature of existence or being) and cosmology (the origin and structure of the universe). (From Random House Unabridged Dictionary, 2d ed)
The total amount of work to be performed by an individual, a department, or other group of workers in a period of time.
A republic in southern Africa, the southernmost part of Africa. It has three capitals: Pretoria (administrative), Cape Town (legislative), and Bloemfontein (judicial). Officially the Republic of South Africa since 1960, it was called the Union of South Africa 1910-1960.
The study of natural phenomena by observation, measurement, and experimentation.

Selecting subjects for participation in clinical research: one sphere of justice. (1/409)

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research.  (+info)

Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective. (2/409)

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.  (+info)

Research, ethics and conflicts of interest. (3/409)

In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest.  (+info)

Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines. (4/409)

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems.  (+info)

Responses by four Local Research Ethics Committees to submitted proposals. (5/409)

BACKGROUND: There is relatively little research concerning the processes whereby Local Research Ethics Committees discharge their responsibilities towards society, potential participants and investigators. OBJECTIVES: To examine the criteria used by LRECs in arriving at their decisions concerning approval of research protocols through an analysis of letters sent to investigators. DESIGN: Four LRECs each provided copies of 50 letters sent to investigators after their submitted proposals had been considered by the committees. These letters were subjected to a content analysis, in which specific comments and requests for additional information and changes in the protocols were recorded and compared. FINDINGS: Overall 24% of proposals were approved without request for changes or clarifications, but this varied by committee: one committee approved only 6% of proposals without change or clarification while the others ranged from 26% to 32%. The content analyses of responses indicated that they could be placed into four categories: (i) further information for the committee to aid in their deliberations; (ii) requests for changes to the design or justification for the design used; (iii) changes to the information sheets provided to potential participants; and (iv) changes to consent procedures. Of these, alterations to information sheets were the most common type of request. These four types of response could be seen as safeguarding the wellbeing of potential participants (the principle of non-maleficence), of promoting the scientific validity of the research (the principle of beneficence), and of enhancing the rights of potential participants (the principle of autonomy). CONCLUSIONS: The committees were consistent in the types of requests they made of investigators, which can be seen as attempts to protect participants' rights and ensure the scientific validity of studies. Without an analysis of the proposals sent to the committees, however, it is difficult to account for the variation in the requirements set by the committees before approval was given.  (+info)

Genetic medicine: an experiment in community-expert interaction. (6/409)

This project tested a two-way model of communication between lay groups and experts about genetic medicine in Perth, Western Australia. Focus group discussion with community group participants was followed by a communication workshop between community group participants and experts. Four groups of concerns or themes emerged from discussion: clinical considerations; legislative concerns; research priorities, and ethical and wider considerations. Community group concerns are not always met by the actions of "experts". This is, in part, because of the differing life-worlds of each group. However, the communication workshop showed the potential of two-way communication for both lay and expert members in understanding the others' viewpoint. Further, the approach developed here offers one possible way for community groups to participate in a substantial way in policy formulation processes.  (+info)

Bioethics regulations in Turkey. (7/409)

Although modern technical and scientific developments in medicine are followed closely in Turkey, it cannot be claimed that the same is true in the field of bioethics. Yet, more and more attention is now being paid to bioethics and ethics training in health sciences. In addition, there are also legal regulations in bioethics, some of which are not so new. The objective of these regulations is to provide technical and administrative control. Ethical concerns are rather few. What attracts our attention most in these regulations is the presence of the idea of "consent".  (+info)

The new system of review by multicentre research ethics committees: prospective study. (8/409)

OBJECTIVE: To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. DESIGN: Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. SETTING: A single multicentre research ethics committee and 125 local ethics committees from six regions of England. MAIN OUTCOME MEASURES: Time to reply, time to approval, and number of non-local changes to the application requested. RESULTS: Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. CONCLUSIONS: The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.  (+info)

BUENO, Mariana et al. Reasons for resubmission of research projects to the research ethics committee of a University Hospital in São Paulo, Brazil. Clinics [online]. 2009, vol.64, n.9, pp.831-836. ISSN 1807-5932. INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. OBJECTIVES: To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. METHOD: This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for ...
Competing interests DH directs the Keele Centre for Professional Ethics training program for research ethics committees and their online MA in research ethics. He sits on the Keele University Research Ethics Committee as well as being an external member of the Liverpool Hope University Research Ethics Subcommittee. He is also the editor of the journal Research Ethics. He is a member of the Association for Research Ethics Council (AREC) and the Universities Research Ethics Subcommittee of AREC. ...
All research involving human subjects within Mount Sinai Hospital (MSH) requires approval of the MSH Research Ethics Board prior to the initiation of a research project. The MSH REB has similar responsibility for investigators from other institutions who may wish to carry out research on Mount Sinai Hospital premises or with Mount Sinai Hospital patients.. IIn the event that an investigator cannot determine whether an intended investigation constitutes research (for instance, quality assurance studies do not constitute research), the investigator should approach the Research Ethics Board office for such a determination by calling 416-586-4875. Providing such consultation on ethics matters is part of the responsibility of the Board.. ...
Susan Marlin is the President and CEO of Clinical Trials Ontario (CTO), an organization established by the Province of Ontario in 2012 to make Ontario a preferred location for global clinical trials while maintaining the highest ethical standards. Susan led the establishment of the CTO and the implementation of a province-wide streamlined research ethics review system. Prior to joining CTO served as the Associate Vice-Principal at Queens University. Susan worked with the National Cancer Institute of Canada Clinical Trials Group for many years, initially coordinating cancer clinical trials and later leading the development and implementation of the Ethics and Regulatory Office. Susan has been actively engaged in research ethics over the years and has served on several research ethics committees. She served as President of the Canadian Association of Research Ethics Boards, as a member of the Canadian Institutes of Health Research (CIHR) Research Integrity Committee, the Ontario Cancer Research ...
Continuation Request: Research projects are approved for a period of one year, unless a shorter interval is specified by the IRB. All projects that continue beyond the maximine shall submit (a) an IRB application cover sheet indicating the PI, the project title, and that a continuation is requested, and (b) a brief statement about any changes or modifications to the protocol since originally approved. This should be sighed by the PI and his/her department head, and submitted directly to the IRB Chairperson (or designee) for review. The IRB Chairperson, or designee, may approve the continuation. If modifications have been made since the original approval that either significantly change the project or significantly increase participant risk, then the IRB Chairperson (or designee) may inform the PI that submission of a completely new application is required. This application will then be reviewed as a new application (see section F1.1.1, F1.2.1, or F1.3.1). If modifications are approved, then the ...
Bioquark Inc. and Revita Life Sciences Receive IRB Approval for First-In-Human Brain Death Study Bioquark, Inc., ( a company focused on the development of novel biologics fo...
Clinical research involving children is essential if we are to increase our understanding of childhood conditions and improve healthcare for children. Yet our 2015 survey of the paediatric workforce demonstrated that very few paediatricians have time allocated for research-related activities related to childrens health.
Subjects. All patients had relapsing-remitting multiple sclerosis and were participants in 1 of 2 clinical trials, CAMMS-223 and CAMMS-224 (Cambridge UK Research Ethics Committee [REC 02/315 and 03/078]), in which alemtuzumab (supplied by Genzyme) is given by intravenous infusion of 12-24 mg/d for 5 days, followed by retreatment at 12 months. Patients and controls consented to venesection for research purposes (studies were approved by Cambridge UK Research Ethics Committee [LREC 02/263]) and all were free from exposure to other disease-modifying agents, including steroids, for at least 1 month at the time of blood sampling. For each experiment, all available samples, from all relevant patients, at all possible time points were used; there was no subgroup selection. More samples were available for serum studies, as retrospective frozen samples could be used. Assays of lymphocyte biology could not be performed on many patients shortly after alemtuzumab due to their profound lymphopenia. All DNA ...
Defining an Institutional Review Board: An institutional review board can be defined in simple terms as a committee which has been formally designated for the purpose of approving, monitoring and reviewing the clinical trials that are involving human participants. This committee can be called in some other names like: - Independent ethics committee - Ethical review board
Are you thinking of starting a research project at the RBWH? Before you begin the submission process, come to an Information Clinic to obtain advice on ethical and governance requirements. Staff from the Human Research Ethics Committee (HREC), Research Governance Office (RGO) and Finance Section are available to provide advice.. The Clinics are held on a Tuesday and Wednesday morning each week, with 2 x 30 minute timeslots available on both days, beginning at 9.00am.. Appointments can be made through the Research Governance Office - telephone: 3646 4301.. ...
The role of the School Research Ethics Committees (SREC) and the University Research Ethics and Integrity Sub-committee (UREISC) is to support the Universitys research activities by implementing our research ethics policies. The committees consider all proposals for research from an ethical standpoint for all staff and research students. The policies each committee uses are underpinned by The Concordat to Support Research Integrity to which we are a signatory. These are also informed by the UK Research Integrity Offices (UKRIO) Code of Practice for Research. In line with the Concordat we will publish an annual report of the work we are doing and the applications made to our ethics committees. The 2019/20 report will appear here shortly. ...
Virtually all research involving human subjects in the US must be reviewed by an institutional review board, a form of research ethics review board. This artic
External IRB specific document revisions. Due to significant changes and enhancements to the process by which HSD authorizes studies for review by an external IRB, most documents related to the external IRB authorization process have been retired or considerably revised.. Summary of enhanced process: UW investigators must complete the form titled REQUEST: External IRB Review and follow the Zipline instructions on the HSD website to Ask for Non UW IRB review. HSD will assess whether the study qualifies for external review, confirm or establish needed reliance agreements with the reviewing IRB, and issue an acknowledgement letter documenting permission to use the external IRB. Researchers should include this letter in their submission to the reviewing IRB. HSDs Online Tutorial for Requesting Review from a Non-UW IRB in Zipline provides details about the forms and processes.. UW research involving cooperative partners such as Seattle Childrens, Hutch, Benaroya, and Kaiser/Group ...
Twelve native Chinese speakers [NCS group, 6 male/6 female; mean age (±SD) = 23.8 ± 0.8 yrs; educational level, college] and 12 native English speakers [NES group, 6 male/6 female; mean age (±SD) = 26.8 ± 2.3 yr; educational level, college] participated. The Chinese participants in the NCS group are senior students from the local universities in Dalian, China. The participants in the NES group all are educators teaching English language in the city of Dalian; eight of them are from the United States of America, two from England, one from Canada, and one from Australia, and none of them are Asian or Chinese Americans. All subjects are right handed and physically healthy. The human experiment was approved by a local Institutional Review Board, and informed consent was obtained from each participant. Two subjects from the NCS group and two from the NES group were excluded from results because of their head motion during the experiment; the remaining subjects in both groups had the same gender ...
Institutional Review Board Bass Hall 416 Smith College Northampton, MA 01063. The IRB will be providing guidance for non-face-to-face research and data security. Belmont University Institutional Review Board. Title of Project: Date proposal submitted to the IRB: Type of Proposal or Activity: ( ) New proposal ( ) Modification . EXAMPLE IRB FORMS .....36 3.0 10/18 EXEMPT RESEARCH IRB APPLICATION.....37 3.0 10/18 ... Belmont Report (1979), as follows: Respect for persons incorporates at least two ethical convictions: first, individuals should be treated as autonomous agents; and second, that persons with diminished autonomy are entitled to protection (thus, the need to obtain informed consent). Address local or federal reporting requirements, if any. Guidelines: 1ğ.ğ)ğ ğ S t a t e w h e t h e r t h e s u b j e c t w i l l b e p a i d o r o f f e r e d o t h e r b e n e f i t s ( e . Belmont Principles Apply: Although exempt research does not require IRB review, this research is not exempt ...
Referred to these hypotheses, we suggested that, antiplatelet drug could reduce inflammation and microthrombi formation, and finally reduce the incidence of DCI. Generally, a dual platelet aggregation inhibitor (aspirin, clopidogrel) is commonly used in the insertion of stents and flow diverters during endovascular aneurysm treatment. The relationship between dual antiplatelet treatment (DAPT) and symptomatic vasospasm and DCI has not been widely studied, thus we investigated the effect of DAPT on symptomatic vasospasm and DCI.. MATERIALS AND METHODS. This study was approved by the local institutional review board. A retrospective single-center study was conducted on patients with aSAH treated at our center from January 2009 to December 2018. In patients with aSAH, CT, CT angiography (CTA) and MRI were essentially performed, and transfemoral cerebral angiography (TFCA) was also performed if necessary. Information about modified world federation of neurosurgical societies (WFNS) grade, whether ...
TY - JOUR. T1 - Long radiology workdays reduce detection and accommodation accuracy. AU - Krupinski, Elizabeth A.. AU - Berbaum, Kevin S.. AU - Caldwell, Robert T.. AU - Schartz, Kevin M.. AU - Kim, John. PY - 2010/9. Y1 - 2010/9. N2 - Purpose: The aim of this study was to measure the diagnostic accuracy of fracture detection, visual accommodation, reading time, and subjective ratings of fatigue and visual strain before and after a day of clinical reading. Methods: Forty attending radiologists and radiology residents viewed 60 deidentified, HIPAA-compliant bone examinations, half with fractures, once before any clinical reading (early) and once after a day of clinical reading (late). Reading time was recorded. Visual accommodation (the ability to maintain focus) was measured before and after each reading session. Subjective ratings of symptoms of fatigue and oculomotor strain were collected. The study was approved by local institutional review boards. Results: Diagnostic accuracy was reduced ...
Before projects can be submitted to a Research Ethics Committee they must have written evidence of a scientific peer review. The Joint Research Office can arrange peer review of your project if this is required. Please speak with the relevant research facilitator supporting your research project.. Once projects have been granted both Research Governance and Research Ethics Approval, they can begin. Investigators are obliged to submit annual/final reports to the research facilitators as a requirement under the Research Governance Framework. The submission of this annual progress data also forms part of the standard terms and conditions for the approval of research activities within the Trust.. Amendments to research must also be notified to the Joint Research Office, in order to check that these do not affect the original terms of approval for the study. The research facilitators will review the amendments and issue approval.. If you are seeking Trust approval for your research we advise that you ...
Figure 1. Flow diagram summarizing patient recruitment and progress in the study. Seventy-three individuals were initially assessed to take part in the study, of these, 18 declined to participate and 7 were excluded for not meeting inclusion criteria. The remaining 48 subjects were randomly assigned to treatment and control groups. Both groups received identical assessments, however only the treatment group received perceptual-cognitive training. Only one individual from the treatment group did not complete the training and subsequent follow-up assessments.. Procedure. This clinical study, using a parallel design, was approved on 27th June 2017 by the University of Victoria Human Research Ethics Board. The authors confirm that all ongoing and related trials for this intervention are registered (NCT03763344). This study was not registered before the enrolment of participants since UVic Research Ethics Board did not consider this study as a clinical trial but as a research study on sub-clinical ...
The James Cook University Human Research Ethics Committee (HREC) reviews all research and teaching applications in accordance with the National Statement on Ethical Conduct in Human Research (2007) - Updated 2018.. JCU staff or students intending to undertake a research or a teaching project involving any form of human participation (including observation of human activity), access to personal documents or other materials, and access to databases must submit a human ethics application.. Undergraduate projects: If undergraduate students are involved in small research projects involving human participants as part of their assessment, then ethics approval must be sought. Usually the lecturer in charge of the subject would submit an ethics application for the course to cover this assessment requirement, or if appropriate, individual or groups of students may also apply for ethics approval.. Teaching activities: Teaching activities that involve physiological or psychosocial experiments, taking of ...
Researchers sought to reanimate recently deceased cadavers to a minimal level of consciousness, but medical research authorities have called a ...
Ethics approval and consent to participate. : Ethical approval was obtained through the Executive Committee of the Sydney Childrens Hospitals Network Human Research Ethics Committee (HREC/16/SCHN/221). : Not applicable. : Dr Penny Ireland, Dr Louise Tofts and Professor Ravi Savarirayan have received fees from Biomarin Pharmaceutical for participating in advisory boards. Dr Louise Tofts is a principal investigator for the Biomarin sponsored clinical trials of Vosoritide in Achondroplasia, she does not receive any financial reimbursment for these activities. ...
A commercial institutional review board (IRB) specializing in human research protection for social science and education research: HeartlandIRB
Protocol Review and Monitoring System Principal Investigator: Pestell, Richard G., M.D., Ph.D. (P30 CA056036) PROJECT SUMMARY (See Instructions): PROTOCOL REVIE...
Ethical considerations. Ethical approval was obtained from the University of Witwatersrand Human Research Ethics Committee (protocol number M081013). Permission was sought from the Provincial Health Department and from the clinics and the unit managers where interviews were conducted. Each participant was provided with sufficient and understandable information regarding the research in order for them to make a voluntary informed decision to participate. Participants signed the consent form before data were collected. Confidentiality and anonymity were ensured throughout by protecting the participants identity and privacy when reporting the findings. The use of a skilled moderator and assistant moderator, welcoming of participants and an overview of the topic, ground rules which included that one person to speak at a time, listening respectfully to one other and emphasising that all participants need not agree with each other and the use of a moderator to keep the group focused, were adhered to ...
The primary goal of the Protocol Review and Monitoring Committee (PRMC) is to ensure that all cancerrelated clinical research studies involving human subjects t...
Ethics Committee Approval: The University of the Health Sciences Clinical Research Ethics Committee granted approval for this study (date: 19/127, 2019/127, numbers: 26/03/2019, 04/09/2020).. Peer-review: Externally peer-reviewed.. Author Contributions: Concept - YY, RI; Design - YY, AU, MK, RI; Supervision - YY, GA, RI; Fundings - YY, NY, FK, IS, GA, ACK, MK, AU, FA, HF, EA, SO, RI; Materials - YY, NY, FK, IS, GA, ACK, MK, AU, FA, HG, EA, SO, RI; Data Collection and/or Processing - YY, NY, FA, FK, HG, EK, GA, ACK, IS, EA, SO, MK, AU, RI; Analysis and/or Interpretation - YY, RI, EK; Literature Search - YY, RI, EK; Writing - YY, RI, EK; Critical Reviews - YY, RI.. Conflict of Interest: The authors have no conflict of interest to declare.. Financial Disclosure: The study was supported by Turkish Association for the Study of the Liver and Fatty Liver Diseases Special Interest Groups.. References. 1. Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, et al. The diagnosis and ...
The 12 kids in the study were treated like guinea pigs. Surgery was done on children even though there were no clinical indications to do so. Others were admitted for invasive procedures without being seen beforehand. Described in one journal article: Dr Wakefield, John Walker-Smith, and Simon Murch are accused of ignoring limitations placed on them by the research ethics committee of the Royal Free Hampstead NHS Trust and subjecting children to procedures that were not clinically indicated, including lumbar punctures, barium meals, general anaesthesia, and colonoscopy. In addition, they gave child 10 an experimental drug called oral measles virus-specific dialyzable lymphocyte extract transfer factor. They did this without having any information on its safety in children and an entire year before the ethics committee gave them the approval to do so. Turns out, this was another business investment for Wakefield. He had submitted a proposal to the Royal Free Hospital School of Medicine to ...
For more detailed information about each of these requirements, see What Information is Reviewed by the RDRC2?. In order to get a fillable application form, you must save it first. To save it-right click on Review Application. If you just wish to view the application you can just open it. When you have completed the application, upload it to the RDRC Application page, see menu to the left. Once you upload the application you will not be able to view or change it. If you are uploading a revised application, please indicate that in the name of the file. The result of your review will be emailed to you. Currently the RDRC meets quarterly.. If you have not also submitted your IRB protocol for review, please visit the IRB website to get information and submit your application for an IRB review. If you are doing an oncology study, please visit the LCCC Oncology Protocol Review Committee website if you have not submitted your materials for the PRC review.. If you have any questions please contact ...
For cell count determination, murine neutrophil glucose and ATP assays, and apoptosis assays, see Supplemental Methods.. Isolation and culture of neutrophils from healthy human volunteers and knockout mice. Human peripheral blood neutrophils were isolated from individuals with active rheumatoid arthritis, in accordance with 1987 American Rheumatism Association criteria (40), and with one or more swollen joints and from healthy volunteers using dextran sedimentation and discontinuous plasma-Percoll gradients (41). Ethical approval was obtained from the South Sheffield Research Ethics Committee, and all participants gave written informed consent in accordance with the Declaration of Helsinki principles. Murine bone marrow-derived neutrophils were isolated using modified discontinuous HBSS-Percoll gradients (82%, 62%, and 51%) and peripheral blood neutrophils by negative magnetic selection following a terminal inferior vena cava bleed into a 23 gauge pre-heparinized needle (42). Cell purity, ...
690206-97-4 treatment-na?ve patients with advanced HIV-1 infection in the HAART era. We retrospectively compared the incidence of CMV-EOD in a cohort of ART-na?ve adult patients with advanced HIV FZD10 infection (low CD4 count and plasma CMV-DNA-positive). One group of these patients had received CMV preemptive therapy, while the other had not received such therapy. Methods Ethics Statement The study was approved by the Human Research Ethics Committee of National Center for Global Health and Medicine, Tokyo. All patients included in this study provided a written informed consent for their clinical and laboratory data to be used and published for research purposes. This study has been conducted according to the principles expressed in the Declaration of Helsinki. Study design We performed a retrospective, single-center cohort study to elucidate the effectiveness of preemptive CMV treatment in HIV-infected individuals with positive CMV viral fill in preventing CMV-EOD. The scholarly research was ...
The mission of the Suffolk University institutional Review Board (IRB) is to ensure quality research involving human subjects conducted under the auspices of the University.
SUZHOU, China, Aug. 22, 2019 /PRNewswire/ -- CStone Pharmaceuticals (CStone or the Company, HKEX: 2616) today announced that the Company has recently received ethics approval from the Human Research Ethics Committee in Australia for the Phase I clinical trial of CS3002, and Australias Therapeutic Goods Adminis...
By recording the firing patterns of the tibialis anterior muscle, we were able to generate irregular trains of stimuli, which incorporate both short (high‐frequency) and long (low‐frequency) interspike intervals. An intramuscular tungsten microelectrode was inserted into the muscle belly of tibialis anterior in a single subject performing isometric ankle dorsiflexions. The subject was asked to sustain ~30% maximal voluntary contraction for 70 sec. The mean frequency for this train was 19.3 ± 8.7 Hz, with a discharge variability of 32.3% (S.D/mean × 100). Instantaneous frequencies ranged from 5.7 to 151.5 Hz. The inter‐spike intervals exhibited by this train were used to create an irregular train that emulated the firing of volitionally activated motoneurones.. Successful experiments were conducted on seven male and three female subjects (19-51 years) under the approval of the Human Research Ethics committee of the University of Western Sydney. Subjects provided informed written consent. ...
The inquiry coincided with the Queensland Governments release of a draft code of conduct governing biotechnology.. Mr Campbell said he had strong reservations about the Queensland code.. Paragraph 25 of the draft code commits biotechnology organisations to agreeing that we will not conduct research into the cloning of entire human beings, but understand that research may continue into the cloning of genes and cells for specific medical purposes … where such research has been approved by the relevant human research ethics committee.. But Mr Campbell said this was a non-enforceable code.. He said legislation would not endanger genuine research in Queensland, would make clear to scientists which direction they can work in and ensure the state would not attract unscrupulous people seeking to escape the constraints of legislation in other states. ...
huA33 production. The construction, production, and preclinical testing of the humanized CDR-grafted A33 IgG1 (huA33) have been described previously (21-25). This study was conducted according to the Food and Drug Administration (FDA) regulations and as part of an Investigatory New Drug application to the FDA and was also approved by the Human Research Ethics Committee of the Austin Hospital.. Trial design. The trial was an open-label, dose escalation, biopsy-based phase I study. The primary objectives were to establish the safety of i.v. administered radiolabeled huA33 in patients with colorectal carcinoma and to determine the biodistribution, pharmacokinetics, and immunogenicity of huA33 in these patients.. A single infusion of huA33, labeled with [131I]huA33 (400 MBq: 10 mCi) and [125I]huA33 (40 MBq: 1 mCi), was administered 7 days before scheduled surgery. Each infusion was administered in 100 mL of 5% human serum albumin/normal saline over a 30-minute period. The uptake of radio-iodine in ...
Institutional Review Boards (IRBs) were born from sound motives of protecting participants in biomedical research protocols from undue risk of harm. Over time,
Andrew Murphy has published nationally and internationally on his research interests of the management of cardiovascular disease in the community, professional practice (with an emphasis on rural practice), patients¿ perspectives and medical education. He is principal investigator of the Health Research Board (HRB) funded five year research programme on the provision of secondary cardiac care in the community as well as a co-applicant of the HRB Unit on Health Status and Health Gain. Andrew is the inaugural Chair of the University Research Ethics Committee and the first Chair of the newly established multi-disciplinary Centre for Clinical Health Services Research. He has contributed to national policy development as the Chair of the Primary Care Sub-Committee of the Advisory Forum of the Cardiovascular Strategy and through his collaboration in the publication of primary care strategies for the North Western and Western Health Boards. He was fortunate to be able to undertake, in Australia, a ...
Students are encouraged to follow the timeline previously described. However, under special circumstances, a student may collect data during the summer following their junior (third) year. If this route is chosen, then the following timeline should be adhered. Once approved by the faculty advisor and second reader, an electronic copy of the written research proposal should be electronically submitted to the Honours Program Coordinators by March 15th of the junior year. Following approval from the advisor and second reader of the written research proposal, the student should formally present his or her proposal in a 10-minute oral presentation followed by 5-minutes of questions before the end of winter term in their junior year. If applicable, an application for Ethical Approval should be submitted to the Human Kinetics Research Ethics Board no later than April 15th of the students junior (third) year.. For additional information on the Honours Program, please see course ...
Human subject research sometimes involves having potential participants engage in some type of screening activity to determine their eligibility for participation in a study. Collecting data directly from subjects or prospective subjects such as through written screening tools or oral responses to questionnaires, or accessing private information, i.e., grades, medical test results, legal records, or any other non-public information linked to a potential subject, for purposes of eligibility screening constitutes a research intervention or interaction that is part of the research activity and therefore requires IRB review.. Although screening activities do not necessarily result in data that are used to evaluate study outcomes, such procedures occur because of the research and are, therefore, reviewed by the IRB during consideration of proposed protocols. Screening activities are reviewed as part of the overall recruitment and consent process and evaluated with respect to the protection of privacy ...
Received: 26 March 2020; Revised: 7 July 2020; Accepted: 22 July 2020; First Online: 10 August 2020; : This work obtained ethics approval by the North West-Greater Manchester Central Research Ethics Committee under the title: Nottingham Health Science Biobank (NHSB), reference number 15/NW/0685. All patients included were consented to participate in the study and to use their materials in research. All samples from Nottingham used in this study were pseudo-anonymised and stored in compliance with the UK Human Tissue Act. The study was performed in accordance with the Declaration of Helsinki.; : Not applicable.; : The authors confirm that data that have been used are available on reasonable request.; : The authors declare no competing interests.; : Not applicable ...
Statistical analysis and ethical issues. Data were added to the data base of the original cohort for analysis in the statistical software SPSS version 15.0. Descriptive statistics, qui-square test, Fishers exact test, measures of association force and logistic regression were used. Five percent random samples of the interviews were repeated by supervisors to control data quality.. This project was approved by the Research Ethics Committee of the Universidade de Passo Fundo (recorded under number 024/2007). All participants read and signed a free informed consent.. Results. From the 2,285 children who composed the initial cohort in 2003, 24 have died and 145 were excluded (8 were adopted, one mother developed mental illness and 2 have died, 134 have moved away from the city). After several attempts, it was impossible to localize 420 children, and 9 refused to participate in the study. In this stage, 1,687 children were included (73.8% of the original cohort).. The most significant losses ...
The research was approved by the South East Essex Research Ethics Committee (Ref. 09/H1102/45) and began in April 2009. All National Health Service (NHS) mental health trusts in England were contacted to confirm whether they had an in-patient or community mental health rehabilitation unit that accepted patients referred from acute admission wards. Units designated as continuing care, forensic or secure rehabiliation were excluded. The research was conducted in keeping with usual research governance guidance and local approvals were gained at each site. Data were collected between July 2009 and March 2011.. The quality of each unit was assessed using the QuIRC,5,6 a web-based toolkit, completed by service managers (available at, which reports on seven domains of care in longer-term units for people with complex mental health problems (Living Environment; Therapeutic Environment; Treatments and Interventions; Self-Management and Autonomy; Social Inclusion; Human Rights; ...
Professor Jackie Campbell is an academic hybrid, initially qualifying as a physicist before working as a researcher into the processes of pain and pain relief at the Walton Hospital in Liverpool, which also confirmed her belief in multi-disciplinary working. She has worked in the healthcare sector of higher education since 1987 and is currently the part-time Professor of Neurophysiology at the University of Northampton and Chair of the Regional Advisory Board of the NIHR East Midlands Research Design Service. She is a chartered statistician and also runs her own statistical and research consultancy business. She has considerable experience in the design, management and data analysis of research and evaluation projects, particularly in the public and voluntary sectors. She has served as the statistician member of an NHS Research Ethics Committee and teaches statistics and research methods to doctoral level. She is a reviewer for many major funding bodies and academic journals, including ...
The study was approved by a Research Ethics Committee and received authorisation from the Medicines and Healthcare Products Regulatory Authority. Patients received verbal and written information prior to consenting to the trial and had the time to consider their participation and opportunity to ask questions. Patient data and samples were anonymised so that their information was kept confidential ...
We aimed to Evaluate the influc in the male street population in the central region of São Paulo. The study consisted of an exploratory, transversal and quantitative field study with data collection through questionnaires with open and closed questions in the regions of the Center of São Paulo, evaluating the socio-demographic profile and the presence of RF for SAH, with random sampling by conglomerate in 96 men aged 20 to 60 years, performed in the years of 2013 to 2017. The project was presented and approved by the Research Ethics Committee, in compliance with resolution 196/96 of the National Health Council (CNS). The volunteers were submitted to a semi structured interview with questions directed to identify the interference of the emotional factors in the HA. Among the 96 men interviewed, 67 reported some value between 1 and 10 on the Psychological Stress Levels scale and 29 did not know how to report, suggesting that the male population suffers from some degree of stress due to their ...
Ian D Boardley has completed PhD, Currently working as an Lecturer in Sports Psycology and Education, And also Chair of School Research Ethics Committee at the Univers..
The University of Sharjah is a comprehensive academic institution with a distinctive learning style and a global vision. It is a pioneer in academia, scientific research and the arts in the UAE and the GCC region. All programs are accredited by the UAE Ministry of Higher Education and Scientific Research. The University of Sharjah (UoS) has 14 colleges and offers 86 programs at the bachelors, masters, doctoral and diplomas levels.
In other words, if you are interacting (communicating or observing) or intervening (administering a procedure, changing the environment, etc.) with humans to obtain data about them for research purposes, then you must submit the project is human subject research and should be submitted to the IRB.. Likewise, if you are obtaining for research purposes private information that is identifiable to the individual about whom it pertains, then you must submit the project is human subject research and should be submitted to the IRB.. Human Subject as defined by FDA:. An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.. If you think that your project is indeed research involving human subjects or a clinical investigation, you should submit your project to the IRB. The IRB will conduct a preliminary review ...
NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 23, Number 38, October 28, 1994 P.T. 42 Keywords: Human Subjects Policy National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes: DATES: December 8-9, 1994 LOCATION Seven Hills Center San Francisco State University San Francisco, CA SPONSORS San Francisco State University, San Francisco, CA California State University, ...
Research Regulatory Committees An Overview of the Institutional Review Board (IRB) Presented by Rowan University Foundation / University Advancement and Office of Sponsored Programs April 22, 2014 OFFICE OF RESEARCH ROWAN UNIVERSITY Provide assistance and guidance to investigators to ensure ethical conduct and compliance in performance of research in the following areas:  Human subjects protection  Animal care and use  Use of hazardous agents, radioactive materials and recombinant DNA material  Responsible conduct of research (Ethics and Integrity) IRB Organization Structure  MANAGEMENT: Institutional official and IRB director  GOALS:    Centralized single Human Subjects Protections Administrator (HSPA) for both institutions Centralized compliance office for all regulated research Management of institutions sponsored programs are maintained directed by Vice President for Research Human Subject Protection Program Mission and Services  To protect the rights, ...
Investigational VariZIG is produced by Cangene Corporation (Winnipeg, Canada) and is distributed by FFF Enterprises (Temecula, California). An expanded access protocol under the IND application enables use of investigational VariZIG for patients who meet the protocols enrollment criteria and who choose to participate. The expanded access protocol has received central institutional review board (IRB) approval. With this central IRB review and approval, FDA does not require an additional approval by the IRB at the treatment site. However, some institutions might require that the institutions IRB be notified before the institution or its physicians participate in a study reviewed by a central IRB. In such cases, notification and any local IRB review may take place before a patient who needs the investigational product is identified. However, if a patient who needs the investigational product is identified before any required local IRB review has taken place, the investigational product may be ...
We used health administrative data from 2 Canadian provinces (Ontario and Alberta) and the Brigham and Womens Hospital in Boston. All data were linked and analyzed anonymously. The study was approved by the research ethics board at each study site (Sunnybrook and Womens College Health Sciences Centre Research Ethics Board, the University of Alberta Health Research Ethics Board and the Partners Human Research Committee).. All health care activities in Ontario and Alberta are publicly funded and are captured in population-based administrative datasets. These datasets include the Discharge Abstract Database, which captures all hospital admissions and, in the years we sampled, used diagnostic codes from the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10); the Registered Persons Database, which captures each persons date of death (including deaths that occur out of province); and the National Ambulatory Care Reporting System, which captures ...
We studied 367 healthy schoolchildren (193 girls and 174 boys) aged 6-15 years. Children participating in this study were recruited from inner city schools in Manchester and Sheffield. Ethical approval for the study was obtained from the Manchester and Sheffield medical research ethics committees. Written informed consent was obtained from the parents and verbal consent from the children. Any child who had a chronic medical disorder or who was taking drugs known to affect the BMD was excluded.. Height was measured to the nearest millimetre using a wall mounted height measuring tape (Raven Equipment, Great Dunmow, Essex). Each child was weighed to the nearest 0.5 kg while wearing their school uniform without shoes or socks. Pubertal assessment was not allowed by the medical research ethics committees.. The BUA (dB/MHz), which reflects the frequency dependence of ultrasound attenuation in the frequency range 200-600 kHz, was measured in triplicate at the left calcaneum of the subjects using the ...
To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications.; Cohort of protocols of randomised controlled trial and subsequent full journal publications.; Six research ethics committees in Switzerland, Germany, and Canada.; 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications.; Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal ...
All investigators (faculty, staff, and students) conducting research that involves human subjects must complete the necessary training prior to submitting their IRB proposals. Ideally this should occur prior to preparing your application as it will provide useful information that can inform the design of your research study. CITI Programs Human Subjects Research (HSR) series covers the historical development of human subject protections, as well as current information on regulatory and ethical issues. It consists of a series of modules.. Beginning 9/1/16, all new IRB applications will require CITI training of all investigators conducting research that involves human subjects. This includes faculty researchers, student researchers, and faculty mentoring both undergraduate and graduate student research projects.. Anyone that has an NIH Certificate of Completion for the Protecting Human Research Participants Training Module issued prior to 9/1/16 can continue to use this as proof of training ...
The Autoimmunity Bible & Norton Protocol Review This page is about The Autoimmunity Bible & Norton Protocol Review. Do you already know the The Autoimmunit
1. WHO Global Health Resources: 2. WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with Participants: 3. Implementation: Capacity Building through the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER): · What is SIDCER? Supports implementing the WHO Operational Guidelines for IRB/RECs around the world, and assessing those operational standards. Accredits RECs.. · · Network of Regional Partner Fora:. · Forum for Ethics Committees in the Confederation of Independent States (FECCIS). · Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP). · Foro Latino Americano de Comités de Ética en Investigacion en Salud (FLACEIS). · Pan-African Bioethics Initiative (PABIN). The Research Ethics Committee Assessment Toolkit ...
a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the ...
Based on the current knowledge, the investigators hypothesized that most children with milk allergy in Israel would be able to ingest baked milk products daily, thus benefiting from improved nutrition and dietary variety and protect them from accidental exposure to milk-containing products.. Objective: The aim of our study is to examine the outcome of cows milk allergic patients who incorporated baked milk products into their diets. In order to recruit a large population, a multicenter study across many hospital related allergy clinics in Israel will be conducted.. Methods. Participants The study protocol is essentially as described previously (12). Subjects will be recruited from the relevant allergy clinics involved in this project. The study will be approved by the local Institutional Review Board, and informed consent will be obtained.. Eligible subjects will be aged 1 to 18 years, had positive skin prick test (SPT) responses or detectable serum milk-specific IgE, and had a history of an ...
Objectives: To use multi-parametric magnetic resonance imaging (MRI) to test the hypothesis that hypertensives would have higher retrograde venous blood flow (RVBF) in the internal jugular veins (IJV) vs. normotensives, and that this would inversely correlate with arterial inflow and gray matter, white matter, and cerebrospinal fluid volumes. Methods: Following local institutional review board approval and written consent, a prospective observational 3-T MRI study of 42 hypertensive patients (53 ± 2 years, BMI 28.2 ± 0.6 kg/m2, ambulatory daytime systolic BP 148 ± 2 mmHg, ambulatory daytime diastolic BP 101 ± 2 mmHg) and 35 normotensive patients (48 ± 2 years, BMI 25.2 ± 0.8 kg/m2, ambulatory daytime systolic BP 119 ± 3 mmHg, ambulatory daytime diastolic BP 90 ± 2 mmHg) was performed. Phase contrast imaging calculated percentage retrograde venous blood flow (%RVBF), brain segmentation estimated regional brain volumes from 3D T1-weighted images, and pseudo-continuous arterial spin ...
Basic biomedical research and clinical trials have been the means of understanding disease and discovery of effective treatments. While research science is portrayed as an objective, empirical field, it too is confronted with specific ethical issues and dilemmas. Yet medical and scientific research at times in its history has not always reflected a genuine concern for the principled research and particularly a commitment to the protection of human subjects. Building on such foundation documents as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, modern research ethics emphasizes the importance of human subjects research protections in the an increasingly complex research environment spanning all areas of biomedical and biotechnological research and beyond, as well as the increasingly international and global nature of such research endeavors. Relevant issues to research ethics include among others: global and national governance, privacy, scientific integrity, ...
Preamble:. Simon Fraser University is committed to ensuring the highest level of ethical conduct for research involving human participants and to following the guidelines outlined in the Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, (the TCPS-2).. University researchers enjoy special freedoms and privileges, which include freedom of inquiry and the right to disseminate the results thereof, freedom to challenge conventional thoughts, freedom from institutional censorship, and the privilege of conducting research on human participants with the trust and support of the general public, often with public funding. With these freedoms come responsibilities to ensure that research involving human subjects meets high scholarly and ethical standards, is honest and thoughtful inquiry, involves rigorous analysis and complies with professional and disciplinary standards for the protection of privacy and for methodological approaches. Review of research proposals by a Research ...
At the present time, the primary service provided is consultation on ethical considerations in designing and implementing IIMS clinical and translational research projects. This consultation is provided in conjunction with the Design and Biostatistics Group. Service requests and customer communications will occur through the IIMS SPOC. This service is provided at no cost to the IIMS K-12 trainees. Charge-back fees for other IIMS investigators will be incorporated into the charge-back structure for parallel services provided by the Design and Biostatistics Group.. Future services will include: 1) access to one or more on-line research ethics courses that complement the CITI course required of all researchers and 2) cross-cultural adaptation of English research instruments for use with Mexican American subjects who speak only Spanish or almost exclusively Spanish. On-line research ethics courses will be developed over the next 2-3 years. These will be available at no charge to IIMS-affiliated ...
BACKGROUND: Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants in Lebanon? METHODS: This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon ...
All health research, as defined by the National Health Act, must be reviewed and approved by a research ethics committee registered with the National Health Research Ethics Council. Thus all health-related research involving: ...
Todays blog posting isnt purely about research ethics but bear with me. I read today in the American Medical News how enthusiastic the bioethics and health care community are with the creation of ethics check lists for physicians and health care professionals to use, to help avoid ethical dilemmas in acute care settings like the…
The study was approved by the Western Sydney Local Health District Human Research Ethics Committee (WSLHD HREC) as a low and negligible risk project (reference number: LNR/17/WMEAD/568). The WSLHD HREC is accredited by the New South Wales Ministry of Health to provide ethical and scientific review to conduct research within the NSW public health system. The study operates in accordance with the National Health and Medical Research Councils National Statement on Ethical Conduct in Human Research and the CPMP/ ICH Note for guidance on Good Clinical Practice and the International guidelines for observational studies. ...
Overview of Human Subject Protections in Côte-dIvoire Governing Agencies and Ethics Review Structure Ministry of Health (French) National Committee on Ethics and Research Useful Documents Essential Medicines and Health Products Information Local Research Institutions Hôpital Triechville (Abidjan). ...
The Medical Sciences IDREC (MS IDREC) utilise a number of CUREC Approved Procedures, which are essentially documents approved by CUREC for how to approach certain types of study or intervention. The main function of such Procedures is to reduce the need for researchers to apply for ethical review using a full CUREC 2 application form. By agreeing to conduct research within the scope of a CUREC-approved procedure, researchers may apply for ethical review and approval using the process for lower-risk research. The Central University Research Ethics Committee (CUREC) has recently approved revisions to several Approved Procedures (see If you are a researcher who utilises any of the above CUREC Approved Procedures as part of an ethically-approved project, it is important that you read the new document to ensure you can still meet with requirements. In particular, your attention is drawn to the following changes: Approved ...
Perhaps Hwang and his team are a bit reluctant because they already know beforehand that it is physically and scientifically impossible that these stem cells from cloned human embryos really match the patients into whom they were injected? What about addressing the other ethical requirements of the Declaration of Helsinki and the Nuremberg Code - e.g., the fact that patients should understand that the research being performed is not standard medical care, that the good of the patient involved outweighs that of society or science, that patients must give ethically and legally valid informed consent to participate, as well as various other ethical obligations of others directly complicit in this research. One wonders why the international press doesnt include some of these international research ethics requirements in their investigative reporting.
Achieve has a vast database of FDA-inspected Institutional Review Boards, providing quick and unrestricted approvals, adherence to regulations and the protection of patient rights. This database of IRBs is maintained along with our central IRB. Some of the IRBs with which Achieve has worked include:. ...
Ethical approval for the substantive extension phase was provided by the Preston Research Ethics Committee North West (15/NW/0590). Cost Of Cymbalta 60 Mg Without Insurance 2019 The Frontier Post , Daily English News Paper - of metoprolol seroquel and anemia viagra for raynauds can i take lisinopril and ibuprofen how much is 60mg prednisone 60 mg cost cymbalta allopurinol price us side pain nizoral Cymbalta generic cost - MedHelp - Health community, … - He said…. If the etiology of hf at rest Free Worldwide Shipping. Very cheap pills online, Secure and Anonymous. You need to start to consider Clomid on the fifth evening of one menstrual cycle within 5 days Clomid for sale. Op vind je alle deelnemende winkels in één overzicht.. Makkelijk te gebruiken. Measuring fundal appearances may. Within a few weeks, accutane treatment cost I could see improvements in the symptoms. Co-ordinated multidisciplinary specialist use walmart viagra 100mg price is in the buy viagra keep ...
Analyses were carried out on data from Quebecs longitudinal study of child development (QLSCD 1998-2002) conducted by Santé Québec, a division of the Institut de la statistique du Québec (ISQ) when children were aged on average 29 months (27 to 31 months). This study annually tracks a representative sample of Quebec children. The initial sample was recruited from the Quebec birth registry when babies were about 5 months old and is representative of singleton births in Quebec in 1997-1998, excluding babies born to mothers living in Northern Quebec, in Cree and Inuit territories as well as on First Nations reservations (2%).38 All singleton births in the included territories were eligible except births of unknown gestational age and premature babies born before 24 gestational weeks.. The research was approved by the human research ethics committee of the Faculty of Medicine of Université de Montréal. Two data sources were used: data on neonatal health problems, weight and height measurements ...
The Australian Defence Human Research Ethics Committee (ADHREC) minutes reported by The Australian and The Sydney Morning Herald this morning provide further damning evidence of the extensive harm caused to Australian soldiers by the unethical drug trials conducted by the Army Malaria Institute (AMI) in Timor Leste in 2000-2002, and the ADFs 15-year long attempted cover-up. During my…
This is a review paper by Dr Jane Quinn from Charles Sturt University on the 1998-2014 (inclusive) Australian Defence Human Research Ethics Committee (ADHREC) annual reports relating to trials of antimalarial drugs and vaccines for tropical diseases. The paper provides an excellent summary of which drugs and vaccines were trialled by the Australian Defence Force,…
An Institutional Review Board (IRB) is a federally mandated committee composed of scientists, clinicians, non-scientists and non-affiliated community representatives charged with overseeing all research projects involving human volunteers to protect the rights and welfare of the volunteers, certifying that the research is conducted according to the highest scientific and ethical standards.
April Hendrickson is a Program Evaluation and Research Associate with WICHEs Mental Health Program. Ms. Hendrickson works with states throughout the West to evaluate and improve mental health and substance use/abuse services. Her expertise includes designing and executing program evaluation plans, principles of effective prevention programs, managing and analyzing data, report writing, and providing evaluation technical assistance and training to clients. Prior to joining WICHE, Ms. Hendrickson was a Researcher at OMNI Institute, a nonprofit social science research organization in Denver, CO. While with OMNI, Ms. Hendrickson led a broad range of evaluations and collaborated with numerous non-profits, foundations, organizations, and government agencies on a variety of projects. She also led the Online Survey Committee and Data Management Committee and served on the Spanish Committee, Data Dashboard Committee, and Research Ethics Committee. Prior to OMNI, Ms. Hendrickson worked for the ISA Group, ...
Professor Deborah Black joined the Faculty of Health Sciences in August 2008. She was appointed to the Chair in Health Data Management in 2009 and took over the position as Associate Dean, Staff Development in August, 2009. She has more than 35 years experience as an applied statistician and is a statistical reviewer for local and international journals. For last 20 years, Deborah has worked as an academic with her teaching and research concentrating on biostatistics and applying statistical models to clinical and health policy issues. She is a member of the NSW Population & Health Services Research Ethics Committee has been jointly convened by the Cancer Institute NSW and NSW Health, a member of the review panel for the 45 and Up Study and the statistical advisor for the Scientific Review Panel for Northern Hospital Network, NSW Health. She is a recognised expert in the application and analysis of large health data sets to identify public health priorities and the impact of health ...
A double-blind randomised controlled trial was conducted. The primary outcome was pain score measured on a 100-mm visual analogue scale (VAS), where 0 mm represented no pain and 100 mm represented worst pain. The sample size calculation in this trial was identical to one used in a previous trial on ropivacaine instillation following laparoscopic sterilisation3 where pain scores were assessed by a similar VAS. Assuming a SD of 17 mm, a total of 74 women were required (37 in each group) in order to provide 80% power at the 5% level of significance in terms of detecting a difference of 13-mm difference in pain scores on a 100-mm VAS. Allowing for a 10% loss to follow up, we aimed to recruit 85 women. Ethics approval was obtained from the Grampian Research Ethics Committee. Women listed for diagnostic L & D test as a part of their fertility investigations from September 2002 to May 2005 were invited to participate in the trial. Women with a known allergy to amide local anaesthetic agents ...
Cell culture. One well-differentiated nasopharyngeal carcinoma cell line (CNE-1), three poorly differentiated nasopharyngeal carcinoma cell lines (CNE-2, C666, and SUNE-1), and two SUNE-1 subclones (6-10B and 5-8F) were maintained in our laboratory. These four nasopharyngeal carcinoma cell lines and two subclones of SUNE-1 were cultured in DMEM supplemented with 10% fetal bovine serum. Primary cultures of NPECs were established as described previously ( 23). Briefly, fresh biopsies of the nasopharynx, which were pathologically exclusive of nasopharyngeal carcinoma, were collected from the Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University, Guangdong, China, and each sample was divided into two parts. One part was directly cultured for the primary epithelial cells. The other part was fixed in formaldehyde and embedded in paraffin. Prior consent of the patients and approval from the research ethics committee were obtained for the use of these surgical materials. To ...
MAZZO, Alessandra et al. Urinary catheterization delay: clinical practice. Enferm. glob. [online]. 2015, vol.14, n.38, pp.50-59. ISSN 1695-6141.. Objective: Verify how the urinary catheterization delay procedure has taken place in clinical nursing practice. Method: Observational, exploratory and descriptive study, undertaken at hospitals in an interior city in the State of São Paulo, Brazil. The ethical premises were complied with (Opinion 233/2008 University of São Paulo at Ribeirão Preto College of Nursing Research Ethics Committee). The data were collected through an interview, using a semi structured script. Nine out of 13 institutions in the city participated in the study. Results: At the participating institutions, the procedure is performed ritualistically in terms of method and materials. Conclusion: To practice urinary catheterization delay, greater professional commitment and further investments in research are needed to clarify aspects that cannot be proven yet.. Palabras clave : ...
Micronutrient deficiencies, in HIV/AIDS infected children, are common and associated with disease progression and increased mortality. There is no evidence to support specific recommendation for in-patient treatment of severely malnourished HIV/AID infected children. We analyzed the impact of daily oral multivitamin and mineral supplementation on nutritional status and on mortality rate, of severely malnourished HIV/AIDS infected infants, hospitalized in a feeding therapeutic center. Children were randomized at admission in one of the two treatment groups: WHO standard group or additional dose group. The trial has been approved by the national health research ethics committee. Case fatality rate was high in each group. There was no difference in mortality rate between WHO standard group (mortality rate = 16.9%) and
Do you have a child with asthma?. Would you like to help us find out whether you can manage your childs asthma and behaviour better by taking part in an oniline research study? Researchers at the University of Manchester and Queensland, Australia are currently conducting research to evaluate a parenting intervention specially designed to help parents of children with asthma. We are looking for parents of children with asthma aged 2-8 years without a significant learning or physical disability to take part in our study.. If you would like more information about taking part on-line please visit our website or text your name and address to 07583 756780 if you would prefer to take part by post.. This project has been approved by the University of Manchester School of Psychological Sciences Research Ethics Committee.. This post was approved by Peter Waite (website founder/owner) on 16/07/10 ...
Members of the cohort were born during the week 3-9 March 1958.5 Between 1999 and 2000, 96 cohort members reported having diabetes (controlled by diet or tablets). We excluded participants with other types of diabetes (n=100).. Of the 11 276 participants contacted at age 41 years, 3777 mothers and 4364 fathers gave information on the birth characteristics for at least one (range 1-9) singleton liveborn child. A total of 34 men with diabetes had had children, and 24 women had become diabetic after childbirth. We used random effects models on birth weight (adjusted for gestational age) to allow for dependence between a parents subsequent births. North Thames Multicentre Research Ethics Committee approved the 41 year survey.. The offspring of the fathers with diabetes weighed on average less by a difference of −186 g (95% confidence interval −330 g to −44 g) than other children (figure). Fathers adult height or social class did not explain the association between a fathers diabetes and the ...
BACKGROUND Diabetic retinopathy (DR) is the major cause of blindness among working age adults. The aim of the study was to investigate risk factors for development of DR. METHODS A case-control study was performed based on data from 240 individuals (80 cases and 160 controls) attending the Outpatient Specialty Clinic of the University of South Santa Catarina (UNISUL), between Mar/2010 and May/2014. Data collection occurred through review of medical charts for presence or absence of DR, determined by an ophthalmologist. Study protocol included demographic characteristics, metabolic control, diabetes mellitus (DM) profile and comorbidities. Statistical analysis used Chi square test for qualitative variables and multivariate logistic regression analysis to select independent variables (SPSS®18.0 software). Odds ratio (OR) was used as measure of association. The study was approved by research ethics committee of UNISUL. RESULTS Mean age of group case was 59.5 years with a slight female predominance.
JHSPH and Johns Hopkins University School of Medicine have in place a reciprocity agreement to eliminate redundant reviews when JHSPH and JHSOM faculty collaborate. The PI of such projects should submit the research application to the IRB associated with his/her primary appointment.. JHSPH and WIRB have in place a contract which permits WIRB to serve as our IRB of record for review of some clinical trials. The cost of this review is available on the WIRB website.. JHSPH and the Baltimore City Health Department have in place an agreement which permits the JHSPH to serve as the IRB of record for JHSPH/BCHD collaborative studies taking place in BCHD sites. Once the JHSPH IRB approves the study, the BCHD official responsible for research must review the study before it may proceed.. IRB Authorization Agreements, through which the JHSPH IRB may defer its IRB review responsibilities to the IRB of a collaborating institution, or vice versa, may be appropriate in certain circumstances. Direct all ...
BACKGROUND:. Growth impairment is common in infants and children with congenital heart disease, most often in the presence of congestive heart failure and/or cyanosis. Growth failure is noted in many infants with a single ventricle who manifest both cyanosis and heart failure that commonly persist after palliative surgery. Whether this impairment is related to persistent or progressive abnormalities in cardiac structure and function is not known. ACE-Is are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth. The ability of an ACE-I to improve somatic growth in infants with a single ventricle has not been previously studied.. This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers:. Hospital for Sick Children, Toronto, Canada. Childrens Hospital Boston, Boston, MA. Columbia College of Physicians and Surgeons, New York, NY. Childrens Hospital of ...
Its been more than a year since the HIPAA privacy rule went into effect and everyone from Institutional Review Board (IRB) members to subject recruiters have felt its effects. The rule initially dragged down the pace of research as organizations learned how to navigate the changes it brought.
Ethics 1: The development of research ethics guidelines. In 1932, the Tuskegee Clinic in the United States began possibly its most infamous research study on human beings. This blind study aimed to collect data on the side effects of syphilis in African-American men. None of the participants enrolled in the study were told what the…
The composition is intended to reflect the diversity of research activity within the SHS. Members are asked to join on the basis of an interest in research ethics and a desire to contribute. Each research centre within the school also sends a delegate, those who lead the proportionate review streams are also required to attend.. The composition of the SHS REC includes a Chair and two Deputy Chairs and up to 8 other academics from the school. There are also two external members, and two ex-officio members: the Information Assurance Officer and the Secretary to Senate REC, both from City, University of London. At present there is no student member nor a lay external member.. The SHS REC is supported by the Research Governance Officer within the School.. From 1st September 2017 the tenure on the committee will be as follows:. Chair & Deputy Chairs: up to 5 years with one reappointment, (total of 10 years) thereafter they must step down for a year. Appointed by the Associate Dean for ...
July 21, 2001 Michael A. Carome, M.D. Director, Division of Compliance Oversight Office for Human Research Protections 6100 Executive Boulevard, Suite 3B01 National Institutes of Health (MSC 7507) Rockville, Maryland 20852-7507 RE: Human Subjects Protections under Multiple Project Assurance (MPA)...
The School of Arts & Letters is responsible only for awarding Intrepid funds in the amounts designated by the school to successful candidates. Students must date and sign the Intrepid contract before any funds are disbursed. Arts & Letters will not provide funding beyond the original amount. Students are responsible for meeting costs that exceed the funding allowance. Students assume all responsibilities and risks associated with projects. Students are responsible for gaining Institutional Review Board (IRB) approval if the project involves human or animal subjects. Evidence of IRB approval for the project is necessary for Intrepid funding to be released. Student responsibility and accountability to complete the proposed project: Intrepid awardees must submit the tangible results--such as a research paper, book, organization, video, research poster, painting, song, sculpture, performance, etc.--of their projects to the faculty advisor and School of Arts & Letters (either the Dean or Associate ...
Celeste has been working as a Clinical Research Manager for more than 5 years. She has become familiar with all the intricate aspects of conducting Phase 1, 2 and 3 clinical trials, including how to interpret and communicate the technical details of a clinical trial to patients, and how to assure compliance to federal, state and institutional regulatory requirements governing the conduct of clinical research, and how to navigate Institutional Review Board (IRB) approval. She is also is involved in the development, implementation, and analysis of our robust and extensive clinical research program. Celeste plays a pivotal role in working with patients to obtain informed consent, and being accessible to all patients on clinical trials. She has also played a pivotal role in many clinical trials leading to regulatory approval of new drugs by the U.S. Food and Drug Administration (FDA) for the treatment of lymphoma. She participates in routine audits for data quality, regulatory compliance and patient ...
Free Online Library: Ethics committees: from ethical comfort to ethical cover. (column) by The Hastings Center Report; Health, general Biological sciences Evaluation Medical ethics Analysis Medical law Ethical aspects
Ethics Committee Information on IEEEs Technology Navigator. Start your Research Here! Ethics Committee-related Conferences, Publications, and Organizations.
The Institutional Review Board (IRB) is responsible for assuring the ethical protection of the rights and welfare of human subjects from research risks. The IRB assures that all human research conducted under the auspices of QBRI are ethically and methodologically sound as required under public law and, most importantly, as expected by the public trust. The IRB is a highly professional committee that reviews and approves human research protocols of various disciplines and all related processes and documents to ensure that the rights and welfare of human subjects are protected above all other considerations. The IRB has the authority to approve, require modifications, or disapprove all research activities that fall within their jurisdiction in conformity with all ethical foundations for the Protection of human subjects. The IRB functions independently, so as to protect its ethical mission without compromise and without any perception of conflict of interest or undue influence of power. QBRI ...
Aspirus Network serves people through Aspirus Wausau Hospital, more than 30 primary and specialty clinics, an affiliated hospital and physician network, and regional home health and hospice services.
House Speaker Nancy Pelosi (D-CA) says she was a little surprised that the House Ethics Committee admonished House Ways and Means Committee Chairman Charlie Rangel (D-NY) for accepting trips to the Carribean, even though he didnt know the travel was paid for by outside groups.

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Research ethics committees. BMJ 1990; 300 doi: (Published 03 March 1990) Cite this ...
Ethics committee structure. The Arts and Humanities Ethics Committee is a sub-committee of the University Ethics Committee. ... To report annually to the University Ethics Committee on the business undertaken by the committee, providing a statistical ... and to refer cases that raise substantive issues to the University Ethics Committee, as appropriate ... Humanities Research Centre. Berrick Saul Building, University of York, Heslington, York, YO10 5DD, UK Tel: work 01904 328097 , ...
... a week of intensive training in critical thinking would be the best preparation for members of research ethics committees ... 2 Victorian Infectious Diseases Service and Centre for Clinical Research Excellence in Infectious Diseases, Royal Melbourne ...
The Human Research Ethics Committee of Cancer Council Victoria ensures participants in our research are not harmed physically, ... Human Research Ethics Our research ethics committees review cancer research projects to ensure ethical standards are met and ... Membership of the Human Research and Ethics Committee. Dr Alice Owen: BSc (Hons), PhD. Chair ... Fund a specific type of cancer research and earn a research award. ...
Research ethics committees have the power to enforce publication of drug trial results BMJ 2013; 346 :f1201 ... It seems to me that research ethics committees (RECs) have much more power than medical journals to enforce a higher ... Research ethics committees have the power to enforce publication of drug trial results ... Research ethics committees have the power to enforce publication of drug trial results ...
Ethics, Regulation & Public Involvement Committee (ERPIC). The Ethics, Regulation and Public Involvement Committee provides the ... The Ethics, Regulation and Public Involvement Committee meets twice a year, and reports formally to Council once a year. ... To maintain an overview of published MRC ethics guidance on the conduct of research that involves human participants or animals ... To advise Council on policy concerning the conduct of research involving human participants (including personal information and ...
Research Ethics Committee (REC). The Research Ethics Committee (REC) was first established in 2001 to promote ethical research ... except where such research has been or will be assessed by a research ethics committee from within recognised hospitals and the ... The Committee is required to review funded and non-funded research projects and any other research activity for which ethical ... It may also undertake research on matters pertaining to ethics at the request of the UCD Governing Authority, the Academic ...
The goal of our review is to ensure that guidance about research involving Aboriginal and Torres Strait Islander peoples ... NHMRC established the Indigenous Research Ethics Guidelines Review Working Committee to undertake the review of the Values and ... Expertise: Institution-based Human Research Ethics Committee representative with Aboriginal and Torres Strait Islander research ... Research Ethics Guidelines Review Working Committee to undertake the review of the Values and Ethics and Keeping Research on ...
The Hastings Center is the worlds first bioethics research institute. It is a nonpartisan, nonprofit organization of research ... IRB: ETHICS & HUMAN RESEARCH. Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs. By Aminu A. ... Database of Registered Health Research Ethics Committees. ... ethics committees of the U.S. Office for Human Research Protections (OHRP) and the Nigeria National Health Research Ethics ...
Federal Ministry of Health" (PDF). National Health Research Ethics Committee. 2007. "National Code for Health Research Ethics. ... The National Health Research Ethics Committee of Nigeria (NHREC) is a national body advising the Nigerian Federal Ministry of ... It is also tasked with the registration and auditing of Nigerian health research ethics committees. As of 12 August 2014, the ... "NHREC Statement on Ebola Care". Nigerian National Health Research Ethics Committee. 9 August 2014. Retrieved 12 August 2014. " ...
It is a pioneer in academia, scientific research and the arts in the UAE and the GCC region. All programs are accredited by the ... UAE Ministry of Higher Education and Scientific Research. The University of Sharjah (UoS) has 14 colleges and offers 86 ... The University Research Ethics Committee (REC) was formed on the 29th Nov 2015 based on the Chancellors Decision No. (86) for ... Research projects already approved by committees outside the University of Sharjah. Prior reviews and approvals of research ...
... Dranseika, Vilius; Gefenas, Eugenijus; Cekanauskaite, ... TWENTY YEARS OF HUMAN RESEARCH ETHICS COMMITTEES IN THE BALTIC STATES.}, url = { ... Medical Ethics. in Developing World Bioethics. volume. 11. pages. 48 - 54. publisher. Wiley-Blackwell. external identifiers. * ... Medical Ethics publishing date. 2011. type. Contribution to journal publication status. published. subject. * ...
Plastic and Aesthetic Research is an open-access, peer-reviewed, continuously online published journal launched in June 2014. ... social ethics, and other medical disciplines associated with the postoperative complications of plastic surgery, etc. ISSN:. ...
Yet our 2015 survey of the paediatric workforce demonstrated that very few paediatricians have time allocated for research- ... Clinical research involving children is essential if we are to increase our understanding of childhood conditions and improve ... Protection of time for paediatricians to take part in Research Ethics Committees Research & Evidence team ... we believe it is important for Research Ethics Committees to appoint member(s) with paediatric expertise and for their work to ...
... is one of the Health Research Authoritys core functions, committed to enabling and supporting ethical research in the NHS. It ... protects the rights, safety, dignity and wellbeing of research participants. ... The Research Ethics Service consists of: *Research Ethics Committees (RECs) in England reviewing health and social care ... The Governance Arrangements for Research Ethics Committees (GAfREC) describe what is expected from RECs when reviewing research ...
The Regional Ethics Committee moved on August 28, 2015 to be closer to the Regional Pharmacists Division at the General ... Regional Research Ethics Committee (CCER) The Regional Ethics Committee moved on August 28, 2015 to be closer to the Regional ... pain symposium obstetrics cancer gynecology training child rapport activité 2015 pregnancy research HUG team More ... to which the Committee has been legally attached since January 1, 2014. ...
The structure of ethics review: expert ethics committees and the challenge of voluntary research euthanasia ... The structure of ethics review: expert ethics committees and the challenge of voluntary research euthanasia ... Journal of Medical Ethics 2015; - Published Online First: 13 Nov 2015. doi: 10.1136/medethics-2015-102688 ... Copyright © 2018 by the BMJ Publishing Group Ltd & Institute of Medical Ethics. All rights reserved.. 京ICP备15042040号-3 ...
The structure of ethics review: expert ethics committees and the challenge of voluntary research euthanasia ... The structure of ethics review: expert ethics committees and the challenge of voluntary research euthanasia ... Copyright © 2018 by the BMJ Publishing Group Ltd & Institute of Medical Ethics. All rights reserved.. 京ICP备15042040号-3 ...
Public Consultation on the BACs Draft Ethics Guidelines for Human Biomedical Research The Bioethics Advisory Committee (BAC) ... Bioethics Advisory Committee seeks public feedback on Ethics Guidelines for Human Biomedical Research. ... Research Integrity. The integrity of the research process is of increasing importance given the competitiveness in research. ... i. Definition of Human Biomedical Research. "Human biomedical research refers to any research done for the ultimate purpose of ...
BUENO, Mariana et al. Reasons for resubmission of research projects to the research ethics committee of a University Hospital ... Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina ... INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order ... RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time ...
Given the wider context of the research, do human research ethics constitute a barrier to publication of this paper? ... If the study was conducted at a university, then there should be a university ethics committee. If the editor decides to ... Considering the importance of both ethics and IC, the ultimate goal of this study is to explore the relationship between them, ... The result of this research will be published by considering privacy issues. It is important to note that the organizations ...
Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee ...
... the Research Ethics Review Committee held its annual meeting from 22 to 23 October, 2017 at the WHO Regional Office for the ... with an essential function of reviewing protocols of health research projects involving human subjects submitted to WHO for ... Following the Regional Directors re-formulation of the Eastern Mediterranean Research Ethics Review Committee, ... identifying best modalities for linking the Research Ethics Review Committee with national committees; ...
This study reviews research ethics committee applications for COVID-19-related research at a Chinese hospital in February 2020 ... This study reviews research ethics committee applications for COVID-19-related research at a Chinese hospital in February 2020 ... 4 Clinical Research Guidance Center, Henan Provincial Peoples Hospital and the Peoples Hospital of Zhengzhou University, ... 1 Department of Scientific Research and Discipline Construction, Henan Provincial Peoples Hospital and the Peoples Hospital ...
... and the Oman National Bioethics Committee, Sultan Qaboos University, organized the first Regional Bioethics Summit for the ... Ethics & Research. 10 key points about research during the pandemic. Guidance for research ethics committees for rapid review ... generating evidence in humanitarian emergencies: ethics of research and research ethics oversight; ... applying research ethics and monitoring ongoing research; developing/enforcing bylaws/regulations for important society ethical ...
Medical and clinical research activities involving human subjects are being increasingly performed in the developing countries ... Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a ... Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a ... Moodley K, Myer L. Health research ethics committees in South Africa 12 years into democracy. BMC Med Ethics. 2007;8:1-8. ...
Research+Ethics+Committees:+How+They+compare&title=IRB:+A+Review+of+Human+Subjects+Research.+&volume=10&issue=5&pages=1988&date ... The Rise of Research Ethics Committees in Western Europe: Some Concomitant Problems  Bergkamp, Lucas (1989-04) ... Research Ethics Committees and the Regulation of Medical Experimentation With Human Beings in the Netherlands  Bergkamp, Lucas ... American IRBs and Dutch Research Ethics Committees: How They Compare. en. dc.provenance. Digital citation created by the ...
The Ethics Review Committee (WPRO-ERC) standard operating procedures  World Health Organization. Regional Office for the ... "Ethics Committee, Research". 0-9. A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T. U. V. W. X. Y. Z. * 0-9 ...
... their own research ethics committee should ensure that scientists make good faith efforts to get their research reviewed where ... Research ethics committees in developing countries: something old, something new February has been a rough month for bioethics ... Ethics committees are not detective agencies, who scour the community to find out who is doing research on what. Researchers ... In many developing countries, this is not straightforward: in some settings, research ethics committees may not exist; where ...
NSW Population and Health Services Research Ethics Committee. A joint initiative of the Cancer Institute NSW and NSW Ministry ... Data and research * Researchers can access NSW cancer data sources, ethics and grants for cancer research. Find clinical trials ... The NSW Population and Health Services Research Ethics Committee undertakes scientific and ethical review of population health ... through the National Health and Medical Research Council and is accredited in NSW as a lead Human Research Ethics Committee ( ...
  • 11 January 2018 - Following the Regional Director's re-formulation of the Eastern Mediterranean Research Ethics Review Committee, with an essential function of reviewing protocols of health research projects involving human subjects submitted to WHO for funding in the Region, the Research Ethics Review Committee held its annual meeting from 22 to 23 October, 2017 at the WHO Regional Office for the Eastern Mediterranean. (
  • As of September 2018, please ensure you apply for your ethical approval online as the SHS REC Committee will no longer be accepting paper applications. (
  • The University's human research ethics approval procedures are designed to ensure that all students and staff, as well as the institution, are meeting all obligations under the National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 and any other relevant legislation or guidelines. (
  • Research that relates to Indigenous peoples of Australia should be informed by Indigenous research ethics principles outlined in AIATSIS guidelines (GERAIS 2012) and the National Health and Medical Research Council (NHMRC) Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018) . (
  • This analysis provides a full national overview of genetic research dossiers pertaining to clinical and nonclinical trials, and to further-use research projects submitted for approval to ethics committees in Switzerland in 2018. (
  • All research dossiers approved by ethics committees in 2018 were screened for genetic investigations. (
  • 2 Victorian Infectious Diseases Service and Centre for Clinical Research Excellence in Infectious Diseases, Royal Melbourne Hospital, Parkville, VIC. (
  • The committee has been certified under the National Approach to Single Ethical Review process, administered through the National Health and Medical Research Council and is accredited in NSW as a lead Human Research Ethics Committee (HREC) for multi-centre ethical review processes for population health and/or public health research . (
  • He is the former Chief Executive Officer of Cancer Council Australia, head of the Royal Adelaide Hospital Cancer Centre, and a former Chair of the Medical Oncology Group of Australia and of Cancer Council Australia's Medical and Scientific Committee. (
  • He is a member of the Advisory Council for Cancer Australia (the Federal Government's cancer control agency) and the Board of the National Breast and Ovarian Cancer Centre, a number of grants and ethics committees and holds several honorary academic and clinical posts. (
  • Canada's International Development Research Centre, Global Affairs Canada and the Bill & Melinda Gates Foundation join forces under $57 million innovation fund. (
  • Canada's International Development Research Centre (IDRC) with support from the Bill & Melinda Gates Foundation and Global Affairs Canada (GAC), launched their Livestock Vaccine Innovation Fund (LVIF). (
  • To approve any projects involving human participants (who may be adults or children), human material (e.g. tissue or fluid samples), human data (e.g. surveys and questionnaires on issues such as lifestyle, housing and working environments, attitudes and preferences), animals or other organisms, following statutory procedures where these apply, and to refer complex or difficult cases to the University Ethics Committee, as appropriate. (
  • Our research ethics committees review cancer research projects to ensure ethical standards are met and that the confidentiality of participants' information is protected. (
  • The principal objective was, and still is, to promote the ethical use of human and animal subjects in research throughout UCD in accordance with internationally accepted ethical norms that focus on the rights and welfare of the study participants. (
  • 2 Some of these discussions have focused on the creation and application of both international and local guidelines, on codes of practice or laws on ethics of research, and on the role of national, local, and institutional research ethics committees (RECs) in the protection system for human research participants. (
  • He argues that the guidelines could help foster protection of the rights of research participants through the application of the informed-consent process in research studies, 12 and Caniza et al. (
  • The Judson College RERC's purpose is to ensure the ethical treatment of human participants in research. (
  • The RERC process may be most applicable to students and their faculty advisors who desire to complete Judson College Honors Program research in disciplines that might utilize human subject participants. (
  • Any other activity that involves observation of or interaction with participants to gather information for research. (
  • Conducting poor research means that research participants might be exposed to harm without any possible benefit to knowledge. (
  • It protects the rights, safety, dignity and wellbeing of research participants. (
  • We have a duty to provide an efficient and robust ethics review service that maximises UK competitiveness for health research and maximises the return from investment in the UK, while protecting participants and researchers. (
  • We have a dual mission to protect the rights, safety, dignity and well-being of research participants and to facilitate and promote ethical research that is of potential benefit to participants, science and society. (
  • The main purpose of these Guidelines is to present an accessible and consolidated ethics resource for biomedical researchers and members of ethics committees or institutional review boards (IRBs).The Guidelines are based on a review of the BAC's past recommendations, which aim to safeguard against unethical practices and to ensure the protection and assurance of the safety, health, dignity, welfare and privacy of research participants. (
  • The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon? (
  • To consider the ethical and legal implications of all research involving experiments, investigations and procedures involving human participants carried out in the School of Health Sciences, or under its auspices, that are not subject to direct oversight by Senate REC. (
  • The design of a research study is critical in determining whether the research achieves its proposed outcomes, benefiting participants and communities. (
  • Co-design, co-production [2] or participatory research designs [3] involve a mutually advantageous collaboration between researchers and participants who may also be the end-users of research discoveries. (
  • 9.6.a Researchers will find it helpful to establish a cooperative relationship with the ethics committee responsible for safeguarding participants' safety and welfare, and to make staged applications [4] . (
  • The major responsibility of ethics committee is to protect the rights, safety and well being of the research participants. (
  • Grinnell's Institutional Review Board oversees all college research involving human participants. (
  • We are committed to protecting research participants, upholding ethical standards, and improving our practice at every step of our work. (
  • This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. (
  • But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. (
  • T he purpose of the Research Ethics Committee: Social Behavioural and Education Research (REC: SBE) in reviewing research, is to contribute to safeguarding the dignity, rights, safety, and well-being of all actual or potential participants in social, behavioural, economic and education research conducted at Stellenbosch University. (
  • 1 The project leader is responsible for the conduct of the research project in Switzerland and for protection of the participants at the research site. (
  • Human Research Ethics Committees (HRECs) review all research proposals involving human participants to ensure that they are ethically acceptable. (
  • The ethics proposal must explain how the research will be conducted ethically and with minimal risks to participants. (
  • Human research ethics review processes are undertaken through either the Executive Review pathway or the Committee Review pathway depending on the nature of the project and its intended participants. (
  • The University has developed and implemented its Policy and Principles on the Ethical Approval of Research as it is concerned with the protection of the rights, dignity, health, safety, well-being and privacy of research participants, the welfare of animals and the protection of the environment. (
  • Prior to any research involving human participants, their tissue or data, the research must be reviewed by an appropriate ethics committee. (
  • The University has defined four different categories of human participants and this determines the most appropriate place for the ethical consideration of the research. (
  • ‌Non-clinical research which involves human participants comes within the remit of the Social Research Ethics Committee (SREC). (
  • They review disclosures from the board, board nominees, committee and initiative participants and makes recommendations to the board and enforces the OARSI Code of Ethics. (
  • Members draw on expertise in philosophy, the ethics of medical research, public health and social science research, clinical medical practice and nursing, disability, law, religion and health consumer issues. (
  • Researchers have important professional and regulatory responsibilities related to the the responsible conduct of research (RCR), which is broadly defined as the practice of scholarship and scientific investigation with integrity. (
  • 1 Despite the growth of medical ethics and publication of professional codes of practice 2 3 there is no clear consensus on how individuals, teams, and hospitals might obtain specific guidance in resolving the dilemmas they face. (
  • Co-design is considered best practice, for example, in research involving indigenous peoples in New Zealand, Australia and Canada. (
  • We use EABP congresses not only as fruitful meeting places for our members, but also to develop Body Psychotherapy theory, methods, research and clinical practice. (
  • The Center for Medicine after the Holocaust (CMATH) is dedicated to challenging doctors, nurses, and bioscientists to personally confront the medical ethics of the Holocaust and to apply that knowledge to contemporary practice and research. (
  • These are also informed by the UK Research Integrity Office's (UKRIO) Code of Practice for Research . (
  • It seems to me that research ethics committees (RECs) have much more power than medical journals to enforce a higher publication rate by drug companies. (
  • This study was undertaken to describe and benchmark the operational and organizational structures as well as functions of research ethics committees (RECs) in Nigeria. (
  • The article explores the factors that contribute to REC conformity with the Nigerian National Ethics Code and World Health Organization (WHO) guidelines for RECs. (
  • RECs with committee chairs who had prior bioethics training were more likely to have operations conforming to the WHO and the Nigerian ethics guidelines. (
  • Topics explored in these studies are varied and include descriptive studies on the structure and functions of RECs, 5 diversity in REC reviews, 6 multicenter ethics review, 7 and both descriptive and mode studies on evaluation of RECs. (
  • 13 Studies from Uganda and Nigeria describe processes for developing national research ethics guidelines, 14 while other studies have focused on RECs in Latin America, Europe, Southeast Asia, and Africa. (
  • The Governance Arrangements for Research Ethics Committees (GAfREC) describe what is expected from RECs when reviewing research proposals. (
  • However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. (
  • This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. (
  • Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. (
  • We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. (
  • Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. (
  • Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. (
  • Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. (
  • Specifically, little data are available regarding processes of ethics review, member composition, training of members, workload and resource needs of RECs, and challenges that RECs encounter in this region. (
  • Exceptions for faculty doing human subjects research with faculty/researchers outside of Judson College may be exempt from this requirement if the project has received approval from another Institutional Review Board. (
  • The researchers' experiences are appropriate for the research being applied for. (
  • It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. (
  • Among the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts about the terms used in the informed consent form as well as lack of information regarding the research at the informed consent form and methodological and statistical issues regarding the protocol. (
  • Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. (
  • The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. (
  • Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. (
  • The REGTRAC database is a worldwide resource for regulators, legislators, health researchers and the general public, and a tool for measuring the impact of the ICTRP project on clinical research transparency. (
  • Or journals should not publish articles in which researchers failed to get their research reviewed where it really is human subjects research, and there really is an adequate body that can appropriately assess its ethics. (
  • The authors rightly point out that if researchers from Nepal were to do a research study in the UK or USA, but only sought ethics approval for it in Nepal, and published it, this would be considered scandalous -- but when developed world institutions do the same in the developing world, there is far less concern, even when committee members do not know much more about Nepal than Everest expeditions. (
  • Researchers can access NSW cancer data sources, ethics and grants for cancer research. (
  • Our researchers are centrally involved in Bristol Neuroscience and Bristol CardioVascular , and form an integral component of the Elizabeth Blackwell Institute for Health Research . (
  • 9.1 Researchers must ensure that their study design is appropriate to answer the research question. (
  • 9.1.c In the case of international research, where a design has already been developed, New Zealand researchers should consider how they can adapt the local documentation for a New Zealand context. (
  • 9.2 Researchers must have the necessary skills and resources to undertake and design the research. (
  • It is therefore difficult for researchers to gain informed participant consent (and ethics committee approval) up front, as they would for traditional designs. (
  • 9.5 Researchers should be able to justify why the co-design approach is likely to maximise the impact and minimise the harms of the research, and should identify which of the study features are likely to be integral and stable components of the research, and which will subject to openness and co-creation with community partners. (
  • The Institute Ethics Committee (Human Studies) of JIPMER plays the vital role of guiding researchers in the ethical issues associated with their research. (
  • Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. (
  • A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. (
  • One approach to implementation research involves developing democratic partnerships between researchers and community stakeholders with a view to involving end-users in the design of research, promoting their understanding and capacity, and encouraging uptake of findings [ 5 ]. (
  • Given this year for the first time, this award went to two researchers: Dr. Jérémie Voix, a professor and researcher at the École de technologie supérieure (ÉTS), and Dr. Franck Sgard, a researcher at the Institut de recherche Robert-Sauvé en santé et sécurité du travail (IRSST) and associate professor at the ÉTS and the Université de Sherbrooke. (
  • When parental consent is obtained, the agreement of school age children who take part in research should also be requested by researchers. (
  • Clinicians and researchers from North Carolina State University and Duke University have developed a first-of-its-kind veterinary medical ethics committee to aid care providers in navigating these situations. (
  • All CDU researchers (employees, honorary appointees or visitors) and research students must obtain approval through the CDU HREC for research involving human subjects or their data, once the methodology of the research project, the oversight of its conduct, and the requirements of any third parties are fully understood. (
  • From the outset of a study, researchers must give consideration to potential conflicts of interest that may arise given the source of funding and the nature of the research project. (
  • In doing so, our researchers work to the highest standards and use the most relevant research models available. (
  • Researchers are required to submit research proposals to the Committee most relevant to their research methodology. (
  • This will among other things put a formal responsibility on higher education research institutions to ensure that researchers act according to national ethical standards. (
  • In addition to the researchers' duty of care, research institutions are obliged to contribute toward ensuring that all research at their institution takes place in accordance with recognised ethical standards. (
  • The Indigenous Research Ethics Guidelines Review Working Committee will be effective for the period 1 January 2015 to 31 December 2017. (
  • Ethical review of research projects on animals has been assigned a specialised committee as of the academic year 2016-2017. (
  • 10 April 2017 - The WHO Regional Office for the Eastern Mediterranean, in collaboration with the United Nations Organization for Education, Science and Culture (UNESCO) and the Oman National Bioethics Committee, Sultan Qaboos University, organized the first Regional Bioethics Summit for the Eastern Mediterranean/Arab States in Muscat, Oman, from 5 to 6 April 2017. (
  • Chair of Australian Institute of Aboriginal and Torres Strait Islander Studies Human Research Ethics Committee. (
  • Please inform RERC Chair if outside research is being conducted. (
  • To report to Senate REC annually on the research, experiments, investigations and procedures which have been allowed by the Committee through the Chair of the Committee. (
  • Professor Ingrid Winship is the inaugural Chair of Adult Clinical Genetics at the University of Melbourne and Executive Director of Research for Melbourne Health. (
  • The chair of the Board of Directors of the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), Manuelle Oudar, is pleased to announce that Marie Larue's contract as president and CEO has been renewed. (
  • R. Alta Charo, J.D. ( Co-Chair ), is a member of the National Academy of Medicine, and is the Warren P. Knowles Professor of Law and Bioethics and the Sheldon B. Lubar Distinguished Research Chair in Law at the University of Wisconsin-Madison, where she is on the faculties of the law and medical schools and teaches public health law, biotechnology regulation, and bioethics. (
  • Richard O. Hynes, Ph.D. ( Co-Chair ), is Daniel K. Ludwig Professor for Cancer Research at the Massachusetts Institute of Technology (MIT) and an investigator at the Howard Hughes Medical Institute. (
  • She is currently Chair of the Victorian Cooperative Oncology Group and a Member of the Victorian Cancer Action Plan Implementation Committee. (
  • Professor Winship is the Chair of NHMRC's Australian Health Ethics Committee. (
  • Jeanette has been the Chair for CHHS and CoM Research Ethics Committee since 2011 and a Board Member of the European Association of Centres of Clinical Ethics since 2011. (
  • It contains the Chair of the current CPC (Congress Planning Committee), organizers of the two last congresses and a future organizer. (
  • Human biomedical research refers to any research done for the ultimate purpose of studying, diagnosing, treating or preventing, any disease, injury or disorder of the human mind or body, and which entails the involvement of humans, human tissues or information derived from humans or human tissues. (
  • The ethics of medical research on humans / Claire Foster. (
  • All research projects in humans should get the approval of the ethics committee before starting their study. (
  • Biomedical research is conducted to improve the quality of life and health for both humans and animals and to reduce suffering through improved methods of preventing disease and development of new treatments, techniques and technologies. (
  • How has animal research helped humans and other animals? (
  • For medical and health research on humans, human biological material or personal health data, it is a prerequisite that projects are pre-approved. (
  • This applies to clinical testing of medicines on humans, clinical testing of medical devices and research projects that come under the rules and regulations of the Biotechnology Act. (
  • For clinical trials of drugs on humans the Act relating to medicines applies, while the Health Research Act applies supplementary when appropriate. (
  • Many codes regulating animal experimentation instruct regulating committees to assume that procedures that would cause pain in humans also will cause pain in vertebrate animals unless there is evidence to the contrary. (
  • The Bioethics Advisory Committee (BAC) is currently seeking comments on its draft Ethics Guidelines for Human Biomedical Research . (
  • While preparing these Guidelines , the BAC has taken the opportunity to update its recommendations, and some new material has been added, to ensure that the Guidelines are relevant to the current state of biomedical research in Singapore. (
  • The Guidelines include a summary of the legislative and regulatory frameworkfor human biomedical research in Singapore, together with the relevant current guidelines from the Ministry of Health, and other authorities. (
  • Definition of Human Biomedical Research. (
  • It covers "economic, sociological and other research in the humanities and social sciences whenever this research fits the above definition of human biomedical research. (
  • It was previously described as "reciprocity", but the term "solidarity" better reflects the importance of general altruism as a basis for participation in biomedical research. (
  • International ethical guidelines for biomedical research involving human subjects. (
  • Research in the Faculty of Biomedical Sciences addresses fundamental understanding of human health and disease, in areas that include the cardiovascular system, neuroscience, cancer, infection and immunity. (
  • Multidisciplinary collaborations demonstrate the Faculty's commitment to translating its expertise in fundamental biomedical research from bench to bedside. (
  • After JIPMER becoming an "Institution of National Importance" there is a great increase in biomedical research and the number of research projects carried out. (
  • Ethics committees are also made a requirement in International Ethical Guidelines for Biomedical Research Involving Human Subjects, produced by the Council for International Organizations of Medical Sciences (CIOMS), a body set up by the World Health Organization. (
  • What is biomedical research? (
  • Biomedical research is the pursuit of answers to medical questions. (
  • Most biomedical research is conducted by scientists in universities and medical, veterinary and agricultural schools. (
  • Institutional Review Board (IRB) is a committee containing members of mixed backgrounds and including both scientist and nonscientist members whose task is to review and monitor biomedical and behavioral research involving human subjects. (
  • The World Medical Association's Declaration of Helsinki ( 2010 ) and Council for International Organizations of Medical Science's International Ethical Guidelines for Biomedical Research Involving Human Subjects establish the international standard for biomedical research and require IRB as scientific review and ethical review committee, which is called the research ethics committee (REC) in the most of the world. (
  • The analysis results should constitute a basis for future discussions surrounding regulatory and ethical procedures that govern genetic investigations in biomedical research in Switzerland. (
  • Our mission is to bring the history of medicine and the Holocaust to the attention of medical professionals and public health policymakers so that the biomedical ethics that guide their decisions will prevent egregious violations of human dignity. (
  • Procedures could be biomedical (collection of blood or sputum samples to develop a diagnostic test), or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant's environment, etc. (
  • We create pathways to a healthier future through our research funding, our health guidelines and the ethical standards we set and uphold. (
  • NHMRC established the Indigenous Research Ethics Guidelines Review Working Committee to undertake the review of the Values and Ethics and Keeping Research on Track guidelines. (
  • Member of NHMRC working committees that developed Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research 2003 and Keeping Research on Track: A guide for Aboriginal and Torres Strait Islander peoples about health research ethics 2005 . (
  • and the absence of national research ethics guidelines and lack of ongoing training in research ethics for REC members were identified as some of the major challenges. (
  • If you have questions about whether a project falls under the guidelines of human subjects research, you may refer to the RERC Decision Tree . (
  • Revise and establish terms of reference, regulations, forms and guidelines needed for research ethical approval of research project proposals from the University of Sharjah that contain animal* and/or human subjects based on international standards. (
  • Research undertaken within the Blood Service must comply with national guidelines contained in the National Statement on Ethical Conduct in Human Research . (
  • The Committee is charged with offering advice on ethical issues regarding human health and to develop guidelines for human research. (
  • This function includes the issuing of human research guidelines. (
  • Under Section 10(2) of the NHMRC Act, the NHMRC Council may only provide human research guidelines to the CEO under Section 9(1) precisely as developed by AHEC. (
  • The Belmont Report : Ethical Principles and Guidelines for the Protection of Human Subjects of Research. (
  • This was further developed in the Declaration of Helsinki in 1964 by the World Medical Association which has since become the foundation for ethics committees' guidelines. (
  • The convening of ethics committees to approve the research protocol in human experiments was first written into international guidelines in the first revision to the Declaration of Helsinki (Helsinki II, 1975). (
  • First published in 1993, the CIOMS guidelines have no legal force but they have been influential in the drafting of national regulations for ethics committees. (
  • The goal of the CCAC guidelines is to strive for best research practices and optimal conditions for the animals, through constant improvement as new information on animal well-being and health becomes available. (
  • These guidelines are written for everyone involved in the planning, review, and conduct of research with children. (
  • General guidelines relating to all medical research provide an essential background to this document on research with children. (
  • In this Committee Opinion, the American College of Obstetricians and Gynecologists (ACOG) Committee on Ethics presents an ethical framework for examining issues surrounding research using preimplantation embryos and proposes ethical guidelines for such research. (
  • The Committee supports embryo research within 14 days after evidence of fertilization but limits it according to ethical guidelines. (
  • The Committee believes that compensation for egg donors for research is acceptable, consistent with American Society for Reproductive Medicine guidelines. (
  • The urgency of these questions makes it timely both to review the moral issues raised by human embryo research and to consider appropriate guidelines for the ethical conduct of these endeavors. (
  • The purpose of this Committee Opinion is to present a relevant ethical framework within which to view contemporary embryo research and to propose ethical guidelines for such research. (
  • The Committee recognizes that the science of this field, especially the science of stem cell research and therapy, is changing rapidly and anticipates that future changes will require revisiting past issues and either modifying previous guidelines or creating new ones in order to address formerly unimagined possibilities. (
  • In Australia, clinical trials must follow the National Health and Medical Research Council guidelines and have approval from a registered Human Research Ethics Committee . (
  • monitor and participate in the preparation of national guidelines on research ethics and ensure adherence to these guidelines at the University of Eastern Finland. (
  • Together, Rosoff, Moga and Bruce Keene, Jane Lewis Seaks Distinguished Professor of Companion Animal Medicine at NC State, set out to adapt human ethics committee guidelines currently in use to address issues in a veterinary hospital, creating NC State's first Clinical Ethics Committee (CEC). (
  • At the National Academies he has previously co-chaired (with Jonathan Moreno and R. Alta Charo) committees on guidelines for human embryonic stem cell research. (
  • Both general and subject-specific national research ethics guidelines have been prepared and are revised regularly, and the committees follow and are engaged in the international work on ethics. (
  • Likewise, several research institutions have prepared their own guidelines and other materials (elaboration and referrals follow). (
  • The mandate and guidelines for such committees may vary somewhat in form and scope, but their core area is the same. (
  • The committee will also develop an OARSI slide deck and translate the guidelines and white paper to various Asian languages. (
  • This study reviews research ethics committee applications for COVID-19-related research at a Chinese hospital in February 2020 to characterize study type, approval rate and review time, reason for revision or denial, and issues with informed consent. (
  • In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine, † and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively. (
  • The ACIP COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings since April 2020 to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccination programs. (
  • OARSI is now accepting applications for new committee members with terms to begin after the Vienna Congress (April, 2020). (
  • The Research Ethics Committee (REC) was first established in 2001 to promote ethical research in UCD and to establish the UCD Research Ethics Approval System (2004). (
  • approves or recommends edits for approval of research proposals involving human subjects, and ensures informed consent requirements are met. (
  • Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. (
  • A recent research ethics article in the Journal of Medical Ethics caught my eye, called ' Ethical Approval in Developing Countries is not an Option ' (Online First, requiring subscription, goddammit). (
  • The authors cite a published article about research conducted in Nepal, which did not have local Nepalese research ethics committee approval. (
  • Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. (
  • To determine how frequently reports of research in human cardiopulmonary resuscitation mention approval by a research ethics committee and address subjects' consent. (
  • Of these, 24 (51%) mentioned approval by a research ethics committee and 12 (26%) addressed subjects' consent. (
  • Significantly more studies reported ethics committee approval or addressed consent during more recent years. (
  • Reports of resuscitation research have not consistently mentioned approval from a research ethics committee or addressed subjects' consent for interventional studies using human subjects. (
  • Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. (
  • Research biobanks established in connection with collection, storage and use of human biological material as part of a research project, must be described in the project's research protocol, and application for approval should be made a the same time as application for pre-approval of the research project is made. (
  • Application for pre-approval of a specific research project must be made to REC when a researcher wants to conduct research on human biological material found in a research biobank that has been established without being associated to a specific project. (
  • These diverse positions range from complete rejection of all human embryo research to approval of the deliberate creation of human embryos for research. (
  • Trust R&D approval for research involving HSC Trust staff. (
  • In this context, a research database consists of a collection of personal data on human subjects with generic ethical approval from a recognised Research Ethics Committee (i.e. (
  • Please note that UEC does NOT process individual research proposals for ethical approval. (
  • A guide is included to help identify the appropriate committee to which applications for ethical approval should be submitted (Page 19). (
  • RESEARCH DESIGN AND METHODS Ten patients with diabetes secondary to chronic pancreatitis were compared with 13 patients with type 2 diabetes and 10 healthy control subjects. (
  • This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). (
  • Several building blocks and attached methods could be identified in the creation of a generic ethics committee proposal. (
  • Hence, an Ethics Committee can make informed decisions on the suggested study via said blocks, using the suggested methods such as "Defining Clinical Questions" within the Context Analysis. (
  • The Provost, Emeritus Prof. Mathew Araoye said that the committee on Medical Education Resources would assist and report to the Provost on the import of medical informatics as well as make recommendations for the Academic Board on the up-to-date resources, devices, and methods required optimizing the acquisition, storage, reticular and using of information in health and Bio Medicine. (
  • The chief purpose of IRB reviews is to assess the scientific and ethical merit and usefulness of the research and its methods and to ensure that research. (
  • On June 23, 2021, the Advisory Committee on Immunization Practices concluded that the benefits of COVID-19 vaccination to individual persons and at the population level clearly outweighed the risks of myocarditis after vaccination. (
  • Well-designed research is scientifically robust, and uses a research methodology that takes account of relevant cultural, social and economic factors. (
  • The University Research Ethics Committee (REC) was formed on the 29th Nov 2015 based on the Chancellor's Decision No. (86) for the academic year 2015/2016. (
  • The Summit was convened in response to the recommendation of the last Global Summit of National Ethics/Bioethics Committees, which was held from 16 to 18 March 2016 in Berlin, Germany. (
  • The meeting was inaugurated by the Secretary of the Research Ethics Review Committee (Dr Ahmed Mandil), on behalf of Acting Regional Director Dr Jaouad Mahjour and the Directorr of the Information, Evidence and Research Department Dr Arash Rashidian and chaired by Professor Gamal Serour (Egypt). (
  • AHEC is responsible for ensuring research is conducted in compliance with the University's ethical standards. (
  • Melbourne University's Professor Helmut Butzkueven has tonight been awarded Research Australia's Data Innovation Award for his incredible work developing MS Base, the world's largest Multiple Sclerosis (MS) database sharing, tracking and evaluating clinical data in more than 55,000 people with MS from 33 countries. (
  • Please consider the University's policy on Research Conduct, see UCC Code of Research Conduct V2.2 , when completing the application, particularly the section pertaining to data management (note: the University expects data to be securely held for a period of ten years after the completion of a research project). (
  • The role of the School Research Ethics Committees (SREC) and the University Research Ethics and Integrity Sub-committee (UREISC) is to support the University's research activities by implementing our research ethics policies. (
  • This article covers recent legal developments involving institutional healthcare ethics committees. (
  • Healthcare ethics committees have also recently been the subject of significant public policy attention. (
  • Do Tanzanian hospitals need healthcare ethics committees? (
  • To receive from individual members of academic staff, students, proportionate review streams, proposals for all other research involving experiments, investigations and procedures falling within its terms of reference (1 & 2) and to allow, refer back or disallow such proposals, specifying where necessary any conditions subject to which proposals may be allowed. (
  • Under Section 36(2) of the NHMRC Act, there must be included among members of AHEC individuals who collectively have membership of all the other Principal Committees. (
  • The Ethics Committee helps the patient, family members and medical team work through tough decisions together. (
  • Members of immunization expert advisory committees have an important role to play in guiding public health decision-making, particularly with regard to the selection of vaccines and the scheduling of immunizations. (
  • For example, consider situations where one or more committee members receive(s) significant funding from industry. (
  • No formal qualifications are required but 20% of serving members have formal training in moral analysis and two have postgraduate qualifications in ethics and law. (
  • Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. (
  • At its recent regular meeting, the board of directors of the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) appointed some new members to the research ethics committee (REC) for three-year terms. (
  • The Committee acknowledges the diversity of opinions among ACOG members and affirms that no physician who finds embryo research morally objectionable should be required or expected to participate in such research. (
  • The Committee on Ethics acknowledges the diversity of opinions regarding these topics among members of the American College of Obstetricians and Gynecologists (ACOG), a diversity mirroring that in society at large. (
  • Make the best use of Scientific Research and information from our 700+ peer reviewed, Open Access Journals that operates with the help of 50,000+ Editorial Board Members and esteemed reviewers and 1000+ Scientific associations in Medical, Clinical, Pharmaceutical, Engineering, Technology and Management Fields. (
  • Questions relating to the status, rights, co-authorship, liabilities and obligations of the members of a research team are determined before the research project starts of a researcher is recruited to the team. (
  • When cases arise, as many as four or as few as two members of the committee meet with the veterinary patient's care team to serve as a resource or a sounding board. (
  • The committee members include vets, animal care staff, a biostatistician, scientists and non-scientists from across the agency. (
  • There are also external lay members of the committee, recruited from the local community, who bring an independent view to the proceedings. (
  • It also acts as an informational resource for EABP members on ethics issues. (
  • Members are elected by their peers for outstanding contributions to research. (
  • WASHINGTON - Members of the U.S. House of Representatives' Energy and Commerce Committee should reject two bills that would undermine regulatory standards for ensuring that drugs and medical devices are safe and effective for each marketed use, Public Citizen and 12 other groups said in a letter sent to committee members today. (
  • The Young Investigator Committee is limited to those OARSI members age 40 and younger. (
  • In Australia, an ethics committee in medical research refers to a Human Research Ethics Committee (HREC). (
  • The Charles Darwin University Human Research Ethics Committee (CDU-HREC) oversees all human research conducted under the auspices of Charles Darwin University. (
  • All Indigenous research requires full HREC review. (
  • Projects posing a greater than negligible risk or that involve research categories requiring full HREC review as specified in the National Statement will be reviewed by the full CDU-HREC. (
  • The Ethics, Regulation and Public Involvement Committee provides the MRC Council with expert ethical advice on a wide range of issues relating to medical research. (
  • For example, in early 2005 it looked at the scientific community's concerns about the impact of excessive bureaucracy and regulation on research involving patients and produced a Policy & governance MRC position statement on this topic. (
  • The Ethics, Regulation and Public Involvement Committee meets twice a year, and reports formally to Council once a year. (
  • Ethics and regulation of clinical research / Robert J. Levine. (
  • Since then, there has been significant progress in the understanding of children's interests, in legal requirements, and in the proper regulation of research. (
  • Specifically, my research has focused on studying the clinical effects of food macronutrient composition and quality on energy regulation and disease metabolism, factors affecting the glycaemic and insulinaemic responses to foods, clinical evaluation of functional foods, satiety effects of foods and food constituents, and factors influencing satiety and food intake. (
  • It shows what are the countries that have policies and regulations on ethics committees and clinical trials registration. (
  • any other functions conferred on the Committee by the NHMRC Act, the regulations or any other law. (
  • Digital citation migrated from OpenText LiveLink Discovery Server database named NBIO hosted by the Bioethics Research Library to the DSpace collection BioethicsLine hosted by Georgetown University. (
  • The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University. (
  • Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. (
  • The Strategic Alliance Committee will identify societies, foundations, groups and industry partners that have an interest in OA and related research and establish mutually beneficial interactions. (
  • The goal of the Asian Alliances Committee is to establish collaborations with local societies to plan scientific and educational programming in Asia. (
  • In this context, it relates to the validity of the research proposal. (
  • The IRB page includes general IRB information, human research proposal forms, online ethics training tutorials and additional links for both students and faculty. (
  • Grinnell's IACUC page contains general IACUC information, animal research proposal forms, online ethics training tutorials and supplementary links for students and faculty. (
  • The nature of the research proposal (whether focused on animal research, clinical research or social research) determines the appropriate Committee (see below). (
  • It is the equivalent to the introduction in a research paper and it puts the proposal in context. (
  • Please Note: If a research protocol falls into both the jurisdictions of CREC and SREC, then the application will usually be referred to CREC. (
  • On receipt, properly completed applications will be forwarded to the committee for review and applicants will be forwarded a SREC Log number. (
  • After first discussing your research with your supervisor or line manager, applications should be submitted to your School Research Ethics Committee (SREC) using the contacts below. (
  • Addressed are major disciplinary perspectives working on nanotechnology, e.g. philosophy, sociology, and political science, as well as the major multidisciplinary areas relevant to the innovation process, e.g. technology assessment and ethics. (
  • Do I go to the School Research Ethics Committee, Faculty Research Ethics Committee or ORECNI? (
  • The following form of indemnity is compulsory for use by all external sponsors who wish to conduct research in Beaumont Hospital. (
  • IRB is assigned to the authority and responsibility for approving or disapproving proposals to conduct research involving human subjects. (
  • Charles Darwin University places great value on the knowledge, expertise and integrity of its research students and staff and on their commitment to conduct research with high standards of ethics and scholarship. (
  • The university requires all research proposals involving human participation to undergo formal ethical peer review. (
  • Find out more about postgraduate research via the Faculty's Graduate School . (
  • All research done by students or faculty* at Judson College involving human subjects, federally funded or not, must be reviewed by the RERC. (
  • What is human subjects research? (
  • The REC should also evaluate the actual and potential benefits, which will be received by the research subjects, including monetary and other incentives, and make sure those are neither inappropriate nor exaggerated. (
  • IRB: A Review of Human Subjects Research. (
  • And in a certain way, the point of the article is obvious: when there is an appropriate body in developing countries to review human subjects research conducted by anyone (local or from abroad), then it should be reviewed. (
  • IACUC for Grinnell College reviews all college research including animal subjects. (
  • In the United States, an ethics committee is usually known as an institutional review board and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. (
  • An important element of an ethics committee's oversight is to ensure that informed consent of the subjects has been given. (
  • Long term follow up of research interventions may be of particular benefit to child subjects. (
  • Research involving human subjects has increased in various regions in the developing world, including the Middle East [ 1 ]. (
  • Prof. Araoye added that another committee on research and ethics has been constituted to promote research on the college, protect the safety of human and animal subjects participating in research among others. (
  • their comments were analyzed to show underlying themes, which are here presented along with supporting quotations.There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. (
  • Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well.Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. (
  • In addition, the court developed 10 basic principles of human subjects research that were subsequently labeled the Nuremberg Code. (
  • Congressional investigations ultimately led to the institutional review boards that supervise human subjects research today. (
  • The Institute Ethics Committee (Human Studies) conducts regular meetings for reviewing the research proposals and gives suggestions to the investigators to make their research ethical before approving them. (
  • It may also undertake research on matters pertaining to ethics at the request of the UCD Governing Authority, the Academic Council, the Vice-President for Research, or initiate research itself. (
  • Its Code of Health Research Ethics was approved by the National Council on Health in its 50th Annual Meeting in January 2007. (
  • The Education Steering Committee (ESC) serves as an advisory group to the University of Minnesota's Curriculum and Assessment Committees, including Education Council (EC), the Committee for Undergraduate Medical Education in Duluth (CUMED), the Clinical Education Committee (CEC), the Scientific Foundations Committee (SFC), and the Assessment Committee (AC). (
  • The Canadian Council on Animal Care (CCAC) is a national organization with a mandate to set standards for the care and use of animals in research in Canada. (
  • He has served as an appointee of President Clinton on his Advisory Committee for Trade Policy and Negotiations, on the Institute of Medicine panel on the Future of Health and Human Services, and as an advisor to the President's Council of Advisors on Science and Technology. (
  • In 2003, James was awarded an Australian Research Council (ARC) Postdoctoral Fellowship. (
  • Swedish Research Council. (
  • Swedish Council for Working Life and Social Research. (
  • The UEC is a committee of Academic Council and it reports annually both to Academic Council and to Governing Body. (
  • It's not surprising that veterinary hospitals also now see the need for ethics committees to mediate and adjudicate disputes about care. (
  • The National Health Research Ethics Committee of Nigeria (NHREC) is a national body advising the Nigerian Federal Ministry of Health, as well as State Ministries, on ethical issues concerning research. (
  • The NHREC was inaugurated in October 2005 by the Nigerian Minister of Health on presidential directives, as an offshoot of the Health Research Ethics Committee that had been in existence since the early 1980s. (
  • The other side is about preventing and handling misconduct in research. (
  • A system has been established with a variety of resources to support the research institutions' work on both of these aspects of research ethics, in the form of national research ethics committees, regional committees for medical and health research ethics and the National Commission for the Investigation of Research Misconduct (elaboration and referrals follow). (
  • The University treats all allegations of misconduct seriously and is committed to ensuring that allegations are investigated with thoroughness and rigour in accordance with the Research Misconduct Policy and Procedures (DOCX, 60.7kB) . (
  • NHMRC is the key driver of health and medical research in Australia. (
  • Local terms for a European ethics committee include: A Research Ethics Committee (REC) in the United Kingdom A Medical Research Ethics Committee (MREC) in the Netherlands. (
  • Long-term data collection is a challenging task in the domain of medical research. (
  • In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. (
  • Medical research involving children is an important means of promoting child health and wellbeing. (
  • When medical research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general, the project or study is required by law to undergo an ethical review by the ethics committee of the hospital district concerned. (
  • The only way is through expensive medical research. (
  • When the rare and devastating Sanfilippo Syndrome struck Megan Donnell's family, she responded by setting up a $3 million Foundation to fund high-quality medical research into the condition. (
  • Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. (
  • 1 Department of Scientific Research and Discipline Construction, Henan Provincial People's Hospital and the People's Hospital of Zhengzhou University, Zhengzhou, China. (
  • 4 Clinical Research Guidance Center, Henan Provincial People's Hospital and the People's Hospital of Zhengzhou University, Zhengzhou, China. (
  • The bioethics literature contains speculation but little data about sociodemographic differences between patients for whom ethics committees (EC) are consulted for conflict about life-sustaining treatment (LST) and the broader hospital population that these committees serve. (
  • I wanted to find an ethics-based way to help our hospital staff address differences and form consensus in these cases. (
  • Rosoff, pediatric oncologist and director of the clinical ethics program at Duke University Hospital, is corresponding author of a new paper describing the committee's formation. (
  • The JIPMER faculty, research scholars and post graduate students conduct several research works which involves patients and healthy human volunteers. (
  • The Research Ethics application process starts within the respective academic departments via the Departmental/Faculty Ethics Screening Committee (DESC/FESC). (
  • The University of Windsor spotlights accomplishments and achievements of faculty at an annual event held to pay tribute to those who have received significant awards and honours for their research or creative activity. (
  • After postdoctoral work at the Imperial Cancer Research Fund in London, where he initiated his work on cell adhesion, he returned to MIT as a faculty member. (
  • The Faculty of Engineering and Physical Sciences is currently hosting the pilot using Faculty Research Ethics Committees. (
  • To devise guidance, set standards, propose and review policy on the ethical conduct of research within the School of Health Sciences in conjunction with Senate REC and the SHS Research Committee. (
  • NSF Competes requires training and oversight in the responsible and ethical conduct of research. (
  • The following resources are provided to assist in developing training and oversight plans for the responsible and ethical conduct of research in an international context and to understand the codes of conduct in other countries. (
  • In Canada, the National Advisory Committee on Immunization is an advisory body to the Public Health Agency of Canada, while the provinces and territories rely on advice from local expert advisory committees. (
  • [1] In particular, PCRM works to educate the public about scientific research demonstrating the health benefits of low fat, vegetarian diets. (
  • They reference a large body of scientific research linking meat and dairy consumption to increased risk of heart disease, diabetes, cancer, osteoporosis, asthma and other diseases. (
  • The Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), established in Québec since 1980, is a scientific research organization well known for the expertise of its personnel and the quality of its work. (
  • For APHA to achieve its mission to "safeguard animal and plant health for the benefit of people, the environment and the economy" it is necessary to do scientific research into diseases that affect this. (
  • These pre-approvals should according to the Health Research Act be sent to the Regional Committees for Medical and Health Research Ethics (REC). (
  • Use of previously collected data in research may require new approvals. (
  • The official approvals by the local Ethics Committee. (
  • CDU is committed to recognising approvals by other properly registered ethics committees by means of reciprocal approvals. (
  • The principle of informed consent was first enacted in the U.S. Army's research into Yellow fever in Cuba in 1901. (
  • Sample informed consent form templates are provided (links below), to assist applicants with formulating an informed consent form appropriate to the applicant's research project. (
  • Applicants will be notified of the School of Health Sciences Research Ethics Committee (SHS REC) decision within 10 working days of the meeting. (
  • Journal of Medical Ethics and History of Medicine. (
  • AHEC may also provide advice on international developments in health ethics issues. (
  • To report annually to the University Ethics Committee on the business undertaken by the committee, providing a statistical overview of the work of the committee and drawing attention to any general issues. (
  • All research undertaken by the Blood Service must therefore not only be scientifically valid but must also be approved by the Blood Service Human Research Ethics Committee. (
  • Research in some federal and provincial government agencies also involves animal use, and private companies-pharmaceutical, biotechnology and agricultural-may also use animals in their research and development programs. (
  • Part of this research involves the use of animals. (
  • The goal of our review is to ensure that guidance about research involving Aboriginal and Torres Strait Islander peoples continues to be up-to-date and relevant. (
  • Please note, this guidance only holds information relevant to research ethics in the School of Health Sciences. (
  • For all other information about research ethics at City, including information about how to apply, participant information sheets, consent form templates, and general guidance please see City's guidance on research ethics . (
  • The revised SOP contains clearer guidance on the purpose and scope of the REC and the requirements for ethics review. (