Research Subjects: Persons who are enrolled in research studies or who are otherwise the subjects of research.Human Experimentation: The use of humans as investigational subjects.Ethics, Research: The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.Nontherapeutic Human Experimentation: 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.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.Informed Consent: 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.Therapeutic Human Experimentation: Human experimentation that is intended to benefit the subjects on whom it is performed.Consent Forms: 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.Patient Rights: 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.Research: 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)Ethical Review: 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).Biomedical Research: Research that involves the application of the natural sciences, especially biology and physiology, to medicine.Conflict of Interest: 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.Moral Obligations: Duties that are based in ETHICS, rather than in law.Therapeutic Misconception: Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.Patient Advocacy: Promotion and protection of the rights of patients, frequently through a legal process.Compensation and Redress: Payment, or other means of making amends, for a wrong or injury.Genetic Research: Research into the cause, transmission, amelioration, elimination, or enhancement of inherited disorders and traits.United States Dept. of Health and Human Services: A cabinet department in the Executive Branch of the United States Government concerned with administering those agencies and offices having programs pertaining to health and human services.Ethics, Medical: 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.Research Design: 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.Healthy Volunteers: Persons with no known significant health problems who are recruited to participate in research to test a new drug, device, or intervention as controls for a patient group. (from http://clinicalcenter.nih.gov/recruit/volunteers.html, accessed 2/14/2013)Research Personnel: Those individuals engaged in research.Confidentiality: The privacy of information and its protection against unauthorized disclosure.Parental Consent: Informed consent given by a parent on behalf of a minor or otherwise incompetent child.Patient Selection: 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.Clinical Trials as Topic: 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.Disclosure: Revealing of information, by oral or written communication.Government Regulation: Exercise of governmental authority to control conduct.Comprehension: The act or fact of grasping the meaning, nature, or importance of; understanding. (American Heritage Dictionary, 4th ed) Includes understanding by a patient or research subject of information disclosed orally or in writing.Vulnerable Populations: 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.United StatesResearch Support as Topic: Financial support of research activities.Terminology as Topic: The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.Randomized Controlled Trials as Topic: 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.Data Collection: 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.Nursing Research: Research carried out by nurses, generally in clinical settings, in the areas of clinical practice, evaluation, nursing education, nursing administration, and methodology.Risk Assessment: 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)Questionnaires: 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.Health Services Research: 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)Translational Medical Research: 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.Clinical Nursing Research: 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.Dental Research: 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)Community-Based Participatory Research: Collaborative process of research involving researchers and community representatives.Behavioral Research: 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)Qualitative Research: 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)
Pediatric Research - Epigenetic Mechanisms and the Mismatch Concept of the Developmental Origins of Health and DiseasePediatric Research publishes original papers, invited reviews, and commentaries on the etiologies of diseases of children and ... This is the subject of this review.. Top of page. MISMATCH, DEVELOPMENTAL PLASTICITY, AND EPIGENETICS. Steep temporal trends in ... Pediatric Research (2007) 61, 5R-10R; doi:10.1203/pdr.0b013e318045bedb. Epigenetic Mechanisms and the Mismatch Concept of the ... Animal research has given us new insights into developmental plasticity and epigenetics. First, it is clear that such ...
What Protections Exist for Research Subjects? | Psych Central... ensure that research meets strict scientific guidelines and follows rules that protect the subject. Several groups who are not ... Home » Library » What Protections Exist for Research Subjects?. What Protections Exist for Research Subjects?. By Psych Central ... Many "checkpoints" ensure that research meets strict scientific guidelines and follows rules that protect the subject. Several ... provides the next review of human subject provisions for clinical research proposals. The funding agency also judges the ...
Children As Research Subjects - Michael A. Grodin; Leonard H. Glantz - Oxford University PressWhat can we learn from the history of the use and abuse of children as research subjects? Do parents have the authority to ... volunteer their children for research projects? How should children participate in the decision to be involved in research? How ... Does the fact that children are medically and psychosocially different from adults have implications for research? ... Is using children as research subjects ever justified? Are there limits to such use? ...
Powerless poor make handy research subjects | Toronto Star... the medical and pharmaceutical research industries have routinely exploited the poor. ... The pharmaceutical and research industries today rely on human subjects as research objects in studies that might, or might not ... Powerless poor make handy research subjects. For more than a century, the medical and pharmaceutical research industries have ... most research subjects are also patients. The protection was insufficient, in the 1980s, to protect the lives of research ...
The Protection of Research SubjectsSummary: In December 1989, a motion was approved by members of the Consortium for Chiropractic Research to adopt the Helsinki/ ... Whatever the risks or costs, a research subject must be adequately and completely informed. The subject must not be deceived or ... The (Pacific) Consortium for Chiropractic Research is a dynamic, interactive research organization composed of the research ... The Protection of Research Subjects. By Robert D. Jansen, PhD. At the December 1989 meeting in Los Angeles, a motion was ...
Human Subjects Research | NIDDKHuman Subjects Research. NIDDK funds pivotal clinical research through the activity codes outlined below. Before applying you ... Human Subjects or Clinical Research (R01): One or Two Sites. For studies that involve up to two investigator sites, R01s may be ... Allows researchers to refuse to disclose names or other identifying characteristics of research subjects in response to legal ... OHRP provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research ...
Research Projects Subjects of Investigation at this Location : USDA ARSResearch Projects Subjects of Investigation at this Location Each ARS research project has related subjects of investigation. ... Clicking on a subject of investigation will list the research projects within that subject of investigation. ... You are here: ARS Home / Plains Area / Houston, Texas / Children's Nutrition Research Center / Research / Research Projects ... Listed below are the subjects of investigation currently conducted at this location. ...
Research Projects Subjects of Investigation at this Location : USDA ARSResearch Projects Subjects of Investigation at this Location Each ARS research project has related subjects of investigation. ... Clicking on a subject of investigation will list the research projects within that subject of investigation. ... You are here: ARS Home / Pacific West Area / Corvallis, Oregon / Horticultural Crops Research / Research / Research Projects ... Listed below are the subjects of investigation currently conducted at this location. ...
Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls - Full Text View -...At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2 AD subjects and up to 5 HC subjects ... Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20 healthy control subjects will be ... Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls. This study has been completed. ... Subjects may decline participation in the second scan. Subjects will be requested to return for this second scan until enough ...
Research on Human Subjects: Academic Freedom and the Institutional Review Board | AAUPReport addresses aspects of the federal government's regulations for research on human subjects that constitute a threat to ... Not all research on human subjects is research on adults who can freely make those decisions, of course. Much human subject ... All of the Institution's human subjects research activities, regardless of whether the research is subject to federal ... 2) Some biomedical research does not impose a serious risk of harm on its subjects-for example, biomedical research that ...
Browsing Woodson Research Center by SubjectEntire ArchiveCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsTypeThis CommunityBy Issue DateAuthorsTitlesSubjects ...
Browsing Dark-eyed Junco Research by Subject "gonadal testosterone production, dark-eyed junco, Junco hyemalis"... ...
https://scholarworks.iu.edu/dspace/handle/2022/15252/browse?value=gonadal testosterone production, dark-eyed junco, Junco hyemalis&type=subject
Human Subjects and Animal Research - Sponsored Projects - Western Illinois UniversityAnimal Subjects in Research * Laboratory Animal Care Facility Standard Operating Procedures * Research With Animals Protocol ... Responsible Conduct of Research * Responsible Conduct of Research Policy and Training Requirements ... Research Compliance Overview. The Office of Sponsored Projects is committed to the highest standards of scientific and ... All sponsored projects and research activities at WIU are governed by institutional, federal and state policies or laws. The ...
Medical Students on the Declaration of Helsinki and Human Research Subjects | IFMSA's Official Blog... including research on identifiable human material and data. It was first adopted at the 18th WMA General Assembly, Helsinki, ... has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, ... roopadhatt Research & Medical AssociationsAMA, Declaration of Helsinki, DOH, Fields, human subject, JDN, research, WMA ... Any access to the platforms is a breach of privacy and violation of the rights of research subjects. The system must be ...
Browsing Peer-reviewed Publications by Subject "integrative research"Title: Implementation of a Shared Data Repository and Common Data Dictionary for Fetal Alcohol Spectrum Disorders Research ...
"Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator" by Susan F....Conclusions: Physicians engaged in research need to be prepared to deal with the discovery of health risks in the otherwise ' ... "Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator" Journal of the American Board ... Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator ... Conclusions: Physicians engaged in research need to be prepared to deal with the discovery of health risks in the otherwise " ...
TeachersFirst - Classroom Resource Resources with the subject "information-literacy-research"233 information-literacy-research results , sort by: Most Recent First. Alphabetical. Most Viewed First. return to subject ... Begin with a keyword search or by subject....more Here is the direct link to share this resource review. Feel free to copy and ... Share this video with students as they begin any research project. Be sure to add a link to this site on your class website for ... Begin with a keyword search or by subject. Use the drop-down box to narrow search terms to include images, topic, books, or ...
TeachersFirst - Classroom Resource Resources with the subject "information-literacy-research"213 information-literacy-research results , sort by: Most Recent First. Alphabetical. Most Viewed First. return to subject ... Use this resource for any project or other classroom research where students can benefit from collaborative research. This is a ... This installment in the Help I lost my library/media specialist series offers a step by step approach to a research unit, ... This installment in the Help I lost my library/media specialist series offers a step by step approach to a research unit, ...
Conducting research with human subjects, such as clinical testing, surveys, human tissue studies, etc. - Research...Conducting research with human subjects, such as clinical testing, surveys, human tissue studies, etc.. Friday August 10, 2012 ... Legal requirements to protect human subjects apply to a broader range of research than many investigators realize. Protections ... Please visit the Office of Human Subject Research Protection for more information. ... Amanda Humphrey joins Research Admin as Director for Award Administration. *NU's SAM registration renewed through August 29, ...
Draft: Consultative Document on Ethical Guidelines on Biomedical Research involving Human Subjects - Clinical Evaluation of...... or usefulness of an intervention include research on therapeutics, diagnostic procedures and preventive measures including ... your chance to provide feedback to the indian government about your views on human research ! human studies designed to ... When a subject is withdrawn from research for medical reasons related to the study the subject should get the benefit for full ... the benefits that might reasonably be expected as an outcome of research to the subject or to others, *any risk to the subject ...
Osborn's Brain: Framework for Understanding the Complex Subject of Brain Imaging - Research and Markets | Business WireResearch and Markets has announced the addition of the 'Osborn's Brain' book to their offering. Comprehensive, visually ... Osborn's Brain: Framework for Understanding the Complex Subject of Brain Imaging - Research and Markets ... Research and Markets. Laura Wood, Senior Manager. email@example.com. For E.S.T. Office Hours Call 1-917-300-0470. ... Research and Markets. Laura Wood, Senior Manager. firstname.lastname@example.org. For E.S.T. Office Hours Call 1-917-300-0470. ...
Star Trek (2009) / Headscratchers - TV TropesEnterprise tried to explain the situation by having the Vulcans themselves be conflicted on the subject. ... The Narada had Borg-derived tech and weapons from a Romulan research center in the future. ... but the subject would inevitably come up), The Undiscovered Country dealt with evacuating a homeworld and the best they could ... attending conventions on other planets or engaging in field research, you should end up with way more than just 10,000 ...
Oppenheimer Trust Company announces appointment of Hunt Worth as PresidentIn need of subject matter experts for your story? Submit a free ProfNet request and find the sources you need. ...
Research participant: A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who participates in human subject research by being the target of observation by researchers.Human subject research legislation in the United States: Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics.ATC code V07: ==V07A All other non-therapeutic products==Monitoring in clinical trials: Clinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials.Andrew Dickson WhiteSystematic Protein Investigative Research EnvironmentErga omnes: Erga omnes is a Latin phrase which means "towards all" or "towards everyone". In legal terminology, erga omnes rights or obligations are owed toward all.Patient advocacyVaccine Information Statement: Vaccine Information Statement is a formal description of a vaccine, with a concise description of the benefits of the vaccine, a concise description of the risks associated with the vaccine, a statement of the availability of the National Vaccine Injury Compensation Program, and is required as a provision of the United States National Childhood Vaccine Injury Act. Such materials shall be provided prior to the administration of a vaccine set forth in the Vaccine Injury Table.Return of results: Return of results is a concept in research ethics which describes the extent of the duty of a researcher to reveal and explain the results of research to a research participant.Mark Siegler: Mark Siegler (born June 20, 1941) is an American physician who specializes in internal medicine. He is the Lindy Bergman Distinguished Service Professor of Medicine and Surgery at the University of Chicago.Medix UK Limited: Medix UK Limited is a UK-based market research consultancy providing online research in healthcare.Legal status of tattooing in the United States: In the United States, there is no federal law regulating the practice of tattooing. However, all 50 states and the District of Columbia have statutory laws requiring a person receiving a tattoo be 18 years of age or older.Community-based clinical trial: Community-based clinical trials are clinical trials conducted directly through doctors and clinics rather than academic research facilities. They are designed to be administered through primary care physicians, community health centers and local outpatient facilities.Slab serif: In typography, a slab serif (also called mechanistic, square serif, antique or Egyptian) typeface is a type of serif typeface characterized by thick, block-like serifs. Serif terminals may be either blunt and angular (Rockwell), or rounded (Courier).List of Parliamentary constituencies in Kent: The ceremonial county of Kent,International Committee on Aeronautical Fatigue and Structural IntegrityAIP Conference Proceedings: AIP Conference Proceedings is a serial published by the American Institute of Physics since 1970. It publishes the proceedings from various conferences of physics societies.Global Risks Report: The Global Risks Report is an annual study published by the World Economic Forum ahead of the Forum’s Annual Meeting in Davos, Switzerland. Based on the work of the Global Risk Network, the report describes changes occurring in the global risks landscape from year to year and identifies the global risks that could play a critical role in the upcoming year.Closed-ended question: A closed-ended question is a question format that limits respondents with a list of answer choices from which they must choose to answer the question.Dillman D.Science Translational Medicine: Science Translational Medicine is an interdisciplinary medical journal established in October 2009 by the American Association for the Advancement of Science.International Association for Dental Research: The International Association for Dental Research (IADR) is a professional association that focuses on research in the field of dentistry. The aim of this association by constitution is to promote research in all fields of oral and related sciences, to encourage improvements in methods for the prevention and treatment of oral and dental disease, to improve the oral health of the public through research, and to facilitate cooperation among investigators and the communication of research findings and their implications throughout the world.List of psychological research methods: A wide range of research methods are used in psychology. These methods vary by the sources of information that are drawn on, how that information is sampled, and the types of instruments that are used in data collection.Essex School of discourse analysis: The Essex School constitutes a variety of discourse analysis, one that combines theoretical sophistication – mainly due to its reliance on the post-structuralist and psychoanalytic traditions and, in particular, on the work of Lacan, Foucault, Barthes, Derrida, etc. – with analytical precision, since it focuses predominantly on an in-depth analysis of political discourses in late modernity.
(1/498) Selecting subjects for participation in clinical research: one sphere of justice.
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)
(2/498) Attitudes, knowledge, and risk perceptions of women with breast and/or ovarian cancer considering testing for BRCA1 and BRCA2.
PURPOSE: This study examined baseline knowledge, beliefs, and risk perceptions among a group of 200 women with breast and/or ovarian cancer who participated in a trial designed to improve decision making about genetic testing for BRCA1 and BRCA2. PATIENTS AND METHODS: Women were identified by self-referral, physician referral, and tumor registry extraction and invited to participate in a randomized trial in which testing for BRCA1 and BRCA2 was offered free of charge. Subjects completed baseline questionnaires and interviews that assessed knowledge, attitudes, and perceptions of risk of having an alteration in BRCA1 or BRCA2. RESULTS: Sixty percent of women overestimated their chances of having a BRCA1 or BRCA2 mutation compared with estimates from a BRCA1/BRCA2 risk model. Women who have at least three relatives with breast or ovarian cancer were one third (95% confidence interval, 0.2 to 0.6) as likely to overestimate their risk of having a BRCA1 or BRCA2 mutation compared with women who have two or fewer affected relatives. Knowledge was limited about BRCA1 and BRCA2 mutations and cancer risk associated with gene mutations. Eighty-four percent of the women indicated a probable or definite interest in testing. CONCLUSION: A high proportion of the high-risk women in this study had knowledge deficits about BRCA1 and BRCA2 and overestimated their risk of having a mutation. Although some degree of caution should be used in generalizing the results of this study to practice settings, the data provide insight into the challenges clinicians will face in communicating with patients about cancer genetics. (+info)
(3/498) An evaluation of "informed consent" with volunteer prisoner subjects.
"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent. (+info)
(4/498) Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study.
OBJECTIVE: To investigate whether including a placebo arm in a clinical trial of hormone replacement therapy influenced women's stated willingness to participate. DESIGN: Quasirandomised, interview based study. SETTING: 10 group practices in the Medical Research Council's General Practice Research Framework. PARTICIPANTS: 436 postmenopausal women aged 45-64 who had not had a hysterectomy. MAIN OUTCOME MEASURES: Stated willingness to enter a trial and reasons for the decisions made. RESULTS: Of 218 women told about the trial without a placebo arm, 85 (39%) indicated their willingness to enter compared with 65 (30%) of the 218 women told about the trial with the placebo arm (P=0.06). Part of this difference was due to explicit reluctance to take a placebo. Altruism and personal benefit were the reasons most frequently given for wanting to take part in a trial. The reasons most frequently cited for not wanting to take part were reluctance to restart periods, not wanting to take unknown or unnecessary tablets, or not wanting to interfere with present good health. CONCLUSION: For preventive trials the inclusion of a placebo arm may reduce patients' willingness to participate. (+info)
(5/498) Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.
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)
(6/498) Research, ethics and conflicts of interest.
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)
(7/498) Can the written information to research subjects be improved?--an empirical study.
OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information. (+info)
(8/498) Responses by four Local Research Ethics Committees to submitted proposals.
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)
- A funding agency, such as the National Institute of Mental Health (NIMH), provides the next review of human subject provisions for clinical research proposals. (psychcentral.com)
- Nonetheless, having a general understanding yourself of how scientists conduct clinical research will help you feel more confident when talking about the project with the research director. (psychcentral.com)
- NIDDK funds pivotal clinical research through the activity codes outlined below. (nih.gov)
- If you are applying for or have already received a clinical research grant you must follow both NIH and NIDDK policies for clinical research . (nih.gov)
- Each proposed study, including its provisions for the protection of human subjects and its consent form, must be approved by an Institutional Review Board (IRB). (psychcentral.com)
- As the first book to be devoted solely to the science, ethics, and law of research with children, it is an indispensable resource to physicians, psychologists, educators, lawyers, ethicists, Institutional Review Board members, child advocates and others involved in performing or reviewing research with children. (oup.com)
- What Protections Exist for Research Subjects? (psychcentral.com)
- There are several pages of specific protections, but most of them are variations on the theme of disclosure, either to the subject for the purposes of informed consent, or about the subject, after the fact. (dynamicchiropractic.com)
- This assurance must be approved by the federal Office of Human Research Protections. (aaup.org)
- This information allows the IRB and more critically you to judge the value, risks, and potential benefits of a research project. (psychcentral.com)
- Whatever the risks or costs, a research subject must be adequately and completely informed. (dynamicchiropractic.com)
- How should research risks be assessed and balanced? (oup.com)
- 4 Members of a campus IRB are instructed by the regulations to decide, among other things, whether the risks the research would impose on its "subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. (aaup.org)
- 5 Thus IRB members are instructed to form their own view of the risks their colleagues' research would impose on its subjects, and on the importance of the results that might be obtained from the research, and to deny permission to conduct the research if in their view the risks are not reasonable relative to the value of the likely results. (aaup.org)
- Conclusions: Physicians engaged in research need to be prepared to deal with the discovery of health risks in the otherwise "normal" control patients. (bepress.com)
- Before applying you must first determine whether NIH defines your research as human subjects research or a clinical trial . (nih.gov)
- The pharmaceutical and research industries today rely on human subjects as research objects in studies that might, or might not, result in some new insight and eventually a new treatment. (thestar.com)
- Both the IRB and the funding agency conduct regular reviews to be sure that the researchers are meeting all the rules for the protection of human subjects. (psychcentral.com)
- At the December 1989 meeting in Los Angeles, a motion was unanimously approved by members of the "Pacific" Consortium for Chiropractic Research to officially adopt the Helsinki/NIH regulations regarding protection of human subjects. (dynamicchiropractic.com)
- These regulations, also endorsed by the World Health Organization, most governments, funding agencies, hospitals, educational and research institutions in the world, document in detail all the various ways that human rights should be protected within the context of research. (dynamicchiropractic.com)
- It is important to realize that in such recruiting programs, even if the research which is being done is well-designed and scientifically valid (which may be open to question), the human rights of the subject are violated, nevertheless, twice before the fact by being misinformed as to the purpose and possible costs, and once after the fact by the violation of confidentiality. (dynamicchiropractic.com)
- OHRP provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by HHS. (nih.gov)
- Mr. Glantz was an advisor to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the area of legal issues concerning research with children, and has been a member of Institutional Review Boards for 15 years. (oup.com)
- The report takes issue with aspects of the federal government's regulations for research on human subjects that constitute a threat to academic freedom. (aaup.org)
- Research on human subjects conducted by college and university personnel has been governed by federal regulations since the 1960s. (aaup.org)
- A second requirement is currently in place, namely, that institutions at which, or under whose auspices, federally funded research on human subjects is to be conducted must provide assurance that they will protect the rights and welfare of the human subjects of all their research on human subjects, whatever its source of funding. (aaup.org)
- The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. (wordpress.com)
- Legal requirements to protect human subjects apply to a broader range of research than many investigators realize. (northeastern.edu)
- Please visit the Office of Human Subject Research Protection for more information. (northeastern.edu)
- When charged with "unprofessional conduct" the physicians involved said the use of the poor as research objects was a common and accepted practice. (thestar.com)
- In fact, it might seem that the ethical obligation of a clinician to treat those who appear to require it, is at odds with the ethical obligations of the researcher not to disclose or otherwise use confidential subject information. (dynamicchiropractic.com)
- The solution to this ethical dilemma is as obvious as it is unlikely to be used: if the subject's diagnosis indicates it, inform them of their condition, but specifically exclude referral to any doctor directly or indirectly associated with the research project, even if, indeed, especially if the patient chooses such an involved doctor because they have gotten to know them during the research project. (dynamicchiropractic.com)
- Ethical issues aside, recruiting patients by violating their rights as research subjects could do serious damage to the credibility of legitimate chiropractic research efforts, and ultimately to chiropractic itself, should someone in the media (Geraldo? (dynamicchiropractic.com)
- Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator" Journal of the American Board of Family Practice Vol. 7 Iss. (bepress.com)
- In my recent book, Thieves of Virtue , I catalogued a part of this sorry history and its relation to contemporary research practices. (thestar.com)
- Interestingly, consensus was reached on many areas of the draft document, but a fundamental debate existed about whether the declaration should be aspirational or should strive to be more pragmatic, similarly, there was clear notion that double standards should not exist in research practices around the globe. (wordpress.com)
- Allows researchers to refuse to disclose names or other identifying characteristics of research subjects in response to legal demands. (nih.gov)
- Every organization that conducts research, for example a university or hospital, must have an IRB. (psychcentral.com)
- If an IRB has concerns about any part of the research proposal, the committee will tell the director of the study. (psychcentral.com)
- If you agree to participate in this research study, the diagnostic and other personal information which will be obtained from you as a part of that research will be used to convince you to accept chiropractic care from this office. (dynamicchiropractic.com)
- The underlying goal of this study is to assess [18F] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) research participants. (clinicaltrials.gov)
- Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20 healthy control subjects will be recruited to participate in this study. (clinicaltrials.gov)
- A linguist seeking to study language development in a preliterate tribe was instructed by the IRB to have the subjects read and sign a consent form before the study could proceed. (aaup.org)
- This information must be encrypted to ensure the privacy of the research subjects and only available to the responsible of the study. (wordpress.com)
- These digital platforms exist in hospitals, schools, research institutions and many others. (wordpress.com)
- The researcher must attend to these concerns before submitting the research proposal to a funding agency. (psychcentral.com)
- The funding agency also judges the scientific importance of a research proposal, and how the researcher will learn from it. (psychcentral.com)
- Several groups who are not part of the research team examine both the scientific plan and procedures to protect the interests of participants before an investigator may begin the research. (psychcentral.com)
- Under the IRB review procedure, an investigator must obtain prior IRB approval of his or her research protocol before the research can be undertaken. (aaup.org)
children as research subjects
- The truly shocking aspect of last week's revelations concerning the use of native children as research subjects is that we were shocked by the revelation. (thestar.com)
- Is using children as research subjects ever justified? (oup.com)
- What can we learn from the history of the use and abuse of children as research subjects? (oup.com)
- Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD and AD subjects will be compared with the HC subjects. (clinicaltrials.gov)
- These disclosure issues in the Helsinki Accords are particularly relevant to programs which purport to be research but are, in fact, primarily designed to recruit patients. (dynamicchiropractic.com)
- Once adopted the Declaration of Helsinki at the next WMA GA will set the new standards of medical research around the globe. (wordpress.com)
- Bioethicists in this area typically focus upon future goods to be obtained by research over the needs, safety and choices of patients in medicine. (thestar.com)
- NIDDK strongly recommends that you contact the Program Director responsible for your area of research . (nih.gov)
- As for social media, while it might not be necessary to explicitly included in the #DOH, it is still an area that requires consideration in the areas of medical research. (wordpress.com)
- The protection was insufficient, in the 1980s, to protect the lives of research volunteers like Jesse Gelsinger and Ellen Roche. (thestar.com)
- Many "checkpoints" ensure that research meets strict scientific guidelines and follows rules that protect the subject. (psychcentral.com)
- Short-term studies should focus on research questions that are likely to have high clinical impact. (nih.gov)
- Each ARS research project has related subjects of investigation. (usda.gov)
- Other hot points were on reporting of research trials-content of the reporting and making it mandatory. (wordpress.com)
written informed consent
- All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. (clinicaltrials.gov)
- A political scientist who had bought a list of appropriate names for a survey of voting behavior was required by the IRB to get written informed consent from the subjects before mailing them the survey. (aaup.org)
- The application of the federal regulations to research methodologies that present no serious risk of harm to research subjects has long been of concern to Committee A, which will continue to keep this matter and other troubling features of the regulations on its agenda. (aaup.org)
- Moreover, no provision is made in the regulations for an appeal process in case a research protocol is rejected by a campus IRB. (aaup.org)
- It is consistent with the regulations for an institution to provide an appeal process, but where the research is to be federally funded, or the institution has opted for a single review procedure that requires IRB approval, the appeal process would have to be to yet another IRB. (aaup.org)
- For more than a century, the medical and pharmaceutical research industries have routinely exploited the poor. (thestar.com)
- For more than 100 years medical and pharmaceutical research industries have routinely used the poor and powerless as research subjects. (thestar.com)
- At that time, a mini-scandal had broken out over medical research on the young inmates of an orphanage in the United States. (thestar.com)
- While the argument of including nitty-gritty details is valid for many aspects of the document, in our opinion, digital platforms are a reality of medical research and care-and often the principles of confidentiality, privacy & consent are not implemented in the case of digital data, especially when looking beyond clinical trials and health systems research. (wordpress.com)
- You can be certain that a range of persons, both scientists and others, have reviewed any IRB-approved research that you may be asked to join. (psychcentral.com)
- You can also review the wide range of NIDDK Research Resources to help clinical researchers work more efficiently, lower costs, and improve effectiveness. (nih.gov)
- For a variety of reasons, which we will return to, most academic institutions have adopted the same protection for subjects of research that is not federally funded as for subjects of federally funded research, that is, they require advance approval of the research by an IRB. (aaup.org)
- The same attitude today transforms the needy and poor from patients into research objects across the industrial world. (thestar.com)
- There I began with an address by Canadian physician William Osler , who in 1907 condemned the use of poor patients as research objects. (thestar.com)
- What the report did was distinguish the "patient" in care from the "subject" of research forgetting, conveniently, most research subjects are also patients. (thestar.com)
- We like to think the transformation of needy patients into research objects is only history. (thestar.com)
- Thus a number of well-known bioethicists have called for the forced enrolment of patients in research trials as a "civic obligation," in the words of England's John Harris . (thestar.com)
- After participating, their right to privacy is violated by using their "research data" to convert them into "patients. (dynamicchiropractic.com)
- On average, about --% of the subjects who have participated in this research in the past have subsequently become our chiropractic patients and have incurred costs for chiropractic care ranging from $--- to $---, with an average expenditure of $---- per month. (dynamicchiropractic.com)
- As Jill Fisher writes in Tissue Economies , in the United States it is not uncommon for those who can't afford health insurance to have enrolment in a research program a precondition of their treatment. (thestar.com)
- Ultimately, as a direct result of participating, a certain percentage of the "subjects" sustain treatment costs which they were not informed about beforehand. (dynamicchiropractic.com)
- Help students learn about narrowing and refining research by demonstrating this site on a projector or interactive whiteboard. (teachersfirst.com)
- How should children participate in the decision to be involved in research? (oup.com)
- Subjects will be requested to return for this second scan until enough second scan data is collected to evaluate the imaging outcome measure for reproducibility. (clinicaltrials.gov)
- The system must be encrypted and ensure that only the responsible for the research is accessing that data. (wordpress.com)
- Dr. Otmar Kloiber stated a strong position about open access to research and that all findings should be reported and made available-the outcomes and the lack of outcomes. (wordpress.com)
- At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2 AD subjects and up to 5 HC subjects) may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. (clinicaltrials.gov)
- Listed below are the subjects of investigation currently conducted at this location. (usda.gov)
- An IRB may demand that a change be made in a research protocol as a condition of approval. (aaup.org)
- If time permits, have students research a specific topic and create a multimedia presentation using one of the many TeachersFirst Edge tools reviewed here . (teachersfirst.com)
- It has, however, been largely complicit in the advance of the frail patient as a research object. (thestar.com)
- To perform blood metabolite characterization of [18F] CFPyPB in subjects with PD, AD and HC to determine the nature of metabolites in assessment of [18F] CFPyPB as a single positron computed tomography (PET) brain imaging agent. (clinicaltrials.gov)
- the subject is simply not told the whole truth as to the purpose of their being recruited. (dynamicchiropractic.com)
- If it is likely that there will be costs to them -- physical, psychological or financial -- subjects must be informed of exactly what and how much those costs will be. (dynamicchiropractic.com)