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.
Ethics Committees, Research
Ethics Committees, Clinical
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).
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 identification, analysis, and resolution of moral problems that arise in the care of patients. (Bioethics Thesaurus)
Professional Staff Committees
The philosophy or code pertaining to what is ideal in human character and conduct. Also, the field of study dealing with the principles of morality.
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.
Clinical Trials Data Monitoring Committees
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.
Nontherapeutic Human Experimentation
Animal Care Committees
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.
Therapeutic Human Experimentation
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.
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.
Research Support as Topic
Financial support of research activities.
Those individuals engaged in research.
The privacy of information and its protection against unauthorized disclosure.
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.
Dissent and Disputes
Interference with the FREEDOM or PERSONAL AUTONOMY of another person, with justifications referring to the promotion of the person's good or the prevention of harm to the person. (from Cambridge Dictionary of Philosophy, 1995); more generally, not allowing a person to make decisions on his or her own behalf.
Peer Review, Research
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.
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.
Guidelines as Topic
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.
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.
Social Control, Formal
Multicenter Studies as Topic
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)
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.
Pharmacy and Therapeutics Committee
Decision Making, Organizational
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.
Records as Topic
"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.
Character traits that are considered to be morally praiseworthy. (Bioethics Thesaurus)
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.
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.
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
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.
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.
Attitude of Health Personnel
Randomized Controlled Trials as Topic
Community-Based Participatory Research
Collaborative process of research involving researchers and community representatives.
Value of Life
The intrinsic moral worth ascribed to a living being. (Bioethics Thesaurus)
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.
Academies and Institutes
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)
Terminology as Topic
The terms, expressions, designations, or symbols used in a particular science, discipline, or specialized subject area.
World Health Organization
Quality Assurance, Health Care
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.
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.
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.
Interviews as Topic
Reproducibility of Results
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)