|Institutional Review Board(IRB) for the Protection of Human Subjects|
Authorized Institutional Official - An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.
Belmont Report - Under the auspices of the former United States Department of Health, Education, and Welfare (later renamed the Department of Health and Human Services), the Belmont Report was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and was entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research." The report was created on April 18, 1979 and gets its name from the Belmont Conference Center where the document was drafted. The conference center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and is now operated by Howard Community College. The Commission was initiated in response to public outrage over revelations about the Tuskegee Syphilis Study (1932–1972).
Beneficence - An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Children - Persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. In Texas, a child is anyone under 18 years of age. See also Vulnerable Subjects.
Cohort - A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
Common Rule - In 1991, 14 other Federal departments and agencies joined the U.S. Department of Health and Human Services in adopting a uniform set of rules for the protection of human subjects of research, identical to subpart A of 45 CFR 46. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.”
Compensation - Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research. (Compare: Remuneration.)
Competence - Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. (See also: Incompetence, Incapacity.)
Confidentiality - Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
Declaration of Helsinki - The Declaration of Helsinki, developed by the World Medical Association, is a set of ethical principles for the medical community regarding human experimentation. It was originally adopted in June 1964 and has since been amended multiple times.
DHHS - A federal agency: U.S. Department of Health and Human Services; formerly the Department of Health, Education and Welfare (DHEW).
Ethics Advisory Board - An interdisciplinary group that advises the Secretary, HHS, on general policy matters and on research proposals (or classes of proposals) that pose ethical problems.
Exempt - Whether or not a research activity is exempt is determined by the IRB, NOT the researcher. In general, the types of research activities that will be considered exempt are:
Expedited Review - Certain kinds of research can be reviewed more quickly by one or more experienced IRB members either because the research is found by the reviewer(s) to involve no more than minimal risk, or it involves minor changes in previously approved research during the period (one year or less) for which approval was authorized. Whether or not review of a research activity is expedited is determined by the IRB, NOT the researcher.
45 CFR 46 - Refers to the Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects. 45 CFR 46 is the the U.S. Government policy for ensuring that the human subjects of behavioral and biomedical research receive the protections to which they are entitled and to minimize risks to them.
Federal Policy (The) - The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy. (Also known as the "Common Rule.")
Full Review - Research that potentially poses more than minimal risk to human research subjects must be reviewed by the entire IRB.
Grant - Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant. (Compare: Contract.)
Human Subject - A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information; i.e., information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place or information provided for specific purposes that the individual can reasonably expect will not be made public.
Human Subject Research - Any research or clinical investigation that involves human subjects.
Informed Consent - Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of any actions. The individual needs to be in possession of all of her/his faculties, such as not being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting. Impairments include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems.
Institutional Assurances - Formal documentary assurance submitted by an institution to the U.S. Office for Human Research Protections attesting to the institution’s compliance with the requirements set forth in 45 CFR 46. Institutions engaged in research which is covered by 45 CFR 46 and which is conducted or supported by a federal department or agency must provide written assurance satisfactory to the department or agency head that it will comply the policy.
Institutional Review Board - An independent administrative body established to protect the rights and welfare of human research subjects. It consists of at least five members from varied disciplinary backgrounds who are qualified to review research. Membership should be diverse, with at least one member having a scientific background and at least one having a nonscientific background. Members should not participate in decisions in which they have conflicts of interest. People with specialized expertise may be invited to advise on specific reviews where the body lacks expertise.
IRB - Abbreviation for Institutional Review Board.
IRB Approval - The determination of the IRB that a research activity has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
Justice - An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
Minimal Risk - The probability and magnitude of harm or discomfort anticipated in research activity that are no greater than those encountered in daily life or the performance of routine physical or psychological examinations or tests.
Nonaffiliated Member - Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
Normal Volunteers - Volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition. "Normal" may not mean normal in all respects. For example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, patients with heart disease but without diabetes may be the "normals" in a study of diabetes complicated by heart disease.
Nuremberg Code - A set of principles for human experimentation set as a result of the Nuremberg trials at the end of the Second World War. Specifically, they were in response to the inhumane Nazi human experimentation carried out during the war.
Privacy - Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Private information - Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Research - A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Respect for Persons - An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Review (Of Research) - The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis [Federal Policy?___.108(e)].
Surveys - Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Voluntary - Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.
Vulnerable Subjects - Human subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Vulnerable subjects must be afforded special safeguards in a study to protect their rights and welfare.
Sources: 45 CFR 46; Wikipedia; Sapp & Martin, 2005.
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