Human Subjects
Glossary of IRB Terms
- 45 CODE OF FEDERAL REGULATIONS PART 46
- 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. Also referred to as 45 CFR 46.
- ADVERSE EVENT
- An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention.
- ASSENT
- Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
- AUTONOMY
- Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.
- BELMONT REPORT
- A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. It identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice.
- 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 Georgia, people under the age of 18 years are considered children (or minors).
- COGNITIVELY IMPAIRED
- Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
- 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.
- DEBRIEFING
- Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.)
- DHHS
- Department of Health and Human Services. An agency of the federal government; formerly the Department of Health, Education and Welfare (DHEW).
- ENGAGED
- Basically, an individual who will intervene or interact for research purposes with any human subjects of the research, obtain the informed consent of human subjects for the research, or obtain for research purposes identifiable private information form any source is considered engaged in the conduct of research with human subjects. See information regarding federal guidance to determine when an individual is engaged in human subjects research.
- EXPEDITED REVIEW
- Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research [Federal Policy §___.110]. More information available here »
- FDA
- Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services. More information available here »
- FULL BOARD REVIEW
- Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting [Federal Policy §___.108].
- FWA (FEDERALWIDE ASSURANCE)
- A written document submitted by an institution (not by an IRB) that is engaged in non-exempt human subjects research conducted or supported by DHHS. Through the assurance, an institution commits to DHHS that it will comply with the requirements set forth in 45 CFR 46 as well as the Terms of Assurance.
- GUARDIAN
- An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)].
- HUMAN SUBJECT
- Living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
- INDIVIDUALLY IDENTIFIABLE
- The identity of the subject is or may readily be ascertained by the investigator or associated with the information.
- INFORMED CONSENT
- A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].
- 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 social/behavioral research.
- INTERACTION
- Includes communication or interpersonal contact between investigator and subject.
- INTERVENTION
- Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
- INVESTIGATOR
- Any individual who is engaged in conducting human subjects research studies. Such engagement would include: obtaining information about living individuals by intervening or interacting with them for research purposes; obtaining identifiable private information about living individuals for research purposes; obtaining the voluntary informed consent of individuals to be subjects in research; and studying, interpreting, or analyzing identifiable private information or data for research purposes.
- IRB (INSTITUTIONAL REVIEW BOARD)
- A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or social/behavioral research.
- 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
- A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults - Risk of physical or psychological harm that is no greater in probability and severity than that ordinarily encountered in the daily lives, or in the routine medical, dental, or psychological examinations of healthy persons.
- OHRP (OFFICE FOR HUMAN RESEARCH PROTECTIONS)
- An administrative unit within the Department of Health and Human Services (DHHS). The OHRP's functions include implementation of the DHHS Regulations for the Protection of Human Subjects (45 CFR 46 ), and the guidance on ethical issues in biomedical or social/behavioral research.
- PARENT
- A child's biological or adoptive parent.
- PERMISSION
- The agreement of parent(s) or guardian to the participation of their child or ward in research.
- PREGNANCY
- The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.
- PRINCIPAL INVESTIGATOR
- The scientist or scholar with primary responsibility for the design and conduct of a research project.
- PRISONER
- An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)].
- PRIVATE INFORMATION
- Includes 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).
- PROTOCOL
- The formal design or plan of an experiment or research activity, specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes but not limited to a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
- 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.
- RISK
- The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." (See also: Minimal Risk.)
- 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.
