Adverse Effect: An undesirable and unintended, although not necessarily unexpected result, of an intervention or therapy.
Anonymity: A research condition in which no one, including the researcher, knows the identities of the research participants. Not the same as confidentiality.
Assent: 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: The personal capacity to consider alternatives, make choices, and act without undue influence or interference from others.
Beneficence: An ethical principle that requires an obligation to protect research participants 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 treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.
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.
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. Not the same as anonymity.
Continuing Review: An IRB review of study that occurs within no more than a year of the previous or initial IRB approval. A current research study that goes beyond 12 months must be reviewed annually.
Debriefing: Giving subjects previously undisclosed information about the research project following completion of their participation in research.
Deception: The intentional withholding of information from participants, or deception about the study’s purpose and exact nature, that is deemed necessary by the researcher in order to meet the study’s goals. Deception should only be used when the researcher feels that participant knowledge about the study would alter participants’ behavior or responses in the study. Deception should not cause any adverse consequences to the participants, and participants should be debriefed after running the study. A study that cannot justify the use of deception may not receive IRB approval.
Ethnographic Research: Ethnography is the study of people and their culture. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or group’s own environment, often for long periods of time.
Expedited Review: Review of a 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 changes in approved research.
Exempt Review: Research determined through an IRB sanctioned request for exemption to fit within specific categories of minimal risk research that are articulated in federal regulations. Once a research study is determined to be exempt, data collection may begin, which is why it is said to be exempt from IRB review.
Full Board Review: Review of proposed research at a convened meeting at which a majority of the membership of the IRB is 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.
Generalized Knowledge: Results gained from research that can be applied to a specific study to groups or situations beyond those actually studied.
Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.
Incapacity/Incompetence: Refers to a person’s mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence.
Individually Identifiable Information: The identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Informed Consent: Is 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.
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 behavioral research.
Intervention: Includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
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.
Legally Authorized Representative: A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
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.
Monitoring: The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.
OHRP: Office of Human Research Protections, which is located within the Department of Health and Human Services (DHHS). It develops and implements policies, procedures, and regulations required in protecting human subjects involved in research sponsored by the department of Health and Human Services. OHRP provides guidance to IRB members as well as scientists and research administrators on the complex ethical issues relating to the use of human subjects in biomedical or behavioral research. OHRP also has a regulator role. It monitors and evaluates an institution’s compliance with the rules governing research subjects.
Principal Investigator: The scientist or scholar with the primary responsibility for the design and conduct of a research project.
Privacy: Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Remuneration: Payment for participation in research.
Research: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalized 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.
Retrospective Studies: Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys.
Review: 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.
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.”
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 research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.
Vulnerable Populations: Pregnant women, human fetuses, neonate of uncertain viability, or nonviable neonates, institutionalized persons, and minors.