This glossary is based on the IRB Guidebook published by the OHRP in 1993. It has been modified and updated to reflect changes to IRB policies in the intervening years, but the original can be found here.
Adverse Event-an undesirable and unintended, although not necessarily unexpected, result of intervention e.g., intestinal bleeding associated with aspirin therapy.
Assurance-a formal written binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.
Belmont Report-a statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects.
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 risk of harm.
Cognitively impaired-having a psychiatric disorder or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.
Compensation-payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
Co-investigator-responsible for any of the following for a project involving human subjects: the project's design, implementation, data collection, and/or data analysis.
Competence-a legal term used to denote capacity to act on one's own behalf; the ability to understand the 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.
Conflict of Interest-an investigator is deemed to have a conflict of interest whenever the research, spouse, depending child, or other family members living in the household: Is involved in a financial arrangement with the sponsor where the outcome of the study could result in a substantial economic benefit; acts as an officer, director, or agent of the sponsor; has equity interest of 5% or more of the sponsor; receives payment or other considerations from the sponsor of $10,000 or more; or independently identified a non-financial conflicting interest.
Consent-see informed consent.
Contract-an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing funds.
Control (Subjects)-subjects used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
Debriefing-giving subjects previously undisclosed information about the research project following completion of their participation in research.
Deception --occurs when a researcher intentionally misleads participants about the nature, research question, or methodologies of a study. Withholding details about the specifics of your hypothesis until after a participant has completed the task does not constitute deception.
Declaration of Helsinki-a code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries.
Dependent Variables-the outcomes that are measured in an experiment. Dependent variables are expected to change as a result of an experimental manipulation of the independent variable(s).
Descriptive Study-any study that is not truly experimental e.g., correlational studies, record reviews, case histories, and observational studies.
DHHS-a federal agency: US Department of Health and Human Services.
Exempt-Federal regulations define certain categories of research as being exempt from IRB review. The IRB must make this determination.
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.
Experimental Study-a study in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation.
FDA-a federal agency: Food and Drug Administration; presently part of the DHHS (see above).
Federalwide Assurance (FWA)-agreement that fulfills the requirement of 45 CFR part 46 approved by the Secretary of Health and Human Services. Gettysburg has an approved number.
Full Board Review-research that is reviewed at a convened meeting at which a major of the membership of the IRB are present, including at least one member who primary concerns are in nonscientific areas. For the research to be approved, it must receive approval of a majority of those present in the meeting.
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.
HIPPA-Health Insurance Portability and Accountability Act of 1996 that protects the privacy of a research participant's health information.
Human Subjects-individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under federal regulations, human subjects are defined as : living individuals about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.
Independent Variables-the conditions of an experiment that are systematically manipulated by the investigator.
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.
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 research.
Institutional Review Board-a specifically constituted review board established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
Longitudinal Study-a study designed to follow subjects forward through time.
Minimal Risk- a risk 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.
NIH-National Institute of Health: a federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is charged with carrying out biomedical and behavioral research.
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, etc.).
Null Hypothesis-the proposition, to be tested statistically, that the experimental intervention has no effect, meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.
Nuremberg Code-a code of research ethics developed during the trials of Nazi war criminals following WWII and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
OHRP-Office of Human Research Protections; the office within NIH, an agency of the Public Health Service, DHHS, responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects.
Principal Investigator (PI)-the researcher with primary responsibility for the design and conduct of a research project.
Prospective Studies --designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
Protocol-the formal design 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 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.
Random Assignment-assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically. It is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.
Research-- A systematic investigation (i.e., the gathering and analysis of information) 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.
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. Case control studies are an example of this type of research.
Review of Research-- The concurrent oversight of research on a periodic basis by an IRB. In addition to at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.
Statistical Significance --A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true. Or, more simply put, the probability of coming to a false positive conclusion.
Surveys--studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Variable--An element or factor that the research is designed to study, either as an experimental intervention or a possible outcome (or factor affecting the outcome) of that intervention.