Main Glossary of IRB Regulatory Terms

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ADVERSE EFFECT An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). {as OHRP}

ANONYMITY A research condition in which no one, including the researcher, knows the identities of research participants.

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. {as OHRP}

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 [Federal Policy 45 CFR 46.103]. {as OHRP}

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. {as OHRP} The Alverno President has assumed this designation.

AUTONOMY Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. {as OHRP}

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. {as OHRP}

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. {as OHRP}

BENEFIT A valued or desired outcome; an advantage. {as OHRP}

CE See: Covered Entity.

CFR Stands for Code of Federal Regulations - This is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal government. The Code is divided into 50 titles that represent broad areas subject to Federal regulation. For research conducted at Alverno the title that most frequently applies is: 45 CFR - Department of Health and Human Services. (See: Common Rule [Pdf file])

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. [45 CFR 46.401(a)] {as OHRP}

COMMON RULE (Pdf file) The common federal policy for protecting human subjects, promulgated in regulation and contained in the CFR, that outlines the provisions regarding the review and approval of research, is generally referred to as the "Common Rule." It was signed by 17 federal agencies, including the VA, which are thus bound by it. The DHHS "Common Rule" is found at 45 CFR 46 Subpart A (Pdf file). Comparable regulations for the VA are found at 38 CFR 16 & for FDA are 21 CR 50 and 56. See also: "Federal Policy" and "CFR."

COMPENSATION Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research. (Compare: Remuneration). {as OHRP}

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) {as OHRP}

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. {as OHRP}

CONSENT See: Informed Consent.

CONTINUING REVIEW An IRB review of a study that occurs within no more than a year of the previous or initial RB approval. May also include explicitly specified continuous monitoring procedures. All research, except for exempt research, is necessarily subject to continuing review. Continuing review address, among other things, risks, potential benefits, informed consent, and safeguards for human subjects. In particular, the review addresses whether any new information has emerged that could alter the IRB’s previous determinations, especially with respect to risk to subjects. [adapted from OHRP guidance 1/17/09 on continuing review]

CONTRACT An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant. (Compare: Grant) {as OHRP}

COVERED ENTITY Refers to institutions regulated by the Privacy Rule and Security Standards established by the Health Insurance Accountability and Portability ACT (HIPAA). The intent of the legislation to is to protect the privacy of an individual’s health records. To be a Covered Entity (CE) a health care provider, payer, or clearinghouse must conduct certain types of electronic billing.

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.) {as OHRP}

DECENTRALIZED REVIEW A formal process for determination of exemption from IRB review that the Alverno IRB has explicitly delegated to a particular individual or Research Review Committee.

DECEPTION Intentionally leading participants to have false beliefs about the study’s purpose and/or the situational context in which they are responding. Deception would only be used when the researcher believes that participant knowledge about the study would alter participants’ behavior or responses in the study in such a way as to undermine the goals of the research. Thus, deception creates conditions that can lead to invasion of privacy. Intentionally withholding information about a study’s purpose is closely related to deception in that both generally limit the capacity of the participant to give full informed consent. Any use of deception or withholding of information would be both explicitly justified and determined necessary in the context of an IRB review process. Participants would be debriefed as soon as it is feasible.

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. It was revised in 1975 and 1989. {as OHRP}

DE-INDENTIFIED DATA (1) Under the federal Health Insurance Portability and Accountability Act (HIPAA) specific requirements were mandated for insuring that recorded Protected Health Information (PHI) that can be linked to an individual will not be accessed by unauthorized persons. Specific standards for de-identification of data specify procedures for how Protected Health Information may be recorded in an anonymous fashion so that it may be legally accessed by persons (such as researchers) who do not otherwise have access to the data and/or recorded for use in a less secure location. Health information that has been stripped of specifically designated identifiers is not subject to the regulations. However, in releasing information, the covered entity must also not have actual knowledge that the remaining information could be used alone or in combination with any other information to identify an individual who is subject of the information. See: 45 CFR §164.514(b) {Adapted from Bankert & Amdur (Eds.) Chapter 8}

DE-INDENTIFIED DATA (2) The application of the above HIPAA standard to define anonymity of any research data on individual whether or not it is covered under HIPAA. This extension of the standard is of particular relevance to whether sensitive recorded information would meet standards for Category 2 Exempt Research.

DHHS A federal agency: U.S. Department of Health and Human Services; formerly the Department of Health, Education and Welfare. (DHEW) {as OHRP}

EMANCIPATED MINOR A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation. (See also: Mature Minor) {as OHRP}

EQUITABLE Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed. [Federal Policy 45 CFR 46.111(a)(3)] {as OHRP}

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 being studied in the group's own environment, often for long periods of time. (See also: Fieldwork) {as OHRP}

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 45 CFR 46.110] {as OHRP}

EXEMPT RESEARCH 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. {as OHRP}

FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT OF 1974 FERPA). Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education. See the Alverno Student Handbook.

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. {as OHRP}

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" [Pdf file]) {as OHRP}

FERPA  see Family Educational Rights and Privacy Act of 1974.

FIELDWORK Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes. (distinguished from laboratory or controlled settings) (See also: Ethnographic Research) {as OHRP}

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 45 CFR 46.108] {as OHRP}

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) {as OHRP}

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)] {as OHRP}

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT Federal legislation that includes a section that mandated standards for for the secure storage and transmission of health information in electronic form. These rules, 45 CFR 160-164, were specified as applying to covered entities (CE) that conduct certain types of electronic billing, but for these entities cover all individually identifiable health information, regardless of how it is communicated. {Adapted from Bankert & Amdur (Eds.). Chapter 8}

HELSINKI DECLARATION See: Declaration of Helsinki. {as OHRP}

HIPAA See: Health Insurance Portability and Accountability Act.

HUMAN RESEARCH PROTECTION PROGRAM The systematic and comprehensive approach by an organization to ensure human subject protection in all research. The implementation of any part of the program may be delegated to specific committees, individuals or entities by the organization.

HRPP See: Human Research Protection Program.

HUMAN SUBJECTS Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. [Federal Policy 45 CFR 46.102(f)] {as OHRP}

INCAPACITY 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. (See also: Incompetence) {as OHRP}

INCOMPETENCE Technically, a legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity. (See also: Incapacity) {as OHRP}

INDIVIDUALLY IDENTIFIABLE INFORMATION The identity of the subject is or may readily be ascertained by the investigator or associated with the information [Federal Policy 45 CFR 46.102(f)(2)]. {as OHRP Decision Chart}

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]. {as OHRP}. Also see Belmont Report.

INSTITUTION (1) Any public or private entity or agency (including federal, state, and local agencies). [Federal Policy 45 CFR 46.102(b)]. {as OHRP}

INSTITUTION (2) A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children. {as OHRP}

IO See: Authorized Institutional Official.

INSTITUTIONAL OFFICIAL See: Authorized Institutional Official.

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. [Federal Policy 45 CFR 46.102(g), &.108, &.109]. {as OHRP}

INSTITUTIONALIZED Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home). {as OHRP}

INSTITUTIONALIZED COGNITIVELY IMPAIRED Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded). {as OHRP}

IRB See: Institutional Review Board.

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. {as OHRP}

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. [Federal Policy 45 CFR 46.102(c)]. {as OHRP}

MATURE MINOR Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. (See also: Emancipated Minor){as OHRP}

MENTALLY DISABLED See: Cognitively Impaired {as OHRP}

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 [Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. {as OHRP}

The definition of minimal risk for research involving prisoners differs somewhat from that given for noninstitutionalized adults. [See: 45 CFR 46.303(d)] {as OHRP}

MONITORING The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections. {as OHRP}

NATIONAL COMMISSION National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. An interdisciplinary advisory body, established by Congressional legislation in 1974, which was in existence until 1978, and which issued a series of reports and recommendations on ethical issues in research and medicine, many of which are now embodied in federal regulations. {as OHRP}

NIH National Institutes of Health: a federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research. {as OHRP}

NUREMBERG CODE A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects. {as OHRP}

OFFICE FOR PROTECTION FROM RESEARCH RISKS (OPRR) The office within the National Institutes of Health, an agency of the Public Health Service, Department of Health and Human Services, responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. {as OHRP}

OHRP Office of Human Research Protection, which is located within the Department of Health and Human Services (DHHS). It develops and implements policies, procedures and regulations required to protect human subjects involved in research sponsored by the department of Health and Human Services (HHS). 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.

PATERNALISM Making decisions for others against or apart from their wishes with the intent of doing them good. {as OHRP}

PARTICIPANTS An alternate and equivalent term for "human subjects" used to express respect for the voluntary nature of their participation in research. In context, use of the term is locally understood at Alverno to mean the same thing as "human subjects," but is not a term used in federal regulation and so is less precise when not supported sufficiently by context.

PERMISSION The agreement of parent(s) or guardian to the participation of their child or ward in research. [45 CFR 46.402(c)]. {as OHRP}

PHI See: Protected Health Information.

PHS Public Health Service. Part of the U.S. Department of Health and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA. {as OHRP}

PPRA see Protectionof Pupil Rights Amendment.

PROTECTION OF PUPIL RIGHTS AMENDMENT (PPRA). Federal law that requires written parental informed consent for minor student participation in any U.S Education Department funded survey, analysis, or evaluation that reveals particular categories of sensitive information (whether or not it is defined as research). It includes parental rights to inspect associated instructional materials. 

PRESIDENT'S COMMISSION President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. An interdisciplinary advisory group, established by congressional legislation in 1978, which was in existence until 1983, and which issued reports on ethical problems in health care and in research involving human subjects. {as OHRP}

PRINCIPAL INVESTIGATOR The scientist or scholar with primary responsibility for the design and conduct of a research project. {as general definition at OHRP}

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)]. {as OHRP}

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. Also includes information provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [Federal Policy 45 CFR 46.102(f)(2)]. {adapted OHRP Decision Chart}

PRIVACY Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. {as OHRP}

PROTECTED HEALTH INFORMATION Individually identifiable health information that is held or transmitted by a covered entity (or its business associate) in any form or media, whether electronic, paper, or oral. Individually identifiable health information includes common identifiers such as name, address, social security number, date of birth, or any other information that can be used to identify the individual. {Adapted APA online)

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 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. {as OHRP}

REMUNERATION Payment for participation in research. NOTE: It is wise to confine use of the term "compensation" to payment or provision of care for research-related injuries). (Compare: Compensation) {as OHRP}

RESEARCH A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)]. {as OHRP} Note: the IRB only holds jurisdiction over Human Subjects Research. (Also see Decision Chart)

RESEARCH REVIEW COMMITTEE A standing committee at Alverno delegated by the Alverno IRB to conduct determinations of exemption of research from IRB review. When located within a School at Alverno (e.g., School of Nursing), the Committee also ensures that student research conforms to the School’s educational policy for protecting human subjects. {Alverno}

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. {as OHRP}

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 45 CFR 46.108(e)] {as OHRP}

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) {as OHRP}

RRC See: Research Review Committee.

SUBJECTS (HUMAN) See: Human Subjects.

SURVEYS Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures. {as OHRP}

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. {as OHRP} (Also see "voluntariness" in the Belmont Report.