The definitions below pertain to usage within the context of the U.Va. Institutional Review Board for the Social and Behavioral Sciences Policies and Procedures, and may therefore differ from general interpretations or definitions. Some of the definitions have been extracted from the Glossary of Terms available in the IRB Guidebook provided by the OHRP.
Anonymity
Pertains to the information that an individual has disclosed in a study with the expectation that the information has no identifiers linked to the participant and therefore cannot in any way be traced to the participant. "Anonymity" and "confidentiality" do not have the same meaning and are not interchangeable.
Assent
Agreement by an individual not competent to give legally valid informed consent (i.e. a child or cognitively impaired person). Ex: to obtain consent for research involving a child between the ages of 7 and 18, an assent form written in language understandable to the child is signed by the child, and a separate Child Consent form is read and signed by the parent(s) or legally authorized representative allowing the child to participate.
At-risk
Vulnerable populations (pregnant females, fetuses or human in vitro fertilization), prisoners, and the cognitively impaired.
Belmont Report
A statement of ethical principles governing research involving human participants issued by the National Commission for the Protection of Human Subjects in 1978.
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.
Benefit
A valued or desired outcome; an advantage.
Certificate of Confidentiality
A document issued by the NIH which provides additional protections to data from legal subpoena. The Certificate provides protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical and other research. (See PHS Act §301(d), 42 U.S.C. §241(d).) For more information, look on the NIH website at the CoC Kiosk, or contact: Mrs. Olga Boikess, NIMH, 17C-02 Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, Tel: (301)443-3877. The CoC Kiosk includes background information on Certificates, application instructions for extramural and intramural investigators, frequently asked questions, and a list of contacts. For protocols which were previously approved with certificates of confidentiality, investigators must submit, at the time of renewal, a copy of the certificate of confidentiality with the packet of materials for IRB review.
Children
Persons who have not attained the legal age for consent to procedures involved in research as determined under the applicable law of the jurisdiction in which the research will be conducted. [45 CFR 46.401(a)]
Coercion
Pertaining to unacceptable participant recruitment methods which involve duress, undue inducement or indirect pressure. One example of an environment conducive to coercion involves the recruitment of employees by their employer for human participant research.
Cognitively impaired
Having either a psychiatric or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence 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.
Cohort
A group of participants initially identified as having one or more characteristics in common who are followed over time. This term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
Compensation
Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
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. "Confidentiality" and "anonymity" do not have the same meaning and are not interchangeable.
Consent (see informed consent)
Continuation
Initial approvals for projects are given for up to one year from the date of IRB review. Projects lasting longer than a year require submission of a Protocol Status Form for approval to continue. Projects extending beyond year three must be resubmitted using full protocol templates.
Control (subjects) or Controls
Subject(s) 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.
Debrief
Giving participants previously undisclosed information about the research project following completion of their participation in research. In studies involving deception, if the participants are not informed of the deception in the informed consent, the IRB-SBS requires a signed debrief form for each participant following completion of his/her participation in the study.
Deception
Withholding particular information about the research project from participants until completion of their participation when prior knowledge would adversely affect the integrity of the data gathered. IRB-SBS policy states that when deception is justified in a research study, a researcher must either inform the participant of deception in the informed consent, or provide a debrief and data release consent form following subject participation.
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 (revisions 1975, 1989.)
Exempt
Only the IRB-SBS can determine if a study is exempt. Certain types of research may qualify for exemption according to federal regulations contained in 45CFR46. Once the IRB-SBS determines that a study is exempt, informed consent is not required. Exemptions are valid from date of IRB review.
Expedited review
Federal rules (45CFR46.110) permit expedited review for certain types of research involving no more than minimal risk and for minor changes in approved research. The IRB-SBS chair or designee may determine that a project is eligible for expedited review using criteria outlined in the IRB-SBS Standard Operating Procedures. Expedited studies are reviewed by the chair or by one or more experienced reviewers designated by the chair.
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. Full board reviews are done on a twice-monthly basis. The majority of social and behavioral sciences proposals at U.Va. receive full review by the board.
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.
Human subject
(participant) Individual whose physiologic or behavioral characteristics and responses are the object of study in a research project. Federal regulations define human subjects 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.
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 measure. 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.
Investigator (see P.I.)
IRB, or 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. There are two IRBs at the University of Virginia that oversee human subject research: the Human Investigation Committee and the Institutional Review Board for the Social and Behavioral Sciences (IRB-SBS).
Key personnel
Key personnel are defined as individuals who are directly involved in conducting research with human participants, or are directly involved with handling identifiable private information related to those participants in the course of a research project, regardless of the source of research funding. Students who are directly involved in either aspect of research involving humans are considered key personnel.
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. The definition of risk for vulnerable populations varies somewhat from that for non-vulnerable populations.
Modification
A change made to the previously approved protocol or consent form. Modifications require IRB review and approval, and are submitted using Modification Forms (DOC). Modifications which are determined by the IRB chair to be minor (minimal or no risk to participants) may be expedited.
Oral consent
Written text describing what will be told to subjects when oral consent is necessary.
P.I. (principal investigator)
The researcher primarily responsible for the protocol or grant. A principal investigator must either be a U.Va. faculty member or have a U.Va. faculty member sponsor the project as faculty advisor.
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.
Project
A protocol or grant involving human subject research. Both protocols and grants involving human research must be reviewed by the IRB. The SBS approval of a grant does not provide authorization to conduct research. Should funding be granted, a separate protocol must be submitted and approved prior to recruitment of subjects.
Prospective study
Study 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.
Remuneration
Payment for participation in research.
Research
A systematic investigation designed to develop or contribute to generalizable knowledge.
Retrospective study
Research conducted by reviewing records from the past or by obtaining information about past events elicited through interviews or surveys.
Review of research
The concurrent oversight of research on a periodic basis by an IRB. In addition to the annual reviews mandated by 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.
Vulnerable populations
Pregnant females, fetuses, human in vitro fertilization, prisoners, the cognitively impaired.
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.
Revision date 10/01/05
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