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.
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.
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 parent consent form is read and signed by the parent(s) or legally authorized representative allowing the child to participate. Templates for this form can be found in Consent Templates.
Participants whose life situation puts them at a higher probability for harm. The level of risk is assessed in context with the research study. For example, the probability that a "normal" population would react badly to a questionnaire about parental relationships is not high, while abused children may be more sensitive to this type of questionnaire. However, abused children (who are not suffering from any injury) may not be "at risk" in a study that tests their ability to learn a math problem using a new method.
A statement of ethical principles governing research involving human participants issued by the National Commission for the Protection of Human Subjects in 1978.
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.
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.
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)]
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.
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. Please see "Diminished capacity to consent" below.
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.
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)
Initial approvals for full board protocols are active for one year and must be reviewed annually for the protocol to remain active. Expedited and exempt protocols do not need annual continuation review.
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.
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.
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.)
Diminished capacity to consent
Participant whose cognitive capacity may be impaired to the state where they are unable to fully understand the consent process and make a decision regarding their ability to participate. Ability to consent can be assessed through a Capacity to Consent form and if a participant is unable to consent, they should have representation from legally authorized representative. The legally authorized representative is provided with a consent form and the participant is provided with an assent form (where appropriate).
Researchers are required to obtain documentation verifying that participants provided consent in order to participate. Documentation can be either a signed paper document or can be obtained using an electronic signature. Documentation can be waived if the protocol meets specific requirements. See When Consent is not Required for more information.
Certain types of research may qualify for exemption according to federal regulations contained in 45 CFR 46. Once the IRB-SBS determines that a study is exempt, informed consent is not required. Exemptions are valid from date of IRB review. Only the IRB-SBS can determine if a study is exempt.
Federal regulations (45 CFR 46.110) 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 HRPP 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.
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.
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.
Personal information that identifies an individual. For example, an individual's name, birthdate, social security number, phone number, or address could all be considered identifiers. For a complete list, please see Identifiers.
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 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. All key personnel are required to obtain CITI certification.
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.
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 risk-sensitive populations varies somewhat from that for "normal" populations.
A change made to the previously approved protocol or consent form. Modifications require IRB review and approval. Modifications which are determined by the IRB chair to be minor (minimal or no risk to participants) may be expedited.
Normal Educational Practice
Activities that happen normally in a classroom in accordance with best educational practice. This term is a category for exemption.
Written text describing what will be told to subjects when oral consent is necessary. Please see Documenting consent above.
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.
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.
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.
A systematic investigation designed to develop or contribute to generalizable knowledge.
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.
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.
Participants whose ability to consent is limited and/or face the possibility of coerced or perceived coerced consent. In the federal regulations, fetuses, prisoners, and minors are listed specifically because of their inherent inability to consent either for legal or practical reasons. Though not listed in the federal regulations specifically, there are many other groups that can be considered “vulnerable populations” such as individuals who are cognitively impaired. Vulnerability can be driven by the context of the research study; for example, an employee may be considered “vulnerable” if the researcher is their supervisor, presenting a potential for coerced or perceived coerced consent.
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.