Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or person who is cognitively impaired) to participate in research.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1979.
A person who has not attained the legal age for consent to treatments or procedures involved in the research.
Use of a credible threat of harm or force to control another. Pertaining to unacceptable subject recruitment methods which involve undue influence or indirect pressure for participation from a subject. (For example, an employee may feel pressure from their supervisor if told to participate in a research project or a subject may feel coerced to participate if the payment were unusually large.)
The central federal policy adopted “in common” by 16 federal departments and agencies (and concurred, with some modifications, by the FDA) that support and/or conduct research involving human subjects. The adoption of the federal policy in 1991 implements a recommendation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research that all federal departments and agencies “adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR 46, Subpart A), as periodically amended or revised, while permitting additions by any department or agency that are not inconsistent with these core provisions” (OPRR Guidebook, Chapter 2).
Confidentiality refers to data. It is the treatment of information already revealed and states that there is an expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without authorization.
See Informed Consent
Co-Principal Investigator. Any individual who collaborates with the principal investigator in the design and/or conduct of a research project, including those with access to data. The PI has the ultimate responsibility for the conduct of a research project, but the Co-PI is obligated to ensure the research is conducted in compliance with applicable rules and regulations for human research protections.
Refers to information that is collected for analysis or used to reason or make a decision.
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.
Exempt does not mean review is not required. Some research may be eligible for an exemption from IRB review (expedited or full board review) according to the Common Rule codified in 45 CFR 46.101(b). Only minimal risk research qualifies for exemption and shall only be determined by the IRB, not the investigator.
A level of review by the committee. The Common Rule codified in 45 CFR 46.110 specifies that research activities may be eligible for expedited review if the protocol involves only minimal risk or a previously reviewed protocol is receiving modifications that are only minor. Expedited review is carried out by the IRB Chair or by one or more experienced reviewers designated by the chair. Such expedited reviews have the force of full reviews, except that if the protocol is found not acceptable, then it must receive review by the full committee; the chair or designee alone cannot reject a protocol.
A level of review by the committee. This category of review applies to all research that does not fall under exempt or expedited review categories. In general, full board review will be required for all projects involving: a) more than minimal risk to participants, b) the deception of subjects, c) sensitive behavioral research (such as research relating to illegal or sexual activity), and d) at-risk populations (e.g., pregnant women, human fetuses, neonates, prisoners, children, individuals with cognitive impairments).
Federal Wide Assurance. A written documentation of an institution’s commitment to comply with the federal regulations that establishes standards for human subjects research. The FWA is submitted to and approved by the Office for Human Research Protection (OHRP). Boise State University has received an FWA.
An individual who is authorized under applicable state or local law to consent on behalf of another person (e.g., children).
A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. 45 CFR 46.102(f)
An individual’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. 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 committee formed to ensure the protection of human subjects in research.
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. 45 CFR 46.102(h)
The probability and magnitude of harm or discomfort anticipated in the 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. 45 CFR 46.102 (i)
Office of Human Research Protections. The office under the Department of Health and Human Services (DHHS) responsible for monitoring and promoting compliance with regulations (45 CFR 46) governing the ethical standards of biomedical and behavioral/social science research involving human subjects.
Office of Research Compliance. The administrative office responsible for oversight of the human subjects review process.
Principal Investigator. The PI is the individual with the primary responsibility for the design and conduct of a research project. The IRB requires principal investigators to be a Boise State University full, assistant, or associate professors. Visiting faculty, adjuncts, instructors, and staff may be listed as a principal investigator as long as an eligible PI is listed as the co-principal investigator. If you are not affiliated with Boise State, the IRB will review your research for approval, but you may be charged. Please contact the Office of Research Compliance for additional information. If the IRB protocol application is part of a grant requesting federal money, the PI must fall under the Boise State PI eligibility policy #5020.
Privacy refers to persons. It is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
The formal design or plan of an experiment or research activity to be reviewed by the IRB committee for approval. Often referred to as just “protocol.”
Payment for participation in research.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR 46.102(d)
The Office for Human Research Protections (OHRP) has identified populations in need of special protections in research, including fetuses, pregnant women, children and minors, and prisoners. IRBs must apply additional regulations and criteria and give special consideration to recruitment, subject selection, informed consent, privacy, and confidentiality issues before approving research involving these populations.