Persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. In Washington, a child is anyone under 18 years of age. See also Vulnerable Subjects.
Under Federal regulations 45 CFR 46.101 (b), certain categories of activity are considered research but may be declared exempt from review by the IRB.
Certain low-risk research is exempt from the requirements in the Federal regulations concerning IRB review and approval. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants’ rights. The researcher should not make the final determination of exemption from the applicable Federal regulations or the provisions of the institution. Researchers should check with their institution’s guidelines or IRB policies to determine who will make the determination of exemption for a proposed study. Further information on exemption review categories.
For IRB purposes, the term “expedited” refers to a process, not a timeline, where the review is conducted by, typically, only one or two IRB members and not the full board.
Studies that involve no more than minimal risk for participants (no greater than the risks we would encounter in our daily lives) generally do not have to be reviewed at a convened IRB meeting. Studies that involve more than minimal risk cannot be reviewed by this expedited process and must be assigned to the next available convened IRB meeting. More information about the Expedited Review Process.
Full Board Review
Research studies involving more than minimal risk to human subjects are required by federal regulations to be reviewed by the IRB full board. Projects that are not eligible for either expedited or exempt review require a full board review.
A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information; i.e., information about behavior in a context in which an individual can reasonably expect that no observation or recording is taking place or information provided for specific purposes that the individual can reasonably expect will not be made public.
Informed consent is a legal condition whereby a person can be said to have given consent based upon an appreciation and understanding of the facts and implications of any actions. The individual needs to be in possession of all of her/his faculties and without an impairment of judgment at the time of consenting. Impairments include illness, intoxication, drunkenness, using drugs, insufficient sleep, and other health problems.
Some acts cannot legally take place without informed consent. In other cases, consent of someone on behalf of a person not considered able to give informed consent is valid. Examples of this include the parents or legal guardians of a child or caregivers.
Institutional Review Board
An independent administrative body established to protect the rights and welfare of human research subjects. It consists of at least five members from varied disciplinary backgrounds who are qualified to review research.
Abbreviation for Institutional Review Board.
The determination of the IRB that a research activity 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.
The probability and magnitude of harm or discomfort anticipated in research activity that are no greater than those encountered in daily life or the performance of routine physical or psychological examinations or tests.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Vulnerable subjects must be afforded special safeguards in a study to protect their rights and welfare.
Sources: 45 CFR 46; Wikipedia; Sapp & Martin, 2005.
Last Updated September 22, 2022