Types of IRB Review
- The level of risk to subjects associated with the project
- The type of research being conducted (e.g., an educational intervention, a survey, etc.)
- The sensitivity of the research questions or complexity of the research design
- The involvement of vulnerable populations as research subjects
- Vulnerable populations are individuals that are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. With the revised Common Rule (effective July 19, 2018), pregnant women have been removed as a vulnerable population.
Although the category is called “exempt,” this type of research does require IRB review to determine exempt status. To qualify, research must fall into one of eight (8) federally defined exempt categories . These categories present the lowest amount of risk to potential subjects because, general speaking, they involve either collection of anonymous or publicly available data, or the use of the least potentially harmful research experiments.
A “Limited IRB review” is required under the 2018 Revised Common Rule for certain Exempt human subjects research categories. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data (categories 2(iii) and 3(i)(C)).
The “Limited IRB reviewer” must determine that, per 45 CFR 46.111(a)(7), “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”
To qualify for expedited review, research must fall into one of nine (9) federally-defined expedited categories and present no more than minimal risk to research participants. “Minimal risk” is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
An investigator must be aware of the following information regarding expedited research:
- The categories in the expedited research list apply regardless of the age of subjects, except as noted.
- The expedited review process may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects in terms of financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
- The expedited review procedure may not be used for classified research involving human subjects.
- The standard requirements for informed consent (or its waiver, alteration, or exception) apply.
Federal regulations and institutional policy require an IRB full board review for applications where the research involves more than minimal risk to human subjects or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, the IRB may require full board review when the research involves: (a) vulnerable populations (particularly prisoners); (b) sensitive topics (e.g., illegal behaviors which may require an NIH Certificate of Confidentiality to protect subject data from compelled disclosure); (c) research involving genetic testing; and/or (d) a complex research design requiring the expertise of multiple board members to evaluate.