Types of IRB Review
DHHS regulations in 45 CFR 46.104 (Common Rule) identify several different categories of minimal risk research as being exempt from federal regulations for the protection of human subjects. This does not mean that submission to the IRB is not required. Exempt determinations must be made by qualified IRB staff or an IRB member; researchers cannot make this determination based on their own evaluation. Therefore, all human research projects must be submitted for review.
To be exempt, the research must be no greater than minimal risk and all of its activities must fall into one or more of the categories defined in the regulations. For additional information on Exempt research, including a list of the Exempt Categories, see IRB Policy: Exempt Review.
Minimal risk research that does not meet criteria for exemption may qualify for expedited review. Research must be minimal risk and its activities fall within one or more of the expedited review categories provided by the Office for Human Research Protections (OHRP). Please see HRP Expedited Review Categories for more information.
The expedited review procedure cannot be used in any of the following circumstances:
- The research involves minimal risk but does not appear in the categories of research eligible for expedited review;
- 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’ 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 research randomizes subjects to a treatment group;
- The research is classified;
- Initial review of research involving individuals with diminished capacity and use of a legally authorized representative to obtain consent; and
- The reviewer determines that the study involves more than minimal risk, even when some or all of the research appears on the expedited review category list, or the IRB determines that full board review is required even if the study is eligible for expedited review (e.g., determined to be minimal risk and some or all of the research appears on the expedited review category list).
Full Committee Review
Committee review by the convened Institutional Review Board (IRB) is required for:
- All more than minimal risk research;
- Initial study submissions that are not eligible for exempt or expedited review procedures;
- Initial study submissions that are eligible for exempt or expedited review procedures, but the IRB otherwise determined convened review is required;
- Modifications that are non-minor changes to approved research that initially required committee review;
- Continuing review for renewed approval of research that initially required committee
review. Exceptions to this requirement are listed below.
- Expedited review procedures may be used for continuing review of research previously
approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- Expedited review procedures may also be used for continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
- Expedited review procedures may be used for continuing review of research previously approved by the convened IRB as follows:
- Disapproval of a research study, regardless of review level;
- Issues in which resolution cannot be made between the IRB reviewer and the investigator.