Levels of Review
- Exempt Research
- Expedited Research
- Full Committee Research
- OHRP Human Subject Regulations Decision Charts
Although the category is called "exempt," this type of research does require IRB review and registration. The exempt registration process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into six (6) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of Exempt research are:
- anonymous surveys or interviews
- passive observation of public behavior without collection of identifiers
- retrospective chart reviews
- analyses of discarded pathological specimens without patient identifiers.
For the exempt review categories click here.
To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
- studies involving collection of hair, saliva or dental plaque samples,
- studies of blood samples from healthy volunteers,
- analyses of voice recordings
- studies of existing pathological specimens with patient identifiers.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.
Applicability of Expedited Review:
- Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
- The categories in this list apply regardless of the age of subjects, except as noted.
- The expedited review procedure 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' 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.
- IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review utilized by the IRB (i.e., expedited or full committee review).
- Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
For the expedited review categories click here
Full Committee Research
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects.
The majority of biomedical protocols submitted to the IRB require full Committee review. Please see the meeting deadline Calendar for submission deadlines and meeting dates for all three IRB Committees.