Types of IRB Review
Although the category is called "exempt," this type of research does require IRB review and the determination of exemption must be made by the IRB.
The exempt determination process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into one or more of six 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 public 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 subject identifiers
- retrospective chart reviews
- analyses of discarded pathological specimens without patient identifiers
Research with minors (under the age of 18) can only be exempted under Category 1. All other research with minors cannot be exempted and must either be reviewed by expedited or full board review
To qualify for expedited review, research must fall into one or more nine federally defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and 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 reviewers cannot approve the research under expedited review, the study is referred to the committee for full board review.
Applicability of Expedited Review:
Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of these 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 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 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 1 through 7 pertain to both initial and continuing IRB review.
Full Committee Research
Proposed human subject research that 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.