Which form to use?

DHHS Guidelines (45 CFR Part 46.101(b) and (c)) define research as exempt from further IRB review when the research involves no risk to the subject. Research that is considered exempt from Committee review must still be filed with the IRB and screened for exempt status.

Examples of exempt review research: survey interview research with adult subjects; the use of nonidentifiable laboratory specimens; review of nonidentified existing records; observation of the public behavior of subjects where there is no manipulation of the subject; and some educational testing and classroom activity.

Forms to use: Research Exempt from IRB Committee Review Application Form

Use the Exempt Review Categories of Research to decide which exemption category might apply to your research and which form to then use. If you don't see a category for your research, expedited or full-committee review is probably required.

To qualify for expedited review (see 45 CFR 46.110), an activity must:

1. involve no more than minimal risk, and
2. be found on the list of Expedited Review Categories of Research

Minimal Risk: "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (from 45 CFR 46.102(i)). More about minimal risk

Examples of research eligible for expedited review : non-invasive recording of data from subjects; minimal blood draw amounts; voice recordings; non-stressful research on individual or group behavior; and moderate exercise by healthy volunteers.

Form to use:
Health & Medical/Biological Application Form, or
Social & Behavioral Sciences Application Form

To request expedited review: Review the Expedited review categories of research and indicate the category number that applies to the research in either Section 12 (Social Sciences form) or 16 (Health & Biological form).

A project that involves greater than minimal risk requires approval by an IRB panel composed of members qualified to review research in that field.

Survey research that involves sensitive questions or information about sexual practice or illegal behavior is subject to full review, in keeping with federal guidelines. Any survey or interview that is likely to be stressful for the subject requires full committee review. IRB staff will make this determination.

Examples of full committee review research: research with children and other vulnerable populations; research that involves experimental drugs or devices, invasive procedures; and any research involving deception.

Form to use:
Health & Medical/Biological Application Form, or
Social & Behavioral Sciences Application Form