Office of Sponsored Research and Programs
Process for IRB Review
Levels of Review:
This section describes the three levels of IRB review for studies that involve human research participants. These levels include “Exempt,” “Expedited,” and “Full Board review.”
§46.109 IRB review of research:
- An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.
- An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
- An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.
- An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
- An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(Approved by the Office of Management and Budget under control number 0990-0260.)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.109
Example of Exempt review:
Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:
- research on regular and special education instruction strategies
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Example of Expedited review:
Research on individual or group behavior or characteristics of individuals, such as:
- studies of perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior
- research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies (some of this may be exempt)
- where the investigator does not manipulate the subjects' behavior and the research will not involve stress to subjects.
Example of Full review:
All other studies, including those involving deception of subjects in ways that may lead to their distress or the collection of data in ways that may identify individual subjects.
IRB Policy document (Word and PDF):
IRB Policy manual (
PDF, 667 KB)
IRB Policy manual (
Word, 1.37 MB)
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