Institutional Review Board Manual
Research That Requires Approval
Expedited Review Procedures
Certain minimal risk projects, not eligible for exempt status, may be approved without full Institutional Review Board (IRB) review. Research activities may be reviewed through the expedited review procedure that:
- Present no more than minimal risk to human subjects; and
- Involve only procedures listed in one or more of the following categories.
- Clinical studies of certain drugs and medical devices;
- Collection of small amounts of blood samples
- Prospective collection of certain biological specimens, e.g., hair/nail clippings, sputum, mucosal and skin cells, by noninvasive means;
- Collection of data through noninvasive procedures routinely employed in clinical practice, e.g., weighing or testing sensual acuity, EEG, EKG, ultrasound, or moderate exercise;
- Research involving existing materials (data, documents, records, or specimens) collected solely for non-research purposes (such as medical treatment, diagnosis, or treatment planning);
- Collection of data from voice, video, digital, or image recordings.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of certain research previously approved by the IRB.
These categories (A-H) apply regardless of the age of subjects. For a review of the complete text, go to http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm
The activities (Categories A-H, above) 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 expedited review procedure may not be used if:
- 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; or
- The research deals with sensitive aspects of the subject’s behavior (e.g., illegal conduct, drug/alcohol abuse, sexual abuse, sexual preference, domestic violence) or studies involving deception.