Directions for Submission of an Application for Expedited Review
Expedited review is for those research activities that involve no more than minimal risk to human subjects and fall into an expedited review category.
Minimal risk as defined by 45CFR 46.102(I) http://www.hhs.gov/ohrp/ means that 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.
Examples of research that may be appropriate for expedited review include the following:
- Obtaining clinical data from subjects using routine noninvasive procedures
- Analysis of video or audio recordings
- Moderate exercise by healthy volunteers
- Studies involving collection of existing unidentifiable specimens
- Studies of individual or group behavior without manipulating subjects' behavior and in a manner that does not cause stress to subjects
There are, however, exceptions. Research which raises the level of risk to greater than minimal risk may require a full review. Some examples include:
- Surveys or interview questions whose answers, if known outside the research, would create safety issues, legal liability, or adverse financial or employment consequences for the participant
- Studies that include members of a protected population in the pool of participants, including but not limited to people with mental illnesses and prisoners.
For further information, please review information regarding full review.
Remember that neither of these lists of examples is exhaustive. As the researcher, you must consider the definitions and apply them to your circumstances. For example, research involving students might not qualify for exempt review, even if they are over the age of 18. If their grade depends upon their participation, and they have no other way to gain that credit, an element of coercion enters the picture.
To apply for an expedited review, the Principal Investigator must submit a complete application to The Institutional Review Board. This includes all supporting documentation such as:
- Consent forms
- Surveys or interview questions
- Test forms
- Subject screening forms
- Recruitment materials (posters, phone scripts, etc.)
- Letters of agreement, or other supporting documentation to assure the IRB that appropriate coordination has been done with outside organizations or institutions (clearances to perform research or distribute surveys, etc., at any facility or institution where the research will be conducted).
Expedited applications are accepted whenever you complete them, and are reviewed on a rolling basis.
Wait for written IRB approval before beginning data collection.
Sponsorship: For student research applications, the Expedited Review Application must have a faculty sponsor. The IRB will review the application for appropriateness as an exempt review and rely on the sponsoring faculty member for subject matter expertise and design issues. The IRB will not accept student research applications without the signature of the faculty sponsor.
1 Supporting documents such as brochures or cited papers, which are not available to the PI in electronic form, may be sent as an appendix with the paper submission and omitted from the electronic submission. In that case, the application must clearly refer to the paper appendices.