Does your research or project qualify for “Exempt” verification?
Some research projects using human participants raise no substantial risk to subjects. To qualify for an exempt review process, your research must involve no more than minimal risk (summarized as no greater risk than that encountered in everyday life) and fall under one of the following categories:
- Research conducted in established or commonly accepted educational settings, involving normal education practices.
- Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior.
- Research involving collection or study of existing data, documents, records, or pathological or diagnostic specimens.
- Research studying, evaluating, or examining public benefit or service programs.
Are there conditions that prohibit the use of an exempt review? Yes. Examples include research or studies that:
- Involve more than minimal risk to the participant.
- Place identified participants at risk of criminal or civil liability or economical or social damage.
- Involve prisoners, pregnant women, fetuses, neonates, (or others requiring special protections).
- Some research involving children. For example, an exempt process if prohibited if the investigator participates in proposed research activities with children.
- Use surveys or interviews that pose questions of a very personal and/or sensitive behavior.
What process is followed for an exempt review?
If your research meets criteria that qualify for an exempt review, you must submit an application for exemption and must comply with all other federal guidelines regarding human subjects research. Exempt applications are accepted whenever you complete them and are reviewed on a rolling basis. To apply for an exempt 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.)
To apply for exempt verification, e-mail all documents to firstname.lastname@example.org . The attachments must be complete and consistent; the receiver must be able to open, print and edit every document in an electronic submission.1 Then, deliver one complete paper application, with all required signatures and appendices, to the IRB office.
Wait for written IRB approval before beginning data collection. Once approved, exempt projects are not subject to ongoing oversight and a yearly progress report is not needed from the principal investigator.
Sponsorship: For student research applications, the Exempt Review Application must have the signature of a faculty sponsor.
1Supporting 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.