Although the category is called “exempt,” this type of research does require IRB review and registration. The exempt review process is much less rigorous than an expedited or full-committee review. To qualify, research must fall into one or more of the federally-defined exempt categories (see Worksheet: Exemption Determination HRP-312). These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of Exempt research are:
- surveys or interviews
- benign behavioral interventions
- passive observation of public behavior without collection of identifiers
- analyses of discarded pathological specimens without patient identifiers.
How do I apply for an exemption determination?
You must complete all requirements for an application for initial review. An IRB analyst will review the information in your application to determine if the research qualifies for an exemption determination.
When the IRB determines that a project is exempt, the reviewer will then determine if the following additional requirements are met:
- The research must involve no more than minimal risk to subjects
- Selection of subjects must be equitable (That is, the research is appropriate for the population being studied).
- If there is recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data
- There are adequate provisions to maintain the privacy interests of the subjects.
- If there is contact with the research subjects there will a consent process meets the following requirements:
- The consent process will disclose that the activities involve research
- The consent process will disclose the procedures to be performed
- The consent process will disclose that participation is voluntary
- The consent process will disclose the name and contact information for the investigator
Use HRP-502 Template – Exempt Research (2018 Common Rule Compliant) for consent in exempt research.