Human Subjects (IRB)
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What's New
- Summary of Activities Requiring IRB Review? [05/2025]
- Updated Human Subject Research (HSR) Determination Form [05/2025]
- Ancillary and Institutional Reviews [5/2025]
- Data Scraping guidance that includes considerations for research teams that are using data scraping as a research method. [03/2025]
- Updated Short Form Consent Process Guidance:
- Witness should be impartial and fluent in both English and the language of the participant. [01/2025]
- Translated consent form required after the short form consent process for certain studies involving investigational biologics, drugs, and/or devices. [02/2024]
- Expedited and exempt IRB protocol applications that have no expiration date (i.e., do not require annual review) will receive a notification to confirm the status of the study three (3) years after the last action taken. If no response, the study will be administratively closed by the IRB. [12/2024]
- Can I use the Chart Review Form? [08/2024]
- What should I consider when doing focus group research? [08/2024]
- Updated Pregnant Partner guidance. This guidance outlines why pregnant partners, and their fetus/child, are not human subject research participants when their involvement is limited to collection of safety data. [07/2024]