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The links on this page are meant to assist researchers in preparing their application for review of research involving human subjects in accordance with the guidelines set forth by the University. Human Research Protection Program staff also developed a downloadable guide to provide more information. Download the Protecting Human Subject Guide.
Guidance on consent forms, recruitment, obtaining consent, and details on what must be included on these forms and how to avoid problems when creating them. This section also contains some assistance regarding consent form language, best pratices, and a few templates are provided.
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Federal regulations 45 CFR 46 and 21 CFR 56 identify the following populations as potentially vulnerable and requiring certain protections:
In addition to these three categories, the IRB has also identified the following subject groups who may be vulnerable to coercion because of their situation or issues pertaining to autonomy. Additional protections may be required for these groups:
Other considerations regarding the status of potential subjects that are reviewed in the specific context of the research include:
Research may also involve otherwise healthy, normal subjects but propose to address sensitive topics, including:
Granted in "Emergency Use" cases for drugs or devices, typically life-threatening, situations.
Outlines Specific Documents Which Demonstrate Compliance For Sponsors and Regulatory Agencies
For guidance on the consent forms, recruitment, and obtaining consent, see: Consent Process & Forms
Feel free to contact our office with any questions or suggestions.