Human Subjects Committee

>> Investigator's Drug or Device Brochure

>> Protocol and Other Amendments

This template is appropriate for studies involving FDA-regulated products. It is also recommended for any other study in which external parties (such as sponsors or collaborators) will receive study data that has not been fully de-identified according to HIPAA standards. *

This template should be used for internal studies and for other projects where all data released to external parties has been de-identified according to HIPAA standards. *

This template is appropriate for persons who are consenting to research on behalf of another adult who does not have decisional capacity.