Guidance and Policies
The links below provide guidance on a variety of issues related to human subjects research. If you do not find information you need, please Contact Us, or bring your questions to one of our Office Hours.
- Individual Investigator Agreement Guidance
- Informed Consent Elements Guidance
- Informed Consent Waivers Guidance (incl. waiving documentation and HIPAA)
- International Research Advisory Committee (IRAC) Policy
- International Research Guidance
- Investigational Device Exemption (IDE) Decision Tool for Investigators
- Investigational New Drug (IND) Decision Tool for Investigators
- Investigator Responsibilities - General Guidance
- Investigator - Sponsor Responsibilities under FDA Guidance