A PI is responsible for the overall conduct of a study. Some of these responsibilities include, but are not limited to, the following:

1. Conducting the study in compliance with relevant regulations (e.g., 45 CFR 46/the Common Rule, FDA, other federal agencies, state law) as well as ethical principles described in the Belmont Report.
2. Completing required human subjects research trainings.
3. Providing adequate training to and oversight of study personnel
4. In the case of certain types of clinical trial research, ensuring the protocol complies with applicable Good Clinical Practice requirements.
5. Obtaining legally effective informed consent, when required.
6. Obtaining permission for the use and disclosure of protected health information in compliance with the HIPAA Privacy Rule, as applicable.
7. Comparing contracts with consent documents.
8. Submitting follow-on applications as required for approved or exempt studies, including changes, continuing reviews, and reportable events.
9. Submitting a closure report when a study is completed.
10. Complying with all institutional requirements related to human subjects research, including conflict of interest.
11. Assuring participant privacy and confidentiality according to institutional and regulatory requirements including HIPAA and FERPA (as applicable).