Forms

For new applications to the PH IRB, first fill out the Initial Review Questionnaire (below). It will point you in the direction of relevant, supplemental documentation required with your submission.

The U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The revisions are to modernize, strengthen, and make more effective the Federal Policy that was originally promulgated in 1991. Now known as the Revised Common Rule, it is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. Effective January 21, 2019, all research proposals submitted to the PH IRB for review will be reviewed following the Revised Common Rule. All research approved prior, will continue to follow the Common Rule regulations.

HIPAA's Privacy Rule does not apply to research; it applies to covered entities, which researchers may or may not be. If you are obtaining individually identifiable health information from a covered entity for purposes of your research, the following forms will apply to your initial application: