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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.

As of December 21, 2018, the PH IRB requires submissions for review be completed using the Final Rule-compliant PH IRB documentation available below. Submissions received between December 21, 2018 - January 20, 2019 will be put on hold and review will not begin until January 21, 2019.

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 Final 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 Final Rule. All research approved prior, will continue to follow the Common Rule regulations.

HIPAA Forms

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:

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