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. The revised regulations are now known as the Final Rule. Effective January 21, 2019, all research proposals submitted to the PH IRB for review will be reviewed following the Final Rule and the post-2019 PH IRB Policy & Procedures Manual. All research approved prior, will continue to follow the Common Rule regulations and the earlier version of the PH IRB Policy & Procedures Manual.
*Links to applicable guidance documents, policies, forms, and websites can be found in the footnotes.
PH IRB Policy & Procedures Manual: The Common Rule PH IRB Policy & Procedures Manual: The Final Rule
(to be used for all studies submitted for initial review post January, 2019)
*Links to applicable guidance documents, policies, forms, and websites can be found in the footnotes of both PH IRB Manuals.
Children Participation in Research
Prisoner Participation in Research
Protocol Deviations and Noncompliance
Responding to Allegations of Research Misconduct