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Policies and Procedures

The U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies 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 Revised Common Rule. Effective January 21, 2019, all research proposals submitted to the PH IRB for review will be reviewed following the Revised Common Rule and the associated revised 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 of both PH IRB Manuals.

PH IRB Policy & Procedures Manual: The Common Rule 

PH IRB Policy & Procedures Manual: The Revised Common Rule

PH IRB Policy on Research Misconduct 

Policy and Procedures for Addressing Allegations of Research Misconduct


Other PH IRB Procedures & Guidelines

Vulnerable Populations

 Other

Compensating Research Participants

Financial Conflicts of Interest in Federally Sponsored Research Activities

Transportation of Information Assets

 

The PH IRB does not have the clinical expertise to review studies involving any FDA-regulated components. The Division directs the PH IRB to cede oversight for research protocols involving experimental drugs or devices or approved drugs or devices. The PH IRB will enter into an Institutional Authorization Agreement with a commercial or central IRB knowledgeable in such research and the FDA regulations with which they must comply. 



Clinical Trials