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Policies and Procedures

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 RuleEffective 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.

Vulnerable Populations

Children Participation in Research

Prisoner Participation in Research

Prompt Reports

Protocol Deviations and Noncompliance

Responding to Allegations of Research Misconduct

Unanticipated Problems and Adverse Events

 Other

Compensating Research Participants

Financial Conflicts of Interest in Federally Sponsored Research

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. 

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