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New Final Rule Information
Revisions to Common Rule Published January 19, 2017
On January 19, 2017, the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services, along with fifteen other Federal Departments and Agencies, issued a revised version of the Federal Policy for the Protection of Human Subjects, also known as "the Common Rule". The Common Rule provides the regulatory basis for IRB oversight of much of the human subjects research that occurs at ISU. OHRP also released a summary of significant changes to current regulations.
While the revised Common Rule has been formally issued, its fate remains uncertain as the new presidential administration could overturn or "freeze" implementation of the updated regulations. ORR staff will continue to monitor the situation at the federal level.
If the revised regulations are not overturned, most changes go into effect on January 19, 2018. It is our understanding that the changes may not be implemented early.
Throughout the next year, ORR staff and IRB members will revise IRB policies and procedures to align with the new regulations. We will also provide outreach and training to keep the ISU research community abreast of changes. Please check the IRB website perioidically for updates.
May 12, 2017 Bloomberg BNA media article: White House Reviewing Obama-Era Update of Human Research Rule
July 27, 2017: Status of Final Rule Revisions
July 27, 2017: Overview of Final Rule Revisions
July 27, 2017: New and Revised Definitions
July 27, 2017: Overview of Informed Consent Changes