Compliance and Policy News

Revisions to federal human subjects research regulations uncertain

Perhaps you have heard that the federal government is revising its regulations concerning protection of human research participants. There has been a great deal of discussion about this, and much confusion, so we thought it would be helpful to clarify the situation for our UW-Madison human subjects research community.

The Common Rule is a set of federal regulations that has been in place for over 30 years to govern the protection of human research participants. In 2011, the U.S. Department of Health and Human Services (HHS) began efforts to modernize these regulations. A “Final Rule” revising the Common Rule was published on the last day of the Obama presidential administration with an effective date of Jan. 19, 2018.

According to HHS, “The new rule strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research.”

The Final Rule is anticipated with great eagerness by the research community.

However, the Trump administration is reviewing all regulations that have yet to be implemented and it is uncertain whether the Final Rule will be adopted. For an overview of the Final Rule, please see a compilation by the Council on Governmental Relations and the Executive order.

In the meantime, we are examining our policies and practices with the goal of reducing burden, while continuing to ensure the safety of human subjects and compliance with current regulations. A few developments on this front include analysis of the results of the survey of our researchers concerning our IRB processes and workflow (results are coming soon!), formation of a faculty working group to develop improvement initiatives based on these results, and optimization of our online protocol submission tools.

 

Nadine Connor

Associate Vice Chancellor for Research Policy and Compliance