Major revisions to human research protection regulations known as the Common Rule go into effect on Jan. 21, culminating a nearly eight-year effort to modernize federal requirements to protect research volunteers from undue harm.
While the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) administers the Common Rule, it applies to research funded by 20 agencies and departments across the federal government—half of which are now shut down.
“My understanding is that the regulatory compliance date is unaffected by the shutdown, which means that research subject to the new rule will have to comply with it regardless,” University of Pennsylvania bioethicist Holly Fernandez Lynch told Bloomberg Law.
If the shutdown continues after the Common Rule compliance date, those shuttered agencies “obviously won’t be engaged in enforcement activities during that period of time,” she noted. “But it seems unwise for the regulated community to bank on that,” she said.
Likewise, Lisa Nichols told Bloomberg Law, “While it is possible that some agencies may have planned to provide additional notice or guidance on the rule prior to Jan. 21, from the perspective of institutions, we don’t foresee the shutdown having a significant impact on implementation of the revised Common Rule.” Nichols is the director of research and regulatory reform for the Council on Government Relations, an association of research universities, affiliated medical centers, and independent research institutes.
David Peloquin, a research attorney with Ropes & Gray LLC in Boston, also said the shutdown appears to be having a minimal impact on the implementation of the Common Rule.
“It may be, however, that some of the other Common Rule agencies and departments that maintain additional policies regarding their own implementation of the Common Rule will be delayed in issuing updates to such policies as a result of the shutdown,” he told Bloomberg Law.
Impact on Guidances
The 20 Common Rule agencies generally must sign off on any guidance documents the OHRP develops before they go out publicly, but an HHS spokesperson told Bloomberg Law the shutdown is not thwarting the OHRP’s efforts to issue guidance.
“There are a number of guidances in the pipeline that have already received input from the other agencies, so those are expected to move forward without a shutdown-related delay,” the spokesperson said.
The HHS has issued five draft documents so far that primarily focus on defining activities that do not have to follow the Common Rule, such as public health surveillance. The OHRP also has offered tips for navigating a six-month regulatory transition period that started in July, when the HHS delayed the start date of the rule.
The most recent OHRP draft document came out on Jan. 10. It addresses compliance dates and provides recommendations on what an institution should and should not do if it wants to transition an ongoing study, which was approved under the old rule, to the new requirements.
Disagreement over border wall funding led to the partial government shutdown, leaving work on seven of the 12 federal spending bills unfinished. The HHS and Department of Veterans Affairs remain open, but other Common Rule agencies such as the National Science Foundation, NASA, and the Environmental Protection Agency are not.
Funding for the Food and Drug Administration also has not been approved, but it is not a Common Rule agency.
Released on Jan. 19, 2017, the revised Common Rule culminated work initiated in 2011 to modernize the regulations, which had not been changed significantly since they were first issued in 1991. Many of the changes are designed to accommodate a transition over that time from single investigators conducting research at one institution to a more global, collaborative approach involving many investigators at multiple institutions.
What’s Open and What’s Not?
These are the Common Rule agencies and departments that have remained open since the partial government shutdown began Dec. 22. Congress either passed their spending bills, or they receive mandatory funding and are not affected by the shutdown:
- Department of Energy
- Social Security Administration
- Department of Labor
- Department of Defense
- Department of Education
- Department of Veterans Affairs
- Department of Health and Human Services
- Office of the Director of National Intelligence
- Central Intelligence Agency
And here are the Common Rule agencies that are shut down:
- Department of Homeland Security
- Department of Agriculture
- National Aeronautics and Space Administration
- National Institute of Standards and Technology in the Department of Commerce
- Agency for International Development
- Department of Housing and Urban Development
- National Institute of Justice in the Department of Justice
- National Science Foundation
- Department of Transportation
- Consumer Product Safety Commission
- Environmental Protection Agency
Read more about the Revised Common Rule and in the recent OHRP draft document.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.