White House Takes Final Steps to Revamp Medical Research Rule

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

By Jeannie Baumann

The final revisions to human research regulations arrived at the OMB, an indication that the first-ever overhaul of the so-called Common Rule will likely be released before President Barack Obama leaves office Jan. 20.

The White House Office of Management and Budget said it received the final rule (RIN: 0937-AA02) Jan. 4 and it is pending review. OMB review indicates a final stage before a new rule becomes public. If finalized, the Common Rule revisions would affect nearly 20 federal agencies, ranging from biomedical to aerospace, defense and energy research.

The Common Rule overhaul is such a big deal in research circles that stakeholders refer to the 2015 draft version as “the” proposed rule among the thousands that are moving through the federal government . But even if the new Common Rule comes out, Republicans are likely to resist implementing these changes. They criticized any move by the Obama administration to release eleventh-hour rules, and the House passed a bill Jan. 4 ( H.R. 21) that would allow Congress to repeal at once a slew of regulations issued in the last half of 2016.

“We’re still working on it,” Diane Gianelli, a spokeswoman for the Department of Health and Human Services, told Bloomberg BNA Jan. 5. But she couldn’t provide a release date. The HHS Office for Human Research Protections administers the regulations, but all the Common Rule agencies would have to sign off on the final version before it goes out.

Clinical trials of medical products regulated by the Food and Drug Administration are subject to a separate but similar set of human subject protection regulations (21 C.F.R. 56). The FDA plans to update its regulations so they line up with any Common Rule changes ( 09 LSLR, 10/30/15 ).

No Guarantees

The OMB Office of Information and Regulatory Affairs has up to 90 days to review the final rule, so there is no guarantee a new Common Rule will move forward by Jan. 20. The OIRA/OMB review is the last required step before final rules can be published in the Federal Register, Gary Chadwick, a senior consultant with HRP Consulting Group, told Bloomberg BNA. Chadwick previously served as the associate director for human subject protections for both the OHRP and the FDA.

“Until the FR publication, the public is not able to access the text of the Final Rule,” he said. “Thus, the regulated community is still in the dark about what will change (scope and magnitude).”

“We can only wait to see if the Obama Administration will push this out in its final days. The change in Administration will certainly affect new rules as of January 20, but what the affect will be on this specific rule is unknown,” Chadwick said in a Jan. 5 e-mail. “By law, the Final Rule cannot become effective until at least 30 days after its publication.”

Republicans to Overturn?

Lisa Nichols, director of research and regulatory reform for Council on Governmental Relations, thinks the final rule would be overturned once President-elect Donald Trump takes office. The proposed revisions to the Common Rule were among regulations that the House Freedom Caucus is looking to overturn in the first 100 days of the new administration, and Nichols noted Trump’s pick to run the OMB, Rep. Mick Mulvaney (R-S.C.), is a founding member of that conservative caucus.

“Perhaps they were concerned about REINS [ Regulations from the Executive in Need of Scrutiny Act of 2017] and thought this was the best approach,” Nichols said in a Jan. 5 e-mail to Bloomberg BNA, referring to legislation (H.R. 26) that would give Congress 70 legislative days to approve a major rule with an annual effect on the economy of $100 million or more.

“Perhaps they are thinking they can convince lawmakers and the next administration that the proposed changes are needed. I don’t see how they would be successful in that given that the research community and most other stakeholder groups strongly disagree,” Nichols said.

COGR, an association of research universities and affiliated medical centers and independent research institutes, expected the Common Rule to move forward based on previous statements from the HHS and National Institutes of Health, Nichols said.

“We feel this is an unfortunate move given the overwhelmingly negative comments to the proposed changes, including those from leading universities and academic medical centers,” Nichols said. She noted key groups, including the OHRP’s advisory committee and a National Academies panel, have called for withdrawing the proposed rule. “We believe due process would require the issuing of a revised Proposed Rule to allow further public comment prior to issuing a final rule.”

Research Rule Modernization

The Common Rule was designed to protect human subjects from undue harm in research, and the Obama administration has worked since its early days to modernize these regulations (45 C.F.R. 46), which have remained largely untouched since they went into effect in 1991. The revisions address major changes in research, including: biobanking; the explosion of genetic and genomic research; and the move from a one-site, one-investigator model to multisite clinical trials.

The 519-page proposed rule would:

  •  change informed consent requirements to move all the most important information to the top of the form;
  •  reclassify all biospecimens to be human subjects, regardless of identifiability;
  •  require one institutional review board of record for multisite studies;
  •  introduce a new class of “excluded” activities that wouldn’t be subject to the regulations, while changing the existing exemption categories; and
  •  extend the scope of the rule to cover all clinical trials, even those not getting federal funding.
The rule has gotten major pushback, particularly on the proposal to reclassify all biospecimens as human subjects—whether or not they have been stripped of identifying information—with limited ability to waive consent requirements when obtaining biospecimens for research.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

The OMB update is available by searching for the regulatory identification number 0937-AA02 on https://www.reginfo.gov.

The proposed new Common Rule is at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.