Proposed Delay to Research Rule Still Up in the Air

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By Jeannie Baumann

An HHS advisory panel couldn’t get clarity on when changes to the research oversight regulation will go into effect because of a federal clampdown on discussing pending rules.

A proposal under review to delay changes to the human subject protection regulations known as the Common Rule has thrown a wrench into the timing of who needs to comply with what revised provisions and when. Research institutions regulated by the Common Rule have asked for a one-year delay and would likely embrace the proposal if it happens. But everyone now has fewer than three months to navigate the typically lengthy process of getting into compliance with regulatory revisions that impact nearly 20 federal agencies and billions of dollars of human subjects research.

The White House Office of Management and Budget received Oct. 7 a proposed rule requesting the delay from the Department of Health and Human Services. If finalized, the new implementation date would be pushed back one year to Jan. 19, 2019.

But any potential delay is currently in the infancy stage of the rulemaking process, which still requires publication of a proposed rule, a comment period, and a possible final rule that would likely have to go back to the OMB for review before it could go out. Unless all that happens in fewer than three months, most provisions of the revised Common Rule will kick in Jan 19, requiring compliance with the biggest revisions to the human subject protection regulations since they were first issued 30 years ago.

Advisory Panel Meeting

The HHS Secretary’s Advisory Committee on Human Research Protections held its final two-day meeting of the year in Rockville, Md., on Oct. 17-18, just 10 days after the OMB received the proposed rule. But within the first few minutes, Jerry Menikoff, director of the Health and Human Services Office for Human Research Protections, dispelled the notion any insight could be gleaned from the meeting.

Menikoff read a statement an HHS spokesperson also gave to Bloomberg Law on Oct. 10 that “It is HHS policy not to discuss the details of such proposals before they appear in the Federal Register for public comment.”

Menikoff told the advisory panel the OHRP is “not permitted to actually discuss the content of the rule that’s proposed. We’re not trying to be obstructionist in any way. We’re following HHS policy.”

The proposed rule under review at the OMB, posted on the RegInfo.gov website, is titled: Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.

The revised Common Rule ( 45 C.F.R. 46) applies to nearly 20 federal agencies and their grantees. The changes include new requirements that informed consent forms be shorter, with the most pertinent information posted at the top, and posted publicly. There is also a requirement that all institutions involved in the same study use the same institutional review board, but that requirement doesn’t take effect until 2020.

HIPAA, Expedited Review

SACHRP approved two sets of recommendations during its final meeting: one on a privacy rule exemption, and another on expedited review.

The first set of recommendations addresses one of the more complex provisions of the Common Rule revisions on the privacy rule under the Health Insurance Portability and Accountability Act. The provision allows for a carve-out of activities using identifiable private information in secondary research, or research on data or biospecimens that already have been collected for another purpose.

The carve-out is not an exemption from HIPAA; rather it’s an exemption from the Common Rule requirements for activities already governed by HIPAA, Ropes & Gray research attorney Mark Barnes explained. Barnes is a co-chairman of the SACHRP subcommittee on harmonization and a member of Bloomberg Law’s health-care advisory board.

The primary risk of activities involving secondary research data is one of privacy, Barnes said, and that risk is mitigated by HIPAA rule requirements. “If HIPAA, as a regulatory matter, already applies, it’s rigorous in its penalties,” he said.

SACHRP’s recommendations address how to navigate situations such as when two investigators at separate HIPAA-covered entities want to share data, and when information can be shared with contractors known as business associates under HIPAA.

The expedited review recommendations are designed to help IRBs and research institutions understand when they can apply the expedited review exemptions, which allow less risky studies to be approved more quickly.

SACHRP recommendations are not binding, but they are forwarded to the HHS secretary’s office. The committee expects to hold its next meeting on March 13.

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 proposed rule review notice is available at https://www.reginfo.gov/public/do/eoDetails?rrid=127614#. The revised Common Rule is available at https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm.More information on the SACHRP meeting is available at https://www.hhs.gov/ohrp/sachrp-committee-meetings-2017-october-17-18/index.html.

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