Emails Show the HHS Immediate Office of the Secretary Gave NIH Lead Role in Rewriting Proposal for Overhauling Rules for Human Subjects Research Despite NIH’s Direct Conflict of Interest

Nov. 20, 2014

Emails Show the HHS Immediate Office of the Secretary Gave NIH Lead Role in Rewriting Proposal for Overhauling Rules for Human Subjects Research Despite NIH’s Direct Conflict of Interest

HHS Action Corrupts the Rulemaking Process and Undermines Authority of the Office for Human Research Protections

WASHINGTON, D.C. – Public Citizen today called on Secretary of Health and Human Services Sylvia Mathews Burwell to immediately reverse the recent decision by one or more senior officials in her immediate office to abruptly transfer from the Office for Human Research Protections (OHRP) to the National Institutes of Health (NIH) the responsibility for rewriting key sections of a draft proposal to extensively revise the federal rules for the protection of human subjects. In its letter to the Burwell, Public Citizen highlighted the fact that NIH has an obvious, direct conflict of interest in this matter because, as the largest federal funder and conductor of human subjects research, it is subject to the very rules being considered for revision.

According to documents Public Citizen recently obtained, NIH was asked — likely by Andrea Palm, HHS chief of staff and a senior counselor to Burwell — to rewrite key sections of a draft notice of proposed rulemaking (NPRM) to extensively revise the Federal Policy for the Protection of Human Subjects (known as the Common Rule). The Common Rule is intended to ensure that the rights and welfare of people enrolled in federally sponsored research are adequately protected.

In particular, NIH has been assigned responsibility for revising what is known as the preamble of the NPRM. The preamble will be the longest and most important part of the NPRM, containing sections describing the resolution of key high-level policy issues, the proposed changes to the Common Rule, and the rationale for making those changes to the regulations, among other things.

The content of the NIH-written preamble ultimately will have a major impact on the actual final provisions of the proposed revised Common Rule regulatory text.

While acknowledging that NIH, like any other regulated entity, certainly should have an opportunity to comment on the completed NPRM, Public Citizen asserted that NIH should not be permitted to be a lead drafter of any part of the NPRM.

“Allowing NIH to play such a lead role in drafting the NPRM for revising the Common Rule corrupts the rulemaking process and is akin to asking the pharmaceutical and medical device industry to write the Food and Drug Administration’s regulations regarding the approval process for drugs and medical devices or asking the pesticide industry to write the Environmental Protection Agency’s regulations regarding pesticide exposure limits for workers and consumers,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The public no doubt would find such circumstances to be grossly unacceptable.”

Public Citizen’s letter further noted that the actions by one or more senior officials in the HHS Immediate Office of the Secretary (IOS) regarding the process for rewriting the Common Rule NPRM undercut the authority of the OHRP and echo unethical conduct by senior HHS officials under Burwell’s predecessor, then-Secretary Kathleen Sebelius. In 2013, those officials knowingly allowed the NIH director and other senior NIH officials to interfere with the independence of OHRP’s ongoing compliance oversight investigation of the NIH-funded SUPPORT study in premature babies.

“These two incidents together demonstrate a disturbing pattern of conduct in which senior HHS officials fundamentally compromised OHRP’s regulatory authority and almost certainly caused long-lasting and possibly irreparable harm to the status of this critically important regulatory agency, whose primary mission is to protect human subjects,” said Carome.

In addition to asking Burwell to immediately return full responsibility for the final drafting of the entire NPRM, including the important preamble, to the OHRP — where it originally resided — Public Citizen urged the Secretary to:

  • Take steps to ensure that agencies, like NIH, are not allowed to play a lead role in matters in which they have significant direct conflicts of interest;
  • Act to ensure that the HHS IOS official(s) who demonstrated such poor judgment in this matter are removed from further involvement in overseeing OHRP activities and the drafting of the Common Rule NPRM; and
  • Provide an explanation of what role, if any, specific NIH officials played in orchestrating the actions that allowed NIH to be assigned responsibility for rewriting the entire preamble to the Common Rule NPRM.

View Public Citizen’s letter.

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