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E&C Republicans Want Answers on Secretive Nature of HHS Research’s Review Process


04.19.22

Washington, D.C. — House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Subcommittee on Health Republican Leader Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Republican Leader Morgan Griffith (R-VA) sent a letter to Health and Human Services Secretary Xavier Becerra on the flawed and overly secretive review process of whether risky research for potential pandemic pathogens can be conducted safely and have a justifiable benefit.

The HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (P3CO Framework) was created in 2017, according to the National Institutes of Health (NIH), “to guide funding decisions on proposed research that is reasonably anticipated to create, transfer or use potential pandemic pathogens resulting from the enhancement of a pathogen’s transmissibility and/or virulence in humans.”

The Framework and its review committee at HHS are shrouded in secrecy and ethical concerns. The members are asking the HHS to be transparent on the process and its personnel.

KEY EXCERPT: “Dr. Chris Hassell, the HHS Deputy Assistant Secretary for Preparedness and Response and the chair of the HHS P3CO review committee, briefed the committee staff twice during the summer of 2021. During the briefings, when asked about the identities of the members, Dr. Hassell did not provide the names of the members of the review group. However, he indicated which agencies or departments were represented on the HHS P3CO Review Committee. Dr. Hassell noted there were members from the NIH on the review committee, but he specifically pointed out that the NIH members were from the Office of the Director and not from any of the NIH institutes or centers that would be funding entities to avoid conflict-of-interest concerns. 

“The minority committee staff requested that HHS provide the names and affiliations of all members of the HHS P3CO review committee. In response, HHS provided some of the names of the HHS P3CO review committee, but on a confidential basis because of personal security concerns.”

The members have significant concerns with the following parts of the HHS P3CO review process:

  • The HHS P3CO review process continues to be unnecessarily shrouded in secrecy.
  • Neither HHS nor NIH have provided the names of the officials who were involved in the clearance process of the HHS P3CO review framework.
  • There are conflicts of interest concerns with some members of the HHS P3CO review committee.
  • HHS has not been able to demonstrate that the HHS P3CO review committee has the necessary areas of expertise.
  • The HHS P3CO review committee does not include all the disciplines it says should be included in the group.
  • The HHS P3CO review process lacks independence on who decides whether the HHS P3CO review committee has jurisdiction.
  • It appears that the Biden administration has not been engaged with the HHS P3CO process. 

The Energy and Commerce Republicans ask that Secretary Becerra respond to the following questions and provide the following information by May 3, 2022.

  • Will HHS reconstitute the National Science Advisory Board for Biosecurity as an independent entity or will you convene an independent body to conduct the policy review and evaluation of the HHS P3CO framework?
  • Can a member of the HHS P3CO review committee participate in the review of a research proposal if the member co-authored an article with the principal investigator on the proposal?
  • Is there a member on the review group whose expertise is ethics?  If so, please provide information about this member (name and affiliation). If not, will a member with ethics expertise be added to the review group and when?
  • Which member has the expertise to handle ethics issues?
  • How many research proposals has the NIH reviewed as potentially subject to HHS P3CO review process? How many proposals were referred to the HHS P3CO review committee? Why did NIAID re-review the EcoHealth research plan, a two-year old proposal for an experiment that was already conducted, under the HHS P3CO framework?
  • How are members of the HHS P3CO review committee selected, and how are candidates evaluated for potential bias?
  • The names of all HHS and NIH officials who were involved in either the development or clearance of the HHS P3CO framework.
  • The names of the DoD and USDA members of the HHS P3CO Review Committee and their areas of expertise.

CLICK HERE to read the letter to Secretary Becerra.

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