The HHS Office for Human Research Protections (OHRP) is currently operating with a 62% vacancy rate among staff, as it has not filled open positions, agency officials say. OHRP has a staff of 20, but there are an additional 12 positions “on hold.”
While vacancies exist in all its divisions, including in the Office of the Director, the Division of Policy and Assurances has the most. If its six openings were filled, the staff would double. OHRP is a critical office in the federal government that oversees participants enrolled in billions of dollars of clinical trials funded by NIH and other Public Health Service agencies.
OHRP Deputy Director Julie Kaneshiro disclosed the vacancies at the annual meeting of Public Responsibility in Medicine and Research (PRIM&R), sharing an organizational chart among her slides. The chart showed a total of 32 full-time equivalents (FTEs) between filled and on-hold positions.
The meeting is the first time in recent memory the agency has released such details. But OHRP’s lack of enforcement action has prompted concerns for a decade. For example, it did not release any determination letters for an 18-month period and all of 2021.
None of the OHRP speakers at the PRIM&R meeting, which was held virtually, addressed funding. But RRC’s review of OHRP’s recent fiscal year (FY) budget documents indicates the agency has not requested funding for 32 FTEs, nor has it filled at least four positions for which it seemingly already has appropriations. OHRP has authority to spend funds on programs and/or staff as it sees fit.
Congress has funded OHRP, like the rest of the government, through a series of continuing resolutions (CRs). The most recent CR expired Dec. 23. As of RRC’s deadline, a new CR had not yet been adopted.
HHS requested $6.412 million for OHRP for FY 2023, which began Oct. 1 and ends Sept. 30, 2023; the requested staff total was 24 FTEs. The request reflected an additional $169,000 but no increase in the current FTE level.
Four New Positions Funded in 2021
The FY 2022 annualized CR provided OHRP $6.243 million, an increase of $18,000, and a staff of 24, an increase of four FTEs. But, as Kaneshiro explained, OHRP has not filled those slots and remains at 20 FTEs.
During the conference, RRC asked how the vacancies affect OHRP’s ability to operate. “We suffer from a common problem that I know many of you probably do as well,” Kaneshiro said, “and that is resource constraints,” which she called “the biggest reason” for the vacancies.
OHRP staff have “had to be creative in how we use our budget,” she said. The agency is “really focusing on increasing our use of technology and trying to improve ways in which we can rely on technology so we don’t have to have staff doing things that we could otherwise accomplish through advances and investments in technology,” Kaneshiro said.
After the meeting, RRC asked OHRP why the positions are on hold—particularly those that seemingly already funded—and for specifics on when the vacancies occurred.
Through an HHS spokesperson, OHRP said the jobs “did not all become vacant in the last fiscal year” but occurred “at various times as people left OHRP.” The posts are on hold “pending the availability of funds,” the agency said.
Regarding timing for possible hiring, OHRP said the FY 24 “budget development process is currently underway at HHS, and OHRP’s budget needs are being considered as part of this process.”
Priorities Include Guide on Revised Common Rule
According to Kaneshiro, staffing at OHRP and vacancies are as follows:
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Office of the Director: five staff, three positions on hold.
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Division of Education and Development: five staff, one position on hold.
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Division of Compliance Oversight (DCO): four staff, two positions on hold.
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Division of Policy and Assurances: six staff, six positions on hold. Kaneshiro said the division has two “core functions”: one related to policy development, including support for the Secretary’s Advisory Committee on Human Research Protections, and the other focused on registering institutional review boards and approving federalwide assurances.
Kaneshiro listed the following “top priorities” for OHRP:
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Staffing, which she said, refers to hiring one policy staffer.
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Collaborating with the Food and Drug Administration (FDA) “to harmonize the revised Common Rule with FDA’s regulations, and with FDA’s compliance team.”
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Developing and issuing policies and guidance on the 2018 revised Common Rule.
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Developing “educational resources for the research community and the public, including new interactive training programs for the research community, hosting more webinars on the revised Common Rule, and adding new videos for research participants.”
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“Modernizing compliance assessment procedures, and developing a new OHRP Human Research Complaints form to facilitate reporting of alleged noncompliance.”
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Developing “tools and capacities to incorporate equity considerations into guidance and policy initiatives, exploring options for language translation to further disseminate OHRP’s educational and policy resources.”
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Improving databases and the use of technology.
Other staff presented information on OHRP’s recent activities.
Lack of Jurisdiction Cited for Most Complaints
During the full 2022 FY, for example, DCO opened four and closed six compliance assessments; these may be for-cause (investigations) or not-for-cause (evaluations). Investigations are “conducted when OHRP determines that what is being alleged constitutes a substantiated written allegation(s) or indication(s) of noncompliance with the HHS regulations,” according to the presentations.
As of the last quarter of FY 2022, the agency had 11 active for-cause and two not-for-cause evaluations. Regarding upcoming initiatives, DCO intends to issue a video that provides an overview of compliance assessments and revised guidelines for compliance oversight procedures for evaluating institutions.
DCO also handled more than 600 “distinct” complaints of noncompliance but found that it lacked “jurisdiction” over “most” of them. Examples of allegations OHRP cannot address include health care complaints, COVID requirements and industry-sponsored research, an official said.
So far this year, it posted seven determination letters issued to institutions, which address areas of noncompliance, just a fraction of the total it issued in the past. Michael Carome, director of the health policy group at the consumer watchdog group Public Citizen, has long complained of lax OHRP oversight and repeatedly sought investigations into allegations of noncompliance, generally to no avail.
