Report on Research Compliance Volume 20, Number 1. With Greater Than Half Its Positions Vacant, OHRP Employing More Technology, ‘Creative’ Spending | Health Care Compliance Association (HCCA)

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.