Despite a universal outcry from affected committee members, the HHS Office of the Assistant Secretary for Health (OASH) is requiring the nation’s highest ranking advisory panel on protections for research subjects to conduct its two remaining meetings this year in a “virtual” format.

In addition, members of the two subcommittees of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) are barred from meeting in person at all for the foreseeable future and must hold all meetings on a yet-to-be-chosen virtual format. OASH is applying its new virtual meeting policy to all its advisory committees and subcommittees, RRC has learned. However, few if any function as SACHRP does, and its workload is increasing as preparations are made for the release of the long-awaited revised Common Rule governing human research (RRC 2/18, p. 1).

Expressing the concerns of many, health care attorney and human subjects research expert Mark Barnes called the decision on the meetings a “mistake”; he and others say it is likely to harm the volume and quality of SACHRP’s work producing detailed and voluminous recommendations that form the basis for guidance. Several people told RRC that SACHRP should be given an exemption from the policy. In addition, Sen. Chuck Grassley, R-Iowa, asked to be kept informed about the impact of the virtual meeting policy.

It is not clear whether Jerry Menikoff, the director of the Office for Human Research Protections (OHRP), to which SACHRP reports, is in agreement with the decision or tried to oppose it. Exerting a tight rein over SACHRP that has engendered criticism, Menikoff has a history of taking actions that some viewed as diminishing SACHRP’s profile and contributions. He also has not been seen, at least externally, as willing—or interested—in challenging the HHS establishment.

SACHRP is an official committee that falls under the Federal Advisory Committee Act (FACA) of 1972, which is enforced by the General Services Administration (GSA). To be in compliance, according to GSA’s website, “federal agencies sponsoring” a FACA committee must:

◆ “Arrange meetings that are reasonably accessible and at convenient locations and times;

◆ Publish adequate advance notice of meetings in the Federal Register;

◆ Open advisory committee meetings to the public [with some exceptions];

◆ Make available for public inspection, subject to the Freedom of Information Act, papers and records, including detailed minutes of each meeting; and

◆ Maintain records of expenditures.”

Historically, SACHRP members have gathered in person three times a year, each time in two-day-long meetings. Previously held in hotels, meetings now take place in HHS buildings and are open to the public. Its most recent meeting was March 13-14. Subcommittee members typically meet in person prior to the general meeting and hold numerous teleconferences as they hammer out recommendations. At the main meeting, SACHRP’s 11 members are usually in attendance. They are joined by subcommittee members, representatives from other government agencies who are ex-officio members, staff from OHRP and others, including any speakers who are addressing SACHRP by invitation.

SACHRP chair Stephen Rosenfeld announced the decision, which he called “disappointing,” at the start of the March 13 meeting. He said he hoped OASH would consider reversing itself, and he requested that SACHRP receive training on whatever methodology is chosen before the committee meets again. He also said SACHRP and subcommittee members made their “dismay” at the decision known to OHRP.