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Crucial Human Subjects Research Protections Weakened by the Department of Health and Human Services With No Public Input

Oct. 23, 2013

Crucial Human Subjects Research Protections Weakened by the Department of Health and Human Services With No Public Input

Change in Remuneration Policy Could Exploit Research Subjects by Luring Them to Take on Greater Risks

WASHINGTON, D.C. – The sudden removal of a key clause from a Department of Health and Human Services (HHS) guidance document could lead to human subjects of research being pressured to take on greater risks than they would otherwise have accepted because they could now be offered greater remuneration. This change undermines protections for human subjects, increases the potential for exploitation, and should have been subject to public input before being finalized and implemented, Public Citizen wrote in a letter sent today to HHS Secretary Kathleen Sebelius and Assistant Secretary for Health Howard Koh.

Without soliciting any public comment, HHS’s Office for Human Research Protections (OHRP) removed the following two important sentences from a long-standing guidance document interpreting regulations regarding consent of human subjects: “In no case should remuneration be viewed as a way of offsetting risks; that is, it should not be considered a benefit to be weighed against study risks. The level of remuneration should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the remuneration.”

HHS’ stated explanation of the change, presented and critiqued in Public Citizen’s letter, rests in part on the opinion of “several [unnamed] members of the research ethics community.”

“The change to the guidance may seem minor,” says Dr. Michael Carome, director of Public Citizen’s Health Research Group, “but the implications are far-reaching because the new policy now permits, if not encourages, researchers to offer remuneration so high that it could unduly influence prospective subjects to accept research risks that they would not otherwise consent to without such remuneration. This could lead to exploitation in particular of subjects who are more vulnerable to such undue influence due to their socioeconomic status.”

In the letter, Public Citizen calls upon HHS to compel its OHRP to rescind the new guidance on subject compensation and issue draft guidance for public review and comment if the agency wishes to pursue the policy change. It also should be required to provide a much more thorough rationale for changing the policy.

The letter is available at https://www.citizen.org/our-work/health-and-safety/articles/letter-hhs-secretary-and-assistant-secretary-health-criticizing.