Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Barbara Holzer, Broadcast Manager
w. (202) 588-7716
bholzer@citizen.org

Karilyn Gower, Press Officer
w. (202) 588-7779
kgower@citizen.org

Ben Somberg, Press Officer (regulatory matters)
w. (202) 588-7742
bsomberg@citizen.org, Twitter

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog
Facebook/publiccitizen

Follow us on Twitter

 

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 http://www.citizen.org/hrg2165.

###

Copyright © 2014 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

 

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.