Oct. 28, 2014

Media Advisory: Public Citizen to Testify Before HHS Advisory Committee Regarding Unethical Baby Trial

In SUPPORT Study, Parents Were Not Given Adequate Information About Risks; Agency Reviewing Proposed Guidance Intended to Prevent Similar Lapses

WHAT: Public Citizen will testify before the U.S. Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Human Research Protections to explain how the unethical SUPPORT study diverged significantly from usual care of premature infants and to provide comments on the just-issued Office for Human Research Protections (OHRP) guidance aimed at preventing similar lapses.

The guidance comes as the result of a controversy that erupted in 2013 after Public Citizen publicized a highly unethical government-funded trial on premature infants. In that trial, in which babies were randomly assigned to be given different levels of oxygen, parents were not adequately informed of the reasonably foreseeable risks of the experiment, which included death and blindness. Nor were they told of the purpose and experimental nature of the study procedures.

In commentary discussing the draft guidance, the OHRP strongly reaffirmed the agency’s position that the parents of premature babies enrolled in the National Institutes of Health (NIH)-funded SUPPORT study were not informed of the reasonably foreseeable risks. The agency soundly rejected the arguments made by the SUPPORT study investigators, the NIH director, the editor of the New England Journal of Medicine and many bioethicists asserting that the SUPPORT study simply involved a comparison of different standards of care for oxygen treatment and therefore did not expose premature babies to any foreseeable risks.

Along with input received during the committee meeting, the OHRP will accept comments on the draft guidance until Dec. 23 before issuing final guidance. Although it is not legally binding, research institutions generally adhere to OHRP guidance.

WHEN: 2:30–4:30 p.m. EDT Wednesday, Oct. 29. The public comment period for the meeting starts at 4:30 p.m.

WHO: Dr. Michael Carome, director, Public Citizen’s Health Research Group

WHERE: Fishers Lane Conference Center, 5635 Fisher Lane, Rockville, Md.

View more information about the SUPPORT study.

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