Government Agency Confirms: Parents Were Not Given Adequate Information About the Risks Posed to Their Premature Babies in NIH Trial

Public Citizen Applauds OHRP’s Reaffirmed Stance Regarding Unethical SUPPORT Study and Proposed Guidance Intended to Prevent Similar Lapses

WASHINGTON, D.C. – Public Citizen applauds the position taken by the Office for Human Research Protections (OHRP) confirming that parents of premature infants enrolled in a government-funded study were not given adequate notice of the trial’s risks. The position comes in a Federal Register notice today announcing the availability of the agency’s draft guidance document, “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.”

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.

Publicity about the trial prompted a heated debate in the medical research community over what constitutes informed consent, and the federal government held an unusual hearing in August 2013 at which parents of babies enrolled in the trial spoke.

“This sends a strong message,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The agency agrees with us that it is not acceptable to enroll people in research without fully informing them of the risks. This makes clear that the agency is standing by its principles and not caving in to pressure from the research community.”

In commentary discussing the draft guidance, OHRP strongly reaffirmed the agency’s position that the parents of premature babies enrolled in the National Institutes of Health (NIH)-funded SUPPORT study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 has 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.

In particular, OHRP noted:

  • “Therefore, for the great majority of infants in the [SUPPORT study], it is likely that their participation altered the level of oxygen they received compared to what they would have received had they not participated.”
  • “Some in the research community maintain that because the lower (85% to 89%) and higher (91% to 95%) ranges of oxygen saturation provided to the infants [in the SUPPORT study] were within the standard of care range, there were no known risks to participants in the study from being randomized to these two oxygen saturation levels. OHRP disagrees with this perspective, and maintains that the key issue is that the treatment and possible risks infants were exposed to in the research were different from the treatment and possible risks they would have been exposed to if they had not been in the trial.”
  • “With regard to which risks should be considered ‘reasonably foreseeable,’ OHRP concluded that at a minimum, identified risks associated with a standard of care that are being evaluated as a purpose of the research, should certainly be considered ‘reasonably foreseeable.’ A core purpose of the [federal regulations designed to protect human subjects in research] is to allow prospective subjects to make informed decision about whether to participate in research. If a specific risk has been identified as significant enough that it is important for the federal government to spend taxpayer money to better understand the extent or nature of that risk, then that risk is one that prospective subjects should be made aware of so that they can decide if they want to be exposed to it.”

While the draft guidance lacks clarity on some important points, OHRP’s position generally aligns with Public Citizen’s previously stated views.

Public Citizen calls for OHRP to take the following actions:

  • Rescind immediately its suspension of compliance oversight enforcement actions against the institutions that conducted the SUPPORT study; and
  • Require that the institutions that conducted the SUPPORT study write letters to the parents of all SUPPORT study babies divulging the previously undisclosed information regarding the risks of the research and the experimental nature of the study procedures, as the agency has done in the past when similar serious lapses have occurred during the conduct of clinical research.

OHRP will accept comments on the guidance for the next 60 days before issuing final guidance. Although it is not legally binding, research institutions generally adhere to OHRP guidance.

View Public Citizen’s prior work regarding the SUPPORT study.

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