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June 5, 2013

The Office for Human Research Protections Reaffirms Main Findings of Inadequate Informed Consent for Premature Baby Study, But Bows to Political Pressure and Puts Enforcement Actions Hold

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group*

*Note: Dr. Carome previously worked at the Office for Human Research Protections as director of the Division of Compliance Oversight and associate director for regulatory affairs.

The federal government has taken an important step toward addressing a highly unethical trial involving premature babies but still is leaving infants and other subjects at risk by permitting current similar trials to continue. This is an abject and unacceptable failure to protect human subjects in clinical trials and is undoubtedly because of political pressure.

On April 10, Public Citizen drew attention to an unethical clinical trial funded by the National Institutes of Health (NIH) that exposed 1,316 premature infants to increased risk of blindness and death as part of a clinical trial without parents of the babies being informed of the risks to their babies or the true nature and purpose of the research.

The trial, known as the SUPPORT study, tested two experimental strategies for managing oxygen treatment in premature babies, with one group maintained at a low blood oxygen level and the other at a high level.

On March 7, 2013, the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) wrote a letter to the University of Alabama at Birmingham (UAB), one of the lead institutions for the SUPPORT study, finding that the consent forms for the study did not disclose to the babies’ parents any of the risks of the experimental oxygen management interventions, including risks of severe retinal damage, possible blindness, neurologic injury and death. Our subsequent analysis of the complete protocol and consent forms from 22 institutions not only affirmed the appropriateness of OHRP’s determination, but demonstrated that the deficiencies of the UAB consent form were far more significant than those discussed in OHRP’s letter. In particular, the consent form failed to disclose the true purpose of the research and the nature of important experimental interventions.

On Tuesday, in the wake of intense criticism for the SUPPORT study investigators, NIH and others, OHRP wrote another letter to UAB, strongly affirming its original findings of inadequate informed consent and providing additional evidence to bolster that finding. OHRP stated the following:

  • “[C]onsistent with OHRP’s mission to protect human subjects of research, the overarching concern of our determination was the adequacy of informed consent, a bedrock principle of research involving human subjects.”
  • “To make truly informed decisions about whether or not to participate in a research study, potential volunteers or their parents or guardians are entitled to certain information, including a description of reasonably foreseeable risks … More significantly, neither the ‘Risks’ section nor any other portion of the form mentioned any risks associated with lower oxygen levels.”
  • “However, the medical profession looks at many factors when assessing potential risks. At the outset of the SUPPORT study, many in the research and clinical communities remained concerned about the possible relationship between low oxygen and increased mortality and neurodevelopmental problems within the oxygen ranges that were to be evaluated in that study.  Indeed, such concerns were a core reason why the study was conducted.”
  • “This principle has direct bearing on the SUPPORT study. When there is a range of oxygen levels within the standard of care, clinicians (and their institutions) often do, in fact, make their own determinations regarding which oxygen levels within that range to employ in treating their patients. Some physicians, recognizing the particular concerns about risks near the low (85%) and high (95%) ends of that range, might choose to avoid one or both of those regions.”
  • “Thus, by participating in the study [at Tufts Medical Center], the treatment of such subjects was substantially altered to make it much more likely that they would be within the [oxygen] range in which there were significant concerns about increased mortality. And this circumstance is likely not unique to that site.”

Despite staying on firm ground with respect to the agency’s original finding regarding the obvious failure of the SUPPORT study consent forms to disclose the risks of the research, OHRP nevertheless has chosen to put on hold appropriate action, saying:

“In addition …we have put on hold all compliance actions against UAB relating to the SUPPORT case, and plan to take no further action in studies involving similar designs until the process of producing appropriate guidance is completed.”

Suspending appropriate and necessary compliance action related to the SUPPORT study and allowing similar research studies, including ongoing studies involving premature babies, to continue, despite suspecting that the consent forms for those studies may have similar serious deficiencies, is unacceptable. The rules and norms regarding informed consent for research have been clearly articulated and well-known for decades but were disregarded by the SUPPORT study investigators and the institutional review boards that approved the study.

Pending any further deliberations and development of guidance regarding informed consent, HHS Secretary Kathleen Sebelius should order an immediate halt to any research studies similar to the SUPPORT study for which there are reasonable doubts about the adequacy of the informed consent process. To blindly allow such clinical trials to continue without knowing whether subjects or subjects’ parents or guardians are receiving appropriate information about the purpose, nature and risks of the research represents an abject failure to protect human subjects. As OHRP stated, informed consent is a “bedrock principle of research involving human subjects.” This principle must not be compromised simply to satisfy the desire of medical researchers for expediency in their quest to advance medical knowledge.

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