“Unethical” Infant Clinical Study Sparks New Research Guidance On Informed Consent

A federal advisory panel is meeting today to discuss ethical issues surrounding infant studies, following a controversial clinical trial that many critics say put infants at risk without properly informing their parents. 

The U.S. Department of Health and Human Services (DHHS) Secretary’s Advisory Committee on Human Research Protections will conclude a two-day meeting later today in Rockville, Maryland, with discussion today focused on clinical trial ethics. The meeting comes in the wake of a draft guidance posted earlier this month by the Office for Human Research Protection (OHRP) on reasonable disclosure of research study risks.

Last year, the consumer watchdog group Public Citizen highlighted concerns about problems with an infant study known as the “Surfactant, Positive Pressure, and Oxygenation Randomized Trial” (SUPPORT), which the group says exposed more than 1,300 infants to increased risk of blindness, brain injury and death during experimental approaches for managing oxygen therapy. Public Citizen says parents were not properly told of the risks their children would face participating in the study.

The OHRP referenced the SUPPORT study as a reason for the new guidance, saying that all foreseeable risks should be provided to potential participants so that they can make informed consent. The group noted that children in the trial were exposed to potentially dangerous levels of oxygen that they would not have been exposed to under normal circumstances, and their parents were not told about the potential risks for blindness and death.

“All standards of care do not pose identical risks, either in terms of the nature or the degree of the risks, and individuals often may have reasons to prefer the risks of one standard of care over the risks of another. Disclosing the reasonably foreseeable risks of research to prospective subjects recognizes the ethical obligation to give prospective subjects sufficient information to make a knowledgeable decision about whether or not to participate,” the guidance states. “This reflects the ethical principle of respect for persons, which recognizes the importance of giving individuals sufficient information during the informed consent process to make a considered judgment about whether to participate in research that could affect their health or wellbeing—for better or worse.”

The OHRP guidelines are non-binding, but most researchers adhere to them.

Public Citizen applauded the guidance and Dr. Michael Carome, director of Public Citizen’s Health Research Group, will provide testimony at today’s hearing.

“The agency agrees with us that it is not acceptable to enroll people in research without fully informing them of the risks,” Carome said in a press release. “This makes clear that the agency is standing by its principles and not caving in to pressure from the research community.”

Public Citizen has called on OHRP to go further and to pursue enforcement actions against the institutions that conducted the SUPPORT study and to force them to write letters to the parents of all the children involved and to provide them with the previously undisclosed information regarding the risks and experimental nature of the clinical trials.

DHHS is taking public comment on the guidance for another 56 days.