The National Institutes of Health acted within its authority when it discouraged an oversight agency from penalizing university researchers involved in an experiment said to have endangered hundreds of premature infants, government auditors have ruled.
The federal oversight agency, the Office of Human Research Protections, also acted properly when it rescinded an initial threat of action against those responsible for the study, the auditors said in a separate review.
The two investigations, made public this week, were conducted by the Office of Inspector General at the U.S. Department of Health and Human Services following complaints about the NIH’s and the research-protections office’s responses to the medical trial, which was conducted from 2004 to 2009 at 23 universities and involved 1,300 premature infants.
The experiment was designed to find the right level of oxygen to give to premature babies, given that previous research and clinical experience had suggested that too little oxygen could increase the risk of death and too much could lead to blindness. But concerns over the work included allegations that oxygen levels were more stringently imposed upon some babies than would happen in the normal course of care, and that parents were not fully informed of the protocols or the risks.
In an initial response last year, the Office of Human Research Protections, or OHRP, wrote to the University of Alabama at Birmingham, the lead institution in the study, threatening penalties. Under pressure from the NIH, which had financed and approved the project, the office later rescinded the threat against UAB while complaining privately about the NIH’s role.
The inspector general’s actions in absolving both the NIH and the OHRP still leave open, however, the ultimate question of what anyone may have done wrong in the experiments with the babies, what lessons other researchers should take from the case, and what bureaucratic changes might still be needed within the department to handle such incidents more smoothly in the future.
As for the latter, the NIH recognized the need for a strong OHRP, even as it pushed back in this particular case, said Kathy L. Hudson, the institutes’ deputy director for science, outreach, and policy. “It’s really important that the organization that’s responsible for the implementation of the ethical standards for biomedical research in this country—they must be strong, they must be robust, they must have good processes and adequate resources,” Ms. Hudson said. “That’s just vital.”
Concern for Independent Oversight
The NIH and the Office of Human Research Protections both sit within the Department of Health and Human Services, and the baby experiments illuminated the degree to which the oversight office feels it lacks the independence to push back when it feels the NIH hasn’t fully protected human subjects of research.
That complaint has been repeated by at least one prominent consumer-advocacy group, Public Citizen, and one member of Congress, Rep. Rosa L. DeLauro, Democrat of Connecticut. Public Citizen called the inspector general’s conclusions “extremely disturbing,” given that the audit confirmed that NIH officials were allowed to review and edit drafts of the OHRP’s response to the infant study.
The audit “represents a complete whitewash,” said Michael Carome, a former associate director for regulatory affairs at the OHRP who now serves as director of Public Citizen’s Health Research Group.
The inspector general’s office, however, said in its report on the NIH that Congress could have given the OHRP more independence if it felt that was necessary. It cited specific examples when Congress has done so, beginning with the multiple instances of inspector general’s offices that are given full organizational and budgetary separation from the departments they oversee.
OHRP officials declined to comment on the two audit reports, while Ms. Hudson, of the NIH, endorsed the idea of structural change. “There’s ways in which their processes could be enhanced,” she said of the OHRP, “so that we don’t recapitulate this particular experience, which has not been beneficial for any of us.”
As for bigger-picture lessons from the infant study, the OHRP is still considering the matter. The OHRP did retreat from its initial threat of penalties against the universities in the infant trial, but it is expected within a few weeks or months to issue proposed new guidance for standards of care in research that involves human subjects. That guidance will go through a period of public comment, officials said, with the hope of eventually giving all researchers more clarity on what is expected of them.
