breath of life. controversial study looked at the amount of oxygen in preterm infants should receive.
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Under fire researchers and ethicists, the US government agency responsible for the protection of patients involved in scientific studies supports near a decision punish the leaders of a clinical trial with premature infants after finding that the researchers failed to disclose the full risks of the test. "We have put on hold all actions of compliance," the US Office for Human Research Protections (OHRP) announced in a letter on June 4 at the University of Alabama, Birmingham (UAB), who led the trial . OHRP also said he plans to hold a public meeting to discuss the controversy with an eye toward clarifying the rules to provide informed consent.
movementOHRP came one day before The New England Journal of Medicine published two pieces urging OHRP to reconsider sanctions and expressing support for researchers who designed and conducted the test. "[W] e respectfully disagree with the conclusions of the OHRP," wrote three senior officials of the National Institutes of Health (NIH), which funded the study, including the NIH Director Francis Collins. "Allow the decision to hold would be unfair for investigators and institutions, "wrote a group of dozens of bioethicists and pediatric leading researchers.
the controversy came to the public light in early April, after the group nonprofit Public Citizen alerted reporters to a letter on March 7 from OHRP at UAB. He concluded that the 23 institutions involved in the trial, known as mEDIA, had failed to fully disclose its risks. the letter UAB also asked to prepare a "corrective action plan." The trial, which lasted from 05 to 09, 1316 provided very preterm infants with different oxygen concentrations to better understand how to prevent the blindness that can accompany treatment. The results of the test, published in 2010 The New England Journal of Medicine indicated that infants receiving the lower oxygen levels were more likely to die, but less likely to become blind than infants who receive higher levels. All infants received oxygen levels that were in the then accepted standards of medical care. OHRP concluded, however, that consent forms adequately emphasizes the possible consequences, including death, to be at one end of the beach or the other. And Public Citizen argued that parents have not signed their children for trial if the risks had been fully explained.
The controversy has provoked much discussion in the biomedical research community, and the trial has been difficult ethical criticism in public forums such as Web sites. But 4 June letter OHRP trying to calm the waters. "OHRP became aware of the widespread misunderstanding of the risks that must be provided to obtain informed consent for certain types of clinical trials," the letter said, adding that "we emphasize that OHRP does not and never asked if the design of the supporting study was ethics. "
But the issues are complex, notes, letters, and" [g] Iven important, we recognize the obligation to OHRP give clear guidance on what are the rules on risk disclosure in randomized studies whose salaries fall within the range of care standards. We are committed to do, and do it quickly. "Not only the agency" engage in the review and usual process on the draft guidance, "he said," we will also conduct a meeting open about it public. "
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