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August 22, 2013

New NIH-Funded Study on Premature Infants Shows Familiar Lack of Compliance With Ethical Consent Standards

Lack of Information for Parents on Dire Risks to Their Premature Babies Indicates Need for Greater Oversight

WASHINGTON, D.C. – Just months after exposing an unethical federally funded experiment conducted on premature infants, Public Citizen has learned of another, similar trial that also poses known risks to premature babies without fully informing the parents about those risks. In a letter sent today, Public Citizen calls on Health and Human Services (HHS) Secretary Kathleen Sebelius to stop recruiting for the trial, which started only recently, and to notify parents of babies already enrolled about the risks to their children.

The National Institutes of Health-funded Transfusion of Prematures (TOP) trial is designed to determine which of two strategies for treating anemia with blood transfusions is more likely to result in death or neurologic injury in extremely premature infants who develop anemia (low blood hemoglobin, which is found in red blood cells and carries oxygen to the body). In certain respects, the ethical lapses in this trial are very similar to those in the NIH-funded Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), which Public Citizen exposed in April as subjecting premature infants to risks of blindness or death without proper consent from parents.

The TOP study apparently began in the past several months. Infants are now being enrolled at as many as 15 major academic medical centers that are part of the NIH-funded Neonatal Research Network. The infants weigh less than 2.2 pounds and are born 22 to 29 weeks into the pregnancy (any birth before 37 weeks is considered pre-term). The study is expected to involve 1,824 extremely premature infants.

In the study, half of the infants are randomly assigned to receive transfusions at a high hemoglobin level (liberal transfusion group) and half at a low hemoglobin level (restrictive transfusion group) – regardless of their individual needs. “Of note,” Public Citizen’s letter reads, “the best available evidence, previously published by some of the TOP trial investigators themselves and extensively cited in the TOP protocol, suggests, overall — as does the study’s subtitle — that the restrictive transfusion strategy is more likely to result in neurologic injury and other harms in extremely premature infants.” The letter is available at http://www.citizen.org/hrg2150.

Yet despite these known risks, the consent forms for the TOP trial, acquired by Public Citizen through Freedom of Information Act (FOIA) requests, have serious deficiencies resembling those found in consent forms used in the SUPPORT study. The consent forms fail to inform parents of prior research suggesting that the liberal transfusion approach has more favorable outcomes and that the purpose of the study is in fact to prove this point – which requires exposing more than 900 infants to the restrictive transfusion strategy.

Of the 17 institutional review board-approved consent forms obtained by Public Citizen, only one mentions the foreseeable risk of death or disability. Five say the research poses no risk, and 15 conflate risks of the research with risks of routine medical care. All but two of the forms fail to explain that part of the primary purpose of the research is to see which transfusion group is more likely to suffer death, and 12 fail to indicate the study’s equally primary goal of seeing which group shows more signs of neurodevelopment impairment.

“This continued pattern of egregious informed consent deficiencies in NIH-funded trials involving the most vulnerable of human beings is deeply troubling,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “These ethical lapses may represent the tip of the iceberg.”

Public Citizen is urging Sebelius to immediate halt the TOP trial and direct HHS’ Office for Human Research Protections (OHRP) to open an investigation into the trial. It also is calling for OHRP to develop a plan to contact the parents of subjects already enrolled in the trial and provide them with full information about the risks, purpose and nature of the research.

Since this is not the first such lapse in research ethics in a large multicenter trial involving premature babies, Public Citizen’s letter also calls for an independent investigation of the HHS system for review and oversight of HHS-funded human subject research, and a suspension of any other similar studies currently being funded by NIH or any other HHS agency.

In the SUPPORT study, which took place from 2005-2009, 1,316 premature infants were exposed to an increased risk of blindness, brain injury and death as researchers tested two experimental approaches for managing oxygen therapy.

Publicity over the SUPPORT trial prompted HHS to announce an unusual public forum, scheduled for Wednesday, Aug. 28, from 9 a.m. to 5 p.m. at HHS headquarters in Washington, D.C. It is designed to solicit comments from experts and the public about what risks should be disclosed to participants when research is focused on the so-called “standard of care” treatment given patients for a particular condition.

Since Public Citizen publicized the lack of adequate informed consent in the SUPPORT trial, a controversy has raged in the scientific community over what kind of consent is needed in certain kinds of clinical trials. The debate goes to the heart of how research is conducted in the United States and could have far-reaching, negative implications if changes are made to weaken the ethical and regulatory standards by which trials are run.

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