Two medical studies of premature infants have come under fire recently because they allegedly did not properly inform parents about the risks their children might face by participating in the research.
Today, experts will gather to discuss whether these studies, and similar ones, do in fact fall short in laying out the foreseeable health risks, and whether researchers process of obtaining consent from parents needs to change.
Researchers appear starkly divided about the issue: some argue that consent forms need to be more explicit about the possible risks of the studies, but others say these are risks that cannot be predicted at the study's start. [ 7 Medical Myths Even Doctors Believe ]
The discussion will be part of a meeting held by the Office of Human Research Protection tomorrow (Aug. 28), at the U.S. Department of Health and Human Services in Washington DC.
One study, called SUPPORT, was conducted between 2004 and 2009 and examined which level of oxygen is optimal for premature babies born between 24 and 27 weeks of pregnancy. More than 1,000 babies were randomly assigned to receive either a "high" or "low" oxygen level, but babies in both arms of the study received oxygen levels that were within the range of those acceptable by doctors todays.
The other study, called TOP, is going on right now and is looking at the best strategy for providing blood transfusions to premature babies with anemia. Babies weighing less than 2.2 pounds are randomly assigned to receive a blood transfusion when their anemia is mild (the liberal transfusion group), or when it is more severe (the restrictive transfusion group).
Both studies involve so-called standard of care treatments, or treatments that are already used by doctors. The goal of the both studies is to make the standard of care better.
But critics say the consent forms for these studies fall short in several ways. For one, the consent forms do not make clear that the risk of side effects — which included blindness and death in the SUPPORT study and brain injury in the TOP trial — might differ depending on which group the babies are assigned to, according to Public Citizen, a consumer advocacy group.
Instead, the consent forms state the following (or something very similar): "because all of the treatments proposed in this study are standard of care, there is no predictable increase in risk for your baby."
George Annas, chair of the Department of Health Law, Bioethics & Human Rights at Boston University School of Public Health, who is scheduled to speak at the meeting today, told LiveScience that he thinks the consent forms need to be more explicit.
Parents should be told "that no one knows which arm of the study is 'best' — that's why the study is being done — but that it is very likely that one will be better than the other, and their baby will have a 50 percent chance of being in the better arm, and a 50 percent chance of being in the less good arm," Annas said.
In addition, the consent forms do not state that a child's care might be different if he participates in the study than if he does not, according to Public Citizen.
"Some babies, the interventions they receive in research don’t match what they would otherwise get in clinical care," said Dr. Michael Carome, director of Public Citizen's Health Research Group.
Improving standard of care
However, others argue that such criticisms presume that researchers have an answer before they even begin the study, which is not the case, said Dr. Jeffrey Drazen, editor-in-chief of The New England Journal of Medicine.
"I think it shows a primary misunderstanding of the research process," Drazen said of the criticism.
In many clinical situations, doctors do not know which method of care is the best, Drazen said. So they use their best judgment, which may be based on their experience, but not hard evidence, he said.
In situations like these, "Your doctor is guessing. When you let doctors guess, they make more mistakes. They need data, we need data, to drive our decision making," Drazen said.
Drazen said both studies had exclusion criteria that prevented babies from entering if a particular method of care was known to be better for them.
"To be in the study, this would have to have been a question" relevant to the participant, and "either [option] could have been your care," Drazen said.
However, Carome said that the exclusion criteria for the SUPPORT and TOP trials were not enough to prevent the possibility that some infants would receive care different from what it would have been outside the study.
In addition, in the case of SUPPORT and TOP, doctors had substantial medical literature to guide their choices, so it was more than just "guessing," Carome said. Some of this medical literature should be mentioned in the consent forms, Carome said. For instance, while researchers didn't have a definitive answer as to when is the best time to transfuse premature babies, the best studies done so far suggest that a restrictive strategy was more likely to result in harm, Carome said.
Referring to the SUPPORT study, Drazen said: "The sad part here is, we didn’t know the answer," before the study began. He pointed out that, as a result of the SUPPORT study, doctors are moving away from using lower oxygen levels, which were found to increase infants' risk of death. "Now we can prevent that from happening."