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Chances are your ethics committee can’t absolutely ensure that consent practices are followed in your facility. The better option, experts suggest, is to adopt a policy that incorporates medical reality.
It might be more appropriate to seek the "best possible" or "best feasible" consent in neonatal research situations, says Jon Tyson, MD, a neonatologist and Michelle Bain distinguished professor of medicine and public health at the University of Texas-Houston. Tyson also is a member of the Neonatal Research Network, a federally funded effort to design multicenter trials in neonatal research.
Try incorporating the following elements into your informed consent procedures:
1. Acknowledge the time constraints. This new concept would be one designed to better take into account the "real-life" situation that the clinicians, parents, and babies are in: The lack of available time to make the decision and the limited amount of information known about the intervention.
"As an [institutional review board] person, we have not accepted the concept of best possible’ consent," says Paula Knudson, executive coordinator of the institutional review board (IRB) at the University of Texas Health Sciences Center. "It is a different and new idea for IRBs that you assume. I think, in time, we will get there."
2. Open dialogue between clinicians and investigators. We need to begin a dialogue with more IRB people and see if we can flesh out the idea and get it more accepted. I think [to require a strict adherence to informed consent] is unrealistic under these kinds of circumstances," notes Knudson.
3. Allow other forms of participation. Part of the dialogue between providers and investigators also should include discussions of other forms of allowing study participation, Tyson adds. These would include determining specific situations in which it might be OK to include babies in trials of therapies that are of no increased risk and the potential for benefit is high, allowing parents to opt out later, if they so choose. Or, as is the case in certain therapies involving adults, situations in which consent can be waived.
"There have been some regulations that are intended to make it more feasible to [perform procedures] when consent is not obtainable at all," he explains. "The patient who has a heart attack in his car and is found slumped over the wheel by bystanders. Or, the mother who comes in bleeding, immediately goes through a cesarean and is anesthetized with no one else there in her family — those kinds of circumstances."
4. Allow waivers for certain scenarios. Considering the limited window of opportunity for inclusion in many neonatal trials, it might be beneficial to have certain scenarios in which a waiver of consent is allowed for research, says Knudson. "If the baby is brought in on Life Flight from another hospital, you can’t wait 24 hours until the mother is feeling better or the father is around and you can really discuss it," she says. "You have maybe three hours in which to get the baby admitted for the intervention."
Options to informed consent need to be fleshed out for neonatal research, she says, from the concept of "best possible" consent all the way down to when to allow waivers of consent, which are currently not invoked in neonatology.