By Gary Evans, Medical Writer
There is considerable ethical debate about the issue of reconsent at age 18 from research subjects who provided biospecimens as infants, children, or adolescents. Practices currently vary widely among institutions, with some permitting continued use of deidentified samples and others requiring all samples to be destroyed when the subject reaches age 18.
Attempting to cut this Gordian knot, a group of bioethicists recently argued that there is no need to seek reconsent for use of biological samples donated by children if permission was given originally by their parents.
“In most cases, parental permission is needed to obtain samples from minors,” the authors reported.1 “In addition, almost all commentators and guidelines maintain that researchers need the consent of donors if they want to continue to store the samples and make them available for future studies after the donors reach the age of majority. We argue that this near-consensus view is mistaken on the grounds that the agreement of the parents at the time of obtaining samples provides sufficient permission.”
Parents have broad authority to make decisions on behalf of their children, they argued, citing examples of financial decisions to distribute future money to children and donating newborn stem cells from the umbilical cord.
“This suggests that parental permission can be sufficient and, for most studies, obviates the need for reconsent when the donors turn 18 years old,” they concluded. “We believe that this position is consistent with a reasonable interpretation of current U.S. regulations protecting human subjects.”
That said, every effort should be made to inform parents during the original consent that their children’s biospecimens may be used for future research, says lead author Benjamin Berkman, JD, MPH, head of the ethics of genetics and emerging technologies at the National Institutes of Health Department of Bioethics.
“It should be made very clear to parents that they are not just providing consent or permission on behalf of their children right then, but they are making a decision that is going to bind children into adulthood,” he tells IRB Advisor. “They are making these kinds of decisions for the kids all the time, but in the research context it is different. I think it should definitely be clarified to parents that they are making a decision that has some lasting implications for their kids.”
This could include at some point explaining to children who were enrolled in research that their biospecimens may be used in the future, he says.
Reconsent at the age of 18 should not be required unless the future studies require interaction with research subjects who now are adults. In addition, reconsent should not be required unless the subsequent research poses greater than minimal risk, Berkman and colleagues argue. What would constitute risk that goes beyond minimal?
“This is a big debate in the literature,” he says. “I am generally of the view that once samples are collected — even if there is going to be genetic analysis done — that it is almost certainly [minimal risk].”
However, the moral implications of some research could raise the perception of risk; for example, if biospecimens were used in cloning research or in experiments with gametes that could be used to produce human embryos, he notes.
“You can imagine the kind of research where people might have a moral objection,” he said. “Those are the kinds of things that would be beyond minimal risk, but in terms of actual welfare harm to people it is, at least to my mind, pretty hard to imagine cases where there would be more than minimal risk.”
A counterview2 on the subject argues that the revised Common Rule and OHRP guidance do not necessarily support the contention that reconsent is not needed. It is something of a gray area, but Berkman and colleagues concede in their paper that they have taken “a controversial view about pediatric reconsent that may seem counterintuitive in a field where autonomy is sacrosanct.”
There is an ethical testing in this process, as Berkman and colleagues conclude that “the broad support for an obligation to obtain new consent at the age of majority is understandable, but ripe for a challenge. Intuitively, it seems odd that a one-time sample donor remains a subject indefinitely.”
In the opposing view, another group of bioethicists underscore that there are important ethical reasons to obtain consent when specimen subjects reach 18. However, they balance this against the demands of efficiently and economically conducting research that benefits children.
“Given current guidance from the relevant regulatory bodies, it remains necessary to obtain consent for the continued use of identified pediatric samples when participants reach the age of majority unless the institutional review board grants a waiver of consent,” the authors stated. “However, we argue that waivers of consent should more frequently be granted by institutional review boards and used for this purpose.”
If the donor children are still involved in the research as they reach adulthood, “there is really no excuse for not getting consent,” says lead author Kyle Brothers, MD, PhD, an associate professor of pediatrics at the University of Louisville in Kentucky, where he also is affiliated with the Institute for Bioethics, Health Policy, and Law.
That would be an obvious case when it is “practicable” to obtain consent when child specimen donors become 18, he adds.
In contrast, a biorepository may store thousands of specimens from children whose parents originally gave consent, but there may be little information to contact the donors even to get reconsent.
“Some of these biorepositories are quite large,” he says. “You don’t necessarily have updated contact information, so it may not be practicable to get consent. However, the IRB is allowed to create a waiver of consent.”
An IRB waiver of consent in these cases cannot be made if the research poses greater than minimal risk to the subjects.
“I think both papers agree it should be possible to continue using these samples without getting permission of the child,” Brothers says. “The difference is we are saying that you have to get waiver of consent from the IRB if you want to store identified samples. Or you need to deidentify the samples, and essentially that moves your research [out] of the human research category.”
Both of those are good options under current guidelines to use biospecimens if obtaining reconsent from research subjects is going to be problematic, he says.
“We are essentially saying, if you can [get reconsent], you should — that’s really a good thing to do,” he says.
Brothers and colleagues conducted a study of a consortium of biorepositories to assess practices on this issue.
“An IRB at one of the sites required them to destroy the samples when the children reached age 18,” he says. “They were not even allowed go back and try and get their consent. Some IRBs allowed them to keep using the samples even if they were identified. Some of them required them to go back and try to contact the people and get their permission. If they did not get permission, then they had to either destroy the samples or deidentify them.”
Although this issue may still fall into a gray area if the Common Rule is finalized as currently drafted, it is clear that IRBs have the aforementioned options and these should become more standardized, he adds.
“The IRBs that are very restrictive and force people to destroy samples are really going beyond what is required by the regulations,” Brothers says. “They are primarily doing that because they are worried about doing something that is not allowed by OHRP. We are trying to make it really clear that you are allowed to do this” through IRB waiver or deidentification of specimens.
“They made some good points,” Berkman adds. “I think our papers are sort of complementary in a way. They’re making, I think, a fairly reasonable legal argument interpreting the regulations as they stand and as they will stand. That is required under the guidance. We were looking at the broader ethical problem. Setting aside what the regulations say, we are saying that, just ethically, we don’t think that obtaining reconsent is normatively required.”
Asked whether IRBs that decide to follow this argument in practice could be open to liability, Berkman reiterated that his position is addressed to the ethical questions more than the legal ones.
“That’s not the fight we want to have,” he says. “I never want to say there are no liability issues, but I think that research subjects would have an uphill battle to be able to win negligence suits. They would have to show duty breached, causation, and damages. Given the minimal risk of most of these research activities, I think they would have a whole lot of difficulty showing that harm was due to a failure to get reconsent at 18.”
1. Berkman BE, Howard D, Wendler D. Reconsidering the Need for Reconsent at 18. Pediatrics 2018; 142(2):e20171202.
2. Brothers KB, Wilfond BS. Research Consent at the Age of Majority: Preferable but not Obligatory. Pediatrics 2018; 142(2):e20173038.