Assent process should focus on children's understanding of research
Focus on capacity to understand, not competence
Giving children a chance to assent to their own participation in research is an important goal of the pediatric research community. Done properly, it can empower young patients, help them develop their decision-making skills, and prompt them to take their participation more seriously.
But too often, some ethicists say, the process of obtaining assent gets confused with the more familiar informed consent process, serving up more complicated forms and more stringent requirements than are helpful or understandable for the children involved.
"Assent is not consent they're two entirely different things," says Yoram Unguru, MD, MS, MA, a pediatric hematology/oncology fellow at Children's National Medical Center in Washington, DC, and a Greenwall Fellow in Bioethics.
"If you view assent as consent, you're holding kids to an unfair standard," Unguru says. "You expect that they understand risks and benefits and by doing that, you're really limiting their ability to meaningfully participate in research."
Unguru, who recently wrote about the issue of pediatric assent for the journal Pediatric Clinics of North America, suggests that assent should be seen as an opportunity to give a child decision-making experience that is appropriate for his or her developmental stage and maturity.1
For one child, that might mean a simple explanation of the research and a verbal OK; for a more mature teen, it could mean an actual document to sign. In every case, Unguru says, the process should involve the child to the extent that it's possible, while still seeking true informed consent from parents.
"It's about being flexible, having a process that you can mold according to each child's individual abilities," he says.
IRBs judge capability
While parents or guardians provide the formal consent for children involved in research, federal regulations (45 CFR 46.408) state that IRBs also must determine that adequate provisions are made for soliciting the children's assent, if the IRB judges they are capable of giving it.
That judgment is to be based on a child's age, maturity, and psychological state, but no age requirement is given for seeking assent.
IRBs also are charged with determining how assent should be documented when it is sought.
Assent is not required if the study holds out the prospect of direct benefit to the child.
Unguru says he likes the fact that the federal regulations don't set an age limit for obtaining assent: "Your 7-year-old is different from my 7-year-old is different from the kid down the street. Every kid is different."
But he says the vagueness of the IRB's duty to decide based on age, maturity, and psychological state does not provide enough guidance.
As a result, he says, IRB assent requirements can vary widely. IRBs in children's hospitals are more likely to be familiar with children's development and their capacity for decision making. On the other hand, he says, a hospital IRB reviewing protocols from the pediatric department may have less expertise, and be more likely to default to the more familiar consent process.
Unguru says that in contrast to the many elements that make up informed consent, he sees four main elements that should be part of a valid assent process:
- the voluntariness of the child's decision, particularly when the study does not offer the prospect of direct benefit;
- the ability of the child to make a reasonable and rational decision;
- the child's ability to understand what he or she is agreeing to do; and
- some way to gauge the child's preferences for his or her involvement in the research.
For Unguru, ensuring that the child understands the decision is key.
"This is probably the area that I find is one of the major problems with the federal regulations, that there's no requirement to ascertain that kids understand what it is that they're agreeing to," he says.
He notes that assent forms often exceed a 6th-grade reading level far too complicated for a typical 7-year-old or 8-year-old to understand. Unguru says such documents need to be reviewed by someone who understands how to write language specifically for children.
And once the form has been read and explained, he says the investigator must use some method to gauge how well the child understands it. Unguru himself has created a questionnaire that can be administered in less than 15 minutes to test the child's comprehension of the information he or she has received.
"You run through this quick little survey with the child and you find out what it is they understand or don't understand," he says. "By doing that, you empower the child to tell you what they get and what they don't get. That makes the assent that you're getting more meaningful."
Once it's clear that the child understands, assent can be obtained, either verbally or for older children, by signing a form.
While some ethicists argue that children shouldn't be made to sign an assent, Unguru says he's found many children want to do so.
"Some kids really find it empowering, especially the older kids, the young teens," he says. "They take it much more seriously."
In cases where the child is hesitant to give assent and the study offers direct benefit, Unguru says gentle "arm-twisting" by parents is not inappropriate. But he says it still should be pursued with respect for the child's ability to understand the situation and give an opinion.
"Kids want to be making decisions with their parents and their doctors," he says. "A lot of the battle is they don't feel that parents and doctors are listening to them. In fact, when a parent and doctor listen to the kid, oftentimes they're happy, even if the ultimate decision doesn't go their way."
Unguru notes that there are cases in which a child's refusal to participate in research should be respected. He gives the example of a patient with relapsed cancer, who has had all of the standard treatments and whose parents are pressing for inclusion in a Phase 1 trial.
"If you've got a kid, say an adolescent, who says, 'I really don't want to,' then I think you have to weigh the child's input much more and give them much more say," he says. "In that scenario, where you're talking about a highly experimental intervention that may have limited efficacy at all, then you go with what the kid has to say."
Unguru says that IRBs looking at assent issues should focus on ensuring the forms are understandable for children and that there's some way to measure the subjects' comprehension.
He says IRBs should focus less on whether a child has the competence to make the decision, which is a legal determination, and instead consider whether the child has the capacity to understand, which is a more developmental approach.
"Assent shouldn't be viewed so much on an autonomy level but based on the best interest level for the kid," he says. "You've got to take into consideration the kid's preferences, emotions, what are the advantages and disadvantages of research participation. And doing that you need to focus on capacity, not competence."
Reference
- Unguru Y, Coppes MJ, Kamani N. Rethinking pediatric assent: From requirement to ideal. Pediatr Clin North Am 2008;55:211-222.
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