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Adolescent research needs extra attention
Experts offer suggestions
The very idea of deciding when to waive parental permission or allow investigators to inquire into a teenager’s sexual history and drug use may make some IRBs a little nervous.
But experts in socio-behavioral research involving adolescents say such situations are common and typically involve less than normal risk.
"Should adolescent assent for a minor be the only consent needed for a study?" asks Cathryn Samples, MD, MPH, principal investigator at the Boston Unit of the Adolescent Trials Network for HIV/AIDS Interventions and faculty member in the unit of adolescent/young adult medicine at Children’s Hospital Boston in Boston.
"There seems to be universal agreement that if you’re doing a study with substantial risk, greater than normal risk, the waiver probably is not appropriate," Samples says. "But when doing a minimal risk study, which most socio-behavioral research is, then if the adolescents don’t normally seek the parent’s permission, a waiver is all right."
For example, adolescents typically do not seek a parent’s permission to seek family planning information or to receive treatment for a sexually transmitted disease, so a waiver would be acceptable in those types of studies, Samples says.
In other cases, waivers of parental permission may not be appropriate, particularly if the study involves treatment, including treatment for substance abuse, says Janet Brody, PhD, research scientist and clinical director of the Center for Family and Adolescent Research at Oregon Research Institute in Albuquerque, NM.
"When it comes to treatment, which is what we do, I don’t believe waivers are particularly useful and appropriate," she says.
An ethical dilemma might arise in states where adolescents are able to seek substance abuse treatment without parental consent. If the treatment also involves a research study and if the adolescent has been court-ordered to participate in the treatment program, the adolescents may believe that if they choose not to stay involved in the research project they will be put in jail, Brody notes.
"So one of the issues that comes up is that participation in the research can be coercive, and it’s important that treatment alternatives are clearly available to kids," she says.
Brody and Samples offer these suggestions for how an IRB can handle the review of protocols involving adolescents in socio-behavioral research:
• Protect anonymity with waiver of written consent. Socio-behavioral research involving adolescents often involves questionnaires or audio-assisted self interviews in which the responses remain anonymous, Samples says.
"If you are doing research and the only thing connecting the young person to the study is the signature on the consent form then waiving that written consent is often a bigger protection for the young person," Samples says. "And sometimes the two are combined — waiver of parental permission and waiver of written consent."
In these cases the top part of the form would constitute the informed consent with instructions for the subject to skip any questions that make him or her uncomfortable and to make certain the subject’s name is not on the questionnaire, Samples explains.
• Offer teenage participants fact sheets that they can share with parents. For teens in the 16- to 19-year-old age group, their parents often do not keep close tabs on their whereabouts after school, so it may be appropriate to waive parental permission and instead provide the teens with fact sheets they can use to discuss the study with their parents, if they choose, Samples says.
"The fact sheet doesn’t mention details, such as that the teen participating in the study is sexually active and sexually transmitted disease screening is a part of the study," Samples notes. "We’re not trying to keep the study secret, but we are keeping some portions of it confidential, and a young person isn’t required to discuss it with parents, but we suggest it."
• Be aware of legal risks to subjects. Adolescent research sometimes involves study of teens who are admitted to substance abuse treatment programs. When these programs are offered free because of the research, this incentive alone might be coercive because the programs often are prohibitively expensive, Brody says.
The other issue is that sometimes the teens referred to such programs are young people who’ve gotten into legal trouble and who are on probation. If the study will require a urine test, it’s possible the subject’s probation officer will request to see the results of that test, she says.
"And if the urine test is positive, then there’s a possibility that because the teenager participated in the research study that collected the urine then he or she will be put in jail," Brody says. "IRBs need to appreciate that there need to be greater protection that the teenager won’t be harmed because of the release of information."
The other issue is that teen subjects who are aware that their study urine test could be used against them in court may fake the urine screening and ruin research data, she notes.
• Pay close attention to privacy issues. In most substance abuse treatment research, the teen subjects are enrolled because their parents brought them in, so parental permission is not an issue, Brody says.
But the subject’s privacy can be jeopardized without appropriate protections in place, she notes.
For example, teen subjects may sign a release to allow their parents to see the results of their urine tests because they don’t understand that marijuana can stay in their urine for a month, and this would be an unintended disclosure if the test returns positive, Brody explains.
"There are studies where parental involvement is not useful, and you can’t get it, and there are kids who want to be in research and get treatment and so it’s not necessary to have the parent’s permission," she says. "But this needs to be determined on a case-by-case basis."
Another privacy issue involves pregnancy testing, particularly in cases of research that requires this as criteria for inclusion, Samples notes.
While these studies often are biomedical, they also could be considered minimal risk for adults, whereas the issue of a pregnancy test disclosure could create privacy problems for adolescent subjects, she says.
"So we make sure the use of assent for the study is very clear around the rules of pregnancy testing and whether or not the adolescent’s parents might find out if there’s a pregnancy," Samples explains. "We make sure the parental permission on the study clearly states that pregnancy testing may be done, and we may not be able to discuss the results of the pregnancy test without the child’s permission."
However, if the study also states that a pregnancy would mean immediate withdrawal from the study and a teenage girl is suddenly taken out of the study without explanation, then her parents might deduce the reason, Samples notes.
• Decide how parental permission would be sought. In some studies that will require parental permission, the big question is whether the parent or child should be approached first, Samples says.
Perhaps investigators will not want to approach the parents first because then the adolescent might feel pressured to by the parent to participate in the study, she says.
In some cases, the parents and child will be seen together, so investigators can discuss the study with them simultaneously, Samples adds.
• Consent must be maturity- and age-specific. "The spectrum of kids from ages 13 to 19 have a developmental range in their capacity to understand what they’re consenting to," Brody says. "So even if you go by state law that says kids have the opportunity to consent to treatment, there may be developmental reasons why they’re not capable of doing that; for instance, if they are substance using and high or intoxicated."
The question IRBs need to consider are the ethical issues related to whether an adolescent is able to give informed consent based on the nature of the disorder, Brody says.
Even a study’s inclusion of adolescents of different maturity levels can be a problem.
Sometimes an IRB might be concerned about the use of an adolescent focus group in which there is too much of an age gap between members, Samples notes.
"Our IRB would be unhappy if we were doing a focus group about condom use and had 13-year-olds in with 19-year-olds, but 15- and 16-year-olds together would be OK," Samples says.
Also, IRBs might consider whether a waiver of parental permission is appropriate for all adolescents in a study or only for adolescents who are ages 16 and older, Samples says.
"So the IRB may look at the study and say, We’ll approve waiver of parental permission for these people, but not for those people,’ or the investigator may propose it that way."
• Look at definition of minimal risk from adolescents’ perspective. "We’re finding differences in perspectives between adolescents and parents and the amount of risk in various kinds of procedures," Brody says. "So the adolescent perspective on the level of risk is an important and not a well-researched topic."
One example is the use of venipuncture in a study, which adolescents often view as a much riskier procedure than it’s considered by parents, physicians, and IRBs, Brody says.
• IRB should have expert member or consultant for this type of research. "In my experience, it’s been extremely helpful to the IRB to have an adolescent-trained person on the IRB or available for consultation when considering these issues," Samples says. "IRBs that deal only with adults get extremely nervous when dealing with adolescent research, and those that deal with research involving children tend to take the parent approach to everything."
Also, IRBs need to review recommendations by the Society for Adolescent Medicine (on web site: www.adolescenthealth.org) for how scientists and IRBs should handle human subjects issues regarding adolescent research, Samples says.