As part of my AER16 conference participation, I attended Panel III: Research With Children and Adolescents: Who and How is the Decisions Made to Participate? moderated by Susan Z. Kornetsky. The presentation examined the tension among the heightened protections of children, specifically adolescent participants, under Subpart D of 45 CFR 46, the need for research with these populations, and the desire for participant autonomy.
This practical and ideological tension was brought into focus by hearing of the actual struggles within families when an adolescent child is invited to participate in a clinical research study involving greater than minimal risk and disagreement about that participation ensues.
The research of Janet Brody, MD, and Eric Kodish, MD, found that disagreement regarding participation between a child and his or her parents may be mediated by a physician-researcher. The physician-researcher was found to have effectively moderated the families’ discussion about participation, and directed support of the adolescent’s maturity to provide meaningful consent to participate.
From my perspective as a young father, the role of the parent(s) in assisting the adolescent in analyzing research risk and facilitating the adolescent’s decision-making was underexamined, but perhaps that was because it was the perspective I most related to! Nevertheless, the study highlighted that a more proactive role for physician-researchers in consent/permission/assent processes supports a child or adolescent participant’s agency to make research decisions, thereby increasing child and adolescent enrollment.
The interfamilial, regulatory, and ethical tensions exposed by research on adolescents were best illustrated by Celia Fisher, PhD, as she discussed her research on adolescent participation in preventative HIV drug research.
Dr. Fisher found that requiring parental permission for at-risk adolescents to enroll in HIV research did not protect potential participants from risk; in fact, it served to do the opposite, as parental permission resulted in low enrollment. This is likely because adolescents sought to avoid family exposure to their sexual orientation.
Dr. Fisher argued that the need for parental permission diminished at-risk adolescent participation and created ethical issues wherein access to a potentially viable, preventative treatment for HIV was not accessible to a population that needs it. Her solution was to apply her “goodness of fit ethics” to rethink adolescents as a vulnerable population per se, based on the strengths and weaknesses of this particular population. Dr. Fisher found that potential adolescent participants sufficiently understood relevant aspects of research, such as random assignment, side effects, and privacy risks, to support their informed consent without the need for parental permission. Dr. Fisher argued that a waiver of parental/ legally authorized representatives (LAR) permission (45 CFR 46.408(c)) should be paired with consent processes which are appropriate to the development and informational needs of the participants to foster adolescent enrollment in HIV drug research.
This session was an excellent example of the application of the presenters’ research to the limitations of the definition of a “vulnerable population” within the federal regulations. As presented by Dr. Brody and Dr. Kodish, it seems a more proactive role by physician-researchers in consent/permission/assent processes could help support an adolescent participant’s agency to make research decisions and thereby increases adolescent enrollment. The takeaway from Dr. Fisher may be more difficult to apply, especially in places where state or local laws are inconsistent with the waiver of parental or LAR permission under the Common Rule, but in light of Dr. Fisher’s research findings—that certain adolescent populations have limited, if any, access to needed HIV research—it is incumbent on research professionals to highlight and address regulatory inconsistencies so that research can work for the benefit of all.
Seth Hall, associate director of the Human Research Office at the University of Mississippi Medical Center, is a member of the PRIM&R Blog Squad for the 2016 AER Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are blogging here, on Ampersand, to give our readers an inside peek of what happened at the conference in Anaheim, CA.