This past November, Public Responsibility in Medicine and Research (PRIM&R), a non-profit organization dedicated to the study and advancement of the highest ethical standards in the conduct of research, held its annual Advancing Ethical Research (AER) Conference featuring Dr. Celia B. Fisher, Director of the Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute at Fordham University. She, along with Janet L. Brody, PhD and Eric Kodish, MD, were panelists on Panel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
Discussing her NIH-funded research on ethical issues in research involving LGBT youth, Dr. Fisher discussed the “interfamilial, regulatory and ethical tensions” that emerge in HIV prevention studies striving to recruit sexual and gender minority adolescents under 18 years of age.
Dr. Fisher discussed the requirement of parental permission for at-risk adolescents to enroll in HIV research and how it, contrary to the assumption that it protects participants, results in low enrollment as adolescents may not wish to share their sexual orientation with their families. Furthermore, she added that the need for parental permission both reduces participation and creates ethical issues as an entire population may now have limited or no access to a potential treatment for HIV.
According to Seth Hall of the PRIM&R blog, Dr. Fisher’s solution was to apply her “goodness of fit ethics” in order to reconsider the adolescents’ characterization as a vulnerable, based on the strengths and weaknesses of this particular population. Dr. Fisher and her colleagues 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.” Additionally, she argued that a waiver of parental/ legally authorized representatives (LAR) permission (45 CFR 46.408(c)) should be included in consent processes which are “appropriate to the development and informational needs of the participants” to promote adolescent enrollment in HIV and drug use research.
Please visit PRIM&R’s blog, Ampersand, for full coverage of the panel in the post titled, “Assent, Consent, and Goodness of Fit.”
Celia B. Fisher, Ph.D. is the Fordham University Marie Ward Doty University Chair in Ethics and Director of the Center for Ethics Education. Fisher’s Decoding the Ethics Code: A Practical Guide for Psychologist, is now in its fourth edition from Sage Publications.