Legal barriers to adolescent participation in HIV, STI research need to be removed

The paper summarizes legal, ethical and policy considerations related to adolescents' participation in HIV- and STI-prevention research in the United States and explores strategies for facilitating adolescents' access. It was co-authored by Quianta Moore, a scholar in health policy at the Baker Institute and adjunct assistant professor in Baylor's Department of Pediatrics; Mary Paul, associate professor in Baylor's Department of Pediatrics-Retrovirology; Amy McGuire, the Leon Jaworski Professor of Biomedical Ethics and director of Baylor's Center for Medical Ethics and Health Policy; and Mary Majumder, associate professor in the Center for Medical Ethics and Health Policy.

The paper was published in the January issue of the American Journal of Public Health.

The second-largest percentage (26 percent) of new HIV infections in the U.S. occurs among people aged 13 to 24 years, and most of those new infections occur in gay and bisexual young men (72 percent), according to the Centers for Disease Control and Prevention. These rates of infection make high-risk adolescents an important target population for primary prevention. Used in conjunction with safer sex practices, pre-exposure prophylaxis has demonstrated effectiveness in preventing transmission in high-risk groups, such as men who have sex with men. In the context of HIV, pre-exposure prophylaxis is defined as the use of antiretroviral medications in HIV-negative individuals to prevent HIV transmission.

Whether adolescents can participate in clinical trials of pharmacologic therapies for HIV prevention, such as pre-exposure prophylaxis, without parental permission hinges on state minor-consent laws. Very few of these laws explicitly authorize adolescents to consent to preventive services for HIV and other sexually transmitted infections. The unclear state laws may lead to research cessation, according to the authors.

To address legal barriers, the authors propose two strategies:

"First, in states with existing minor-consent provisions for STI treatment that do not expressly include prevention, we urge public-health advocates and officials to partner with state legislators to promote amendments to minor-consent statutes that would explicitly authorize minors to consent to preventive care related to STIs, including HIV," the authors wrote. "There is little reason to believe that legislators craft treatment-focused state laws to exclude prevention.

Their second strategy is to urge institutional review boards to adopt an open stance toward claims that the word '"treatment" in state minor-consent laws should be interpreted to encompass prevention. If there is no clear evidence of a legislative intent to exclude prevention from treatment, "we believe that institutional review boards act reasonably and responsibly in concluding that treatment includes prevention in states with laws that authorize adolescents to consent to STI treatment, including HIV, but do not explicitly authorize minors to consent to preventive services," the researchers wrote. They recommended consultation with legal counsel to ensure proper interpretation of state law.

The authors suggest it would be helpful if the Food and Drug Administration's Office of Human Research Protections provided guidance to foster greater consistency in institutional review board determinations within states that allow minors to consent to treating HIV and other STIs but do not explicitly address prevention.