Legal barriers to adolescent participation in HIV and STI research need to be removed
HOUSTON – (Jan. 11, 2016) – Parental permission for adolescent participation in research on HIV pre-exposure prophylaxis and other sexually transmitted infections (STIs) is not required ethically and may undermine public health interests, according to a new paper by law and public health experts at Rice University's Baker Institute for Public Policy and Baylor College of Medicine.
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.
For a copy of the paper, "Legal Barriers to Adolescent Participation in Research About HIV and Other Sexually Transmitted Infections," e-mail firstname.lastname@example.org.
For more information or to schedule an interview with one of the authors, contact Jeff Falk, associate director of national media relations at Rice, at email@example.com or 713-348-6775.
Moore bio: http://bakerinstitute.org/experts/quianta-moore.
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Founded in 1993, Rice University's Baker Institute ranks among the top 10 university-affiliated think tanks in the world. As a premier nonpartisan think tank, the institute conducts research on domestic and foreign policy issues with the goal of bridging the gap between the theory and practice of public policy. The institute's strong track record of achievement reflects the work of its endowed fellows, Rice University faculty scholars and staff, coupled with its outreach to the Rice student body through fellow-taught classes — including a public policy course — and student leadership and internship programs. Learn more about the institute at http://www.bakerinstitute.org or on the institute's blog, http://blogs.chron.com/bakerblog.
Located on a 300-acre forested campus in Houston, Rice University is consistently ranked among the nation's top 20 universities by U.S. News & World Report. Rice has highly respected schools of Architecture, Business, Continuing Studies, Engineering, Humanities, Music, Natural Sciences and Social Sciences and is home to the Baker Institute for Public Policy. With 3,888 undergraduates and 2,610 graduate students, Rice's undergraduate student-to-faculty ratio is 6-to-1. Its residential college system builds close-knit communities and lifelong friendships, just one reason why Rice is ranked No. 1 for best quality of life and for lots of race/class interaction by the Princeton Review. Rice is also rated as a best value among private universities by Kiplinger's Personal Finance.