Should Parental Permission be Required for Adolescents to Participate in HIV Research?

Few state minor-consent laws authorize participation in clinical trials and therapies.

A recent study suggests that adolescents participating in research aimed at preventing HIV and sexually transmitted infections (STIs) should not be required to gain parental permission first.

Currently, 26% of new HIV infections in the United States happen to people between the ages of 13 to 24 years. This is the second largest percentage for HIV positive patients. Furthermore, 72% of gay and bisexual young men have this infection.

Researchers feel that these numbers are a clear indication that high-risk adolescents are an important target for the prevention of HIV and other STIs.

However, few of the state minor-consent laws authorize participation in clinical trials and therapies, such as pre-exposure prophylaxis, which is the use of antiretroviral medications in patients who are HIV-negative and is administered to prevent and avoid future transmissions.

By not allowing adolescent participation in preventative HIV research and studies, investigators fear it could lead to the end of this research altogether.

The study authors believe that 2 main steps need to be taken to allow adolescent prevention without parental consent and bypassing the laws.

"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 study authors wrote. "There is little reason to believe that legislators craft treatment-focused state laws to exclude prevention.”

Researchers believe consultation with legal counsel is necessary for the proper interpretation of the law, and that institutional review boards need to adopt an open position with claims that “treatment” should be interpreted to include prevention in state minor-consent laws.

"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 authors wrote.

The authors also believe that with the help of the FDA’s Office of Human Research Protections, they could lend support and guidance while also creating consistency in institutional review board determinations within states, which allow minors the ability to give consent for the treatment of HIV and STIs, but do not address prevention.