Do ethicists hinder HIV prevention research?

(Reuters Health) – – Ethics panels may be hindering HIV prevention efforts by requiring gay and bisexual adolescents to get parental consent before taking part in research, experts suggest.

Fear over coming out as gay or bisexual may prevent young men from asking their parents for permission to participate in HIV prevention studies. But leaving them out of such studies would likely result in huge gaps in scientific knowledge.

“Without the science, we won’t have service,” said Brian Mustanski, of the Institute for Sexual and Gender Minority Health and Wellbeing at Northwestern University in Chicago. “Without the service we’re going to continue to see a growing epidemic in this population.”

Roughly one in five new HIV diagnoses in the U.S. in 2014 were in people ages 13 to 24, according to the Centers for Disease Control and Prevention (CDC). Most of those were in gay and bisexual males.

This high-risk group has not been a focus of research, however, thanks in part to ethics panels – known as institutional review boards (IRBs) – that insist on having parental consent before a minor can take part in a study, according to Mustanski and Celia Fisher, of the Fordham University Center for Ethics Education in Bronx, New York.

For example, none of the 93 CDC-endorsed HIV prevention programs were tested in gay and bisexual males under age 18, and only four were tested in gay and bisexual young adults, Mustanski and Fisher write in the American Journal of Preventive Medicine.

HIV prevention strategies that work for older gay and bisexual men may not be effective among their younger counterparts, the authors point out.

“We have many of these prevention programs, but not for the leading edge of the epidemic,” Mustanski told Reuters Health.

Some states already allow minors to get HIV testing without parental permission, and the U.S. Office for Human Research Protections allows IRBs to waive parental consent in research settings, he said.

But many refuse to do so, write Mustanski and Fisher.

“I think part of it is that gut instinct that we should have parents involved,” said Mustanski. “Also, there is that gut reaction of protecting the institution.”

Some U.S. hospitals could not take part in an ongoing trial of an HIV prevention pill among young gay and bisexual adolescents because their IRBs refused to waive parental consent for participants.

Of 13 research institutions considering participation in the trial, known as ATN113, only seven actually joined. An analysis in the Journal of Adolescent Health found trial implementation “hinged primarily on IRB interpretations of state minor consent laws.”

IRBs tend to be very conservative around issues of sex, said Dr. Robert Klitzman, director of the Masters of Bioethics Program at Columbia University in New York City.

“I would hope that IRBs would realize at points it would be impossible to get parental permission,” said Klitzman, who is also the author of The Ethics Police: the Struggle to make Human Research Safe.

The problem of IRBs restricting research is not confined to HIV prevention among young gay and bisexual men, he told Reuters Health. IRBs are also reluctant to approve research in prisons or in pregnant women or people with suicidal thoughts. The result may be gaps in research.

“I think the authors put their finger on an important area,” he said.

Mustanski said IRBs lose the forest for the trees, because they evaluate studies on a case-by-case basis, and denying study after study on HIV prevention adds up.

“If we don’t do this research we’re not going to reach the goals of the National HIV/AIDS Strategy,” he said. The Strategy aims to reduce new HIV diagnoses by 25 percent by 2020.

SOURCE: American Journal of Preventive Medicine, online April 6, 2016.

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