Brian Mustanski, PhD, a clinical psychologist and professor at Northwestern University, studies the health and development of LGBTQ youth. In 2007, while at the University of Illinois at Chicago, he received a two-year grant to study mental health and HIV prevention in LGBTQ teens—and spent the first 10 of those 24 months fighting for approval from his university’s institutional review board (IRB).
The delay came down to a question of consent: Mustanski felt it was important that the 16- and 17-year-olds he was studying should be allowed to participate without their parents’ permission, since many potential participants weren’t open with their parents about their sexuality or sexual activity. The IRB wasn’t so sure waiving parental permission was a good idea.
“After a lot of discussions and consultations with experts in ethics and law, I was able to get a waiver of parental permission,” Mustanski says. “But it came at a huge cost—almost half of my study time was spent getting IRB approval.”
In a 2016 paper, Mustanski and Celia Fisher, PhD, director of the Center for Ethics Education at Fordham University in the Bronx, argued that the IRB’s policy requiring parental consent for minors to participate in the research created a research bias that put vulnerable youth at risk of contracting HIV (American Journal of Preventive Medicineopens in new window, Vol. 51, No. 2, 2016).
Mustanski and Fisher are among the many researchers who run into this issue when studying sensitive or stigmatized subjects such as substance use, sexual activity and gender identity in youth. Although federal regulations and most state laws allow for parental permission to be waived in certain instances, many IRBs remain wary, says Sangeeta Panicker, PhD, director of research ethics at APA and staff liaison to the association’s Committee on Human Research.
Now, a new APA resolution aims to encourage IRBs to be more judicious when reviewing research protocols that request a waiver of parental permission. The resolution was adopted by the APA Council of Representatives in August 2018.
“If you require parental permission for research on at-risk populations, you can end up introducing a bias into the data. There are good methodological reasons for this resolution, and important ethical reasons too,” says Emil Chiauzzi, PhD, principal scientist at the health data sharing website Patients Like Me and 2018 chair of the Committee on Human Research, which drafted the resolution. “If we’re going to get a good handle on what’s going on with our younger populations, develop interventions and target high-risk populations, we need to know we’re getting a true picture.”
Protecting minors
The resolution aims to clear up confusion. Regulations in most states already allow mature minors to seek health care for sensitive or stigmatized health issues without parental involvement—but investigators and IRBs aren’t always aware of that. There’s no clear age at which a minor suddenly becomes “mature,” but research cited in the resolution supports the idea that adolescents as young as 14 are capable of making such decisions for themselves.
In developing the resolution, Panicker says, one important consideration was that most state laws allow adolescents to access health care without parental permission, though the specifics vary from state to state. Such legislation ensures that young people can freely access important services such as contraceptives and reproductive health care. The new resolution asserts that IRBs should extend that right to include participating in health research.
Waiving parental permission isn’t necessary for all types of research, Panicker notes. If you’re studying nonsensitive topics such as attention or memory, adolescents aren’t likely to be put off by the idea of asking parents for permission. But for young participants in stigmatized groups or those engaging in high-risk behavior, involving parents could prevent minors from participating—or put adolescents at risk of parental conflict or even abuse.
Better studies
In his research with sexual- and gender-minority youth, Mustanski found most of the participants reported they would not have joined the study if parental permission had been required, often because they were not “out” to their parents about their sexual or gender identities or did not want to reveal to parents that they were sexually active (Archives of Sexual Behavioropens in new window, Vol. 46, No. 5, 2017). “The majority would not do the study if they had to get their parents’ permission. And those who would allow us to get parental permission looked very different on many health outcomes,” he says.
In other words, requiring permission may lead to biased samples, causing researchers to overestimate or underestimate the scope of health problems in at-risk populations. Failure to accurately characterize those problems could lead to inadequate funding and a lack of important services such as HIV prevention or substance use interventions.
The APA resolution supports waiving parental permission when consent could potentially harm the mature minor—and, importantly, when alternative research protections are in place. Parental permission is only one type of protection, Mustanski says. In its absence, researchers can put other protections into place, such as creating developmentally appropriate study materials and explaining the terms of consent in ways that young people can understand.
“Researchers should think about what protections participants need in order to make an informed decision, what the risks of harm are and how they will reduce those risks,” Mustanski says.
He was not involved in drafting the new APA resolution, but he welcomes the development.
“We don’t actually need to change the regulations [around parental permission]. We need to help investigators and IRBs understand the regulations and apply them correctly,” he adds. “Resolutions such as this can help with that initiative.”
To read the resolution, go to www.apa.org/about/policy/resolution-minors-research.pdfopens in new window.
