More people in the United States are openly lesbian, gay, bisexual, or transgender (LGBT) than ever before. And the prevalence of people who identify as LGBT is close to five times greater among young people than among seniors.
“A Massachusetts behavioral risk survey for 2016 showed that 15.5% of people in the 18 to 24 age group had self-identified as homosexual, bisexual, or other; among the 65 and older group, 2.7% identified that way,” says Sean Cahill, PhD, director of health policy research at the Fenway Institute, and affiliate associate clinical professor in the department of health sciences at Bouve College of Health Sciences, Northeastern University in Boston.
“Looking at data, the younger age cohorts are much more likely to self-identify as lesbian, gay, and bisexual than the older age cohorts, and I think we’re seeing a similar phenomenon with transgender people,” Cahill says.
“In our survey, 0.4% of adults identified as transgender in 2016,” he adds. “Fully 2% of high school students identify as transgender, so there are many more young people who identify as transgender or gender nonbinary or gender nonconforming.”
Transgender people are more at risk for stigmatization and violence or threats of violence, or bullying — physical, mental, or otherwise, says Beth E. Roxland, JD, MBioethics, an independent senior consultant on law, ethics, and policy, and an associate in the division of medical ethics at NYU Langone Medical School in New York City. Both Cahill and Roxland discussed situational vulnerability and gender identity at the Advancing Ethical Research Conference in San Antonio, TX, by Public Responsibility in Medicine and Research (PRIM&R) Nov. 5-8, 2017.
Transgender people also are at greater risk than the general population for behavioral health issues, social victimization, abuse, poverty, suicide, HIV infection, unemployment, and homelessness, Cahill says.
“The National Transgender [Discrimination] Survey 2016 by the National Center for Transgender Equality surveyed 27,715 transgender people in the U.S. and found 46% reported verbal harassment in the past year,” he says. “Nineteen percent reported being physically attacked in the past year, and there was three times the rate of unemployment when compared with the general population, and a 30% rate of lifetime homelessness.”
Also, most transgender people say they experience discrimination. Those same people have twice the risk of adverse emotional and physical symptoms, including headaches, upset stomach, feeling sad, frustration, anxiety, and a pounding heart, Cahill says.
All of these factors mean that the transgender population has situational vulnerability that should be taken into account when IRBs review studies enrolling these individuals.
“If someone is going to do research with transgender people to benefit the transgender community and improve health outcomes, then it’s important to know that transgender people experience a lot of health issues,” Cahill says. “Some are related to discrimination and victimization in society.”
Cahill and Roxland offer the following suggestions for ethical and other issues to consider when reviewing studies involving a transgender population:
• Include input from someone knowledgeable about transgender people in the IRB review. “Ideally, you might find a community member who can be involved with the review, or you could get someone with a parallel life experience involved,” Roxland says.
Other populations with situational vulnerability, such as homeless people, experience similar issues, she notes.
The idea is for both IRBs and researchers to find people who can engage with the LGBT community, recruit, and help mitigate the risks of the research, including privacy and confidentiality risks, Roxland says.
Professional research groups, like the Fenway Institute, include experts who often are willing to speak with researchers and IRBs about the issues they see in LGBT populations, Cahill says.
• Seek information about transgender and LGBT communities. The Fenway Institute has a lot of information and materials on its website for healthcare providers, Cahill says. (For more information, visit: http://bit.ly/293wV0w.)
“We do a huge amount of training and technical assistance to provide firm and competent care to LGBT people, including on-demand webinars,” he says.
It’s important that researchers and IRBs learn more about these communities because of their vulnerability and additional risks when participating in research, Cahill notes.
“I recommend that the research team has familiarity with the population, and it’s not just the principal investigator,” he says. “They should be encouraged to have some tools and resources on hand for the other researchers to also become familiar with it.”
• Consider risk of harm with parental/guardian consent. “Usually minors can’t give personal consent, but by requiring guardian consent in certain circumstances you may be exposing them to more stigmatization within their family,” Roxland says. “So, with some studies that are no more than minimal risk, you can expose them to more harm by getting parental consent than if you waived it.”
Whether to seek parental consent or a waiver of parental consent is an important risk and privacy consideration. Regulations give IRBs the authority to waive parental permission if the research protocol is designed with conditions or for a population where parental/guardian consent is not reasonable, Cahill explains.
“An appropriate mechanism for protecting the children is substituted,” he says. “So, we argue that if we seek parental consent to interview the adolescent about same-sex attraction or behavior or identifying as gay or bisexual, then that could potentially out young people who are not out to their parents, and it could cause trouble for them at home.”
Simply contacting a guardian could place a transgender youth at risk of abuse or being abandoned. Researchers could argue that obtaining parental consent would make it impossible for them to conduct the research study and understand that population, Cahill adds.
• Ensure privacy and confidentiality. Research involving transgender populations can expose study participants to harm should their identity be reported, so data security, privacy, and confidentiality safeguards are very important.
“Our national online survey is very anonymous, and we give people pseudonyms,” Cahill says. “They are totally confidential and include no identifying information.”
For in-person focus groups, investigators use a screener and all information is confidential, he adds.
“There is a risk someone will go to the in-person focus group and see someone they know,” he adds.
And at the end of the focus group, researchers offer participants a referral to a suicide prevention-focused LGBT youth hotline?TY if they need help.
• Watch out for additional risks. Transgender individuals often have high levels of stress and sexually transmitted diseases, Roxland says.
Weight management, especially for transgender females, can be an issue, and there is greater risk of sexually transmitted diseases, she adds.
“A lot of time, when we’re talking about youths, there could be more cutting school classes and acting out and avoiding the folks who stigmatize them,” Roxland says.
Whether research could exacerbate these issues is a question for an IRB to consider.
“They might need additional support because of what they have to deal with, but they’re not weak or at fault,” she says.
• Consider including transgender individuals in single-gender studies. When researchers are conducting studies involving Pap smears, they might consider enrolling transgender men who were born female and now identify as men, but could still be at risk of cervical cancer, Cahill suggests.
Likewise, transgender individuals could be enrolled in prostate cancer research.
• Include transgender people in participatory research. “We have another research project where we’re trying to understand health risk factors of LGBT youth of color, and we’re using the community research participation approach,” Cahill says. “We have a pilot intervention to reduce disparity, and we’ve identified depression and social anxiety as significant behavioral health issues.”
The participatory action research works with the youths to see if strategies of mindfulness for stress reduction have any effect on their social anxiety and depression, he says.
“These youths have been incredibly involved in informing our research approach,” Cahill says. “What’s cool is that young transgender people and gay and bisexual men have been very involved in developing the project.”