In recognition of Pride Month, PRIM&R is pleased to offer our members a short summary with recording time stamps from a 2021 PRIM&R-hosted webinar, LGBTQIA+ Equity in Human Subjects Research: Strategies for Justice-Focused IRBs. During this session, Amy Ben-Arieh, JD, MPH, and Diane Burrell, JD, discuss LGBTQIA+ health disparities, explore inclusive research data collection methods, and introduce meaningful strategies for IRBs when reviewing studies including LGBTQIA-specific research.
Earlier this year, PRIM&R sat down with Amy Ben-Arieh, session speaker, to ask her about her current thoughts on LGBTQIA+ equity in research in light of Pride Month.
View Webinar Here
(0:00-7:47) Introductions, Learning Objectives, & Terminology
(7:48-9:51) Statistics
In 2017, 4.5% of US adults identified as LGBTQIA+. In 2020, that number rose to 5.6% of US adults identifying as part of the LGBTQIA+ community. Younger generations of Americans have a higher percentage of LGBTQIA+ identifying individuals.
(9:51-11:12)
LGBTQIA+ equity in research is hugely important because there is currently a large gap in our LGBTQIA+ health disparities knowledge. Sexual orientation is one of the most pronounced gaps. Older LGBTQIA+ individuals are some of the most misunderstood populations in terms of their health and aging related needs. Health research statistics are glaringly absent in studies about lesbian, gay, bisexual, and transgender aging.
(11:13-14:55)
LGBTQIA+ equity in research is also essential because the overall health in the LGBTQIA+ community has higher rates of chronic diseases such as cardiovascular disease, diabetes, asthma, cancer, and osteoarthritis. There is not an abundance of research as to why this disparity occurs. Sexual violence, intimate violence, alcohol abuse, and nicotine use rates are also higher within this population.
LGBTQIA+ mental health is also disproportionally affected compared to their heterosexual/cisgender counterparts. Higher rates of anxiety, depression, and suicide have been reported especially among bisexual and transgender people.
(14:56-17:13)
Historically, there have been barriers to healthcare, discrimination, and minority stress and trauma within the LGBTQIA+ community, which has led to these health disparities. There are no biological or physiological differences between LGBTQIA+ people and their heterosexual/cisgender counterparts; rather, the disparities are caused by a combination of economic and social factors.
(17:14-19:47)
To begin closing this gap and addressing these health disparities, we need to develop inclusive research practices. Sexual orientation and gender identity (SOGI) data collection is a way that researchers can contribute to the health and wellness of the LGBTQIA+ community. Collecting SOGI data in healthcare has proved to be very beneficial; it helps providers respect their patients’ lives, experiences, and identities. It signals to patients that they can safely disclose their identity—it builds trust. Given that most studies have a strong chance of including LGBTQIA+ people, demographic questions for all research study participants should include sexual orientation and gender identity questions. This is the only way that we will be able to address specific health care needs and health disparities.
(19:48-22:50) Where are we in terms of SOGI data collection?
The Department of Health and Human Services is trying to increase the number of states that include these questions that identify sexual orientation and gender identity on state level surveys. The NIH has the Sexual &Gender Minority Office that encourages researchers to consider the inclusion of sexual orientation/gender minority populations in larger studies. There is currently no standard in the ways in which we collect SOGI data.
(22:51-29:00) Community Strengths
Instead of letting oppression describe the LGBTQIA+ community, and instead of having to reestablish injury in order to achieve or justify healing or reparation, we need to leverage the intrinsic value, rightness, and strength within the LGBTQIA+ community. As IRBs, we can look for the invocation of strength focused frameworks and thoughtful understanding of community inclusive methods when performing ethics review. We can and should pose hard questions around how hypotheses are framed and interrogate cis or hetero-normative assumptions and definitions.
(29:01-35:37)
Any IRB operating under Federalwide Assurance has to review all non-exempt human subjects research subject to its oversight, and the IRB is charged with upholding national standards. And although not expressed by the standards, we should also be considering sexual orientation and gender minorities, as well as issues around racial justice and cultural appropriateness.
(35:38-1:01:41) Strategies for Review: Big Questions through a SOGI lens
- Are risks to subjects minimized?
- Be sure to build an inclusive board, think beyond expert consultants or advisory boards, build a bigger table. Try to have multiple community members present. Having members of the community that you often research part of the review process is essential to better understanding the risks. We can’t expect the community to trust research if the research doesn’t trust the community.
- Are risks to subjects reasonable in relation to anticipated benefits (if any) to subjects, and the importance of the knowledge that will result?
- Consider the population of interest; are there intersections of oppression that may impact some research subjects in a disparate way? Has the PI thought of ways to minimize and/or control these disparate impacts and adequately summarized this for your IRB? Have you reviewed the data collection instruments for gendering language or assumptions?
- Is the informed consent process and documentation appropriate to the work?
- Be sure to review informed consent documents for microaggressions, and train staff to be sensitive to and competent on SOGI language, issues, and concerns.
- Are there adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data?
- Privacy breaches may have additional implications for SOGI minority populations.
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Are people being unnecessarily or unintentionally excluded?
- For example, when doing research involving pap smears to gather data on cervical cancer, consider involving trans men who were assigned female at birth.
- If certain genders are not included, has an adequate rationale been provided?
- Consider recruitment strategies. Are you likely to get a representatively diverse sample?
- Are you thinking about SOGI diversity in your analysis?
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Follow-up interview with session speaker, Amy Ben-Arieh.
Q: What is your title and organization, and what are your current areas of responsibility?
A: I am the Director of Research Compliance at the Fenway Institute (TFI), which is the research department of Fenway Health in Boston, MA. I oversee research integrity/responsible research conduct, human subjects protections, biosafety and objectivity in research. This can include financial conflict of interest, biosafety, and internal monitoring.
Q: What does a typical workday for you look like?
A: There is no typical day at FTI. It's a small shop, we only have about 80 studies going on at any point in time. But they run the gamut of everything between phase one HIV vaccines to long term trans health epidemiology.
Because our investigators often work with populations that have been deemed ‘hard to reach’ in traditional healthcare settings, they often want to try new things, adopt new approaches, and conduct avant-garde recruitment and outreach.
I get to explore and investigate really important questions, but it's a wild ride. I feel like my one constant is that I'm always reading and I'm always researching novel topics. I’m always trying to understand how these questions need to be viewed under the regulations. I do a lot of consulting with both the research teams and the administrative staff at the institute. And I rely very heavily on my PRIM&R network when I'm doing all this.
Q: How did you get to this point in your career?
A: I'm a person who intentionally came into the IRB world. I grew up in a community with Holocaust survivors, their children, and their grandchildren, and I'm also the kid of scientists. The historical significance and impact of the Nuremberg Code made a huge impression on me, and so, I studied philosophy and medical ethics as an undergraduate. I came to Boston to do a joint degree in law and public health, and the focus of that was health law, bioethics, and human rights.
I then found myself looking for a job in this field and I stumbled into consent editing for Mass General Brigham with their IRB. I had some fantastic mentors there: Marilyn Mosier; Jo O’Driscoll Davis; Steve Vacirca; Lawrence Tsen; and the incomparable Pearl O’Rourke. They really supported my learning, and they taught me so much about why and how we do what we do—why we have ethical oversight.
But when the position opened at TFI, I knew I had to jump. I am a lifelong HIV activist, and I have this amazing, deeply sustaining, and hugely affirming queer community. The idea that I could combine my personal and professional interests to serve the conduct of world class LGBTQIA+ research was a total revelation. [TFI] has been amazing because as an administrative chair, you do very specific work, it's very proscribed work, I would say. And at TFI, my lane can be as expansive as solving questions about acceptable lube ingredients to participating in advocacy. They give me a lot of flexibility and freedom, and I love it.
Q: What’s your favorite part about Fenway?
A: I get to work with these incredibly brilliant and committed, mission driven people. They’re intellectual titans--they're just so smart. It's really fun to be a part of training the next generation of LGBTQIA+ researchers. It’s such a rewarding place to work.
Q: Are there any specific individuals that you admire when you think about LGBTQIA+ advances in the research world? Why?
A: I think it would be a real oversight for me not to mention Judy Bradford, she passed away a few years ago. She, along with Kenneth Mayer, are the co-founders of TFI, started the national conversation around LGBTQIA+ research. She led some of the first national studies on lesbian health. She gave us really crucial early information on health disparities that even now, is used to explain why it's important to look at health through this lens--why it's so important to collect sexual orientation and gender identity information from research participants.
One of Judy's great strengths was her amazing ability to connect with people; to explain her work and to gain visibility for the work. She sat on national committees and expanded the vision of what LGBTQIA+ health research could be, what it could look like. Her work was also crucial in informing the NIH Policy on Sex and Gender Minority Health.
And as a lifelong HIV activist, Ken Mayer is someone I also really admire. He began working at TFI during its very early days because he was interested in community health and research. But then, shortly after [he joined TFI] young gay men and trans women started dying and people had no idea why. So, Ken began the research program at TFI to start answering that question. From the very beginning, TFI was a place where gay and trans folk could go to get care. It was their community health center. Ken expanded the research program to give those patients access to clinical trials for HIV treatment. They didn't have to end up at the fanciest hospitals to get access.
Fenway participated in so many trials, Ken had this lean and mean team since the inception of the HIV epidemic. At the beginning, they were just trying to treat the symptoms, right—there was no therapy. But, then, it was the early antiretrovirals, and then the highly active antiretrovirals. And now we're working on vaccines and preventive care. A lot of our work is focused on things like quality of life, healthy habits and longevity--things that seemed impossible 40 years ago. And that's due to Ken’s vision! He’s the best.
Lastly, something that is really central to our work, that Judy really prioritized, and Ken continues, is mentoring those early career professionals with training programs, fellowships, and collaborations. It's a real pay-it-forward ethos that I think is very inspiring. It's incredible to see the ripple effects they've created, and continue to create in this field.
Q: What would you like the future of research with LGBTQIA+ people to look like?
A: That question is both very hard and easy for me. My hope is for a wider recognition of the role that sex, sexual orientation, and gender play in our health and in our lives--I want it to become mundane. I want this information to become truly routine, to consider these very basic demographic variables in our analysis. I want us to think about sexual orientation and gender identity as we think of blood pressure or any social determinant of health. It’s not this ‘special flower’.
I also hope that more energy and resources are dedicated to understanding and unpacking these roles—the roles that sexual orientation and gender play in our lives and health.
I hope we can begin to understand where different and dedicated, or novel treatments or approaches, are truly warranted. We want to optimize approaches based upon strong evidence. Right now, we have so little evidence, we don't know what we don't know.
In terms of the future, what I really wish I could do is just share with all of you the biographies of the TFI faculty members. I think about Abigail Batchelder’s work on shame and stigma as a barrier to self-care. Calvin Fitch and how he explores psychosocial and structural factors that influence risk and mortality among young black men who have sex with men. Sari Reisner, who's doing work to build our understanding of transgender and gender diverse populations. I want more of all of that.
Q: Do you have any specific advice for IRBs when reviewing LGBTQIA+ research studies?
A: I have three pieces of advice. When we’re reviewing LGBTQIA+ research studies, I think first and foremost, we need to look at how the relevant communities were consulted during the study design process. And if, and how, the investigators plan to continue that during the conduct of the study. Was it effective? Was it thoughtful? Was it real?
Second, we want to ensure the investigator has adequately considered situational vulnerabilities of the population of interest when they were characterizing and attempting to mitigate the study risks. We need to think about the position and place that the study participants are in. We think about local context and consider if this creates any additional risks beyond what you might typically think.
My third piece of advice is that if you're not sure how to do either one or two, bring in an expert like you would with any topic in which your board lacks expertise. Don’t assume it doesn’t require special knowledge, because in some cases, it really does. And there are lots of folks out there who would love to help. You can’t see me, but I’m raising my hand on behalf of TFI’s IRB.
Q: Historically, how has the underrepresentation of LGBTQIA+ people in research affected LGBTQIA+ health today?
A: I touched on this a little bit earlier, but the great tragedy of this is we don't know what we don't know. And frankly, we don't even know if there has been underrepresentation of any or each of these groups, because, in too many cases, we don't ask. We don't know if a huge percentage of the participants were lesbian. We don't know if a participant is transgender.
What we do know is that these health disparities exist. Because when we do collect that information, we see the increased rates of diabetes. We see an increased rate of depression. We see the increased rates of cardiovascular disease. We know there is a cost, and we're being intentionally blinded to it. One cruelty of the current anti-LGBTQIA legislative climate, is that states are creating scenarios in which it's very hard to collect this information and making it almost impossible to do this work. So, there's no clear line that's drawn around the gap in our knowledge. And I think that it’s profoundly sad that states are intentionally creating a situation in which all of our health information has this flaw. It ultimately impacts everyone.
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