On May 11, the incomparable Alma Castro of Harvard Business School (her brain absolutely crushes) and I had the pleasure of presenting a workshop to SOCRA (the Society for Clinical Research Professionals) on risk in social, behavioral, and educational research (SBER). The workshop centered on a case study we wrote with TFI’s own Natalie Marks for the Harvard Catalyst (it’s not in the case study library yet – we’re saving it for our forthcoming book, stay tuned). Harvard Catalyst has a Regulatory Foundations, Ethics, and Law subcommittee on SBER that we’re a part of – but I digress. The case study focuses on situational vulnerability of trans research participants (like I said –always pushing that queer research agenda, and Alma is HERE FOR IT).
One of our big jobs at TFI (in addition to conducting research to inform equitable policy and transform the health/life of LGBTQIA+ folks in Boston and far far beyond) is to train the next generation of researchers and to help the research community as a whole do better when it comes to understanding the interests, needs, strengths, and risks faced by the LGBTQIA+ community. Enter a VERY useful concept: Situational Vulnerability.
When ethics boards look at a study plan and try to decide if it appropriate/acceptable (i.e., ethical), a major task is to assess if the potential benefits of the research outweigh the risks to participants. The human research subject protection regulations name certain categories of people as vulnerable (problematic, we know). Sex, Sexual Orientation, and Gender are not among those categories. HOWEVER, we know LGBTQIA+ folks may be more susceptible to certain risks, or more vulnerable to harm due to due to socio-political factors beyond the control of any single institution or researcher. Therefore, it’s not enough to just consider the risks and benefits of a study in vacuum – we have to consider them in context, and think about the participant population that investigators are seeking to enroll or are likely to encounter.
Thinking through “situational vulnerability” is a way to consider these vulnerabilities caused by the research context and exacerbated by position in society. LGBTQIA+ people may have a limited field of options because of circumstance (for example, only able to obtain community competent care in certain states, and within those states, only at certain facilities). What makes this concept so useful (in my opinion) is that it does not imply any impairment in the ability to make choices among limited options or advocate for their own interests – but rather focuses the susceptibility to risk of harm posed by research or vulnerability to additional risk. It gives us a framework in which to consider the impacts of minority stress. Researchers need to think about these things when designing studies, and ethics boards when reviewing them!
We had an outstanding discussion with a group of about 50 research professionals – they were really able to deeply interrogate how what appeared to be a study with very little risk had the potential to harm trans participants and the trans community. We GOT INTO IT. I love this kind of outreach.