September 8, 2011

Scientific Studies: For Everyone, By Everyone

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After finishing my third year of medical school, I decided to take a much-needed breather from school and accepted a one-year research position to work on a multi-center clinical study in San Francisco. The study would involve collecting urine and blood samples from pregnant women, and along with donating the biological specimens, the participants would be asked to fill out several lengthy questionnaires. As we were preparing to go live with the recruitment portion of the project, the primary investigator sent out the rough drafts of the questionnaires and asked for feedback from the study staff. Initially, feeling slightly overwhelmed and underqualified for the task, I decided to let the more senior people handle editing the questions.As the e-mails started pouring in with suggestions and edits, curiosity got the best of me and I ventured a look at the questionnaire. Among the standard conception questions like “When is your due date?” and “Is this your first pregnancy?” a few stood out. They all had one phrase in common: “father of the baby” (FOB). Immediately a red flag went up. This is San Francisco — not everyone has an FOB! Some even have two MOBs. While the phrasing of the questions made sense, it seemed entirely unnecessary for the information they were trying to elicit.Immediately I wanted to inform the P.I. of my findings, but I hesitated. Did I really want to be known as “that girl?” Maybe my attempt at making the study more “sensitive” to “sexual minorities” would annoy the other study staff. The other centers in the study were nowhere near as liberal as San Francisco. Maybe the “two moms” issue would be a nonissue for them. Maybe it would be a nonissue at our center as well. Maybe no one really cared about the few lesbian couples who could potentially be interested in the study.I swallowed my anxieties and wrote the e-mail. I pointed out the poor wording and suggested a change. To my surprise, the P.I. and the rest of the study staff were incredibly receptive to the suggestion. I was thanked for my astute reading of the questionnaire and the wording of the questions was changed. “FOB” was out.Many researchers have argued that lesbian, gay, bisexual and transgender persons have been explicitly left out of clinical research (see Engleston et al., 2010). In a letter published in the New England Journal of Medicine, researchers at Fox Chase Cancer Center described a search they conducted for heterosexual/homosexual inclusion and exclusion criteria in over 80,000 clinical trials sponsored by the National Institute of Health and other government and private groups. Of the studies the group identified that dealt with sexual health, 15 percent explicitly excluded lesbians and gays from participating. The authors failed to find similar exclusion criteria in non-sexual health related studies. On the other hand, others have found that medical publications that do specifically address LGBT health focus nearly exclusively on HIV/AIDS or sexually transmitted infections (see J.E. Snyder, 2011).Even when homosexuality is not an exclusion criteria for recruitment or when well-meaning researchers conducting non-sexual health related studies seek out a diverse population, the language used in the study could serve to dissuade LGBT persons from enrolling. Research questions that refer to a person’s opposite-gender spouse or stereotyped family and gender roles may make LGBT persons reluctant to participate. More often than not, potential LGBT study participants — and language that would be sensitive to their backgrounds — are just simply not thought of.Findings from research studies can only be useful when they are generalizable. This requires the recruitment of a socioeconomically and demographically diverse study population — including persons of different sexes/genders, races, cultural backgrounds and sexual orientations. So the next time you are a study assistant and are asked to come up with ways to better the project, think outside the box. When the first of many lesbian patients joined our study, I was certainly glad I did.Marina Stasenko is in her final year of medical school at Weill Cornell Medical College. She may be reached at What’s Up, Doc? appears alternate Fridays this semester.

Original Author: Marina Stasenko