Elizabeth Rouha learned about the clinical trial she would later join in an unusual place: “I was at a restaurant in Leiden, and there was a poster in the toilet,” she said. The poster was recruiting healthy volunteers for a challenge study using Clostridioides difficile, the leading cause of hospital-acquired diarrhoea. The placement made her laugh. But the study itself also sparked her curiosity.
The study was run by Leiden University Medical Center and it was the first time healthy participants would be experimentally exposed to C. difficile in a challenge model. The bacterium lives harmlessly in many people’s guts, but for others it causes serious illness that recurs despite treatment. The trial set out to understand why.
Elizabeth enrolled in the trial for two immediate reasons. The first was her straightforward excitement about its potential impact. She wanted to contribute to science in a way that she felt was “bigger than just my usual job or… my usual obligations.” Her second reason for enrolling in the study was that she felt personally well-suited. “Gut health-wise, I felt like I was a pretty healthy person,” she said. She felt she could reasonably take on a small amount of risk to help those who were more vulnerable.
There was one concern that Elizabeth had to confront. She had always been “really scared of getting… blood drawn.” She recalls that she “would usually faint or just… panic about it.” And this particular study required frequent blood draws over a period of three months. But Elizabeth didn’t let this stop her. As a psychologist, she thought of the trial as a structured place to confront her fear: “I saw it as an opportunity for exposure therapy for myself.” She mentioned this to the research team, and thanks to their active support, she finished the trial with her fear much diminished.
This experience reflected one of the most positive aspects of her experience. She felt she was treated very well by the research team:
I wasn’t just some random participant… I was a person that they’re collaborating with rather than a test subject… I felt included, and that also increased my motivation to do the whole trial.
Research Participation: Phase I Controlled Human Infection Model study of Clostridioides difficile at Leiden University Medical Center
Passionate About: Communication of research to participants; making volunteering more accessible and less intimidating; the ethics and rights of volunteers
Outside the Council: Yoga, dancing, running, swimming, and fibre arts (knitting and crocheting)
Her Friends Describe Her as: Reflective, warm, and conscientious
Looking back, Elizabeth has no doubt that she “made the right decision” when she enrolled in the trial. But not everyone around her understood her decision. While her friends were curious and supportive, close family members questioned whether she was “putting herself into harm’s way for no reason” or whether C. difficile could be transmitted between them, given that they shared a living space. The latter was a question Elizabeth hadn’t thought through. Her takeaway was that anyone considering a trial should talk through it with the people close to them, particularly those they live with. However, she also realized that these reactions were based on fear. And while her fears had driven her towards participation, others found their fears to be an obstacle.
It was this contrast that nudged her toward advocacy. She noticed that others were “not as willing to participate in… [trials] even if they’re not harmful to them” and she he was struck by how often negative reactions are based on the way a study is described, and not on the actual risk it poses for participants. Informed consent forms, she feels, are often written “more for almost a medical student rather than a normal person who doesn’t understand these things.” This discourages potential participants before they can weigh the real risks, or consider the possibility of the longer term positive impact of trial participation. As someone who found study participation meaningful and beneficial, she finds this troubling.
By participating in the trial, she confronted her fear of blood draws and turned the experience into an opportunity for personal growth.
She also pushes back on the assumption that participants enrol in clinical trials primarily because they are seeking compensation. “I just found that really strange,” she says, “because all medical research, all progress is dependent on people who are willing to put themselves in danger… You should be compensated for the time and sometimes the risks that you’re enduring.” She is especially opposed to the frequency with which repeat healthy volunteers are stigmatized as individuals seeking financial gain, rather than being recognized for their contributions.
Elizabeth grew up between Canada and Czechia and attended school in both French and English. She learned early how to move between cultural environments. She now lives in Amsterdam, where she works as a developmental educator for children on the autism spectrum and with ADHD. She is also finishing her Master’s in Clinical Psychology. Between a multicultural and multilingual childhood and her experience making knowledge accessible to children, Elizabeth is practiced at translating complex ideas across audiences. This is a sensibility she brings to 1Day Sooner’s Participant Council, an international body of healthy research participants brought together to ensure that the people who take part in trials have a meaningful voice in shaping the research that depends on them. As a Council member she is excited to have the opportunity to help other potential participants weigh the risks and benefits of enrolling in clinical trials, and she would welcome opportunities to review informed consent forms and participant-facing materials. She hopes that, if she can draw on and share her experience, “other people will also find it easier” to enroll in clinical trials. She is also interested in a question she feels the Council hasn’t yet asked: what do the people around participants — family, friends, partners — actually think about healthy volunteering? Hearing from them, she suspects, could make recruitment easier for everyone.
If you’ve participated in a clinical trial as a healthy volunteer, or are interested in doing so, 1Day Sooner wants to hear from you. You can sign up at here or reach out at volunteer@1daysooner.org.