Guest Expert Connie Ulrich: Ethics of clinical research participation~three questions for us to discuss
Dr. Connie Ulrich, is an Associate Professor of Bioethics and Nursing at the University of Pennsylvania School of Nursing. Connie's research is all about clinical trial participation. I hope you find her insights as useful as we have. Please review her comments below and let us know your thoughts.
Dr. Ulrich's Post:
As a nurse bioethicist, I am particularly interested in the ethical issues associated with the recruitment and retention of cancer patients into clinical trials and how we can best understand what helps or hinders research participation. Recruiting and retaining subjects is a complex problem that impacts many different stakeholders. This includes the funders of our research, clinicians who use our research to improve clinical practice, and importantly, the public citizens who participate in, or are consumers of, research. Indeed, without public support, research would suffer. There are many ethical concerns associated with research participation; what is not clear, however, is how these issues influence the willingness of the public to participate in clinical research or clinicians to recommend it.
In my current research, I am interviewing and surveying cancer patients on clinical trials and clinicians. I have been struck by the candor and willingness of cancer patients to help me and my colleagues shed some light on the problem of recruitment and retention as well as the views of clinicians who are critical to engaging patients and translating our science (specifically nurse practitioners in primary care).
What have I heard from cancer patients? Some patients worry that the “researcher is not telling them everything” and that there is a generalized “fear of the public to participate in research.” Or, they feel burdened by the uncertainty of the research and whether it is helping or hurting them. Trust and confidence in the researchers as well as open, transparent communication in the research process are vital to participation. Without a doubt, integrity is integral to scientific inquiry; how, then, do we improve our image with the public? Second, what have I heard from clinicians? Clinicians have also expressed concerns about recommending clinical research because patients might be used as guinea pigs; it might be an additional burden for patients to consider; and patients might not understand randomization or be randomized to the non-active arm of the trial. Additionally, clinicians reported ethical concerns about the scientific value of the proposed research.
As one subject enrolled in a cancer clinical trial commented to me “there is no future without clinical trials.” I believe that we need to help the public and clinicians understand the importance of research and translate our science in a way that is beneficial to them. Thus, I pose three questions for us to ponder and dialogue on these issues.
- What can we do to improve our public image as researchers?
- How can we best engage the public and clinicians to better understand the scientific value of research?
- What could a researcher do to gain your trust if you were part of a clinical trial?
Looking forward to your thoughts!