In our National Institutes of Health–funded studies at the University of Pittsburgh’s Center for Integrative Medicine, our consent process includes brief PowerPoint presentations to summarize the methods, risks and benefits, privacy measures, and voluntary nature of research participation. This helps to ensure that the research coordinator or investigator does not “drift” from the legal and ethical guidelines of informed consent. At the Arthritis Group, a private clinical practice with a research center in Philadelphia, the coordinator highlights the participants’ rights by saying, “this is not a time-share in the Poconos—you can take as long as you like to decide whether to participate, and you don’t have to stay in the study if you don’t want to.”
Regarding the overly enthusiastic research coordinator described above, some additional subtleties are worth considering. A robot-like coordinator is unlikely to successfully recruit patients into trials (and may be unable to remain employed!). And, although overselling a trial is problematic, it is also clear that patients’ perceptions of their providers and expectations of treatment can contribute to health outcomes2,3. In clinical practice, providers may make the most of such factors in order to facilitate treatment adherence. So, why not acknowledge their value in research recruitment efforts? This may be particularly relevant in comparative effectiveness research, behavioral trials with active controls, and trials without a placebo arm. Clearly, there is a middle ground between overselling a study and sabotaging recruitment through robotic recruitment.
Another subtle but pervasive ethical issue in research trial recruitment is the balancing of patient self-determination and choice with financial needs or other incentives. Many patients cannot afford their treatment. When a research trial is available, study subjects may receive a potentially helpful treatment free of charge. Does the patient, who may have already failed other treatments, truly have a choice? Or, might this be considered coercive? As providers, we are motivated to help patients improve their health in any way possible, so we may recommend trials more frequently to patients with limited income. In addition, there may be financial incentives to the practice for enrolling patients into research trials. Clinical trials may have a subtle or obvious impact on a practice’s bottom line. How might this affect our interactions with patients?
What do you think? We welcome comments from the readership and would be delighted if you would share helpful tips for maintaining ethical standards in research recruitment.
Dr. Greco is assistant professor of psychiatry at the University of Pittsburgh School of Medicine and a licensed psychologist at the Center for Integrative Medicine, both in Pittsburgh, Pa. Donah Zack Crawford is director of clinical trials at the Arthritis Group in Philadelphia.
