Ethics Forum: The Ethical Challenges of Recruiting Patients for Clinical Trials

The Case

At an academic healthcare facility, a research coordinator is highly successful at recruiting patients into clinical trials. On several occasions, he is overheard enthusiastically promoting a trial of a new drug of unknown efficacy to a potential study subject. The research coordinator tells her, “I think this trial could really help you.”

Is this going overboard a bit? Should he be counseled to tone down his enthusiasm and keep to a more scripted and balanced framing of the trial?

Discussion

The dilemma of how to balance friendliness and enthusiasm with the legal and ethical constraints of recruiting research subjects is worth careful consideration. This is an issue that is probably quite common but rarely addressed.

A major concern with the situation described is that the coordinator appears to suggest that the treatment is effective even as it is under investigation to determine its safety, appropriate dosing, or efficacy. Although the coordinator’s apparent wish to be helpful to the patient is admirable, it is definitely not appropriate to oversell a trial to persuade a patient to enter a study.

In conducting clinical research we are guided by a number of ethical principles, including:¹

• Social and clinical value;
• Scientific validity;
• Fair subject selection;
• Favorable risk–benefit ratio;
• Independent review;
• Informed consent; and
• Respect for potential and enrolled subjects;

Informed consent and respect for potential and enrolled subjects are of particular relevance in this case. Potential subjects must make an informed decision not only about whether to participate in research but also whether to continue once they begin. When informed consent procedures are conducted properly, patients are truthfully informed about the purpose, methods, and potential risks and benefits of the research, as well as any alternatives to participation. Armed with accurate and balanced information and an understanding of how the research might or might not relate to their individual situation, the patient can make the decision to participate or to decline.

Inherent in the informed consent procedures is the idea of respecting the person’s ability and right to decide whether participating is appropriate. Likewise, researchers must respect the participants’ right to change their mind and withdraw from a study without penalty and without adverse effects on their medical treatment.

How do we make sure that research with human subjects meets ethical standards with respect to recruitment? Generally, the Institutional Review Board (IRB) overseeing the study strictly regulates all recruitment procedures. Initial screening of potential research subjects may require the use of an IRB-approved “script” designed to be unbiased, noncoercive, and respectful of the person’s privacy and wishes. Once the potential subject has been screened, strict informed consent procedures are followed prior to conducting any research procedures. Ideally, the IRB-approved informed consent document is written for a 6th grade reading level; even so, it can be daunting to patients.

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 outcomes^2,3. 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.

References

1. National Institutes of Health. Ethics in clinical research: Ethical guidelines. Published November 21, 2011. Available at www.cc.nih.gov/recruit/ethics.html. Accessed January 10, 2014.
2. Enck P, Benedetti F, Schedlowski M. New insights into the placebo and nocebo responses. Neuron. 2008;59:195-206.
3. Kaptchuk TJ, Kelley JM, Conboy LA, et al. (2008). Components of placebo effect: Randomised controlled trial in patients with irritable bowel syndrome. [see comment]. BMJ. 2008;336: 999-1003.