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Explore This IssueFebruary 2014
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?
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.