The Inter-role Confidentiality Conflict in Recruitment for Clinical Research

Abstract

Recruiting patients into clinical research is essential for the advancement of medical knowledge. However, when the physician undertaking the care of the patient is also responsible for recruitment into clinical research, a situation arises of an inter-role breach of confidentiality which is distinguishable from other conflicts of interest. Such discord arises as the physician utilizes confidential information obtained within the therapeutic relationship beyond its primary objective, and safeguards ought to be observed in order to avert this important, and generally overlooked, problem. The moral worth of the pledge of confidentiality is based not on its innate value but on its being a promise on which subsequent interactions and disclosures are founded. Within the patient-doctor interaction, confidentiality is an important facet of the promised fidelity and, as such, a loose interpretation of the notion threatens the essence of the relationship, and any violation thereof requires compelling moral justification. To avoid conflict, patients' confidential information ought not be used for the purpose of recruitment, which needs to be undertaken through general education and non-directed appeals, and a preliminary consent to be approached for research should be obtained from the patient prior to her being identified as a suitable research subject. Securing this prior consent would avoid one source of potential, albeit unintended, coercion.

Timing Invitations to Participate in Clinical Research: Preliminary versus Informed Consent

“…This is important to note because in some cases investigators ask other physicians to participate in recruitment by telling eligible patients about trials in which they might participate. Even though these clinicians are not investigators on these particular trials and do not obtain informed consent, Habiba and Evans' (2002) paper would imply that even they may not inform patients about such trials. Habiba and Evans (2002) suggest an alternative model involving preliminary consent for recruiting patients into clinical trials.…”

“…Their observations regarding the problems associated with the conflation of research and care are important, as others have argued (e.g., Appelbaum, Roth, & Lidz, 1982;Dresser, 2001;Miller & Rosenstein, 2003). But the radical solution recommended by Habiba and Evans (2002) is neither necessary nor appropriate. Habiba and Evans (2002) argue that patients see their physicians as caregivers only and not in their dual roles as clinicians and researchers.…”

“…Although they do not discuss this, Habiba and Evans' (2002) claims regarding inter-role breaches of confidentiality also bear on the role of clinicians as educators. Their argument may imply that clinicians who use patient information to teach are also in breach of confidentiality because they have used information gathered in their role as clinicians to advance their role as teachers.…”

“…But the radical solution recommended by Habiba and Evans (2002) is neither necessary nor appropriate. Habiba and Evans (2002) argue that patients see their physicians as caregivers only and not in their dual roles as clinicians and researchers. These dual roles make the physician who also engages in research the moral equivalent of two persons, such that to use clinical information to support or inform his or her role as a researcher is morally equivalent to sharing patient information with another person who should not have access to the patient's clinical information.…”

“…Habiba and Evans' (2002) analysis highlights important considerations for clinicians who enroll their own patients in clinical trials. However, the interpretation and application of the obligation of beneficence as presented by Habiba and Evans (2002), which is a primary reason for their argument that preliminary consent to research is necessary, does not altogether conflict with invitations to participate in research as they believe it does. Moreover, the alternative procedure of preliminary consent they recommend is problematic.…”