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

Abstract

This article addresses the impact of the potential conflict between the roles of physicians who are both clinicians and researchers on the recruitment of persons into research trials. It has been proposed (1) that a physician breaches inter-role confidentiality when he or she uses information gathered in his or her clinical role to inform patients about trials for which they may be eligible and (2) that clinician-researchers should adopt a model of preliminary consent to be approached about research prior to commencing a clinical relationship. This article argues that even if we grant the legitimacy of inter-role confidentiality (which is open to question), there are circumstances in which other obligations physicians bear override the obligation of inter-role confidentiality. Moreover, it is argued that the practice of preliminary consent is morally suspect and that such consent cannot be deemed valid. The article concludes with a series of recommendations of ways in which the legitimate concern regarding the conflicting roles of clinician-researchers can be addressed in the recruitment stage of research.

Implementation of a consent for chart review and contact and its impact in one clinical centre

“…She stated that if consent is presented at the first interaction with one's physician, a patient might feel pressured to agree because refusal could affect their relationship with their physician 7. Iltis also argued that for patients to give informed consent requires a self-knowledge that they don't yet possess, as the patients do not know their diagnoses, prognoses or the possible treatments 7…”

“…Overall, CCRC, if properly implemented, is an elegant solution to the concerns raised by Habiba and Evans1 and Iltis 7. Most importantly, however, the CCRC provided our institution with a practical solution to the challenge of allowing patient information to be accessed by personnel outside of the direct circle-of-care while still respecting patient privacy.…”

Is the Red Queen Sitting on the Throne?

“…Studies indicate that there may be confusion among patients as to whether they were immediately signing up to research, 34 and this may be especially true when patients are recruited upon arrival to the hospital prior to diagnosis. 35 Consequently, permission to contact approaches not only have the potential to increase administrative burden, thus potentially negating efficiencies created elsewhere, but also raise important questions as to the status of such permission and how it should be considered within the regulatory process.…”