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Open Access Debate

The fiduciary obligation of the physician-researcher in phase IV trials

Rosemarie DLC Bernabe1*, Ghislaine JMW van Thiel1, Jan AM Raaijmakers2 and Johannes JM van Delden1

Author Affiliations

1 Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Heidelberglaan 100, Utrecht 3584 CX, The Netherlands

2 GlaxoSmithKline, Zeist, The Netherlands

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BMC Medical Ethics 2014, 15:11  doi:10.1186/1472-6939-15-11

Published: 7 February 2014

Abstract

Background

In this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.

Discussion

We first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.

Conclusion

The fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished.

Keywords:
Phase IV; Fiduciary obligation; Interventional trials; Physician-researchers