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

BMC Medical Ethics

Johannes JM van Delden²  Jan AM Raaijmakers¹  Ghislaine JMW van Thiel²  Rosemarie DLC Bernabe² 

[1] GlaxoSmithKline, Zeist, The Netherlands;Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Heidelberglaan 100, Utrecht 3584 CX, The Netherlands

关键词: Physician-researchers;    Interventional trials;    Fiduciary obligation;    Phase IV;   

Others  :  799586
DOI  :  10.1186/1472-6939-15-11

 received in 2013-01-24, accepted in 2014-01-27,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Bernabe et al.; licensee BioMed Central Ltd.

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