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Ethical considerations in adherence research

Authors Patel NU, Moore BA, Craver RF, Feldman SR

Received 21 July 2016

Accepted for publication 11 October 2016

Published 5 December 2016 Volume 2016:10 Pages 2429—2435


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Johnny Chen

Video abstract presented by Nupur U Patel.

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Nupur U Patel,1 Blake A Moore,1 Rebekah F Craver,2 Steven R Feldman1,2

1Department of Dermatology, Center for Dermatology Research, 2Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA

Abstract: Poor adherence to treatment is a common cause of medical treatment failure. Studying adherence is complicated by the potential for the study environment to impact adherence behavior. Studies performed without informing patients about adherence monitoring must balance the risks of deception against the potential benefits of the knowledge to be gained. Ethically monitoring a patient’s adherence to a treatment plan without full disclosure of the monitoring plan requires protecting the patient’s rights and upholding the fiduciary obligations of the investigator. Adherence monitoring can utilize different levels of deception varying from stealth monitoring, debriefing after the study while informing the subject that some information had been withheld in regard to the use of adherence monitoring (withholding), informed consent that discloses some form of adherence monitoring is being used and will be disclosed at the end of the study (authorized deception), and full disclosure. Different approaches offer different benefits and potential pitfalls. The approach used must balance the risk of nondisclosure against the potential for confounding the adherence monitoring data and the potential benefits that adherence monitoring data will have for the research subjects and/or other populations. This commentary aims to define various methods of adherence monitoring and to provide a discussion of the ethical considerations that accompany the use of each method and adherence monitoring in general as it is used in clinical research.

Keywords: compliance, stealth monitoring, deception, adherence monitoring

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