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Updated: Jan 26, 2026

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Research imperative.

Howard Trachtman1

  • 1Department of Pediatrics, Division of Nephrology, NYU, Langone Health, New York, NY, 10016, USA.

Contemporary Clinical Trials Communications
|April 24, 2019
PubMed
Summary
This summary is machine-generated.

Physician-researchers enrolling their own patients in clinical trials, known as dual-role consent, may not be an ethical lapse. This practice, when a patient is eligible for an IRB-approved trial, can represent optimal patient care.

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Area of Science:

  • Medical Ethics
  • Clinical Research
  • Patient Care

Background:

  • Dual-role consent, where clinicians enroll their own patients in investigational trials, raises ethical concerns.
  • Potential conflicts of interest, diminished patient voluntarism, and therapeutic misconceptions are associated with this practice.

Purpose of the Study:

  • To review the ethical considerations of clinician-researchers enrolling their own patients in clinical trials.
  • To propose that this practice, under specific conditions, can align with optimal patient care.

Main Methods:

  • This is an opinion paper reviewing existing literature and ethical principles.
  • Analysis of the intersection between clinical research participation and standard patient care.

Main Results:

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  • The paper argues against the automatic classification of dual-role consent as an ethical lapse.
  • It suggests that soliciting enrollment in IRB-approved trials by clinician-researchers can be ethically sound.

Conclusions:

  • When a patient is eligible for an institutional review board-approved clinical trial, the clinician-researcher enrolling their own patient may represent optimal care.
  • This approach challenges the traditional view of dual-role consent as inherently problematic.