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When Physicians Recruit Their Own Patients in Clinical Trials…
(Thursday, August 3, 2023) In the realm of clinical research ethics, the concept of dual-role consent has long been a subject of debate. Dual-role consent occurs when physician-investigators seek consent for research participation from patients whom they already treat. While it has raised concerns, this practice is quite common in clinical research, e.g., clinical oncology research, where studies are closely intertwined with patient care. A 4-year study at a National Cancer Institute–designated comprehensive cancer center evaluated the perspectives of key stakeholders on dual-role consent in clinical oncology trials. The study involved physician-investigators, research coordinators, and patients, providing valuable insights into this challenging aspect of clinical research. Many doctors felt that being both the patient's caregiver and researcher could lead to better outcomes. Since doctors know their patients well, they can offer personalized treatment options through clinical trials that align with the patient's needs. This personalized approach could improve the patient's overall well-being and provide them with more suitable treatment choices. Including patients in research under their doctor's care had both positive and negative effects on the informed consent process. On one hand, patients understood the research better, increasing the likelihood of them agreeing to participate. This heightened understanding resulted from the established trust and communication between the physician-investigators and the patients. On the other hand, some patients felt pressured to join the study, fearing that declining might affect their treatment or their relationship with the doctor. Participants in the study preferred a team-based approach to consent. They believed that both doctors and research coordinators should work together to communicate with patients about the study. This way, patients can make more informed decisions, and the risk of feeling coerced into participating would be reduced. By working together, physician-investigators and research coordinators can strike a balance between providing comprehensive information about the clinical trial and minimizing potential undue influence on the patient's decision. To address concerns with dual-role consent, participants suggested several strategies. They stressed the importance of open and transparent communication between doctors and patients. Doctors should disclose any potential conflicts of interest and make it clear that patients have the right to refuse without any negative consequences on their care. Although dual-role consent has its challenges, the study showed that it can be beneficial if managed correctly. By following a team-based approach and implementing effective communication strategies, doctors can ensure that patients are well-informed and have the freedom to make their own decisions. Involving patients in medical research while being their doctors presents both advantages and disadvantages. The study demonstrated that when done ethically and transparently, this practice can lead to better-tailored treatments and improved patient outcomes. However, doctors must be cautious to avoid any potential coercion and ensure patients understand their rights and choices. By embracing a team-based approach and adopting effective strategies for managing tensions, physician-investigators can navigate the delicate balance between research participation and patient care, ensuring the utmost ethical standards are maintained throughout the process. Ultimately, the goal should be to advance medical knowledge while prioritizing patient well-being and autonomy. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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