Can a clinician consent a patient they have seen clinically for research purposes?

From the Guidelines

It is generally not appropriate to consent someone you saw clinically for research due to potential conflicts of interest and power imbalances. The treating clinician-patient relationship creates an inherent power dynamic that may make patients feel obligated to participate in research to please their doctor or out of fear that refusing might affect their care. Instead, a neutral third party should approach patients about research participation to ensure truly voluntary consent. This separation helps protect patient autonomy and reduces the risk of undue influence. If research recruitment must occur within a clinical setting, best practice involves having a research team member who is not involved in the patient's direct care handle the consent process. Additionally, institutional review boards (IRBs) often have specific requirements regarding this situation to safeguard patients' rights. The fundamental ethical principles of respect for persons and justice in research participation require that consent be obtained in a manner that minimizes coercion and maximizes voluntary choice, as emphasized in the Ottawa Statement on the ethical design and conduct of cluster randomized trials 1. Some studies suggest that clinicians' roles should be limited to providing information and presenting the patient with options, while others propose a model of "shared decision-making" between clinicians and patients or caregivers 1. However, in the context of research, it is crucial to prioritize patient autonomy and minimize potential biases. The American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care also provide guidelines for the implementation of community consultation and public disclosure under the FDA's "exception from informed consent requirements for emergency research" 1. Overall, the key consideration is to ensure that patients are fully informed and able to make voluntary decisions about their participation in research, without undue influence from their treating clinicians. In line with the principles outlined in the Belmont Report and the Declaration of Helsinki, researchers must obtain informed consent from human research participants, unless a waiver of consent is granted by a REC under specific circumstances 1. By prioritizing patient autonomy and minimizing potential conflicts of interest, researchers can ensure that consent is obtained in a manner that respects the principles of respect for persons and justice in research participation. The most recent and highest quality study on this topic is the Ottawa Statement on the ethical design and conduct of cluster randomized trials 1, which provides clear guidelines for obtaining informed consent in research studies. Therefore, it is essential to involve a neutral third party in the consent process to ensure that patients are able to make informed and voluntary decisions about their participation in research.

From the Research

Informed Consent in Clinical and Research Settings

• Informed consent is a crucial aspect of both clinical care and research, as it allows individuals to make informed decisions about their participation in studies or treatment [(2,3)].
• The elements of informed consent include disclosure, understanding, decision-making capacity, and voluntariness, each posing distinct difficulties 2.
• Research has shown that disclosure has improved, but comprehension is often poor, and trust is a motivating factor for research participation 2.

Consent in Research Settings

• The process of informed consent is essential in research settings, as it ensures that participants are aware of the risks and benefits associated with the study [(3,4)].
• The standard view of informed consent holds that valid consent requires understanding of certain information, but this view has been challenged, suggesting that disclosure and understanding requirements have distinct grounds 4.
• It is sometimes permissible to enroll willing participants who have not understood everything about their clinical trials 4.

Clinical Settings

• Informed consent plays an integral role in governing the patient-physician relationship, with origins traced back to ancient Greek philosophy 5.
• The main pillars of informed consent are autonomy, integrity, respect, and care, which have been codified into legislation to promote healthy patient-physician relationships 5.
• Understanding the process of informed consent is critical for patients, researchers, and medical practitioners 5.

Relevance to the Question

• There is no direct evidence to suggest that someone seen clinically can be consented for research without following the proper informed consent procedures [(2,3,4,5)].
• However, the principles of informed consent apply to both clinical and research settings, emphasizing the importance of disclosure, understanding, and voluntariness [(2,3,4,5)].