Informed Consent and the Role of the Treating Physician

Holly Fernandez Lynch, Steven Joffe, and Eric A. Feldman
Originally posted June 21, 2018
N Engl J Med 2018; 378:2433-2438
DOI: 10.1056/NEJMhle1800071

Here are a few excerpts:

In 2017, the Pennsylvania Supreme Court ruled that informed consent must be obtained directly by the treating physician. The authors discuss the potential implications of this ruling and argue that a team-based approach to consent is better for patients and physicians.

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Implications in Pennsylvania and Beyond

Shinal has already had a profound effect in Pennsylvania, where it represents a substantial departure from typical consent practice.  More than half the physicians who responded to a recent survey conducted by the Pennsylvania Medical Society (PAMED) reported a change in the informed-consent process in their work setting; of that group, the vast majority expressed discontent with the effect of the new approach on patient flow and the way patients are served.  Medical centers throughout the state have changed their consent policies, precluding nonphysicians from obtaining patient consent to the procedures specified in the MCARE Act and sometimes restricting the involvement of physician trainees.  Some Pennsylvania institutions have also applied the Shinal holding to research, in light of the reference in the MCARE Act to experimental products and uses, despite the clear policy of the Food and Drug Administration (FDA) allowing investigators to involve other staff in the consent process.

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Selected State Informed-Consent Laws.

Although the Shinal decision is not binding outside of Pennsylvania, cases bearing on critical ethical dimensions of consent have a history of influence beyond their own jurisdictions.

The information is here.

Conflict of Interest and the Integrity of the Medical Profession

Allen S. Lichter
JAMA. 2017;317(17):1725-1726.

Physicians have a moral responsibility to patients; they are trusted to place the needs and interests of patients ahead of their own, free of unwarranted outside influences on their decisions. Those who have relationships that might be seen to influence their decisions and behaviors that may affect fulfilling their responsibilities to patients must be fully transparent about them. Two types of interactions and activities involving physicians are most relevant: (1) commercial or research relationships between a physician expert and a health care company designed to advance an idea or promote a product, and (2) various gifts, sponsored meals, and educational offerings that come directly or indirectly to physicians from these companies.

Whether these and other ties to industry are important is not a new issue for medicine. Considerations regarding the potential influence of commercial ties date back at least to the 1950s and 1960s. In 1991, Relman reminded physicians that they have “a unique opportunity to assume personal responsibility for important decisions that are not influenced by or subordinated to the purposes of third parties.” However, examples of potential subordination are easily found. There are reports of physicians who are paid handsomely to promote a drug or device, essentially serving as a company spokesperson; of investigators who have ownership in the company that stands to gain if the clinical trial is successful; and of clinical guideline panels that are dominated by experts with financial ties to companies whose products are relevant to the disease or condition at hand.

The article is here.