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Utilizing Community Research Committees to Improve the Informed Consent Process

Millum and Bromwich’s (2021) excellent article provides both conceptual and practical rationale for reexamining the fundamentals of the informed consent process for research and clinical interventions. Rather than a process that shares the same content—which one party requests and the other party proffers—they convincingly show that each party is essentially working toward a middle ground by fulfilling distinct requirements for “valid consent.” By teasing out these requirements of disclosure and understanding, they show that the standard view and process for obtaining valid consent is inadequate. We have likewise postulated that the consent process outlined in journal articles, textbooks, and legal manuals fails to meet the needs of patients and physicians (Tunzi, Satin, and Day 2021). Eschewing the standard view, which is all too similar to “terms of use agreements,” we propose instead the consent continuum model. Our approach to clinical consenting requires and incorporates a deep understanding of community standards, ethical judgment, and physician-patient relationships. In line with Millum and Bromwich, we find that the traditional approach to consent can overburden patients with jargon, is often irrelevant to their preferences, and ultimately leaves them uninformed. Due to reliance on the traditional, autonomy-based approach to obtaining consent, physicians often commence the process primarily for legal coverage of physically invasive, hospital or clinicbased procedures. Otherwise, decisions that can have a more meaningful impact on a patient’s life and health, such as switching to a new medication for cholesterol or undergoing a mammography, have minimal legal requirements for consent, leaving it up to individual providers to determine when and how to inform patients. Millum and Bromwich end with a practical approach to the recent Common Rule provisions, suggesting that researchers should interpret the provision of “key information” as (1) the information understood in order to give valid consent, plus (2) the information that actual prospective participants would consider relevant and expect to be told. The one-size-fits-all legalistic consent under the traditional paradigm is not well suited to this adaptive view. Our model offers a format for implementing Millum and Bromwich’s approach. In our model, clinical activities fall along a continuum constituted by categories of consent (informed consent, assent, or nondissent) that are bound by the context of the patient-physician relationship and informed prima facie by a community, not regulatory, standard. The requirements for “key information” and the moral imperative to avoid illegitimate control can result in unintuitive departures from the current standard for what demands formal informed consent. Our model further categorizes and justifies these departures along conceptually distinct lines. For example, a patient who makes a follow up appointment with their PrimarCare Provider, specifically for a mole biopsy, should not need to go through a formal consent process describing the risks and benefits of treatment, non-treatment, and alternative treatments. Instead, seeking assent by summarizing the major risks and