Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.
The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.
Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.”
My first thought was, “Really?” It is widely acknowledged that the roles of physicians are quite different depending on whether they are providing medical treatment or are engaged in clinical research. The fiduciary duties of treating physicians to their patients are firmly rooted in decades of malpractice law. In contrast, courts have struggled to define the extent of researchers’ duties to participants, often straining to find a “special relationship” between the two that would ground a heightened duty of care. Common law’s disparate treatment of patients and research participants in tort cases has been widely acknowledged in the legal and medical literature – although scholars debate whether this approach is logical. And principles of medical ethics and research ethics acknowledge the important differences in the roles and responsibilities of physicians depending on whether they are treating patients or conducting research.
As a matter of practice, physicians are the ones who secure consent to medical treatment, while informed consent to research is frequently secured by study coordinators or other staff, not by physician-investigators. The FDA’s draft guidance on the clinical trial process recognizes that the informed consent interview may be conducted by the investigator or “other study staff,” and its website notes that while the investigator is ultimately responsible for ensuring that consent is obtained, “FDA does not require the investigator to personally conduct the consent interview.” The delegation of this responsibility to non-physician staff is accepted for a variety of reasons. First, they are able to spend more time with study participants explaining risks and benefits as compared to physician-investigators with other responsibilities and more pressing priorities. They are certainly in a better position than physician-investigators to disclose practical information about things like logistics, financial reimbursement, and compensation for research-related injury – notably, federal law’s disclosure requirements for consent to research are quite different from, and much more comprehensive than, state law requirements for consent to treatment. In some cases study staff, like nurses, may be more qualified to speak to technical and clinical aspects of the research than a physician-investigator whose focus is on the research process as a whole. It’s also arguable that the likelihood of coercion or undue influence in recruiting research participants is lower when staff are responsible, as compared to situations where an authority figure like a physician-investigator engages with the participant. Requiring physicians to conduct the informed consent discussion, as some IRBs have recently suggested, would defeat these goals.
Given common law precedent about the limited duties owed by researchers to study participants – and more importantly, given the fact that the Shinal decision and the Pennsylvania statute upon which it was based spoke exclusively to the duties of physicians to their patients in the context of medical treatment – it is perplexing that IRBs and investigators would consider extending the case’s reasoning to the research context. Perhaps this abundance of caution represents a new example of “defensive research,” equivalent to the practice of defensive medicine. But to the extent that requiring physician-investigators to secure consent may result in less robust informed consent conversations, this move would offer less protection for participants who voluntarily expose themselves to significant risk with no guarantee of personal benefit.
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Our institution, and some others engaged in treatment research, have long required a study physician to be involved in the consent process. Informed consent to a treatment intervention is ultimately about choice–and to make a choice, the prospective participant must be able to understand and consider treatment alternatives. It is our view that no patient or subject, not in the clinical circumstance or in the research context, should be expected to make a treatment decision without the opportunity to discuss options with someone qualified to do so. A study coordinator who is not medically trained does not fit that bill. And the idea that physician-investigators have “more pressing priorities” than talking with participants reflects a mistaken notion of an investigator’s obligation to those who entrust them with their well-being.