 Valerie Cook is the Director of Law and Ethics at the McLean Center. She previously served as visiting assistant professor at the Chicago College of Law and is currently a visiting fellow at the DePaul University College of Law. Professor Cook has also served as the special advisor for the New York State Task Force on Life and the Law. She received her AB in bioethics from Princeton University's Woodrow Wilson School and her JD from Harvard Law School in 2005. Professor Cook's research interests include human subjects research, emerging technologies, genomics, and privacy, informed consent, and intellectual property issues. Today, she's going to talk to us about delegating informed consent. Please welcome. Is this the star? Nope. So being the rural follower that I am, I was instructed to add this disclosure information, which I have none. But in late 2007, Megan Shinell sought the care of Dr. Steven Thoms, who is the Director of the Department of Neurosurgery at Geisinger Medical Center in Pennsylvania. And she was seeking his care for the treatment of a recurrent, non-malignant tumor from the pituitary region of her brain. The tumor jeopardized her eyesight and carotid artery caused headaches and threatened to impact her pituitary and hormone function. So on November 26th, 2007, Mrs. Shinell and Dr. Thoms met for a total of 20 minutes. They discussed her goals and expectations in life and the risks of different approaches to surgery. Tellingly, Mrs. Shinell stated that she wanted to be there for her child, who was at the time nine years old. Dr. Thoms interpreted this to mean that she wanted him to push forward if he got in a situation where he thought he could remove all of the tumor with a reasonable risk. So whether this was an accurate or reasonable interpretation of her values and her wishes is debatable. Regardless, it is quite clear from the subsequent litigation that he hadn't cultivated a sufficient relationship with the patient to comprehend her understanding and meaning. But although they addressed the alternatives, risks and benefits of total resection versus subtotal resection, she did not actually make a final determination as to which surgical approach she wished to pursue. So Mrs. Shinell then in the following month had two meetings, one by phone and one in person with Dr. Thoms' physician assistant. And at the latter meeting, she signed the informed consent form, which also did not appear to designate the surgical approach she had chosen. The operation occurred on January, or sorry, January 31st, 2008, and Dr. Thoms did perform a total resection. During that operation, Dr. Thoms perforated her carotid artery, which resulted in hemorrhage, stroke, brain injury and partial blindness. Subsequently, Mrs. Shinell and her husband sued Dr. Thoms, alleging that he had failed to fulfill his informed consent obligations. At trial, Mrs. Shinell testified that had she known all of the alternatives, she would have chosen subtotal resection as the safer, less aggressive treatment option. The court then at the end of the testimony instructed the jury that in deciding whether Dr. Thoms had fulfilled his informed consent obligations that they could consider, the jury could consider any information that was provided to Mrs. Shinell by, quote, any qualified person acting as an assistant to Dr. Thoms. Based on these instructions, the jury found that Dr. Thoms had fulfilled his informed consent obligations prior to performing the total tumor resection. But just this summer, in June, 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania medical care availability reduction of error or MCARE Act. The act had been passed with the intention, as an aside, to reduce the costs of malpractice insurance. So this is much more the law is about reducing costs, not necessarily protecting patients, although there is a fair share of evidence that the costs of insurance go down when there's effective and appropriate amounts of communication. So the court found, and this is an excerpt of the MCARE Act, I'm not gonna go through it in detail here, but they found that the language of the act, and the bold is my own just to flag it, is unambiguous in its requirement that a physician's duty to provide information to a patient is sufficient to obtain or inform consent is non-delegable. So like the doctrine of informed consent, generally the court's decision was premised on the primacy of the principles of bodily integrity and on autonomy. The court focused on the fact that the patient is in a vulnerable position, there's an inherent information asymmetry between the doctor and the patient, and in that relationship. So by mandating disclosures by the physician him or herself, the court envisioned a meeting of the minds that's integral in the court's mind to the doctor-patient relationship. The Cheynails, attorneys were quick to publicize their win. However, I would argue that the decision's problematic for at least four reasons. So first, the decision incentivizes a narrower approach to inform consent than the one that envisions that informed consent should be a process focusing on the totality of the information and on the patient's comprehension of that information. The court's reasoning may highlight a problem that the legal doctrine of informed consent generally, that it focuses primarily on the duty of the physician to disclose information to the patient and secondarily on the patient's voluntary informed consent. In his defense during the jury trial, Dr. Tom's noted this issue, stating that it is the information conveyed rather than the person conveying it that determines informed consent. So in other words, the patient's multiple conversations, at least in this case three, and meetings with healthcare providers coordinating her care should have allowed greater comprehension of the risks and benefits of the proposed intervention and its alternatives, as well as a continued opportunity to convey and discuss the patient's values, goals, and preferences. Second, and this is related, the decision underscores physician disclosure at the peril of patient comprehension. Over the last decade, the value of shared decision-making for medical care has been increasingly acknowledged. Proponents claim that moving to a shared decision-making model will help shift the law's policy objective to comprehension and consent rather than physician disclosure. Excuse me. Tried to avoid that. Legally, legally mandating that only the physician may make informed consent disclosures may unduly emphasize the latter, that is physician disclosure. A qualified and trained individual with the time to spend on the informed consent process may help patients better understand and comprehend the risks, benefits, and alternatives of a proposed treatment. Third, a decision like the one in Chineau may reflect a judicial reaction to a dramatically evolving doctor-patient relationship. Patients increasingly see a number of specialists. Third parties, such as hospitals, insurance companies, have a greater impact on decisions that impact a patient's health. And the provision of care increasingly involves more advanced technology. The tenuous nature of some doctor-patient relationships may appear to undercut the historic duty on the part of the physician to disclose information. The decision in Chineau therefore might reflect a judicial reluctance or a judicial actually insistence that the physician, him or herself, maintain a level of engagement that's becoming less and less the norm rather than acknowledging the shift to a more team-based approach. Fourth, in reaching its conclusion that informed consent is non-delegable, the court relied on what I consider to be a problematic analogy. It reasoned that because a hospital under case law in Pennsylvania and many other jurisdictions cannot be held liable for a physician's failure to provide informed consent, a physician therefore cannot rely upon a subordinate to disclose the information required to obtain informed consent. But for one, delegation of responsibilities to another would not necessarily insulate the physician from liability. The ultimate duty to ensure informed consent would still rest with the physician even if the delegation was appropriate or allowable. The ultimate duty ends, sorry, second, it's exactly the relationship between the physician and his subordinate that makes the behavior controllable by the physician. If a PA is legally permitted under Pennsylvania law to do important clinical work such as prescribing and administering drugs and medical devices, there's less justification for limiting their ability to participate in the disclosure of the risks, benefits, and alternatives of a proposed intervention. If the physician has authority over the subordinate's disclosure, then informed consent remains as the court wants it to a product of the physician-patient relationship. In contrast, the physician cannot mandate hospital behavior most of the time nor can he or she rely on the hospital to make appropriate disclosures. So to the extent, however, that the court's imperfect analogy can be legally justified, it may also be argued that the law's persistent policy that shields a hospital from informed consent is also ill-advised. Courts and other jurisdictions, as I mentioned, have concluded that informed consent is not delegable to hospitals due to the delicacy of the physician-patient relationship. In Chinelle, the court relied on similar justifications for the non-delegation of informed consent to the PA, reasoning that allowing additional parties into the fray might disrupt the doctor-patient relationship, quote, depriving the patient of the opportunity to engage in dialogue with his or her chosen health care provider. But scholars have argued that for reforming the policy as it applies to hospitals, based on, quote, the clinical reality that hospitals are deeply involved in the informed consent process. And one scholar has stated that this policy undermines trust in medicine by subscribing to a view that, quote, fails to account for the role of hospitals and the informed consent process in creating a trustworthy system for care. Presumably, the Pennsylvania Supreme Court's rule of non-delegation applies beyond the surgical theater to other major treatment decisions. And it's unclear whether it applies to other professionals in what would be considered a subordinate position to the treating physician, such as residents and fellows who, particularly in teaching hospitals, often perform a bulk of the medical consults and provide treatment under the supervision of the treating physician. So I should say that in arguing, and this is the paper that this is coming out in the next, I think, couple weeks, but in arguing that the decision in Chinell versus Thoms does not reflect the evolving nature of the doctor-patient relationship and the healthcare delivery system, it must be acknowledged that disclosures from multiple parties, including physicians, PAs, hospitals, et cetera, could potentially lead to increased patient confusion and the potential for conflicting information imparted to the patient. It's worth considering potential approaches, therefore, to streamlining the informed consent process for complex medical or surgical decisions. Such proposals include an official designation of a single individual or committee to whom the patient can go whenever a question or concern arises regarding the informed consent process. An informed consent ombudsman or committee might be a viable option in other jurisdictions, although in Pennsylvania, as we saw from the language of the MCARE Act and the way the court interpreted that act, that the law would forbid such an approach. Further ensuring reimbursement, this is a big one, reimbursement or compensation for the informed consent process may help ensure that these discussions do not get delegated to those who lack the time or are insufficiently trained or are not well-suited to the task. And as promised, I am in under time. Thank you. So do you think that that'll be upheld everywhere, that we will have to dispense with the practice of having residents consent all the patients? I'm not sure that other courts will be coming down with such decisions. This is actually going to be sent back to the trial court to render a decision in Pennsylvania consistent with this new rule. That said, what happens in a lot of these types of cases is that courts in other jurisdictions or institutions in other jurisdictions freak out because of what's happened across state lines and will then start instituting policies that follow the policies in these other states. Another really interesting thing actually about this case is that even in Pennsylvania, a lot of IRBs and institutions are interpreting this case, which very clearly applies the MCARE Act, which applies to medical practice, they're applying it to research. So now they're saying, as some of them are saying or recommending that the PIs must require that a physician, the PI must be a physician and that physician PI must be the one to ensure informed consent. And there's a fair share of scholarship indicating that at least in the research context, the informed consent process is rendered more robust if it's somebody who's not the PI doing that. Yeah, because the PI has a vested interest in them signing up for the study. Exactly. Yeah, that's...