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Why Informed Consent Needs to Be Reinvented

Op-Med is a collection of original articles contributed by Doximity members.
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“I never imagined that this could happen.”

In just a few months, I have heard more than a few of my patients say this to me after undergoing an operation.

In these moments, I cannot help but ask myself, what did we fail to communicate to these patients during informed consent such that they are blindsided by an outcome? I wonder, what could we have done differently such that patients can better understand the choices they face?

As earnestly as I wish to go back to our conversation prior to the operation, it is already too late.

The process of informed consent has not fundamentally improved over the past 50 years. In our current model, the physician and the patient meet in an office or inpatient setting to discuss consent for an upcoming procedure or clinical trial. Often filled with medical jargon, the conversation rarely assesses the patients’ baseline level of knowledge or their degree of comprehension afterwards. In the constraints of a single visit, it is difficult to see the line between sharing too little and too much information for the provider7. For the patient, there is limited time to process the material fully and to think of all of the questions to ask prior to making a truly “informed,” life-altering decision.

Especially when it comes to more sophisticated and serious interventions, I see tremendous limitations in our ability as providers to communicate to our patients and their caregivers the full extent of their possible consequences or complications. As a cardiothoracic surgery resident, I encounter many high-risk, high-reward technologies such as ventricular assist devices or extracorporeal membrane oxygenation circuits of which the public is generally unknowledgeable. Explaining the procedure, the technology, and the plethora of its potential complications in a 20 minute conversation with patients who have little background scientific knowledge is virtually an impossible task.

By the time I finish training, it will have taken me four years of undergraduate education, four years of medical school, and eight years of residency to understand all of the intricacies of these concepts. How can I hope to convey them to someone who is just encountering them for the first time under significant duress? Too often, I end up having to cut the conversation short, knowing that it was not a fully “informed” consent.

Admittedly, it may not be a realistic goal to equate informed consent to the patient having the same degree of understanding as a physician. However, this does not change the fact that something about the informed consent process needs to change and adapt to the growing gap between the advances in science and the general public’s scientific literacy. It is my opinion that we can do better, as it is our ethical responsibility to ensure that our patients are able to understand what they will undergo.

For instance, given the advances in computer software and even social media, we no longer need to be limited to a single place or time.

The patient can be engaged in informed consent as soon as he or she makes an appointment.

Using a virtual platform, the patient can find all essential information related to the intervention in one location prior to the hospital admission or office visit. Its content, organized by the provider, will walk the patient through the traditional components of informed consent. While the basic components stay the same, the fundamental difference here is that social media has the potential to render it more dynamic, interpersonal, and equitable.

To optimize patient learning, medical jargon can be linked to background articles or easy-to-understand media. Occasional quiz questions can pop-up to ensure the patient comprehends the crucial details. Because interactions are not restricted by office space and one-on-one time, patients can spend as much time as needed to review the content and even pose questions to the provider-team directly, to be answered during the upcoming appointment.

The platform should enable patients to learn from each other

One of the fundamental limitations of informed consent is that no matter how much we optimize the process, the patient cannot fully understand the implications of an intervention until he or she experiences them firsthand. For instance, no words from a physician could ever hope to illustrate the feelings of post-operative pain, or the day-to-day limitations of living with stroke deficits. Physicians may know the science, but we have not experienced the day-to-day realities of patients. It is oftentimes our failure to convey these types of information that patients often find themselves blindsided by the aftermath.

However, they may be able to get some of these perspectives from other patients who have gone through them. If mutually desired, the platform can help connect patients to share their experiences or organize meetings, so they may be able to better understand the realities of potential benefits and complications. In these instances, we need to believe that patients, not just physicians, may also know best, and enable them to empower each other.

The platform will not only help patient learning, but also help providers become better communicators

Lastly, when we transform informed consent into a more dynamic process, physicians and other providers have an opportunity to receive feedback and recognize the gaps in their communication. Based on such feedback, providers can continually update their content to meet the needs of their patients. Over time, the team will grow more adept at anticipating the needs of their patients.

Admittedly, in this digital era where there are fewer opportunities for human connection in medicine, taking the informed consent process online can render it even less personal. Hence, it is crucial that the platform supplements, and not replaces, the sacred one-on-one conversation. Moreover, any community engagement should respect user privacy since any encroachment would undermine exactly the trust in the research enterprise that we hope to restore.

Ultimately, social media can augment patient understanding that is essential to autonomy. Knowing its potential benefits and risks, it is time for the medical community to consent to its own digitization.

Jason Han, MD is a thoracic surgeon and a 2018–2019 Doximity Author.


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  3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. “The Belmont Report”, 1979. Federal Register, 44(76):23192–23197. [Available online]
  4. Faden, Ruth R., and Tom L. Beauchamp. 1986. A History and Theory of Informed Consent. New York: Oxford University Press.
  5. Donald Oken, “What to Tell Cancer Patients,” Journal of the American Medical Association 175 (April 1, 1961): 1120–1128
  6. Office for Human Research Protections — IRBs and Assurances. Retrieved 2018–03–11.
  7. Grady C, “Enduring and Emerging Challenges of Informed Consent” February 26, 2015, N Engl J Med 2015; 372:855–862

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