Informed Consent and Disclosure of Surgeon Experience
Sabha Ganai
Surgical Ethics, 27 March 2019; pp 217-229
Abstract
This chapter reviews ethical issues and legal precedent relevant to informed consent for surgical procedures using a shared decision-making framework. The process of informed consent is examined in a systematic fashion, including reviewing ways to improve doctor-patient communication and important considerations for documentation of the consent process. Disclosure of surgical experience will also be explored, including the complexities of dealing with statistics from surgeon-specific reports. Ethical principles including respect for patient autonomy, beneficence, and distributive justice and duty to tell the truth will be explored as relevant to the doctrine of informed consent.
Month: May 2019
The Surgical Informed Consent Process: Myth or Reality?
The Surgical Informed Consent Process: Myth or Reality?
Miguel A. Caínzos, Salustiano Gonzalez-Vinagre
Surgical Ethics, 27 March 2019; pp 203-216
Abstract
Informed consent is currently considered to be a highly important factor which is becoming a critical component of surgical practice. It is a complex process and not just an event or a single encounter. In the twenty-first century, it is accepted that the traditional paternalist relationship between the patient and physician has been replaced by a new type of relationship in which the patient detents a very active and crucial role. For patients who need a surgical procedure, the informed consent process represents the honing of this link between the surgeon and his or her patient. The legal principle emphasizes the fact that the patient is an independent adult who has the capacity to authorize what is going to be done to his or her body. This is a process with significant ethical and legal aspects where both the surgeon and the patient play a major role.
The components which make up the informed consent process are the preconditions, the information provided to the patient, and the consent itself. The most complex step of the informed consent process for the surgeon is providing correct, truthful, unbiased, and accurate information to the patient while keeping hope in him or her. The physician disclosure has three stages: the disclosure of information, the patient understanding, and the patient decision-making. It is necessary to adapt the information to each patient in a language they can always understand. The physician must provide information about the surgical procedure, the benefits, the associated risks, potential complications, and alternative procedures, if any.
Surgeons must use all the available tools to adequately inform the patient and the relatives and improve his or her understanding: information leaflets, multimedia interventions, decision aids, the Internet, and government and professional organization guidelines. New tools as surgical risk calculators which estimate patient-specific postoperative complications for different procedures are now available.
The ultimate goal of the informed consent process should be fostering the patient’s trust in his or her surgeon.
Editor’s note: The ultimate goal of informed consent as stated here is the author’s view and does not represent the views of this digest.
Post-Hong Kong: Human Genome Editing’s Brave New World [VIDEO; 1:33:17]
Post-Hong Kong: Human Genome Editing’s Brave New World [VIDEO; 1:33:17]
Wednesday, March 27, 2019 2:00 pm – 3:30 pm; CSIS Headquarters, 2nd Floor
Summary
A firestorm followed Professor He Jiankui’s disturbing announcement last fall in Hong Kong that he had made heritable genetic changes in human embryos that resulted in the birth of twin girls. Critics pointed to the lack of oversight and transparency, the inadequacy of the informed consent process, the lack of a compelling medical rationale, potential unknown future harms to the edited babies, and the lack of a clear consensus about the actual use of new, powerful gene editing technologies. This historic incident has stirred an intense debate over both the promise of these technologies to cure devastating diseases, such as Huntington’s Disease, and alarm over the idea that these same technologies might be used to create “designer babies.” The U.S. National Academy of Sciences and National Academy of Medicine, together with other international academies, have led vital international discussions over next steps.
On Wednesday, March 27, 2:00-3:30 pm, the National Academy of Medicine and the CSIS Commission on Strengthening America’s Health Security [hosted] a conversation on the unfolding debate as to whether human germline genome editing should be permitted, the types of applications which might be appropriate, the standards and criteria that should be followed, and what regulatory or governance framework is needed.
Editor’s Note: In the context of the hour long broadcast by CSIS an audience question related to informed consent and relating to this digest was posed. It was answered by Jeffrey Kahn; Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics, an excerpt of which has been transcribed below. Readers can find this exchange at around 1:20:45 in the broadcast.
Excerpt
Q – audience member:
Can you talk about some of the therapies that [Editas Medicine] is developing and walk through the informed consent process that would happen in, say for example, childhood blindness? How does that work?
A – Jeffrey Kahn; Andreas C. Dracopoulos Director, Johns Hopkins Berman Institute of Bioethics:
I served on the recombinant DNA advisory committee, the so called RAC as Victor mentioned, when the drug that became the Spark Therapeutics drug for treatment of genetic inherited forms of blindness was being considered in its early phase. So that’s the body that reviews gene transfer, so called gene therapy, research in humans. You must get approval from that body advisory to the NIH before you can go forward.
What was really interesting about that particular story which was and is for children, was that the parents of those children, first of all there are no other treatments, there are no alternatives, it was very promising in animal studies and so this is the first time in humans it is being offered. They showed a video I remember very clearly of a child walking through a maze, which was how they set up and assess levels of vision before and after one eye being treated. It was remarkable to watch this child stumble into the obstacles in the before film and then navigate it very easily after.
The question wasn’t so much about whether it should go forward as a clinical trial but whether parents should be permitted to give consent to having both eyes of their children injected at the same time. So the question was, do we know enough about this very novel first in human use of a therapy to say we’re willing to let you risk your child’s vision, because we don’t know the long term effects of this and whether the child’s restored vision would last or plummet and go away after a few weeks.
And the parents said let us make the decision about preserving whatever vision our child may have. The sooner you treat these kids the more vision you preserve it turns out.
What I learned from that was that is not consent in the sense that we really wish for. There aren’t good alternatives and these parents are willing to do anything for their children to preserve or restore their vision, understandably.
Consent doesn’t work in the way that I think we hope it will in some of these first in human devastating diseases, no other therapy, contexts. People will do anything effectively, so it’s an insufficient tool for doing the ethics work that I think your question implies. I don’t have a good alternative but in lived experience it’s really challenging.
Center for Informed Consent Integrity 