Informed consent in spinal surgery
V. Todd, N. C. Birch
The Bone & Joint Journal, 31 March 2019; 101B(4) pp 355-360
Abstract
Informed consent is a very important part of surgical treatment. In this paper, we report a number of legal judgements in spinal surgery where there was no criticism of the surgical procedure itself. The fault that was identified was a failure to inform the patient of alternatives to, and material risks of, surgery, or overemphasizing the benefits of surgery. In one case, there was a promise that a specific surgeon was to perform the operation, which did not ensue. All of the faults in these cases were faults purely of the consenting process. In many cases, the surgeon claimed to have explained certain risks to the patient but was unable to provide proof of doing so. We propose a checklist that, if followed, would ensure that the surgeon would take their patients through the relevant matters but also, crucially, would act as strong evidence in any future court proceedings that the appropriate discussions had taken place. Although this article focuses on spinal surgery, the principles and messages are applicable to the whole of orthopaedic surgery.
Informed Consent and Disclosure of Surgeon Experience
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.
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.
Informed Consent: A Monthly Review
___________________________
April 2019
This digest is intended to aggregate and distill key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
Publisher
David R. Curry
President & CEO
GE2P2 Global Foundation
david.r.curry@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_April 2019
HPV vaccination and sexual health in France: Empowering girls to decide
HPV vaccination and sexual health in France: Empowering girls to decide
Hervé Lefevre, Stéphanie Samain, Nour Ibrahim, Christine Fourmaux, Anne Tonelli, Sébastien Rouget, Emmanuelle Mimoun, Renaud De Tournemireci, Marie Devernav, Marie Rose Morp, Jonathan Lachal
Vaccine, 22 March 2019; 37(13) pp 1792-1798
Objective
Vaccination coverage against HPV in France is among the lowest in the industrialized world, although the public authorities have recently become aware of this issue. Few studies have looked at teenaged girls’ representations of this vaccination, even though they are the most concerned by it. This qualitative study explored the experiences and representations of HPV vaccination by adolescent girls seeing doctors at least occasionally.
Study Design
We used a written essay question to explore this issue among 101 adolescent girls at six urban medical centers and a semi-structured interview to discuss it in further depth with five of them. The analysis was lexicometric (ALCESTE®) and phenomenological (Interpretative Phenomenological Analysis).
Results
These results are organized around four superordinate themes: the teenage girls’ factual knowledge about this vaccine, their motives for and obstacles to vaccination, their involvement in this decision, and finally the need for information about and solutions to this issue.
Conclusions
Teenage girls know little about this vaccine and are more sensitive to the emotional discourse that surrounds it than to rational knowledge about it. The requirement for parental authorization for this vaccine reinforces the girls’ lack of investment. Vaccination programs should integrate the HPV vaccine more thoroughly into general prevention concerning sexual health and should send a strong signal by offering minors anonymous vaccination free of charge, as is already the case in France for requests for contraception, the morning-after pill, elective abortion, and screening and treatment of sexually transmitted infections.
Communication with children and adolescents about the diagnosis of their own life-threatening condition
Communication with children and adolescents about the diagnosis of their own life-threatening condition
Alan Stein, Louise Dalton, Elizabeth Rapa, Myra Bluebond-Langner, Lucy Hanington, Kim Fredman Stein, Sue Ziebland, Tamsen Rochat, Emily Harrop, Brenda Kelly, Ruth Bland
The Lancet, 16 March 2019; 393(10176) pp 1150-1163
Summary
When a child is diagnosed with a life-threatening condition, one of the most challenging tasks facing health-care professionals is how to communicate this to the child, and to their parents or caregivers. Evidence-based guidelines are urgently needed for all health-care settings, from tertiary referral centres in high-income countries to resource limited environments in low-income and middle-income countries, where rates of child mortality are high. We place this Review in the context of children’s developing understanding of illness and death. We review the effect of communication on children’s emotional, behavioural, and social functioning, as well as treatment adherence, disease progression, and wider family relationships. We consider the factors that influence the process of communication and the preferences of children, families, and health-care professionals about how to convey the diagnosis. Critically, the barriers and challenges to effective communication are explored. Finally, we outline principles for communicating with children, parents, and caregivers, generated from a workshop of international experts.
Informed Consent in Biomedical Research
Informed Consent in Biomedical Research
Fida K.Dankar, MartonGergely, SamarDankar
Computational and Structural Biotechnology Journal, 25 March 2019
Abstract
Informed consent is the result of tumultuous events in both the clinical and research arenas over the last 100 years. Throughout this time, the notion of informed consent has shifted tremendously, both due to advances in medicine, as well as the type of data being gathered. As such, informed consent has misaligned with the goals of medical research. It is becoming more and more vital to address this chasm, and begin building new frameworks to link this disconnect. Thus, we address three goals in this paper. First, we discuss the history of informed consent and unify the varying definitions of the term. Second, we evaluate the current research on the topic, classify them into themes, and attend to the problems therein. Lastly, we employ these themes of informed consent research mentioned previously to provide guidance and insight for future research in the arena.
Factors associated with refusal or acceptance of older patients (≥ 65 years) to provide consent to participate in clinical research in cardiology: a qualitative study
Factors associated with refusal or acceptance of older patients (≥ 65 years) to provide consent to participate in clinical research in cardiology: a qualitative study
Fiona Ecarnot, Nicolas Meunier-Beillard, Jean-Pierre Quenot, Nicolas Meneveau
Aging Clinical and Experimental Research, 21 March 2019; pp 1–8
Background
Clinical research is an essential step in the successful translation of knowledge from basic research into concrete clinical applications, yet many people are reluctant to provide consent when actually approached to actively participate in clinical trials.
Aims
We investigated the factors that influence older patient’s (≥ 65 years) decisions to accept or refuse to participate in a prospective randomized clinical trial in secondary prevention after acute coronary syndrome.
Methods
Qualitative approach based on individual semi-structured interviews with patients who were approached for consent to participate in a currently ongoing clinical trial was adopted. Patients were interviewed after the consent process (8 accepted; 8 refused the trial). Interviews were analysed using grounded theory methodology.
Results
Sixteen patients aged ≥ 65 years participated. The main concept to emerge from these interviews is that the actual trial itself does not appear to be the primary determinant in the decision to participate in clinical research. Rather, patients’ decisions to participate (or not) in clinical research appear to be primarily determined by their capacity to deal with the current health event that has disrupted their life, and by their available mental and physical resources.
Discussion and conclusion
Older patients display varying levels of engagement in their own health, ranging from low engagement with high trust in the medical profession, to high engagement mirrored by distrust of the medical profession. Structural conditions, such as personal benefit from trial participation, or logistic barriers to participation, seem to affect both accepters and refusers in the same manner.
Informed Consent for Genetics Research in Italy
Informed Consent for Genetics Research in Italy
Piergiorgio Fedeli, Nunzia Cannovo, Rosa Guarino, Vincenzo Graziano
Open Medicine Journal, 28 February 2019; 6 pp 6-12
Background
Genetic research has become an indispensable instrument for medical research, and the subjects involved have both divergent and convergent interests.
Objective
The possibility of having more detailed genetic information undoubtedly offers benefits for the health of the subject, but could also pose risks and make the subject vulnerable to discrimination. The scientific community has viewed very favorably the public health utility of family history, in which data from a family whose members suffer from chronic pathologies is collected and filed, in order to develop a sort of “stratification of family risk.” Even though in the last decade the scientific and juridical literature has contributed greatly to the topic of biobanks, the perplexities that continue to surround this theme give the idea that current ethical protocols on research are inadequate.
Conclusion
Genetic data must be used not to exploit, but to serve the person. Freedom and responsibility must be the twin guiding lights for establishing parameters for the use of biological samples. An evaluation of how this technology impacts the various aspects of the future of society is urgently needed.
Center for Informed Consent Integrity 