Patient informed consent, ethical and legal considerations in the context of digital vulnerability with smart, cardiac implantable electronic devices
Leanne N. S. Torgersen, Stefan M. Schulz, Ricardo G. Lugo, Stefan Sütterlin
Plos Digital Health, 23 May 2024
Open Access
Abstract
Advancements in digitalisation with cardiac implantable electronic devices (CIEDs) allow patients opportunities for improved autonomy, quality of life, and a potential increase in life expectancy. However, with the digital and functional practicalities of CIEDs, there exists also cyber safety issues with transferring wireless information. If a digital network were to be hacked, a CIED patient could experience both the loss of sensitive data and the loss of functional control of the CIED due to an unwelcome party. Moreover, if a CIED patient were to become victim of a cyber attack, which resulted in a serious or lethal event, and if this information were to become public, the trust in healthcare would be impacted and legal consequences could result. A cyber attack therefore poses not only a direct threat to the patient’s health but also the confidentiality, integrity, and availability of the CIED, and these cyber threats could be considered “patient-targeted threats.” Informed consent is a key component of ethical care, legally concordant practice, and promoting patient-as-partner therapeutic relationships [1]. To date, there are no standardised guidelines for listing cybersecurity risks within the informed consent or for discussing them during the consent process. Providers are responsible for adhering to the ethical principles of autonomy, beneficence, non-maleficence, and justice, both in medical practice generally and the informed consent process specifically. At present, the decision to include cybersecurity risks is mainly left to the provider’s discretion, who may also have limited cyber risk information. Without effective and in-depth communication about all possible cybersecurity risks during the consent process, CIED patients can be left unaware of the privacy and physical risks they possess by carrying such a device. Therefore, cyber risk factors should be covered within the patients’ informed consent and reviewed on an ongoing basis as new risk information becomes available. By including cyber risk information in the informed consent process, patients are given the autonomy to make the best-informed decision.

Patient Consent for Medical Student Pelvic Exams under Anesthesia: An Exploratory Retrospective Chart Review
Jessica A. Jushchyshyn, Lakeisha Mulugeta-Gordon, Cara Curley, Florencia Greer Polite, and Jon F. Merz
The Journal of Clinical Ethics, 10 May 2024
Abstract
Objective
We performed this study to examine patients’ choices to permit or refuse medical student pelvic examinations under anesthesia (EUAs) during planned gynecologic procedures.
Design
We conducted an exploratory retrospective chart review of electronic consent forms at a single academic medical center using contingency tables, logistic regression, and nonparametric tests to explore relationships between patient and physician characteristics and consent.
Results
We identified and downloaded electronic consent forms for a census of 4,000 patients undergoing gynecologic surgery from September 2020 through calendar year 2022. Forms were linked to anonymized medical record information. Of the 4,000 patients, 142 (3.6%) were removed from analysis because consent forms were incomplete. Of 3,858 patients, 308 (8.0%) were asked for EUA consent more than once, 46 of whom were not consistent. Overall, 3,308 (85.7%) patients consented every time asked, and 550 (14.2%) refused or limited EUA consent at least once. Nine patients limited their consent to female students, and two patients refused medical student participation at all. We performed exploratory multiple logistic regression analyses exploring differences in rates of consent across patient and physician demographic groups.
Conclusions
We find that some patients are more likely than others to refuse a pelvic EUA, magnifying the dignitary harm from a nonconsensual invasion of intimate bodily integrity and perpetuating historic wrongs visited upon vulnerable people of color and religious minorities. Patients’ rights to respect and control over their bodies require that physicians take seriously the ethical obligation to inform their patients and ask them for permission.

Overlapping Surgery Verbiage in Informed Consent Documents
Original Study
Margaret B. Mitchell, George Lin, Kavita Prasad, Daniel R. S. Habib, Alexander Langerman
Annals of Surgery, 6 May 2024
Abstract
Objective
To assess informed consent documents from United States (US) institutions for verbiage regarding overlapping surgery.
Summary background data
Overlapping surgery remains a controversial practice. Recent guidance from the Senate Finance Committee and American College of Surgeons emphasizes transparency with patients regarding this practice through the informed consent process, but it remains unclear how many institutions adopted their recommendations.
Methods
Informed consent documents were collected from a national sample of 104 institutions and assessed for verbiage regarding overlapping surgery and/or attending absence during a surgical case. The verbiage of these forms was further analyzed for inclusion of key terms (e.g., “overlapping surgery,” “critical portions”) as well as transparency regarding surgeon absence.
Results
Thirty (29%) forms included verbiage regarding overlapping surgery and/or surgeon absence during a case. Most of these 30 utilized the terms “overlapping surgery” or “critical portions” (18 [60%] and 25 [83%], respectively), although only 3 (10%) explicitly stated that portions of the procedure that may be performed in the absence of the attending surgeon. Six forms (20%) specifically stated who may perform the procedure without the attending present, and 3 forms (10%) had patients acknowledge this section of the consent form with an additional signature or initial. Only 2 of the forms (7%) fulfilled all of the criteria set forth by the SFC.
Conclusion
Detailed information regarding overlapping surgery is infrequently included in hospitals’ procedure informed consent documents. Forms that include this information rarely provide explicit statements of attending presence and trainee participation, raising concerns regarding surgeon-patient transparency.

Informed Consent Should Be Required before Brain Death Testing
Joseph M. Eble
Ethics & Medics, May 2024
Abstract
Informed consent is an important principle in medicine. It protects patients and their families from being unduly pressured into procedures they do not understand with risks they may not fully appreciate. While organ donor status is near ubiquitous for anyone with a driver’s license or ID card, rarely is this status accepted with fully informed consent. As a result, patients are left vulnerable to tests that may cause them irrevocable harm or even procedures that may cause their death. The test for brain death is an example of the former possibility. This article explores the dangers of this and the apnea test, as well as the lack of informed consent present when organ donor agreements are generally made.

Informed Consent and Digit Replantation: Current State and Recommendations for Ethical Patient Care
Emily Gudbranson, Adnan Prsic, Ashley Pistorio, David L. Colen
The Journal of Hand Surgery, 18 April 2024
Abstract
The importance of informed consent and the value of shared decision-making in hand surgery are well-established and particularly critical in the setting of digit amputation when considering replantation. Informed consent requires an understanding of not only the immediate and long-term risks and benefits of surgery, as well as the risks and alternatives involved, but also the capacity of the patient to make a medical decision. However, patients who have acutely sustained a disfiguring trauma are often in distress and may not fully process the consent discussion. Digit replantation is an “elective emergency”—the decision must be made immediately but is not lifesaving—which poses a difficult dilemma: are surgeons acting in patients’ best interests by pursuing replantation if we engage those patients in informed consent discussions when they may not have capacity? This article explores the relevant bioethical principles associated with digit replantation, summarizes updated literature regarding informed consent and shared decision-making, and provides recommendations for patient education materials to standardize informed consent discussions for surgeons approaching patients at this unique intersection of considering revision amputation versus replantation.

Informed consent in clinical practice: Old problems, new challenges
Research Article
Isaac KS Ng
Journal of the Royal College of Physicians of Edinburgh, 14 April 2024
Abstract
Informed consent is a fundamental tenet of patient-centred clinical practice as it upholds the ethical principle of patient autonomy and promotes shared decision-making. In the medicolegal realm, failure to meet the accepted standards of consent can be considered as medical negligence which has both legal and professional implications. In general, valid consent requires three core components: (1) the presence of mental capacity – characterised by the patient’s ability to comprehend, retain information, weigh options and communicate the decision, (2) adequate information disclosure – based on the ‘reasonable physician’ or ‘reasonable patient’ standards and (3) voluntariness in decision-making. Nonetheless, in real-world clinical settings, informed consent is not always optimally achieved, due to various patient, contextual and systemic factors. In this article, I herein discuss three major challenges to informed consent in clinical practice: (1) patient literacy and sociocultural factors, (2) psychiatric illnesses and elderly patients with cognitive impairment and (3) artificial intelligence in clinical care, and sought to offer practical mitigating strategies to address these barriers.

Preparing Patients for Oral Immunotherapy (PPOINT): International Delphi consensus for procedural preparation and consent
Douglas P. Mack, Timothy E. Dribin, Paul J. Turner, Richard L. Wasserman, Mariam A. Hanna, Marcus Shaker, Mimi L.K. Tang, Pablo Rodríguez del Río, Brad Sobolewski, Elissa M. Abrams, Aikaterini Anagnostou, Stefania Arasi, Sakina Bajowala, Philippe Bégin, Scott B. Cameron, Edmond S. Chan, Sharon Chinthrajah, Andrew T. Clark, Paul Detjen, George du Toit, Matthew Greenhawt
Journal of Allergy and Clinical Immunology, 8 April 2024
Abstract

Background
Despite the promise of oral immunotherapy (OIT) to treat food allergies, this procedure is associated with potential risk. There is no current agreement about what elements should be included in the preparatory or consent process.
Objective
We developed consensus recommendations about the OIT process considerations and patient-specific factors that should be addressed before initiating OIT and developed a consensus OIT consent process and information form.
Methods
We convened a 36-member Preparing Patients for Oral Immunotherapy (PPOINT) panel of allergy experts to develop a consensus OIT patient preparation, informed consent process, and framework form. Consensus for themes and statements was reached using Delphi methodology, and the consent information form was developed.
Results
The expert panel reached consensus for 4 themes and 103 statements specific to OIT preparatory procedures, of which 76 statements reached consensus for inclusion specific to the following themes: general considerations for counseling patients about OIT; patient- and family-specific factors that should be addressed before initiating OIT and during OIT; indications for initiating OIT; and potential contraindications and precautions for OIT. The panel reached consensus on 9 OIT consent form themes: benefits, risks, outcomes, alternatives, risk mitigation, difficulties/challenges, discontinuation, office policies, and long-term management. From these themes, 219 statements were proposed, of which 189 reached consensus, and 71 were included on the consent information form.
Conclusion
We developed consensus recommendations to prepare and counsel patients for safe and effective OIT in clinical practice with evidence-based risk mitigation. Adoption of these recommendations may help standardize clinical care and improve patient outcomes and quality of life.

Valid consent in the acute hospital setting: perspectives of patients and members of the public
Original Article
Živa Kovic, Motheo Kobua, Mary Fogarty, Claire L. Donohoe, Michael E. Kelly, Gerard J. Fitzmaurice, Mella Fitzgerald, Paul Zambra, Una Geary, Marie E. Ward
Irish Journal of Medical Science, 5 April 2024
Open Access
Abstract
Background
People who interact with healthcare services have an ethical and legal right to control their own lives, to make informed decisions, and to consent to what happens to them. For consent to be considered ethically and legally valid, three key criteria must be met: consent must be given voluntarily; people must be sufficiently informed of all options; and people should have capacity to make the decision to give or withhold their consent.
Aim
This study set out to explore, through the use of surveys, the perspectives of patients and public in relation to consent.
Method
Surveys were developed for patients and the public and administered paper based (patients) and through social media (public).
Results
One hundred and forty surveys were posted to patients, with a 38% response rate; 104 responses were received from the public. Ninety-six percent of patients were satisfied that the decision they made was informed; 100% felt they had made a voluntary decision; 98% felt the clinician seemed knowledgeable about the procedure. What matters most to the public were being informed about the risks associated with the proposed procedure and being assured that whatever choice they make they will receive the best care possible.
Conclusions
The results highlight interesting similarities and differences in relation to consent between members of the public thinking about a possible treatment, surgery, or procedure and those patients who have actually been through the process in the past 12 months. Recommendations have been developed on the basis of these findings to co-design improvements in consent practices.

Standardized Informed Consent Form for Clinicians Administering Platelet-Rich Plasma
Satvik N. Pai, Naveen Jeyaraman, Ravichandran Venkatasalam, Ravi VR, Swaminathan Ramasubramanian, Sangeetha Balaji, Arulkumar Nallakumarasamy, Shilpa Sharma, Bishnu P. Patro, Madhan Jeyaraman
Cureus, 3 April 2024; 16(4)
Abstract
Introduction
When it comes to medico-legal malpractice suits, lawyers and insurers tend to focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for the use of platelet-rich plasma (PRP) injections, which might cause problems. This study aimed to mitigate this concern through the development of a standardized informed consent document for PRP injections, grounded in evidence-based practices.
Materials and methods
An examination of databases was conducted to explore the medico-legal ramifications associated with PRP injections, as well as the broader topic of informed consent, with a particular focus on the context of PRP injections. Moreover, interviews were carried out with healthcare providers and individuals who had received PRP injections within the preceding year, utilizing a semi-structured methodology.
Results
We developed an evidence-based informed consent document tailored for PRP injections. To guarantee its legal validity, the document underwent review by a legal specialist. Subsequently, our institutions implemented the finalized form for PRP injection procedures over one year.
Conclusion
A legally valid and evidence-based informed consent form for PRP injections would ensure patient’s rights, and encourage open communication and transparency between them and the doctor. Moreover, if a lawsuit were to arise, it would serve as a critical document in the doctor’s defense and withstand scrutiny from lawyers and the judiciary.

Informed consent in endoscopy: read, understood, or just signed?
Ana Catarina Carvalho, Ricardo Cardoso, Hugo Marcelo Vieira, Américo Silva
iGIE, 2 April 2024
Abstract
Background And Study Aims
While informed consent is a requirement for all interventional procedures such as those in gastrointestinal endoscopy, its standardization is a challenge. While very thorough documents have been proposed, it is unknown whether patients actually read them. We intended to evaluate if patients read and understand informed consent forms and information leaflets for gastrointestinal endoscopy.
Patients And Methods
This single center prospective observational study was performed between April 2021 and April 2022 and included adult patients proposed for outpatient elective esophagogastroduodenoscopy and colonoscopy. Informed consent forms and information leaflets were mailed to patients, with a small text instruction added to the informed consent form. Prior to endoscopy it was assessed whether patients adequately read the informed consent form, based on patient signature, table questionnaire completion and performance of the text instruction.
Results
The study included 232 patients (50.6% males, mean age 63.8±12.76 years). Most had only basic education (78.0%) and had previously undergone gastrointestinal endoscopy (90.6%). 86.6% of patients stated they had read the form while 13.4% did not. While most signed the form (83.6%), only 24.6% adequately read and understood it. No statistically significant association between informed consent form adequate reading and any of the assessed variables was found.
Conclusions
Despite the timely provision of information, most patients do not read or adequately understand the provided documents. It is necessary to develop new strategies to enhance patients’ involvement in decision making, improving the doctor-patient relationship in obtaining informed consent.

Editor’s note: iGIE is published by Elsevier Inc. on behalf of American Society for Gastrointestinal Endoscopy.