Consent and Deidentification of Patient Images in Dermatology Journals: Observational Study
Japbani K Nanda, Michael Armando Marchetti
JMIR dermatology, 6 July 2022; 5(3)
Excerpt
Publication of patient images contributes to research and education in dermatology. However, it is important to protect patients’ privacy and rights. The Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) have provided best practices and recommendations, respectively, for the protection of patients’ rights in scholarly publications [1,2]. Nonetheless, requirements for the deidentification of patient images and for the acquisition of consent to publish such images vary across governing bodies and journals. Our objective was to describe leading dermatology journals’ instructions regarding deidentification and consent to publish patient images as well as the content and readability of consent forms…

Consent in organ transplantation: putting legal obligations and guidelines into practice
Research
Farrah Raza, James Neuberger
BMC Medical Ethics volume, 5 July 2022; 23(69)
Open Access
Abstract
Consent in medical practice is a process riddled with layers of complexities. To some extent, this is inevitable given that different medical conditions raise different sets of issues for doctors and patients. Informed consent and risk assessment are highly significant public health issues that have become even more prominent during the course of the Covid-19 pandemic. In this article we identity relevant factors for clinicians to consider when ensuring consent for solid organ transplantation. Consent to undergo solid organ transplantation is more complex than most surgical and other clinical interventions because of the many factors involved, the complexity of the options and the need to balance competing risks. We first outline the context in which consent is given by the patient. We then outline the legal principles pertaining to consent in medical practice as it applies in the UK and the implication of recent legal judgments. The third section highlights specific complexities of consent in organ transplantation and identifies relevant factors in determining consent for organ transplantation. The fourth section offers practical recommendations. We propose a novel ‘multi-factor approach’ to informed consent in transplantation which includes understanding risk, effective communication, and robust review processes. Whilst understanding risk and communication are a given, our suggestion is that including review processes into the consent process is essential. By this we specifically mean identifying and creating room for discretion in decision-making to better ensure that informed consent is given in practice. Discretion implies that health care professionals use their judgement to use the legal judgements as guidance rather than prescriptive. Discretion is further defined by identifying the relevant options and scope of clinical and personal factors in specified transplantation decisions. In particular, we also highlight the need to pay attention to the institutional dimension in the consent process. To that end, our recommendations identify a gap in the current approaches to consent. The identification of areas of discretion in decision-making processes is essential for determining when patients need to be involved. In other words, clinicians and healthcare professionals need to consider carefully when there is room for direction and where there is little or no room for exercising discretion. In sum, our proposed approach is a modest contribution to the on-going debate about consent in medicine.

Sufficient informed consent to medical treatment of adults: legal and ethical perspectives from Malawi
Eva Maria Mfutso Bengo, Adamson Muula, Joseph Mfutso Bengo
Malawi Medical Journal, June 2022; 34(2) pp 143-150
Open Access
Abstract
This special communication discusses the current legal and ethical requirements for informed consent to medical treatment of adults in Malawi. It analyzes the scope of the laws and code of ethics on professional discipline, including criminal privilege for surgeries and clarifies when insufficient disclosures entitle patients to compensation under civil law. Inconsistencies and uncertainties in the law are made apparent. It evaluates to which degree disclosure standards of other Commonwealth jurisdictions (e.g. the case of Montgomery) would be suitable for the health care setting of a country like Malawi that is characterized by shortages of resources, high illiteracy rates and a communitarian cultural context. Doctor-patient communication is not alien to African culture and part of sufficient informed consent. In order to balance the need for efficiency in health care delivery, accountability for quality care, fairness and effective patient-doctor communication the authors suggest to adopt the reasonable patient test only, if a defence of heavy workload on case-to-case basis is introduced at the same time. This does not dispense the need for organisational diligence on part of the institutional health care provider within its capacity.

Informed consent: more than just a signature
Parker O’Neill, Sierra Schaffer, Fallon O’Neill, Andrew Poullis
Gut, 19 June 2022; 71
Abstract
Introduction
Informed consent is a core component of ethical medical practice and is vital to ensure patient autonomy is upheld. However, consent is not a static concept and physicians need to remain engaged with the literature to ensure they minimise their liability. This study aims to clarify the legal duties of gastroenterologists when gaining informed consent by analysing the current literature and past legal precedents.
Methods
A bibliometric analysis of the Web of Science (WoS) Core Collection database was performed with the MeSH terms ‘gastroenterology’ AND ‘informed consent’. The top 50 most-cited articles were extracted and analysed. A scoping review was performed of the case law surrounding informed consent in the UK and the USA.
Results
A total of 383 articles were identified on the WoS, with 228 articles excluded due to not meeting the inclusion criteria. of the top 50 articles, 48% were from American institutions and 16% were from the UK. The American Journal of Gastroenterology had published 20% and the Journal of Digestive Diseases had published 8% of the top 50 articles. Since 1970, there has been a steady rise in citations of articles pertaining to informed consent in gastroenterology with the record of 63 citations occurring in 2015. Thematic analysis showed 72% of the top 50 articles discussed informed consent in relation to diagnostic procedures, 14% regarding treatment, and 14% regarding research participation. of the articles discussing diagnostic procedures, half specified the type of diagnostic tool evaluated. Thirty-three percent of articles focused on colonoscopy, 26% on OGD, 22% on ERCP, 11% on flexible sigmoidoscopy, and 7% on genetic testing. The UK has progressed from what was previously a paternalistic Bolam’s test with the Bolitho addendum to the Montgomery test 2015 which demands physicians establish what is relevant to their specific patient when gaining informed consent. The USA experienced a similar evolution, progressing from the Natanson case holding physicians to the standard of a ‘reasonable and prudent medical doctor’ to the Canterbury case 1972 requiring physicians to disclose what would be important to a ‘reasonable patient’. Exponentially more articles have been published since the American Canterbury case came into effect. Most articles focused on invasive procedures and discussed complex ethical questions seeking to increase patient autonomy.
Conclusion
Physicians in both the UK and USA now have a legal duty to ensure their patients are fully informed to a standard that their individual patient deems appropriate. Most articles published are American-based and focus on informed consent in the context of diagnostic colonoscopy. Physicians may benefit from international guidelines on consenting patients for invasive procedures in gastroenterology.

The need for a standard for informed consent for collection of human fetal material
Commentary
Roger A. Barker, Gerard J. Boer, Elena Cattaneo, R. Alta Charo, Susana M. Chuva de Sousa Lopes, Yali Cong, Misao Fujita, Steven Goldman, Göran Hermerén, Insoo Hyun, Steven Lisgo, Anne E. Rosser, Eric Anthony, Olle Lindvall
Stem Cell Reports, 14 June 2022; 17(6) pp 1245-1247
Summary
The ISSCR has developed the Informed Consent Standards for Human Fetal Tissue Donation and Research to promote uniformity and transparency in tissue donation and collection. This standard is designed to assist those working with and overseeing the regulation of such tissue and reassure the wider community and public.

Impact of Informed Consent and Education on Care Engagement After Opioid Initiation in the Veterans Health Administration
Tigran Avoundjian, Lara Troszak, Jennifer Cohen, Mary Beth Foglia, Jodie Trafton, Amanda Midboe
Journal of Pain Research, 25 May 2022; 15 pp 1553-1562
Abstract
Objective
To ensure all patients receiving long-term opioid therapy (LTOT) understand the risks, benefits and treatment alternatives, the Veterans Health Administration (VHA) released a national policy in 2014 to standardize a signature informed consent (SIC) process. We evaluated the impact of this policy on medical follow-up after LTOT initiation, a guideline recommended practice.
Methods
Using VHA administrative data, we identified patients initiating LTOT between May 2013 and May 2016. We used an interrupted time series design to compare the monthly rates of medical follow-up within 30 days and primary care visits within 3 months after LTOT initiation across three periods: 12 months before the policy (Year 1); 12 months after policy release (Year 2); and 12– 24 months after policy release, when the SIC process was mandatory (Year 3).
Results
Among the 409,895 patients who experienced 758,416 LTOT initiations, medical follow-up within 30 days and primary care engagement within 3 months increased by 4% between Year 1 and Year 3. Compared to Year 1, patients in Year 3 were 1.12 times more likely to have any medical follow-up (95% CI: 1.10, 1.13) and 1.13 times more likely to have a primary care visit (95% CI: 1.12, 1.15). Facilities with a greater proportion of patients receiving SIC had increased medical follow-up (RR: 1.04, 95% CI: 1.01, 1.07) and primary care engagement (RR: 1.06, 95% CI: 1.03, 1.10).
Conclusion
The VHA’s SIC policy is associated with increased medical follow-up among patients initiating LTOT, which may result in improved patient safety and has implications for other healthcare settings.

The Conceptual Legal Structure of The Patient’s Right to Informed Consent
Noelia Martínez-Doallo
European Journal of Health Law, 12 May 2022
Abstract
Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite. From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors — namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions of the parties involved in the healthcare relationship regarding informed consent.

Informed Consent in Pringsewu Regional General Hospital: Legal Evidence Perspective
Samino Samino, Agung Aji Perdana, Selamet Kuntoro
Jounral Ilmu Kesehatan, 2022; 7(1)
Abstract
Quality health care is the right of every patient and his family. One of the indicators of quality services is the fulfillment of informed consent in accordance with the laws and regulations. Preliminary studies of several informed consent documents at Pringsewu Hospital found that all of them were not filled out completely. This study aims to analyze informed consent documents from the perspective of legal evidence.The study was conducted at Pringsewu Hospital in July 2021. The research method used a qualitative descriptive analysis approach, with 75 informed consent documents and two informants. How to collect data by reviewing the informed consent document that has been filled in at the hospital medical record installation, by checking the completeness of filling out the informed consent document for the five most types of actions, and in-depth interviews with the responsible leadership.The results showed that 75 informed consent documents were reviewed, none of which were filled out completely. The five most important indicators were not filled in completely, consecutively: name and signature of witness II, name and signature of witness I, gender of the patient, and gender of the giver of consent. To improve the completeness of filling out documents, the hospital will provide education to doctors, nurses, and administrative staff, as well as strict supervision. It was concluded that incomplete informed consent documents, as legal evidence, were low quality. The hospital leaders should conduct socialization to doctors, nurses and administrative staff regarding the importance of filling out the medical treatment approval form properly and completely.

Who Decides?: Informed Consent Doctrine Applied to Denial of Reproductive Health Care Information at Crisis Pregnancy Centers
Kassandra DiPietro
Iowa Law Review, March 2022; 107(3) pp 1253-1281
Abstract
Crisis pregnancy centers are largely religiously affiliated organizations that advertise pregnancy support but often do not provide full and accurate information about abortion or contraception. Often attacked for false advertising and operating without medical licenses, crisis pregnancy centers recently have begun converting to medical centers with medical staff on site. Since medical providers owe additional duties to their patients, crisis pregnancy centers operated by medical staff must follow additional procedures, such as providing informed consent. Informed consent doctrine is based on the idea of autonomous decision-making and requires medical providers to accurately inform patients of their viable medical options. Even though crisis pregnancy centers often fail to inform people about critical reproductive health care, people who visit crisis pregnancy centers still would have difficulty bringing a claim of informed consent against these centers. Applying informed consent doctrine to crisis pregnancy centers highlights the discrepancy between the philosophical purpose of informed consent and the doctrine in practice today. Courts should loosen the causation and injury requirements for informed consent doctrine, at least in reproductive health care cases. Making this change would be the first step in holding crisis pregnancy centers accountable and could help courts more accurately apply reproductive-specific tort claims generally.

Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors
Hillary Chua
Modern Law Review, 25 February 2022
Abstract
In September 2021, the Court of Appeal reversed the controversial decision of Quincy Bell v Tavistock and Portman NHS Trust in a victory for transgender rights. At first instance, the Divisional Court had set a high legal threshold for transgender children to attain Gillick competence to consent to treatment with puberty blockers – effectively restricting access to treatment for many. On appeal, the Court of Appeal held that children are capable in law of giving valid consent to treatment for gender dysphoria, and court authorisation would not be routinely required before children could access such treatment. This note considers the implications of the Court of Appeal decision for the law on minors and consent to medical treatment in the transgender health context.