Informed Consent in Medical Law in the Romanian Legal System: A Comparative Perspective

Informed Consent in Medical Law in the Romanian Legal System: A Comparative Perspective
Camelia Mihăilă
Journal of Intercultural Management and Ethics, 2022
Open Access
This paper aims to analyse the principle of consent in the medical act from a comparative law perspective. While the introduction gives a brief presentation of the definition of consent from the perspective of legal doctrine, the content of the paper analyses some legislative landmarks in the Romanian legal system, as well as in the French and Spanish legal systems. Consent is one of the basic principles of modern medical bioethics and an essential element of the validity of the medical contract, ensuring respect for human dignity and protection of the patient’s bodily integrity. While Romanian law is based more on the idea of information, Spanish law analyses consent from the point of view of a personalist right, including it in the short list of personal rights enshrined in Law 1/1982 on the protection of honour, image and privacy. French law, on the other hand, has a long history of case law regulating consent in medical acts, with the Teysier and Mercier cases being worth mentioning.

Cameroon: New Law on Medical Research Involving the “Human Person” Adopted

Cameroon: New Law on Medical Research Involving the “Human Person” Adopted
Nicolas Boring
The Global Legal Monitor, Library of Congress, 2022
On April 27, 2022, the Parliament of Cameroon adopted a law providing a new framework for medical research involving the “human person.” This law places a particular emphasis on the right to information and the free, informed, and written consent of the participants. It also provides guarantees regarding respect for privacy and confidentiality of personal data and respect for human integrity, dignity, and vulnerability…
Background to the Law
According to Cameroonian press reports, the new law was drafted in reaction to a scandal involving the trial of a preventive treatment for AIDS conducted in 2004 by the American NGO Family Health International on sex workers in Douala “in violation of [their] ethical and deontological rights.” The new law also represents a response to the recent proliferation in Cameroon of clinical trials of COVID-19 treatments conducted without rigorous controls.
Content of the Law
The newly enacted law delimits the scope of consent for medical research involving minors (articles 15 and 16), disabled persons (articles 17 and 18), and pregnant women (articles 19 and 20). It also provides a framework for medical research on in vivo fetuses and in vivo embryos (articles 19 to 22). Finally, the law addresses research conducted on stillborn children (articles 23 and 24) and on the dead (articles 27 and 28)…

The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent

The Legal Requirements for—and Limits to—the Donor’s and the Patient’s Consent
Book Chapter
Silvia Deuring
Brain Organoids in Research and Therapy, 10 July 2022; pp 131-190 [Springer]
Research with and on brain organoids implicates well-known problems of consent: under which circumstances is consent required, when is it valid, and how far does it reach? In some cases, these problems are exacerbated by the applicability and complex interplay of specific statutes such as the Transplantation Act, the Transfusion Act, and the regulations on medicinal products. For that reason, this article seeks to provide an overview of the problems of consent within the various contexts of brain organoid use.

Consent and Deidentification of Patient Images in Dermatology Journals: Observational Study

Consent and Deidentification of Patient Images in Dermatology Journals: Observational Study
Japbani K Nanda, Michael Armando Marchetti
JMIR dermatology, 6 July 2022; 5(3)
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

Consent in organ transplantation: putting legal obligations and guidelines into practice
Farrah Raza, James Neuberger
BMC Medical Ethics volume, 5 July 2022; 23(69)
Open Access
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

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
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

Informed consent: more than just a signature
Parker O’Neill, Sierra Schaffer, Fallon O’Neill, Andrew Poullis
Gut, 19 June 2022; 71
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.
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.
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.
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

The need for a standard for informed consent for collection of human fetal material
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
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

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
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.
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).
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).
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

The Conceptual Legal Structure of The Patient’s Right to Informed Consent
Noelia Martínez-Doallo
European Journal of Health Law, 12 May 2022
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.