Informed consent for medical student involvement in patient care: an updated consensus statement
Walker S, Reid P, Anderson L, Bull S, Jonas M, Manning J, Merry A, Pitama S, Rennie S, Snelling J, Wilkinson T, Bagg W
The New Zealand Medical Journal, 21 July 2023; 136(1579) pp 86-95
Abstract
Enabling patients to consent to or decline involvement of medical students in their care is an essential aspect of ethically sound, patient-centred, mana-enhancing healthcare. It is required by Aotearoa New Zealand law and Te Kaunihera Rata o Aotearoa Medical Council of New Zealand policy. This requirement was affirmed and explored in a 2015 Consensus Statement jointly authored by the Auckland and Otago Medical Schools. Student reporting through published studies, reflective assignments and anecdotal experiences of students and teachers indicate procedures for obtaining patient consent to student involvement in care remain substandard at times. Between 2020 and 2023 senior leaders of Aotearoa New Zealand’s two medical schools, and faculty involved with teaching ethics and professionalism, met to discuss these challenges and reflect on ways they could be addressed. Key stakeholders were engaged to inform proposed responses. This updated consensus statement is the result. It does not establish new standards but outlines Aotearoa New Zealand’s existing cultural, ethical, legal and regulatory requirements, and considers how these may be reasonably and feasibly met using some examples.

Legal changes to informed consent and application to clinical practice in surgery
Research Article
Marco Dalle Carbonare, Elizabeth A Gruber
Medico-Legal Journal, 6 July 2023
Abstract
For consent to be fully informed, it must be tailored to each patient, who must be appraised of alternative treatments (including that of no treatment) and informed of the material risks which an individual would wish to know and consider significant. This also includes Covid-19 related risks. Whilst surgeons had at times to offer sub-optimal treatments due to pressures caused by the pandemic, patients should still be given the choice to delay their treatment. Consent obtained remotely via digital technology must comply with the same requirements as in a face-to-face setting.

Consent and Rights within human healthcare IT solutions for lawful basis processing
Peter Barnsley, James Fleming
Francis Crick Institute, 27 June 2023
Abstract
This paper argues for ‘consent by design’ and ‘rights by design’ in IT systems through a framework of atomic consents. It highlights the value of improved openness for users and benefits from standardization that come from such an approach. It argues for a new IT design concept focused on the human at the heart of information systems: the creation of a set of ‘atomic consents’ and ‘atomic rights’, the latter derived from General Data Protection Rights, to help architect IT systems that maintain trust and engagement in IT systems that support human health, societal and people data use. Although this paper concentrates on, and refers in part to, a health context, it is believed that all (or much) of the framework can be applied to all realms of IT development and deployment. The application of a set of atomic consents, embedded within an IT system, can facilitate trusted systems such as research environments. By combining these atomic consents with the atomic rights (as per data protection laws), a way of expressing requirements and architecture for, and within, IT systems is simplified and standardised. This should save money, ensure extensibility and allow flexibility and transparency as social practice and legal frameworks evolve. By enabling both a more granular model of consent, and also by defining what parts of an IT system invoke these, IT systems should become more open (to regulation and audit), more flexible and so more trusted.

Judging in a Brave New World?: Adjudicating Cases of Parental Refusal on Religious Grounds to Consent to Medical Treatment
Michelle Flynn
Journal of Law, Religion and State, 15 June 2023
Abstract
This article considers case law concerning parental refusal to consent to medical treatment of a child based on religious belief or conscience. The focus of enquiry is on three pivotal decisions of the Irish Superior Courts which will serve to chart the development of judicial reasoning in this contentious area of law. In the last few decades, Ireland has experienced significant changes in its population and attitudes toward religion as a result of increased immigration, multiculturalism, and secularism. This case law analysis reveals that there has been a shift from a test that examines the motivations or reasons for parental decision making to one that focuses on the effect on the child. This shift in focus raises concern about the extent to which the religious or conscientious objection of a parent concerning a child’s medical treatment will be considered in future cases. The present analysis provides an illuminating example of the way in which religion and the state can be in tension with each other.

The Legal History of Informed Consent
Máté Julesz
Journal on European History of Law, 2023; 14(1) p  161-171
Abstract
Human experiments during the national socialist and communist eras remind us that medical research involving human subjects should have legal limitations. Nowadays, in medical malpractice cases, instead of simple medical consent, the informed consent of the patient or a proxy is required to exculpate the health care provider sub judice. The origin of these types of medical consent is discussed with special regard to their development before and during the twentieth century. Simple medical consent appeared in England in the Slater v. Baker and Stapleton case of 1767. The legal history of medical consent dates back to at least the eighteenth century, although informed consent arose as late as in the Nuremberg Code and was literally called “informed consent” in the Salgo v. Leland Stanford Jr University Board of Trustees case of 1957 in the US. Despite the international rules of informed consent in effect in medical research involving human subjects and in health care provision, we still find countries with medico-legal cultures differing from Western norms. For example, the Confucian style of informed consent in China, involving the family’s role in granting or declining informed consent, sometimes collides with the expectations of the Food and Drug Administration in the US or those of the European Medicines Agency in the EU. Moving different medico-legal cultures closer to each other should be an important objective of both international lawmakers and national legislators.

Patient choice: the shape of consent post-Montgomery
Shaun Sellars, Lauren Sutherland
British Dental Journal, 12 May 2023; 234, pp 655 – 659
Abstract
The law relating to consent and the process dentists need to go through to gain valid and informed consent to treat patients changed significantly following the landmark ruling of Montgomery v Lanarkshire Health Board. In this paper, we revisit the history of patient consent, give an update on the current legal situation in the UK, and produce a unique ‘consent workflow’ to aid in the process of gaining valid and informed consent to treat. The aim is to clarify the legal standing and provide a framework that dentists and other healthcare professionals can adapt to their current clinical practice while increasing the confidence of those involved in the consent process; both professionals and patients.

Disclosing Privacy and Discrimination Protections in Informed Consent
Anya E.R. Prince
Health Matrix: The Journal of Law – Medicine, May 2023; 33(1)
Open Access
Abstract
Recent empirical work shows that providing greater detail about limitations of genetic anti discrimination protections in informed consent documents is likely to lower individuals’ willingness to participate in research studies. This article presents these empirical findings and analyzes the implications of the findings for clinical care and for privacy and discrimination risks beyond genetic discrimination. While the paper argues that further research is needed to fully understand the potential implications of disclosure of legal protections in the clinical setting, there are clear implications in the research setting. Since individuals are likely to alter their decision to participate in research based on the depth of information provided, informed consent should contain detailed information about privacy and discrimination risks. However, for participants to truly understand the risk of loss of privacy and potential for discrimination that flows from information disclosures in research, they arguably must have a robust understanding of both when and how information may be shared, but also the legal protections and limitations that govern use of that data. Now, more than ever, it is essential to understand the privacy risks associated with joining a study since research trends related to big data and secondary research are vastly increasing the privacy risks for participants. Yet, while it is easy to state that individuals should be told of both privacy and anti-discrimination laws and their respective limitations, disclosing these in practice is much more complex. For every law, there are countless limitations that could be enumerated, but such disclosures would quickly make informed consent unwieldy and counterproductive. Thus, this paper argues that institutional review boards (“IRBs”) can help to find a limiting principle to the disclosures by assessing the likelihood of harm and contextualizing the risks to the study population. This will balance between over- and under-disclosure of legal protections and limitations while still fulfilling important foundational goals of informed consent.

Adoption without parental consent
Book Chapter
Julie Doughty
Adoption Law, 25 April 2023 [Elgar]
Abstract
This chapter places controversy about adoption without birth parents’ consent in England and Wales in a wider historical and social context. Although it may appear that legal challenges have become more common in adoption proceedings, it is argued that these rarely succeed and that the relatively few reported cases give only a partial picture of birth parents’ experiences. Three aspects of consent are considered: whether the consent given is valid; withholding consent; and actively contesting court proceedings. Research suggests that, historically, birth parents in the UK, Australia and the USA have been coerced into surrendering their babies, some in circumstances that raise doubts about mothers’ mental capacity to consent. Current debates focus on less direct coercion through a lack of support services for families facing poverty and adverse circumstances. The background to relevant provisions in the Adoption and Children Act 2002 is examined, and case law relating to different stages of the court process is analysed. Although courts give serious consideration to human rights principles and due process, the discussion indicates limited opportunities for birth parents to effectively resist adoption by refusing their formal consent or making court applications. Legal mechanisms designed to allow non-consenting parents to challenge the adoption process, where this was justified, do not appear to offer a realistic prospect of overturning an adoption plan, once this has been approved in care proceedings.

Incapacitous patients, assisted reproductive technology, and the importance of informed consent
Lisa Cherkassky
Legal Studies, 20 April 2023
Abstract
The principle of self-determination has gained significant judicial support over the last three decades, and the choice to procreate using assisted reproductive technology is a clear example of our right to choose a treatment that enhances our personal lives. The Human Fertilisation and Embryology Act 1990 (as amended in 2008) stipulates that each party must give written, informed consent to ensure that our reproductive materials are used within strict parameters. However, the growing number of posthumous conception cases in several jurisdictions has raised concerns, particularly in situations where gametes are extracted from incapacitous patients without their consent, leading to posthumous parenthood. The landmark case of Y v A Healthcare NHS Trust [2018] EWCOP 18 caused significant concern when it authorised the retrieval, storage and use of sperm from a suspected brain stem dead man for procreative purposes under the Mental Capacity Act 2005. It has never been known to be in the ‘best interests’ of a patient who lacks capacity to procreate in English law, and the consequences of this decision could be highly significant, raising questions about the exploitation of incapacitous patients and the misuse of genetic material. The decision has since been confirmed as the correct approach by the Court of Protection in Re X (Catastrophic Injury: Collection and Storage of Sperm) [2022] EWCOP 48, and a public consultation has now been opened by the Human Fertilisation and Embryology Authority. This paper examines the rigorous consent regime of the 1990 Act and the ethical complexities of retrieving gametes from incapacitous patients for procreative purposes. It will be determined that the 1990 Act’s preference for a rigorous consent regime for public policy reasons is appropriate, and any alternative forms of consent could open a slippery slope to the unethical use of vulnerable individuals for their reproductive materials.

The Relevance of Consent in the Digital Age: A Consideration of Its Origins and Its Fit for Digital Application
Book Chapter
Marietjie Botes
Security and Trust Management, 4 April 2023 [Springer]
Abstract
Consent originated in the 1800s to protect incarcerated prisoners against unwanted medical treatment and was later formalized in the Nuremberg Code in response to harmful medical experiments that was conducted on prisoners of war during World War II. These co-called ethical principles was later reinforced and extended to protect the control and decisional power that individuals need over their bodies in The Belmont Report. Today these ethical consent principles are codified in laws such as the GDPR. Considering that these ethical consent principles were developed around biomedical treatments and experiments, it begs the question whether these same principles are still relevant and can be successfully applied in a digital environment. This paper critically considers the application of the original ethical consent principles in the digital age and highlights certain critical challenges. The aim of the paper is to draw attention to the fact that the concept of consent and whether it can still be applied ethically in a digital environment must be considered first before digital consent models or consent automation tools are developed, because such a consideration will have a critical impact on how these tools must be developed to remain, not only legal, but also ethical and subsequently sustainable.