Adoption without parental consent
Adoption Law, 25 April 2023 [Elgar]
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
Legal Studies, 20 April 2023
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  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)  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
Security and Trust Management, 4 April 2023 [Springer]
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.
Legally Effective but Ethically Inadequate: Institutional Review Board Policies for Consent from Legally Authorized Representatives
Robert R. Harrison
Ethics & Human Research, 27 March 2023
The prevailing approach to enrolling decisionally impaired adults in clinical research is to rely on permission from a default surrogate, one identified by law rather than by the prospective research participant. Reliance on a surrogate transfers the focus of ethical protection from a researcher-participant relationship to a researcher-surrogate relationship; the selection and role of the surrogate are therefore important. The Common Rule defers to state law governing default surrogate consent to research, but most states have no such law; for those states, the Common Rule defers to institutional policy. I reviewed twenty-five of the study sites with the highest National Institutes of Health funding levels to elaborate the content of institutional review board (IRB) policies and compare those to a suggested paradigm for ethically defensible policies. My findings suggest that IRB policies provide inadequate protection because they recognize surrogates who lack knowledge of the subject’s current values and preferences without imposing adequate additional safeguards.
Minor Consent Laws for Sexually Transmitted Infection and Human Immunodeficiency Virus Services in the United States: A Comprehensive, Longitudinal Survey of US State Laws
Kimberly M. Nelson, Alexandra Skinner, Claire D. Stout, Will Raderman, Emily Unger, Julia Raifman, Madina Agénor, Michele L. Ybarra, Shira I. Dunsiger, S. Bryn Austin, Kristen Underhill
American Journal of Public Health, 8 March 2023
To assess changes in minor consent laws for sexually transmitted infection (STI) and HIV testing, treatment, and prevention services in all 50 US states and the District of Columbia from 1900 to 2021.
We coded laws into minor consent for (1) health care generally; (2) STI testing, treatment, and prevention; (3) HIV testing, treatment, and prevention; and (4) pre- or postexposure prophylaxis for HIV prevention. We also coded confidentiality protections and required conditions (e.g., threshold clinician judgments).
The largest increase in states allowing minors to consent to STI services occurred during the 1960s and 1970s. By 2021, minors could consent independently to STI and HIV testing and treatment in all 50 states plus DC, STI prevention services in 32 jurisdictions, and HIV prevention services in 33 jurisdictions. Confidentiality protections for minors are rare. Prerequisites are common.
Although the number of states allowing minors to consent independently to STI and HIV services has increased considerably, these laws have substantial limitations, including high complexity, prerequisites requiring clinician judgments, and neglect of confidentiality concerns.
Waivers of informed consent in research with competent participants and the Declaration of Helsinki
European Journal of Clinical Pharmacology, 8 March 2023
The World Medical Association started revisions to the Declaration of Helsinki in 2022 and it will have to address numerous issues that have arisen in research ethics since the last 2013 revision . In the face of critical issues that have surfaced during the COVID-19 pandemic, less salient but nevertheless critically important issues may go unnoticed. One of these concerns is the conditions under which it is ethically permissible to modify or waive written informed consent in research with competent participants…
A GDPR-Compliant Dynamic Consent Mobile Application for the Australasian Type-1 Diabetes Data Network
Zhe Wang, Anthony Stell, Richard O. Sinnott
Healthcare, 8 February 2023; 11(4)
Australia has a high prevalence of diabetes, with approximately 1.2 million Australians diagnosed with the disease. In 2012, the Australasian Diabetes Data Network (ADDN) was established with funding from the Juvenile Diabetes Research Foundation (JDRF). ADDN is a national diabetes registry which captures longitudinal information about patients with type-1 diabetes (T1D). Currently, the ADDN data are directly contributed from 42 paediatric and 17 adult diabetes centres across Australia and New Zealand, i.e., where the data are pre-existing in hospital systems and not manually entered into ADDN. The historical data in ADDN have been de-identified, and patients are initially afforded the opportunity to opt-out of being involved in the registry; however, moving forward, there is an increased demand from the clinical research community to utilise fully identifying data. This raises additional demands on the registry in terms of security, privacy, and the nature of patient consent. General Data Protection Regulation (GDPR) is an increasingly important mechanism allowing individuals to have the right to know about their health data and what those data are being used for. This paper presents a mobile application being designed to support the ADDN data collection and usage processes and aligning them with GDPR. The app utilises Dynamic Consent—an informed specific consent model, which allows participants to view and modify their research-driven consent decisions through an interactive interface. It focuses specifically on supporting dynamic opt-in consent to both the registry and to associated sub-projects requesting access to and use of the patient data for research purposes.
Consent Rights of Gender Diverse Children in Australia and the United Kingdom: Will the Court’s Involvement End?
Journal of law and Medicine, 1 December 2022; 29(4) pp 1269-1287
Gender diversity allows individuals to express their innate sense of self and has been increasingly recognised over time. Consequently, paediatric gender services have seen exponential increases in referrals internationally. This has resulted in novel issues for courts, such as a child’s “best interests” when accessing puberty-suppressing and gender-affirming medical care. Most recently, in the United Kingdom, the adequacy of information provided to transgender children and their families was also debated. Progression of the common law in Australia has resulted in transgender children consenting to medical treatment once Gillick competent. Yet, Bell v Tavistock  EWHC 3274 temporarily halted the care of the United Kingdom’s transgender children, who were previously afforded consenting rights. On appeal it was determined to be inappropriate for the divisional court to have provided generalised guidance on children’s capacity to consent to medical therapy. Through comparative analysis of case law, the adequacy of these regulations will be assessed.
Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Evelien De Sutter, Pascal Borry, Isabelle Huys, Liese Barbier
BMC Health Services Research, 21 February 2023; 23(181)
Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research.
Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis.
Stakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard.
The creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level.
[Improper informed consent of the patient: legal and expert assessment]
Sudebno-meditsinskaia Ekspertiza, 1 January 2023; 66(1) pp 59-62
The purpose of the study is to draw the attention of the legal and medical community to the problem of insufficient awareness of the patient about the upcoming medical intervention; to identify the scope of interaction between the court and the expert in relation to disputes related to improper information. Despite the fact that the conclusion about improper informing of the patient implies a legal assessment of the circumstances, special medical knowledge is needed to identify some defects of voluntary informed consent. The expert, in particular, can answer the questions of the court about what risks are characteristic of a certain type of medical intervention (perforations, bleeding, etc.) and how high their probability was in relation to a particular patient (taking into account his state of health, anatomical features); whether there were alternative treatment options. Based on the explanations received, the court will be able to assess whether the patient’s attention was focused on the relevant circumstances, whether his consent was conscious, and the complications that occurred were foreseeable.
Editor’s note: This is a Russian language publication.