Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors
Modern Law Review, 25 February 2022
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.
Our data? An examination of the possible role of individual consent in the regulation of posthumous medical data donation (PMDD)
Computer Law & Security Review, 17 February 2022
This article considers the regulation of posthumous medical data donation (PMDD) and examines the extent to which the law should require the opt-in ante-mortem consent of deceased persons for their medical data to be retained and used as part of PMDD initiatives. The article considers arguments on either side of this debate (i.e., pro-consent vs. anti- consent) before tentatively suggesting that, as a general matter, opt-in consent should not be required for medical data of deceased persons to be used for PMDD purposes. It is also proposed, however, that whilst opt-in consent should not be required by law, individuals should be provided with a qualified right through which they can object or “opt out” of their medical data being used in this way.
Free, Prior and Informed Consent in Kenyan Law and Policy After Endorois and Ogiek
Nqobizitha Ndlovu, Enyinna S Nwauche
Journal of African Law, 14 March 2022
This article examines the Kenyan legal and policy framework as well as jurisprudence on the principle of free, prior and informed consent (FPIC) occasioned by the decision of the African Commission on Human and Peoples’ Rights (African Commission) in Centre for Minority Rights Development (Kenya) and Minority Rights Group (on behalf of Endorois Welfare Council) v Republic of Kenya (Endorois) and the judgment of the African Court on Human and Peoples’ Rights (African Court) in the case of African Commission on Human and Peoples’ Rights v Republic of Kenya (Ogiek). The main objective of this article is to examine the development and level of operationalization of the principle of FPIC in Kenyan domestic law and policy using the Endorois and Ogiek standard. It examines how the Kenyan domestic legal system has responded to these regional and international developments on FPIC and its operationalization.
Health care users’ acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda
Research Article [awaiting peer review]
Hellen Nansumba, Mugalula Flaviano, Semanda Patrick, Ssewanyana Isaac, Douglas Wassenaar
Wellcome Open Research, 1 March 2022
Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Bio-repository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a short informed consent statement (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda.
A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental draft ICF for this study was developed and attached to the Laboratory investigation form.
Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. HCUs who did not understand the draft ICF were 90% less likely to accept broad consent compared to those who understood (OR=0.10, CI [0.03-0.32] while those who partly understood the ICF were 73% less likely to accept broad consent compared to those who understood (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health.
Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.
Informed consent in a patient with aortic dissection and mild intellectual impairment
Wafa Abdelghaffar, Elyes Lagha, Fares Azaiez, Nadia Haloui, Rym Rafrafi
QScience, 19 January 2022
Informed consent is an ethical and legal requirement in modern medicine. A valid consent implies that the patient can decide on treatment after receiving adequate information from his doctor. In case of incapacity and specific conditions, doctors can administer treatments without patient consent. Nonetheless, some cases are borderline, such as the patient presented in this paper who had a mild intellectual impairment and refused to undergo urgent intervention for aortic dissection. In this case, psychiatrists and cardiologists collaborated to check whether the patient could consent and decided to respect his choice. He was not operated, and the local ethical committee agreed with this decision. In Tunisia and developing countries, the paternalistic approach is still prevalent in the doctor-patient relationship. This paper highlights that ethical considerations should be universal and applied to all patients in all cultures and discusses ethical and legal aspects.
Editor’s note: QScience is the online publishing platform from Hamad bin Khalifa University Press, Qatar.
Meaningful Digital Consent in Canada: Recommendations from Pan-Canadian Consent Management Workshops
Nelson Shen, Iman Kassam, Daria Ilkina, Sarah Wickham, Abigail Carter-Langford
Healthcare Quarterly, January 2022; 24(4) pp 40-47
The digital health landscape is rapidly evolving with regard to how society accesses and interacts with digital information and technologies. With a largely commercial marketplace, there are growing concerns that users are not fully informed about how their data are used. Canadian privacy legislation is currently undergoing modernization to improve the transparency of commercial information handling practices through the introduction of meaningful consent. This paper reports on workshops held across Canada, exploring the implications of meaningful consent in a digital health context. Recommendations focus on measures to promote transparency, improve digital literacy and foster public trust in digital health innovations.
Consent to Research in Madagascar: Challenges, Strategies, and Priorities for Future Research
Elysée Nouvet, Simon Grandjean Lapierre, Astrid Knoblauch, Laurence Baril, Andry Andriamiadanarivo, Mihaja Raberahona, Chiarella Mattern, LorieDonelle, Jean Rubis Andriantsoa
Canadian Journal of Bioethics, 2022; 5(1) pp 33-44
The ethical conduct of research in any setting hinges on the voluntary and informed consent of research participants. Working towards consent that is truly voluntary and informed, however, is far from straightforward, and requires attention to contextual factors that may complicate achievement of this ideal in specific research settings. This paper is based on Madagascar’s first “Consent complexities in health research in Madagascar” workshop, held in Antananarivo, Madagascar, in October 2018. It identifies a number of challenges encountered by individuals responsible for the conduct or oversight of health research in Madagascar related to informed and voluntary consent. Key challenges identified included: adaptation of consent tools into local dialects and for limited literacy populations; perceived acquiescence of potential participants regardless of actual preference based on cultural norms; perceived time pressures within tight project timelines to collect data as quickly as possible, limited time for consent processes; fears and taboos related to specific research procedures or topics; and, uncertainty about how best to approach and verify the validity of individual consent in contexts where traditional leaders’ influence is conventionally sought out and respected. Potential strategies for responding to each of these challenges are proposed, as are key questions meriting further study.
Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns
Ferdinand Chinedum Maduka-Okafor, Onochie Ike Okoye, Ngozi Oguego, Nnenma Udeh, Ada Aghaji, Obiekwe Okoye, Ifeoma R Ezegwui, Emmanuel Amaechi Nwobi, Euzebus Ezugwu, Ernest Onwasigwe, Rich E Umeh, Chiamaka Aneji
Research Ethics, 8 September 2021
School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents.
More Needs to Be Done During the Informed Consent Process
Cureus Journal of Medical Science, 20 March 2022; 14(3)
Retinal detachment is an emergency commonly encountered in ophthalmic practice. In this article, a reflection about the ethical implications surrounding the informed consent process of retinal detachment repair is presented. We look at how premade informed consent forms allow for a better patient understanding of their condition, the procedure they are due to undergo, their postoperative course, and the potential complications they might face, hence potentially improving the overall outcome.
An overview and top tips for gaining informed consent for DCPs
Rana Fard, Keerut Oberai
BDJ Team, 18 March 2022; (9) pp 20-22
In the past, dental ethics was based on a paternalistic ‘doctor knows best’ approach. Accordingly, dental care professionals (DCPs) would decide what is in the patient’s best interest in terms of their treatment and the patient would have minimal input. Over the last 50 years, we have moved away from this approach to one which is focused on the concepts of autonomy and consent. Today, instead of the patient being a passive subject, they are at the centre of any decision which relates to their general and oral health. In addition, these are made in partnership with their DCP who has a duty to ensure that the key components of informed consent are met…