Moving from ‘fully’ to ‘appropriately’ informed consent in genomics: The PROMICE framework

Moving from ‘fully’ to ‘appropriately’ informed consent in genomics: The PROMICE framework
Julian J Koplin, Christopher Gyngell, Julian Savulescu, Danya F Vears
Bioethics, 7 April 2022
Abstract
Genomic sequencing technologies (GS) pose novel challenges not seen in older genetic technologies, making traditional standards for fully informed consent difficult or impossible to meet. This is due to factors including the complexity of the test and the broad range of results it may identify. Meaningful informed consent is even more challenging to secure in contexts involving significant time constraints and emotional distress, such as when rapid genomic testing (RGS) is performed in neonatal intensive care units. In this article, we propose that informed consent matters not for its own sake, but because obtaining it furthers a range of morally important goals, such as promoting autonomy, well-being, and trust in medicine. These goals form the basis of a new framework [PROmoting Morally Important Consent Ends (PROMICE)] for assessing the ethical appropriateness of various informed consent models. We illustrate this framework with two examples: (a) a tiered and layered consent model for obtaining consent for GS, and (b) consent for RGS in critically ill newborns. We conclude that appropriately-rather than fully-informed consent provides the correct standard for genomic medicine and research.

Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations

Machine learning applications in healthcare and the role of informed consent: Ethical and practical considerations
Research Article
Giorgia Lorenzini, David Martin Shaw, Laura Arbelaez Ossa, Bernice Simone Elger
Clinical Ethics, 24 April 2022
Abstract
Informed consent is at the core of the clinical relationship. With the introduction of machine learning (ML) in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML.

Public opinion on sharing data from health services for clinical and research purposes without explicit consent: an anonymous online survey in the UK

Public opinion on sharing data from health services for clinical and research purposes without explicit consent: an anonymous online survey in the UK
BMJ Open, 7 April 2022
Abstract
Objectives
UK National Health Service (NHS/HSC) data is variably shared between healthcare organizations for direct care, and increasingly de-identified for research. Few large-scale studies have examined public opinion on sharing, including of mental health (MH) versus physical health (PH) data. We measured data sharing preferences.
Design/Setting/Interventions/Outcomes
Pre-registered anonymous online survey, measuring expressed preferences, recruiting Feb–Sep 2020. Participants were randomized to one of three framing statements regarding MH versus PH data.
Participants
Open to all UK residents. Participants numbered 29275; 40% had experienced a MH condition.
Results
Most (76%) supported identifiable data sharing for direct clinical care without explicit consent, but 20% opposed this. Preference for clinical/identifiable sharing decreased with geographical distance and was slightly less for MH than PH data, with small framing effects. Preference for research/de-identified data sharing without explicit consent showed the same small PH/MH and framing effects, plus greater preference for sharing structured data than de-identified free text. There was net support for research sharing to the NHS, academic institutions, and national research charities, net ambivalence about sharing to profit-making companies researching treatments, and net opposition to sharing to other companies (similar to sharing publicly). De-identified linkage to non-health data was generally supported, except to data held by private companies. We report demographic influences on preference. A majority (89%) supported a single NHS mechanism to choose uses of their data. Support for data sharing increased during COVID-19.
Conclusions
Support for healthcare data sharing for direct care without explicit consent is broad but not universal. There is net support for the sharing of de-identified data for research to the NHS, academia, and the charitable sector, but not the commercial sector. A single national NHS-hosted system for patients to control the use of their NHS data for clinical purposes and for research would have broad support.

Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study

Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study
Nelson Shen, Iman Kassam, Haoyu Zhao, Sheng Chen, Wei Wang, Sarah Wickham, Gillian Strudwick, Abigail Carter Langford
JMIR Medical Informatics, 31 March 2022; 10(3)
Abstract
Background
Canadians are increasingly gaining web-based access to digital health services, and they expect to access their data from these services through a central patient access channel. Implementing data sharing between these services will require patient trust that is fostered through meaningful consent and consent management. Understanding user consent requirements and information needs is necessary for developing a trustworthy and transparent consent management system.
Objective
The objective of this study is to explore consent management preferences and information needs to support meaningful consent.
Methods
A secondary analysis of a national survey was conducted using a retrospective descriptive study design. The 2019 cross-sectional survey used a series of vignettes and consent scenarios to explore Canadians’ privacy perspectives and preferences regarding consent management. Nonparametric tests and logistic regression analyses were conducted to identify the differences and associations between various factors.
Results
Of the 1017 total responses, 716 (70.4%) participants self-identified as potential users. Of the potential users, almost all (672/716, 93.8%) felt that the ability to control their data was important, whereas some (385/716, 53.8%) believed that an all or none control at the data source level was adequate. Most potential users preferred new data sources to be accessible by health care providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Prior digital health use was associated with greater odds of granting default access when compared with no prior use, with the greatest odds of granting default access to digital health service providers (odds ratio 2.17, 95% CI 1.36-3.46). From a list of 9 information elements found in consent forms, potential users selected an average of 5.64 (SD 2.68) and 5.54 (SD 2.85) items to feel informed in consenting to data access by care partners and commercial digital health service providers, respectively. There was no significant difference in the number of items selected between the 2 scenarios (P>.05); however, there were significant differences (P<.05) in information types that were selected between the scenarios.
Conclusions
A majority of survey participants reported that they would register and use a patient access channel and believed that the ability to control data access was important, especially as it pertains to access by those outside their care. These findings suggest that a broad all or none approach based on data source may be accepted; however, approximately one-fifth of potential users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for potential users to make informed consent decisions. Understanding their information needs will be critical, as these needs vary with the use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.

A Big Data Framework for Consent

A Big Data Framework for Consent
Book Chapter
Wei Yap, Muhammad Rizwan Asghar
Trust, Security and Privacy for Big Data, 2022 [Taylor&Francis]
Abstract
Privacy is a vast and vital area of law with possibly diverse interpretations, legislation and standards worldwide with the aim to protect data. Consent plays a vital role in preserving privacy as it ensures that all involved parties understand the reason for the use and collection of data. Many organisations still have lengthy guidelines that cause legibility and usability issues. This makes it difficult for a data subject to understand what they are consenting to and creates a restrictive environment for consent. Unfortunately, existing works do not provide any solution for implementing a dynamic privacy consent framework. In this book chapter, we aim at presenting a dynamic consent framework for big data to ensure that each privacy consent policy is legible, understandable, usable, and customisable. We propose a new method to communicate, analyse, and request consent from a data subject in a way that is simple and understandable. We also aim to ensure that this framework does not increase the burden on data subjects to provide consent while implementing an ability to simplify and audit the consent process.

Research Ethics and Intellectual Disability

Research Ethics and Intellectual Disability
Book Chapter
Kevin Mintz, David Wasserman
The Disability Bioethics Reader, 2022 [Routledge]
Abstract
This chapter focuses on the exclusion of people with cognitive disabilities from research that is not related to their disabilities. Wasserman and Mintz argue that despite real limitations with regard to consent (most people with cognitive disabilities will only be able to assent), denying people with cognitive disabilities the ability to participate in research is largely unjustifiable. Moreover, it has effects that ought to be avoided namely, moral harm of persons with cognitive disabilities and increased vulnerability to abuses and violations when they do participate in research. Wasserman and Mintz argue that there is no good reason to exclude people with cognitive disabilities on the basis of their limitations, especially because people of similar cognitive ages are able to participate in research.

Living bioethics, theories and children’s consent to heart surgery

Living bioethics, theories and children’s consent to heart surgery
Research Article
Priscilla Alderson, Deborah Bowman, Joe Brierley, Nathalie Dedieu, Martin J Elliott, Jonathan Montgomery, Hugo Wellesley
Clinical Ethics, 7 April 2022
Abstract
Background
This analysis is about practical living bioethics and how law, ethics and sociology understand and respect children’s consent to, or refusal of, elective heart surgery. Analysis of underlying theories and influences will contrast legalistic bioethics with living bioethics. In-depth philosophical analysis compares social science traditions of positivism, interpretivism, critical theory and functionalism and applies them to bioethics and childhood, to examine how living bioethics may be encouraged or discouraged. Illustrative examples are drawn from research interviews and observations in two London paediatric cardiac units. This paper is one of a series on how the multidisciplinary cardiac team members all contribute to the complex mosaic of care when preparing and supporting families’ informed consent to surgery.
Results
The living bioethics of justice, care and respect for children and their consent depends on theories and practices, contexts and relationships. These can all be undermined by unseen influences: the history of adult-centric ethics; developmental psychology theories; legal and financial pressures that require consent to be defined as an adult contract; management systems and daily routines in healthcare that can intimidate families and staff; social inequalities. Mainstream theories in the clinical ethics literature markedly differ from the living bioethics in clinical practices.
Conclusion
We aim to contribute to raising standards of respectful paediatric bioethics and to showing the relevance of virtue and feminist ethics, childhood studies and children’s rights.

Who Decides?: Informed Consent Doctrine Applied to Denial of Reproductive Health Care Information at Crisis Pregnancy Centers

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.

Free prior and informed consent and Indigenous rights: a bulwark against discrimination and platform for self-determination

Free prior and informed consent and Indigenous rights: a bulwark against discrimination and platform for self-determination
Book Chapter
Cathal Doyle
Research Handbook on the International Law of Indigenous Rights, 12 April 2022; pp 96-128 [Edward Elgar]
Abstract
This chapter examines the development of free prior and informed consent (FPIC) norms in the international law of Indigenous rights. The first section traces the international law lineage of FPIC from initial colonial encounters through to contemporary Indigenous rights instruments. The second part probes more deeply into the cotemporary concept of FPIC based on extensive jurisprudence and recommendations, linking FPIC to self-determination and non-discrimination. The third part provides some perspective on state measures undertaken to implement FPIC and closes with attention to roles taken up by Indigenous peoples themselves in doing so.

Tips for Managing Ethical Challenges in Advance Care Planning: A Qualitative Analysis of Japanese Practical Textbooks for Clinicians

Tips for Managing Ethical Challenges in Advance Care Planning: A Qualitative Analysis of Japanese Practical Textbooks for Clinicians
Article
Environmental Research and Public Health, 9 April 2022
Yoshihisa Hirakawa, Kaoruko Aita, Mitsunori Nishikawa, Hidenori Arai, Hisayuki Miura
Abstract
Background
While advance care planning (ACP) provides healthcare professionals with valuable tools to meet patients’ needs in a person-centered manner, several potential ethical challenges are inherent to the process. However, recent studies have largely focused on ACP practicalities such as implementation, execution, and completion rather than on the ethical challenges that clinicians routinely encounter in ACP practices.
Research question/aim/objectives
This study aimed to identify tips for clinicians managing ethical challenges in ACP practices.
Methods
It performed a brief search for all Japanese published books pertaining to ACP practice available as of January 2021 using the keywords “advance care planning (ACP)” and “autonomy” and analyze the content of nine practical ACP textbooks for clinicians.
Results
Two major themes capturing the essential recommendations for managing ethical challenges in ACP were ultimately identified, namely interprofessional ethics and informed consent.
Conclusion
The findings suggested tips for managing ethical challenges in ACP: refer to ethical frameworks for interprofessional collaboration and ethical decision making, assess decision-making capacity of family substitute decision makers and one’s eligibility for the role, understand the standard process of informed consent and how to handle situations when the patient are not well informed about the diagnosis and prognosis of non-cancer illness.