Consent to treatment
Mary E. O’Hara
Journal of the European Wound Management, 2020; 21(1)
Open Access
Abstract
Patients’ valid consent to treatment must be gathered prior to providing treatment to ensure the protection of a person’s rights. This article discusses the key components of a valid consent to treatment, as well as different forms of consent. Two case scenarios also consider pertinent consent issues related to wound care provision. Using a human-rights-based approach, the Fairness, Respect, Equality, Dignity and Autonomy (FREDA) principles, linked to the Convention of the Rights of People with Disabilities (2006), provide a useful guiding framework and resource for clinical decision-making.

Consent Through the Lens of Semantics: State of the Art Survey and Best Practices
Anelia Kurteva, Tekraj Chhetri, Harshvardhan J. Pandit, Anna Fensel
Semantic Webb, 11 December 2020
Open Access
Abstract
The acceptance of the GDPR legislation in 2018 started a new technological shift towards achieving transparency. GDPR put focus on the concept of informed consent applicable for data processing, which led to an increase of the responsibilities regarding data sharing for both end users and companies. This paper presents a literature survey of existing solutions that use semantic technology for implementing consent. The main focus is on ontologies, how they are used for consent representation and for consent management in combination with other technologies such as blockchain. We also focus on visualisation solutions aimed at improving individuals’ consent comprehension. Finally, based on the overviewed state of the art we propose best practices for consent implementation.

A Blockchain-Based Consent Platform for Active Assisted Living: Modeling Study and Conceptual Framework
Original Paper
Journal of Medical Internet Research, 4 December 2020; 22(12)
Pedro Elkind Velmovitsky, Pedro Augusto Da Silva E Souza Miranda, Hélène Vaillancourt, Tania Donovska, Jennifer Teague, Plinio Pelegrini Morita
Open Access
Abstract
Background
Recent advancements in active assisted living (AAL) technologies allow older adults to age well in place. However, sensing technologies increase the complexity of data collection points, making it difficult for users to consent to data collection. One possible solution for improving transparency in the consent management process is the use of blockchain, an immutable and timestamped ledger.
Objective
This study aims to provide a conceptual framework based on technology aimed at mitigating trust issues in the consent management process.
Methods
The consent management process was modeled using established methodologies to obtain a mapping of trust issues. This mapping was then used to develop a conceptual framework based on previous monitoring and surveillance architectures for connected devices.
Results
In this paper, we present a model that maps trust issues in the informed consent process; a conceptual framework capable of providing all the necessary underlining technologies, components, and functionalities required to develop applications capable of managing the process of informed consent for AAL, powered by blockchain technology to ensure transparency; and a diagram showing an instantiation of the framework with entities comprising the participants in the blockchain network, suggesting possible technologies that can be used.
Conclusions
Our conceptual framework provides all the components and technologies that are required to enhance the informed consent process. Blockchain technology can help overcome several privacy challenges and mitigate trust issues that are currently present in the consent management process of data collection involving AAL technologies.

Living Donors and the Issue of “Informed Consent”
Susan E Lederer
Hastings Center Report, November 2020; 50(6) pp 8-9
Abstract
This essay considers the issue of informed consent as it arose in the context of 1960s living kidney donors. In one of the earliest empirical inquiries into informed consent, psychiatrists Carl H. Fellner and John R. Marshall interviewed donors about their decision-making process and their experience and reflections on donorship. In their much-cited 1970 paper, the physicians reported that living donors, rather than reaching a reasoned, intellectual, and unemotional decision about donating a kidney (as stipulated in the Ethical Guidelines for Organ Transplantation issued by the American Medical Association’s Judicial Council), instead made instantaneous and “irrational” decisions about participation. Fellner and Marshall’s studies contributed to the public debate and professional discussion about the moral and ethical dimensions of donorship, even as they challenged the developing consensus on informed consent.

Consent to Data Linkage in LSAC
Dinusha Bandara, Michelle Silbert, Galina Daraganova
International Journal of Population Data Service, November 2020
Abstract
Introduction
   Linking the existing longitudinal data assets with administrative datasets provide the opportunity to transform longitudinal data into valuable assets to inform research and policy development.
Objectives and Approach
   This paper will focus on Growing Up in Australia: The Longitudinal Study of Australian Children (LSAC) data linkage landscape and consents which are invaluable for the development of evidence-based health-social-economic policies.
Results
    LSAC is Australia’s first nationally-representative longitudinal study of child development. Since 2004, two cohorts of 5,000 children and their parents have been interviewed every two years (B (baby) cohort and K (kindergarten) cohort). Over the years, multiple data linkage has been undertaken based on either parental consent or study child consent.
    In 2004 parents were asked to consent on behalf of the study child to link Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS)/Repatriation Pharmaceutical Benefits Scheme (RPBS) and Australian Childhood Immunisation Register (ACIR) administrative data to LSAC. The consent rate was 93% was for MBS, PBS and ACIR. Nearly 90% of B cohort parents provided consent to link Australian Early Development Census (AEDC)/National Assessment Program – Literacy and Numeracy (NAPLAN) and 95.4% of K cohort parents provided consent to link NAPLAN.
    Then ten years later, children in the K cohort were asked to consent to MBS/PBS and income-support administrative data. The rates were 86.6% for MBS, 85.4% for PBS and 81.2% for income-support administrative data. Parental consent to link their MBS, PBS and income-support administrative data was also sought and these rates varied between 60% to 88%.
Conclusion/Implications
    The discussion will focus on differences in consent rates by time of consent, consenting individual and type of administrative data to be linked. Challenges and considerations that researches should be aware of when designing the linkage consent methodology will also be discussed.

Informed consent for patient data processing in electronic health records
M M H Jayasekara
Primary Health Care, 2020; 10(5)
Abstract
Objective
To report the results of a systematic review of national Health policies of different countries in relation to patient consent in patient data processing in electronic health records
Method
Health policies of 19 (14.07%) countries are reviewed with regard to patient consent, from a total of 135 countries that are indexed in the World Health Organization Directory of eHealth Policies. 68 (50.37%) policies were excluded based on language and 67 policies in English were selected for further consideration. These 67 (49.62%) policies were further evaluated resulting in exclusion of 43 (31.85%) policies due to policies being outdated and 5 (3.70%) due to broken links. Finally, a total of 19 (14.07%) countries were selected for the review.
Results
57.89% out of 19 countries require patients’ informed consent to store patient data, 26.32% allow selective storage of patient data as defined by the patient, 89.47% require patients’ informed consent when sharing or transferring or accessing patient data, 68.42% of the countries allow patients access their own EHR, 73.68% facilitate correction/modification in EHR, and 26.32% facilitate deletion of patient records. 89.47% of countries highlight mechanisms to assure privacy and security of EHR.
Conclusion
Policymakers’ emphasis on various ethical concerns raised by EHRs has been increased highlighting patient rights related to eHealth as well as the requirement for compliance to different standards and regulations. eHealth policies must address requiring patients’ informed consent in processing of patient data whereas patients have the ability to grant or withhold consent to different processing operations related to their EHR. Furthermore, facilitating patients with access to their own records, facilitating patients with modification, correction and deletion of EHR are widely discussed topics.

Informed Consent: A Monthly Review
___________________________

December 2020

This digest aggregates and distills key content adressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_December 2020

Editor’s Note:
The latest in the GE2P2 Global Foundation Center for Informed Consent webinar series was held on November 18^th 2020. Speakers Dr. Aoife Daly and Sheila Varadan spoke about aspects of children’s capacity and exercise of consent from their recent articles which appeared in The International Journal of Children’s Rights :: Special Issue, Article 5 of the Convention on the Rights of the Child: Families, Guidance and Evolving Capacities. Full information and the call recording can be found at the Center for Informed Consent Integrity website.

Further to children’s capacity to provide consent and assent, we take special note of six articles which appear throughout this edition of the Monthly Review with their respective abstracts:

Children’s autonomy during medical treatment is explored by Díaz-Pérez et al. in Moral structuring of children during the process of obtaining informed consent in clinical and research settings and Fisher et a. in Young women’s autonomy and information needs in the schools-based HPV vaccination programme: a qualitative study.

Proxy consent for children is examined by House et al. in COVID-19 Trial Enrollment for Those Who Cannot Consent: Ethical Challenges Posed by a Pandemic and Strode et al. in Be legally wise: When is parental consent required for adolescents’ access to pre-exposure prophylaxis (PrEP)?.

The use of comics and cartoons to aid in the consent transaction with children is raised by Ghia et al. in Informing children citizens efficiently to better engage them in the fight against COVID-19 pandemic and Qui et al. in Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey.