Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum
Phil Walton, Alicia Pérez-Blanco, Stephen Beed, Alexandra Glazier, Daniela Ferreira Salomao Pontes, Jennifer Kingdon, Kim Jordison, Matthew J. Weiss
Transplant Direct, 23 April 2023; 9(5)
Open Access
Abstract
Background
Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system.
Methods
This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members.
Results
Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process.
Conclusions
We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system’s most valuable resource: public trust.

Bridging the “consent gap”. Mechanisms of legitimization in a cross-border megaproject
Silvia Lucciarini, Rossana Galdini
Policy & Society, 2023
Abstract
In the recent debate on megaprojects, greater attention is devoted to the functioning of the inter-organisational and multi-actor networks that are one of the most innovative features of recent years. The complexity of these structures brings out governability issues for a megaproject’s management. Mutual recognition and consent become elements capable of inaugurating more collaborative processes and practices to reduce organisational and management criticalities in megaprojects. This paper focuses on a neglected relational dimension, namely legitimacy. We argue that legitimacy is instead the central dimension that attributes effectiveness and capacity for action to the organisations involved. Legitimacy regulates the relationship between various organisations – and especially – between organisations and the public sphere. Institutionalist theory assigns a central role to legitimacy in the construction of social processes, defining it as a generalised form of social acceptance towards an actor, an idea or a project. In this paper, we hypothesise that the legitimacy attributed and “held” by the stakeholders is a crucial element in countering three critical aspects of megaprojects, namely the uncertainty, complexity and conflict acting on the construction of public consensus and the quality of relations between the participating stakeholders. We verify our hypothesis by analysing a cross-border megaproject, the Fehmarnbelt Fixed Link between Germany and Denmark. The paper concentrates on the mechanisms with which stakeholders can acquire legitimacy using the Eriksen discursive legitimation scheme. These mechanisms are different (evidence-based, public participation, and legislators’ command) and produce different outcomes in terms of increasing or containing these three criticalities.

Editor’s note: This is an Italian language publication.

Guidance Paper 2: Obtaining Consent in Research involving Children – Understanding the Legal and Ethical Framework
National Centre for Research Methods, 2023
Open Access
Excerpt
This guidance paper describes the importance of obtaining consent from and on behalf of child participants involved in research. It is Guidance Paper 2 in the series The Ethics of Research Involving Children: Common Questions, Potential Strategies and Useful Guidance. Ethical research considers the international and domestic law, as well as ethical and professional, obligations towards ensuring that participants provide valid consent. Issues around consent are paramount in research ethics applications. The law and ethics of consent are not just about ensuring that the child is fully aware of the implications of his or her involvement in the research and is kept safe (which might necessitate obtaining consent also from adults with parental responsibility); it is equally about ensuring that overly paternalistic approaches to consent are avoided, as such approaches may unintentionally undermine children’s autonomy and prevent children from making decisions and expressing themselves on their own terms. As the ESRC notes in its ethical guidance: “Researchers should consider the ethics implications of silencing and excluding children from research.” Beazley et al. (2009: 370) refer to this as children’s right to be ‘properly researched’ which ‘translates into: children being participants in research; using methods that make it easy for them to express their opinions, views and experiences; and being protected from harm’…

Editor’s note: The national Centre for Research Methods delivers a programme of research methods training across the UK. The ESRC referenced stands for the Economic and Social Research Council in the UK.

Individualised consent for endoscopy: update on the 2016 BSG guidelines
Guideline
Nicholas Ewin Burr, Ian D Penman, Helen Griffiths, Andrew Axon, Simon M Everett
Frontline Gastroenterology, 7 February 2023
Abstract
In 2016, the British Society of Gastroenterology (BSG) published comprehensive guidelines for obtaining consent for endoscopic procedures. In November 2020, the General Medical Council (GMC) introduced updated guidelines on shared decision making and consent. These guidelines followed the Montgomery ruling in 2015, which changed the legal doctrine determining what information should be given to a patient before a medical intervention. The GMC guidance and Montgomery ruling expand on the role of shared decision making between the clinician and patient, explicitly highlighting the importance of understanding the values of the patient. In November 2021, the BSG President’s Bulletin highlighted the 2020 GMC guidance and the need to incorporate patient -related factors into decision making. Here, we make formal recommendations in support of this communication, and update the 2016 BSG endoscopy consent guidelines. The BSG guideline refers to the Montgomery legislation, but this document expands on the findings and gives proposals for how to incorporate it into the consent process. The document is to accompany, not replace the recent GMC and BSG guidelines. The recommendations are made in the understanding that there is not a single solution to the consent process, but that medical practitioners and services must work together to ensure that the principles and recommendations laid out below are deliverable at a local level. The 2020 GMC and 2016 BSG guidance had patient representatives involved throughout the process. Further patient involvement was not sought here as this update is to give practical advice on how to incorporate these guidelines into clinical practice and the consent process. This document should be read by endoscopists and referrers from primary and secondary care.

Physician’s Code of Medical Ethics updated
Press Release
World Medical Association, 8 October 2022
The revised Code, regarded as the foundation of ethical principles for physicians worldwide, defines the professional duties of physicians towards their patients, other physicians and health professionals, themselves, and society as a whole. It was adopted today in a unanimous vote at the WMA’s annual General Assembly in Berlin by physician leaders from almost 60 national medical associations…
The Code says that physicians must respect not only the dignity and the rights of patients, but also explicitly mentions their autonomy…
Excerpt
…Duties to the patient

13. In providing medical care, the physician must respect the dignity, autonomy, and rights of the patient. The physician must respect the patient’s right to freely accept or refuse care in keeping with the patient’s values and preferences.
14. The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interests. In doing so, the physician must strive to prevent or minimise harm for the patient and seek a positive balance between the intended benefit to the patient and any potential harm.
15. The physician must respect the patient’s right to be informed in every phase of the care process. The physician must obtain the patient’s voluntary informed consent prior to any medical care provided, ensuring that the patient receives and understands the information needed to make an independent, informed decision about the proposed care. The physician must respect the patient’s decision to withhold or withdraw consent at any time and for any reason…

Patient involvement in the development, regulation and safe use of medicines
Council for International Organizations of Medical Sciences (CIOMS)
Working Group XI on Patient involvement, 2022; 236 pages
Overview
…Informed consent and informed assent
Informed consent is a fundamental patient’s right and an ethical imperative in medicine, whether for research, treatment, or sharing personal data. The patient needs to be given all relevant information and invited to ask questions about the procedure, treatment or data-sharing arrangement. To give informed consent, the patient should have the capacity to understand the implications of the consent. Also, the patient should be able to make the decision to give consent freely and without undue pressure.

When a child is too young to give informed consent, informed assent must be sought. The child should be meaningfully engaged in discussions about the research or medical procedure, according to the child’s capacity. Consent should also be obtained from the child’s parents or legal guardian. Moreover, the child’s written agreement can be obtained if the child’s literacy level allows this, taking into account emotional and psychological maturity as well as relevant individual circumstances. Informed assent is also appropriate for adults who do not have the legal capability to give consent…

Informed Consent for Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
NIH – Office of Science Policy/Office of Extramural Research, May 2022; pp 1-7
Introduction
…The following resource… outlines suggested points to consider when addressing data and biospecimen storage and sharing for future use in consent language and provides supplemental sample language that could be modified as needed when developing informed consent documents. Of note, the sample language provided below is designed to be incorporated into a primary research consent document. The use of the sample language by itself does not address federal, state, local, tribal, or international requirements that may apply to the primary research. Furthermore, this resource is designed for research consent documents; it does not address the storage and sharing of data and biospecimens initially collected for clinical purposes. Use of the information provided in this resource, including sample language, is completely voluntary.

Emergency use of unproven clinical interventions outside clinical trials: ethical considerations
Technical Document
World Health Organisation, 12 April 2022
Open Access
Introduction
Outbreaks and other events that may become public health emergencies frequently face a lack of  safe and effective therapeutic or preventive interventions, such as drugs specific to the pathogen or condition. WHO and its partners therefore established the “WHO R&D blueprint” in 2016 to stimulate research into diseases or conditions that pose the greatest public health risks because of their epidemic potential or for which there are no or insufficient countermeasures (31). In response to the ethical duty to conduct research during public health emergencies (17), rapid, rigorous, simple clinical trials or other types of research (32, 33) are essential to establish the safety and efficacy of unproven interventions – including “off label” interventions (9) – and to discard those that are unsafe or ineffective to avoid their use in health systems. When a PHEIC is declared, “it is critical that the global research effort is rapid, robust, conducted at scale and coordinated across multiple countries” (33)…

Ethical Research in Fragile and Conflict Affected Contexts: Guidelines for Reviewers
Guidelines
UKRI Research and Innovation, 16 November 2021
Open Access
Rationale
Ethical considerations arise in all research. They are, however, amplified in fragile and conflict-affected contexts. The power imbalances between local and international researchers are increased and the risk of harm is augmented. The research takes place in a context where appropriate safeguards are often reduced and the probabilities of unethical research are magnified. Existing explorations of ethics and ethical review processes often focus primarily on the front end of the data cycle. Yet, we know that harm can occur at any stage in the research cycle. Ethical research in fragile and conflict-affected contexts therefore requires that researchers and funders reflect even more critically and systematically on every step of the research process – from defining the research agenda and selecting researchers through to data collection, analysis and dissemination and communication of findings. These UKRI and UNICEF reviewer guidelines provide a unique tool for reviewers to assure themselves, as reviewers and/or funders, that research projects funded will give systematic and on going consideration to the ethics of research in fragile and conflict-affected contexts. The tool provides seven criteria for consideration and a checklist for reviewers to use systematically to support their review process…

Editor’s note: UK Research and Innovation provides research and innovation funding, funded through the science budget of the Department for Business, Energy and Industrial Strategy.