Transplantation and consent
Healthcare ethics and communication
John Saunders
Medicine, 29 May 2024
Abstract
This is an overview of issues relating to consent in donation and transplantation, including the types of consent currently in use in organ donation. There is a discussion of altruistic consent, opt-in, opt-out and deemed consent, and mandated choice. Donation of organs after cardiac death and after brain death is described. Reference is made to current guidance from the UK National Health Service, the Human Tissue Authority, the UK Government and the Spanish model of Organ Donation and Transplantation.
Month: June 2024
Risks and Complications Discussed in Consent for Strabismus Surgery
Risks and Complications Discussed in Consent for Strabismus Surgery
Research Article
Carolyn May, Evan Silverstein
Journal of Binocular Vision and Ocular Motility, 28 May 2024
Abstract
This study is a qualitative analysis of the consent process for strabismus surgery, using recordings of physicians doing a mock consent for bilateral medial rectus recession. There is considerable variation in the risks of surgery and odds of complications that are cited by pediatric ophthalmologists during the consent process. We propose a reference table with complication rates for use during the consent process.
Better Conversations for Better Informed Consent: Talking with Surgical Patients
Better Conversations for Better Informed Consent: Talking with Surgical Patients
Margaret L Schwarze, Robert M Arnold, Justin T Clapp, Jacqueline M Kruser
Hastings Center Report, May 2024; 54(3) pp 11-14
Abstract
For more than sixty years, surgeons have used bioethical strategies to promote patient self-determination, many of these now collectively described as “informed consent.” Yet the core framework-understanding, risks, benefits, and alternatives-fails to support patients in deliberation about treatment. We find that surgeons translate this framework into an overly complicated technical explanation of disease and treatment and an overly simplified narrative that surgery will “fix” the problem. They omit critical information about the goals and downsides of surgery and present untenable options as a matter of patient choice. We propose a novel framework called “better conversations.” Herein, surgeons provide context about clinical norms, establish the goals of surgery, and comprehensively delineate the downsides of surgery to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm shift meets the standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of treatment.
Consent and clarification: duty and right to information in dentistry
Consent and clarification: duty and right to information in dentistry
Zilda Betânia Barbosa Medeiros de Farias, Márcia Maria Fonseca da Silveira, Richardson Silva, Rebeka Thiara Nascimento dos Santos, Ana Paula Veras Sobral
Revista Bioética, 2024
Abstract
Studies on informed patient consent in the field of dentistry are scarce and present divergences, highlighting the need to deepen knowledge about definitions, dynamics, normative acts, case law and limits of responsibility in the face of diverse factors and risks inherent to the profession. From a bibliographic review that included studies indexed in the SciELO and LILACS databases, as well as textbooks, this study aimed to define what is meant by a patient’s free and informed consent, distinguish different types and highlight the so-called “informed choice,” considering that the activity of the dental surgeon is classified as a service and is regulated by the 1988 Federal Constitution of Brazil, the Consumer Defense Code, the Civil Code and special laws. The aim is to see if it is possible to improve the process of obtaining informed consent from patients, transforming it into a process of informed choice that takes into account appropriately indicated treatments whose main purpose is health.
Obtaining Informed Consent in Veterinary Clinical Trials Mini Review
Obtaining Informed Consent in Veterinary Clinical Trials Mini Review
Carol Frederick
Frontiers in Veterinary Science, 11 June 2024
Abstract
In September 2023 the US Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.
Current Calls For Public Consultation
Current Calls For Public Consultation
We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Global Consultation: First Draft Text of UNESCO Recommendation on Ethics of Neurotechnology
UNESCO – 10 June 2024, This survey remains available until 12 July 2024 (midnight Paris time)
Overview
UNESCO has embarked on a two-year process to elaborate the first global Recommendation on the ethics of neurotechnology. This Recommendation is expected to define shared values, principles, and ethical challenges as well as identify concrete policy actions to promote and strengthen an ethical development, deployment and use of neurotechnology worldwide.
The purpose of this questionnaire is to collect feedback from different actors bringing in different perspectives and points of views on the first version of a draft text of a Recommendation, elaborated by an Ad Hoc Expert Group (AHEG) during their first meeting at UNESCO HQ (Paris, 22-26 April 2024). This meeting will be followed by a second meeting (Paris, 26-30 August) to embed inputs received through a wide range of consultations, including inputs received through this online consultation.
Your participation will help enrich the first draft of the Recommendation with your views about how to harness the potential benefits of neurotechnology and mitigate the risks. The questionnaire is structured to provide you with the option to comment on the different parts of the text: definition and scope, approach, values principles and rights and policy actions.
To efficiently reply to this questionnaire, you are invited to consult the first draft of the Recommendation.]attached] For more information on UNESCO Social and Human Sciences Sector’s work on the Ethics of Neurotechnology, please visit our website.
Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning
Posted on May 21, 2024 Comments must be received by July 22, 2024
NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramuralresearch-program-policy-promoting-equity-through-access-planning.
In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024. More information on the agenda and how to register will be provided shortly.
For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Questions may be sent to SciencePolicy@od.nih.gov.
Center for Informed Consent Integrity 