Does silence imply consent? Organ Donation and the Presumption of Informed Consent
Cárdenas Krenz, Arturo Ronald, Córdova Pérez, Edwin Francisco
Medical Research Archives, 2024
Abstract
In response to the global shortage of organ donation, each country has been applying different public policies to reduce the donor deficit. One of them has been to propose regulatory modifications to the presumed consent system, in order to establish a system in which a favorable will is presumed for post-mortem organ donation, unless the person has declared otherwise while alive. Recently, the Peruvian law has established the presumed consent system for the donation of organs; it means that, in the absence of express will, the donor’s willingness to donate his or her organs at the time of death is now presumed. This regulatory modification follows a tendency established in other countries; however, others remain and respect the free and inform consent regards the willing of donating organs. This article presents a critical vision of this legal presumption. Under analyzing others health legal systems, we deveal the risks of violation of people’s rights when applying a regulation in this sense, which establishes a kind of compelled solidarity, highlighting policies that promote organ donation without compromising fundamental rights.

How Much Is Enough?: Informed Consent in Healthcare Minimal-Risk Research and Quality Improvement
Book Chapter
Paula Garcia McAllister
IRB, Human Research Protections, and Data Ethics for Researchers, 2025 [IGI Global]
Abstract
This chapter provides key takeaways for investigators and clinical researchers in healthcare settings doing minimal-risk research and quality improvement. Following an in-depth overview of the current regulations for informed consent (IC) with a focus on the 2018 regulatory revisions, it then describes the current state of IC in quality improvement activities commonly employed in learning healthcare systems and the ethical challenges they present. This chapter does not address the complexities of IC in clinical trials or in research with greater than minimal risk because the IC processes in such activities are well established. Instead, the focus is on what the regulations state regarding the requirements of informed consent; when and how consent can be waived; how research and quality improvement activities differ from the viewpoint of IC; and what information potential research subjects need to make decisions about participating in minimal-risk research and quality improvement in healthcare settings.

Increased Infectious Risk Donor Status and Equity-Relevant Predictors of Organ Donation Organization Approach and Caregiver Consent for Deceased Organ Donation in a Canadian Province (2015-2021)
Murdoch Leeies, Karen Doucette, Brenden Dufault, Tricia Carta, Owen Mooney, Carmen Hrymak, Nicolette Balzer, Ben Borys, Yasmine El-Salakawy, Mirna Ragheb, Davie Xie, Emily Christie, David Collister, Matthew J Weiss, Sonny Dhanani, Julie Ho
Clinical Transplantation, 2 December 2024
Open Access
Abstract
Background
Current donor risk assessments to identify risk of infectious transmission through transplantation have been criticized as unnecessarily discriminatory for sexual and gender minorities. Little is known about how increased infectious risk donor (IIRD) patients transition through the deceased donation system. We sought to evaluate how IIRD status and other equity-relevant identities impacted the likelihood of a caregiver of a deceased donor being approached for organ donation and the likelihood of caregiver consent.
Methods
We conducted a retrospective, observational cohort study of potential deceased donors referred to a Canadian provincial organ donation organization (ODO) from 2015 to 2021. Our primary outcome is the difference in the likelihood of being approached by the ODO for organ donation for IIRDs compared to baseline risk donors, amongst referred potential deceased organ donors. Secondary outcomes include the difference in caregiver consent for donation for IIRDs compared to baseline risk donors, amongst approached deceased organ donors. We built multivariable logistic regression models to evaluate these outcomes.
Results
Amongst all referred potential deceased organ donors, IIRD status did not impact the likelihood of being approached by our ODO for deceased organ donation compared to baseline risk donors (OR 1.695, 95% CI 0.902-3.197). Amongst approached deceased organ donors, there was no significant difference in caregiver consent for donation between IIRD and baseline risk donors (OR 1.854, 95% CI 0.902-3.929). Approached eligible IIRDs were younger with fewer comorbidities, lower KDPI scores, were more likely to have died from anoxic brain injuries and have death determined by neurologic criteria, and more likely to have non-medical injection drug use than baseline risk donors. There were no cases of donor-derived human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) reported for any donors included, regardless of IIRD status, during the study period.
Conclusions
We found no significant difference in the likelihood of ODO approach in IIRDs compared to baseline risk donors. There was no difference in caregiver consent for donation in IIRDs compared to baseline risk donors. A greater proportion of IIRDs became successful donors compared to baseline risk donors.

Free, prior, and informed consent, local officials, and changing biodiversity governance in Hin Nam No, Laos
Peter Bille Larsen, Chantaly Chanthavisouk
Conservation Biology, December 2024; 38(6)
Abstract
Free, prior, and informed consent (FPIC) is now a globally established norm and is a condition of equitable engagement with Indigenous peoples and local communities in biodiversity conservation. However, implementation is frequently questioned in terms of its efficacy in top-down-driven governance contexts. Local officials represent core voices often absent from mainstream discourse. Conservation practices are framed by local discourses, value frameworks, and relationships that offer critical opportunities to tailor localized consent processes. Relative to an FPIC process for a prospective World Heritage Site in Hin Nam No National Park, Laos, we examined the importance of mediation by local officials in a comanagement context. The mediation led to commitments to address long-standing community grievances and reconcile conservation and development relationships in the area. Building the capacity of local officials as critical duty-bearers helped shape rights-based conservation and development outcomes. Enhancing nonconfrontational mechanisms for rights holders to air concerns and dialogue spaces for duty-bearers to respond plays a key role in this respect.

Protocol and Statistical Analysis Plan for a Comparative Interrupted Time Series Evaluation of the Impact of Deemed Consent for Organ Donation Legislative Reform in Nova Scotia, Canada
Organ Donation and Procurement
Matthew J. Weiss, Kristina Krmpotic, Stephen Beed, Sonny Dhanani, Jade Dirk, David Hartell, Cynthia Isenor, Nick Lahaie, Scott T. Leatherdale, Kara Matheson, Karthik Tennankore, Gail Tomblin-Murphy, Amanda Vinson, Hans Vorster, Caroline King
Transplantation Direct, December 2024
Abstract
The Canadian province of Nova Scotia recently became the first North American jurisdiction to implement deemed consent for deceased organ donation as part of a comprehensive legislative reform of their donation and transplantation system. This study will examine the performance metrics and effectiveness of this policy in comparison with other Canadian provinces via a natural experiment evaluation. We will use a cross-sectional controlled interrupted time series quasi-experimental design. Our primary outcome will be consent for deceased donation as confirmed at the time of eligibility (prior registered intent to donate will be noted but not be considered positive unless affirmed at the time of eligibility). Secondary outcomes will include identification and referral of patients who are potential donors, rates of family override of previously registered intent to donate, and donation and transplantation rates per million population. Data will be collected from potential donor audits in Nova Scotia and 3 control provinces (provinces in Canada without deemed consent policies). Study outcomes will be compared in Nova Scotia relative to control provinces in the 3 y before and 3 y after the implementation of legislative reform. These provinces were selected as having systems resembling those of Nova Scotia but without deemed consent.Using controlled interrupted time series methodology compared with other Canadian provinces with otherwise similar systems, we aim to isolate the impact of the deemed consent aspect of legislative reform in Nova Scotia using a robust natural experiment evaluation design as much as possible. Careful selection of outcome measures will allow donation and transplantation stakeholders to properly evaluate if similar reforms should be considered in their jurisdictions.

Subgroup differences in public attitudes, preferences and self-reported behaviour related to deceased organ donation before and after the introduction of the ‘soft’ opt-out consent system in England: mixed-methods study
Research
Paul Boadu, Leah McLaughlin, Jane Noyes, Stephen O’Neill, Mustafa Al-Haboubi, Lorraine Williams, Jennifer Bostock, Nicholas Mays
BMC Health Services Research, 21 November 2024
Open access
Abstract
Background
In the UK, over 7,000 people are on the waiting list for an organ transplant and there are inequalities in need, access and waiting time for organs, with notable differences between minority ethnic groups. In May 2020, England changed the law and introduced a ‘soft’ opt-out system of consent to organ donation with a view to increase consent rates. We aimed to learn more about the impact of the law change on attitudes and views likely to be relevant to consent to deceased organ donation between different population subgroups.
Methods
Mixed-methods design involving latent class analysis of data from twelve repeated cross-sectional surveys undertaken from 2015 to 2021 (n = 19,011); analysis of the law change survey dataset collected quarterly from 2018 to 2022 (n = 45,439); and interviews with purposively selected members of the public (n = 30) with a focus on minority perspectives.
Results
Support for the principle of deceased organ donation remained high and stable in the general population (80%) but was 20% lower among ethnic minorities. From 2018 to 2022, an average of 58% of the general population was aware of the law change; this was lower among minority ethnic groups (31%). We identified four population subgroups (supportive donors (24% of the population); unengaged donors (22%); uncommitted donors (46%); and unsupportive donors (9%)). Interview themes included the challenges of discussing organ donation decisions, balancing autonomy with respecting family relationships, targeted misinformation, frustrations at the lack of consensus between community leaders, limited understanding of what happens during the end-of-life care leading to organ donation, and how this aligns with cultural values and preferences.
Conclusion
Implementation of the law change has not been associated to date with any change in public attitudes and preferences likely to influence consent overall or in minority ethnic groups in England. Uncommitted donors may benefit from encouragement to express their organ donation decision, and unengaged donors from attempts to address mis/information, confusion, and uncertainty. Interventions to raise the consent rate need to take account of the significant role of the family as well as wider community influences on attitudes, preferences and decision-making, particularly among certain minority (ethnic) groups.

A review of consent policies in Dermatological Surgery in the United Kingdom and the impact of leaner pathways and teledermatology on consent
Aparna Potluru, Daniel Sokol, Aaron Wernham
Clinical and Experimental Dermatology, 21 November 2024
Abstract
   Obtaining valid consent is an ethical and legal requirement in clinical practice, ensuring patients are adequately informed about their treatments. Recent updates in consent policies, including GMC guidance, the Patterson inquiry report, and key legal rulings like Montgomery, emphasise a shift towards patient-centred care and the importance of a comprehensive patient-clinician dialogue. Budget constraints and increasing NHS demand have led to the adoption of digital solutions and streamlined pathways, such as teledermatology and direct booking to surgery, potentially compromising the consent process.

This review examines the current state of informed consent in UK dermatology, particularly in light of the Montgomery ruling, which requires clinicians to ensure patients are aware of all material risks and alternatives associated with their treatments. The two-stage consent process, involving consent at two distinct points, is advocated to allow patients adequate time for reflection and decision-making. However, challenges remain in pathways like one-stop clinics and direct booking for surgery, where limited face-to-face interaction and time constraints can undermine the quality of informed consent.

To mitigate these issues, integrating multimedia tools and standardised procedure-specific consent forms can enhance patient comprehension and satisfaction. These tools ensure consistent and clear communication of risks, benefits, and alternatives, maintaining robust informed consent amidst evolving healthcare delivery models. Sustaining a thorough and individualised dialogue throughout the patient care journey is essential for upholding patient autonomy and shared decision-making in dermatological surgery.

Unproven stem cell therapies: an evaluation of patients’ capacity to give informed consent
Research Article
Laura Langford, Patrick Foong
Griffith Law Review, 30 October 2024
Abstract
Capitalising on the hype surrounding regenerative medicine, there are clinics worldwide marketing unproven stem cell-based therapies to patients. Some patients have travelled overseas to access treatments they believe are safe and effective. This practice, known as stem cell tourism, could result in adverse effects in some patients. This paper seeks to examine how the industry could threaten the validity of the patient’s informed consent. The vulnerable groups include adults, minors and incompetent patients. Since patients are exposed to exaggerated claims and inaccurate information, this article argues that each cohort may not truly consent to such therapies. While each group hopes to obtain a miracle cure, the reality is that these purported medical treatments may not enable patients to give their informed consent, which thereby inhibits good decision-making. Accordingly, states could restrict patients’ access to unproven stem cell-based therapies to control the problem. This paper illustrates how the regulatory framework in countries such as Australia and the United States (U.S.) has allowed the industry to thrive. Recommendations on how states can take a restrictive stance against this complex phenomenon are proposed.

Exploring the Foundations of Informed Consent, Legal Capacity, Privacy, and Dignity in Medical Law and me
Parvina Ismayilova
Juridical Sciences and Education, July 2024; 75(75) pp 136-151
Abstract
This article presents a comparative study exploring the foundations of informed consent, legal capacity, privacy, and dignity in medical law across different jurisdictions. The concept of informed consent is fundamental to medical practice and is rooted in the principle of patient autonomy. Legal capacity, on the other hand, refers to an individual’s ability to make decisions about their own healthcare and is often closely linked to informed consent. Privacy and dignity are also crucial aspects of medical law, protecting the rights and autonomy of patients. Through a comparative analysis of laws and regulations in various countries, this study examines the legal frameworks surrounding informed consent, legal capacity, privacy, and dignity in medical practice. The research aims to identify common principles and differences in the implementation of these concepts, addressing potential challenges and areas for improvement. By shedding light on the foundations of informed consent, legal capacity, privacy, and dignity in medical law, this study contributes to a better understanding of the rights and responsibilities of patients and healthcare professionals. The findings may inform future developments in medical law and practice, promoting ethical and respectful treatment of patients and upholding their rights to autonomy and dignity.

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

Nova Scotia’s Deemed Consent for Deceased Organ Donation: Family Member Perspectives and Experiences in the ICU Setting
Aimee J. Sarti,  Stephanie Sutherland, Matthew J. Weiss, Alain Landry, Heather Hemming, Jade Dirk, Ken Lotherington, Stephen Beed
Transplantation Direct, November 2024
Abstract
Background
The purpose of this study was to explore the experience of family members of potential organ donors in the intensive care unit following the change to deemed consent legislation in Nova Scotia.
Methods
This was a qualitative study with semistructured, in-depth interviews with 17 family members who were asked to make an organ donation decision on behalf of patients admitted to the intensive care unit in Nova Scotia. We analyzed themes using a descriptive approach. Participants were recruited from the organ donation organization in Nova Scotia, Canada.
Results
Participant awareness and knowledge of the Human Organ and Tissue Donation Act legislation varied from individuals having no awareness and knowledge of the bill to those who had awareness and optimism that the legislation would be beneficial for increasing organ donation rates in the province. Other themes emerging from the interviews included (1) COVID context, (2) quality of healthcare professional care, (3) family support, and (4) barriers to donation (waiting, consent questionnaire, and patient transfers).
Conclusions
The Human Organ and Tissue Donation Act legislation included enhanced support, which was viewed positively by family members. There is a need for continued evaluation as most participants felt it was too early to see the tangible impacts of the newly implemented legislation.