Barriers to Familial Consent in Deceased Organ Donation among Racialized and Indigenous Communities in Canada: A Qualitative Study
Simran Sandhu, Jagbir Gill, Reetinder Kaur
Journal of the American Society of Nephrology, October 2024
Poster
Metrics
Background
In Canada, over 3700 people are on the organ transplant list, with deceased donor kidney transplants making the majority of transplants completed annually. Despite the increasing numbers of transplants, populations marginalized by race and ethnicity have lower rates of organ donation registration and are less likely to consent to donation. Gaining insight into barriers to providing consent is critical in developing strategies to address disparities. This study aimed to identify barriers to familial consent among members of racialized and Indigenous communities.
Methods
48 participants were recruited through community-based organizations in British Columbia (BC) and included BC residents, aged over 19, who spoke English. 31 participants completed interviews and 17 completed focus groups. Participants were oversampled for members of racialized and Indigenous communities. A case vignette was used to collect data with data analyzed using summative content analysis.
Results
Four overarching barriers were identified: 1) system-level; 2) community-based; 3) related to decision-making; and 4) informational. System-level barriers highlighted mistrust of Canadian healthcare institutions, perceived coercion, and the role of language in consent. Community-based barriers involved ideas around the deceased body, funeral, afterlife, and general perceptions of organ donation. Decision-making was affected by family dynamics and donor and recipient identity. Informational barriers such as age eligibility also influenced consent. Facilitators to address barriers include culturally diverse resources, increasing community knowledge, and providing language, cultural, and religious support to build trust and facilitate discussions.
Conclusion
This study highlights barriers and modifiable determinants to familial consent in deceased organ donation among members of racialized and Indigenous communities. Although it examines barriers to familial consent for all organ donation, findings are of significant relevance to kidney care, as patients waiting for kidney transplants constitute the majority of patients on transplant waitlists. Education and engagement initiatives must be targeted at the health system and community levels to fully address barriers to consent and reduce racial and ethnic disparities in organ transplantation.
Informed consent in global outreach
Editor’s Note:
We recognize a growing literature which argues [in whole or in part] that norms requiring the individual, prior, free, express and informed consent of persons to be involved in research must accommodate notions which integrate terms such as ‘community-driven’, ‘decolonized’, or ‘culturally-appropriate’ and which insist that consent processes “prioritize local/indigenous values and protocols.” As an editorial policy, we have decided to group such literature together in this section of the digest.
More broadly, we recognize that this literature raises critically important issues around consent integrity. Our Center for Informed Consent Integrity is actively developing a position on this matter, mindful of core guidance in research involving human participants overall, and selected instruments such as the Universal Declaration on Bioethics and Human Rights [2005] which notes:
Article 12. Respect for cultural diversity and pluralism
The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.
We will keep readers advised of our progress. If you have an interest in participating in our working group, please contact Paige Fitzsimmons [paige.fitzsimmons@ge2p2global.org].
Informed consent in global outreach
Book Chapter
Meseret E. Kassa, Morris E. Hartstein
Global Oculoplastics: A Guide to the Care of Patients in Resource-Poor Environments, 2025; pp 93-95
Abstract
Informed consent in resource-poor settings is equally important as in Western settings. However, language and cultural barriers exist, making it much more challenging to obtain. This chapter will discuss the potential barriers, enhance understanding and respect of the culture, and discuss methods to modify the process in order to successfully obtain informed consent in resource-poor environments.
Editor’s note: The barriers discussed in this chapter include understanding and respecting community norms, cultural and religious variations, communities with strong social interdependence family structure, informed consent for women, deference to physician, rejection of medical interventions, confidentiality, justice, and patient anonymity, and language and illiteracy.
Women’s Decision-Making Autonomy and Free and Informed Consent in Accessing Reproductive Health Care in Community Settings: A Qualitative Study in the N’djili Health Zone (Kinshasa City, Democratic Republic of the Congo)
Women’s Decision-Making Autonomy and Free and Informed Consent in Accessing Reproductive Health Care in Community Settings: A Qualitative Study in the N’djili Health Zone (Kinshasa City, Democratic Republic of the Congo)
Bertine Mbongopasi Ekeni, Koto-Te-Nyiwa Ngbolua, Bernard Ntoto Nkunzi, Félicien Mukandu Basua Babintu
Mechanisms and Machine Science, 14 November 2024
Abstract
The aim of this study is to identify factors influencing the improvement of decision-making autonomy and free, informed consent among women in the N’djili Health Zone. A cross-sectional analytical study was conducted from September 25 to October 26, 2022. Results revealed that participants faced challenges in exercising autonomy over reproductive health decisions, impacting their capacity to give informed consent. Additionally, a lack of information and awareness about reproductive health rights and options perpetuates existing inequalities. Developing educational and awareness programs that inform women of their rights, while involving the community and health professionals, are crucial to fostering sustainable change.
How Much Is Enough?: Informed Consent in Healthcare Minimal-Risk Research and Quality Improvement
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)
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
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.
When Understanding Fails: How Diverging Norms in Medicine and Research Led to Informed Consent Failures During the Pandemic
When Understanding Fails: How Diverging Norms in Medicine and Research Led to Informed Consent Failures During the Pandemic
Daniel Pinto
Journal of Medical Ethics, 18 December 2024
Abstract
During the COVID-19 pandemic, there were many vaccine trials which had significant purposes which participants needed to understand to validly consent. For example, participants needed to understand that the purpose of dose-escalation vaccine trials was to give incremental doses of vaccine until participants became ill. Likewise, participants needed to understand that if they received placebos, they could no later take a genuine vaccine to preserve the integrity of the trials. Yet, these intuitive judgements about what participants need to understand to validly consent are rejected by recent accounts of consent. According to these accounts, as long as participants were given a good opportunity to learn these purposes, they do not need to actually understand them to consent. In this paper, I reject this consensus, and I argue that participants who failed to understand these aims associated with vaccine trials failed to provide legitimate consent. I defend this claim by developing and defending a new understanding condition for valid consent. According to this understanding condition, a participant must understand when a consent transaction has features which violate the norms which govern the medical practice with which they are acquainted. I argue that this condition is independently plausible and best explains why participants needed to understand these aims associated with vaccine trials to validly consent.
Medical Ethics and Informed Consent to Treatment: Past, Present and Future
Medical Ethics and Informed Consent to Treatment: Past, Present and Future
Alan Mordue, Elizabeth A Evans, James T Royle, Clare Craig
Cureus, 9 December 2024; 16(12)
Open Access
Abstract
It has been asserted that there was an erosion of medical ethics during the Covid-19 pandemic and a departure from the principle of obtaining fully informed consent from patients before treatment. In light of these assertions, this article reviews the historical development of medical ethics and the approach to obtaining informed consent and critiques the consent practices before and during the pandemic. It then describes a new tool for displaying key statistics on the benefits and risks of interventions to help explain them to patients and suggests a more rigorous process for seeking fully informed consent in the future.
Consent to medical student teaching: an observational, cross-sectional study exploring the patient view
Consent to medical student teaching: an observational, cross-sectional study exploring the patient view
Research
Niki Newman, Fraser McKenzie, Jonathan M. Wells, Tim Wilkinson, John Dean, Matthew Doogue, Lutz Beckert
BMC Medical Education, 24 December 2024
Open Access
Abstract
Background
New Zealand guidelines stipulate that patient consent is obtained for medical student involvement in clinical care, however, patients’ preferences regarding consent for medical student teaching have not been widely explored. This study examined patient preferences for consent for medical student teaching with the aim to increase patient empowerment, to optimise care and to reflect societal expectations more accurately.
Method
Observational, semi-qualitative, cross-sectional study of in-patients. Each participant was presented with a series of nine hypothetical clinical scenarios and were allowed a limited number of responses. For each scenario the participants completed a short questionnaire about their preferences for consent. These included their preferred mode of consent (implicit, verbal or written), timing of consent, and who should take their consent. The analysis used descriptive statistics and ordinal logistic regression mixed models to investigate associations between patient characteristics and chosen mode of consent.
Results
There were 123 participants (50% male), median age was 64 years. Patients were admitted to either medical (69%), surgical (22%) or women’s health (9%). Increasing age was statistically significantly associated with a preference for verbal and implicit rather than written consent with the exception of ‘breaking bad news’ and ‘bedside teaching’. The majority of patients preferred verbal consent across all nine clinical scenarios (57–82%), including two surgical scenarios where verbal consent was preferred by 59%. Most patients preferred the supervising doctor to take consent, with no clear preference about the timing.
Conclusions
This study identifies the patient voice in the consent process for the involvement of medical students in clinical care. Although the patients’ views generally align with an existing national consensus statement, there is variability in the expectations of the patients suggesting flexibility in the consent process is still needed. The preference for older patients for verbal or implicit consent compared with younger patients for more invasive scenarios highlights the need for consideration of inter-generational differences. Most patients in this study were willing to contribute to student learning in all scenarios.
The German Medical Informatics Initiative Broad Consent in the Emergency Department: A Single Centre Prospective Observational Study to Assess Consenting Mode Dependent Success Rates
The German Medical Informatics Initiative Broad Consent in the Emergency Department: A Single Centre Prospective Observational Study to Assess Consenting Mode Dependent Success Rates
Felix Patricius Hans, Jan Kleinekort, Melanie Boerries, Alexandra Nieters, Gerhard Kindle, Micha Rautenberg, Laura Bühler, Gerda Weiser, Michael Clemens Röttger, Carolin Neufischer, Matthias Kühn, Julius Wehrle, Anna Christine Slagman, Antje Fischer-Rosinsky, Larissa Eienbröker, Frank Hanses, Gisbert Wilhelm Teepe, Hans-Jörg Busch, Leo Benning
JMIR Medical Informatics, 19 November 2024
Abstract
Background
The Broad Consent (BC) by the German Medical Informatics Initiative (MII) was developed to serve as a national blueprint for consenting patients for the use of routinely collected medical-, insurance- and contact data and biomaterials for research purposes, ensuring compliance with European General Data Protection Regulation (GDPR). Emergency departments (EDs) are characterized by a broad and unselected patient population that provides the opportunity to include patients from different demographic and socioeconomic groups, as well as from different disease groups. While also posing regulatory and ethical challenges, obtaining BC in an ED environment presents a promising opportunity to increase the availability of ED data for research.
Objective
This study aimed to evaluate the success rate of obtaining BC through different consenting approaches in a tertiary ED. The study also explored factors influencing consent and dropout rates.
Methods
A single-center prospective observational study was conducted in a German tertiary ED from September to December 2022. Patients were randomly selected (every 30th patient) and screened for eligibility to be informed about BC. Eligible patients were informed through one of three modalities: (a) directly in the ED, (b) during inpatient stay on the ward, or (c) via telephone after discharge. The primary outcome was the success rate of obtaining BC within 30 days of ED presentation. Secondary outcomes included analysis of potential influences on the success- and dropout rate concerning patient characteristics, information mode, and the interaction time applied for the information.
Results
Out of 11,842 ED visits in the study period, 419 patients were randomly screened for BC eligibility, with 151 meeting the inclusion criteria. Of these, 68 patients (45.0 %) consented to at least one BC module, while 24 (15.9 %) refused participation. The overall dropout rate was 39.1 %, with the highest dropout occurring in the telephone-based group (52.3 %) and lowest in the ED group (7.1 %). Patients who were informed face-to-face during the inpatient stay following their ED treatment had the highest consent rate (85.2 %), while those approached in the ED or by telephone consented in 69.2 %. Logistic regression analysis indicated that longer interaction time was significantly associated with higher consent rates, whereas female gender was associated with increased dropout rates. No significant differences were found between consenting and non-consenting groups concerning age, triage category, billing details (inpatient treatment), or diagnosis distribution.
Conclusions
Obtaining BC in an ED environment is feasible, and showed representative inclusion of the ED-population. However, discharge from the ED and female gender negatively influenced the odds of obtaining consent to the BC. Face-to-face interaction significantly improves consent rates and seems to be the most promising approach for consenting inpatients. Telephone-based approaches, conversely, resulted in higher dropout rates but equal consent rates as the direct consenting in the ED. The study highlights the need for tailored consent strategies, indicating a benefit to maintain staff in EDs and on wards to provide information on BC and obtain consent from eligible patients.
Center for Informed Consent Integrity 