Assessing informed consent in surgical patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: a cross-sectional study
Lucy Kaomba, Wakisa Mulwafu
Malawi Medical Journal, December 2024; 36(4) pp 249-254
Abstract
Introduction
Informed consent is critical to medical practice, and a clearly outlined process that results in signing the consent form may improve the validity of the given consent. There is a paucity of studies in Malawi that have assessed the informed consent process in surgical patients.
Aim
To assess the informed consent process for patients undergoing surgery at QECH in Malawi.
Methods
A cross-sectional quantitative descriptive study was conducted among postoperative patients in the adult surgical wards at QECH through face-to-face interviews. The calculated sample size was 235. A consecutive sampling technique was used. Those below 18 years and those who didn’t or couldn’t consent were excluded. Data was entered and analyzed in Microsoft Excel 2016 and IBM SPSS 25.0. The level of significance was considered as P<0.05.
Results
A total of 222 patients were interviewed. The age range was 21 to 75 years, with a median of 38.5. Two hundred and twelve (95%) patients signed a consent form before surgery, and 21 (9%) knew the content of the form. Most patients, 100 (47%) had a primary school education, and 156 (70%) could read and write. Those with secondary or tertiary education were more likely to want to ask a question given the opportunity (OR 2.82, p= 0.0012), but there was no significant difference in the likelihood of being given time to ask questions between the two groups who had primary and no formal education vs those who had secondary and tertiary education (OR 1.4, p=0.3367)
Conclusion
This study highlights the necessity of employing effective communication strategies during the consent process for surgical procedures and the need to tailor the consent form to the patient’s education level.
Month: December 2024
Awareness of consent among Nigerian orthodontic patients; a study of perceptions and practices
Awareness of consent among Nigerian orthodontic patients; a study of perceptions and practices
Sylvia Simon Etim, Onyinye Dorathy Umeh
Acta Stomatologica Marisiensis, December 2024
Abstract
Introduction
Orthodontic treatment is elective but not without risks. Prospective patients need to be fully informed of their treatment options and understand the associated risks and benefits.
Aim of the study
To assess the perception of Nigerian orthodontic patients regarding the consent and assent-giving process before orthodontic treatment.
Material and Methods
A total of 349 patients from the University of Port Harcourt Teaching Hospital and Lagos University Teaching Hospital, who received orthodontic treatment between December 2023 and May 2024, participated in this study. A 21-item questionnaire was administered via Google Forms. The questionnaire contained demographic questions and items assessing knowledge, perception, and practice of consent in orthodontics. Data were analyzed using IBM SPSS Version 26, employing descriptive statistics (frequencies and percentages).
Results
Of the 349 participants, 99 (28.4%) were male, and 250 (71.6%) were female, with a mean age of 23.43 ± 10.49 years. Of the study population, 88% of female and 91.9% of male participants had heard of consent before treatment. A total of 93.1% of participants gave consent, with 78.5% of these being verbal. Pain (45.6%) was the most commonly explained complication, while infection (6.9%) was the least. In terms of satisfaction, 92% of participants were satisfied with the consent process.
Conclusion
Most Nigerian orthodontic patients are aware of the consent process and are generally satisfied with it. Orthodontists in Nigeria should prioritize obtaining written informed consent to ensure patient protection and avoid potential legal issues.
Editor’s note: Acta Stomatologica Marisiensis is the Journal of George Emil Palade University of Medicine, Pharmacy, Science, and Technology in Romania.
The Role of Informed Consent in Medical Disputes at State University Hospitals
The Role of Informed Consent in Medical Disputes at State University Hospitals
Putu Agus Prawira Eka Putra, Gusti Ayu Putri Kartika, R.A. Tuty Kuswardhani
Unram Law Review, 11 November 2024
Abstract
The research aims to understand how informed consent functions in the context of medical disputes at state university hospitals in Indonesia. The main benefit of the study is to provide an overview of how informed consent offers legal protection to the medical profession, particularly in resolving disputes that may arise in the hospital setting. The research utilizes a normative legal research method, focusing on the examination of written laws, regulations, and legal materials applicable in Indonesia. The research concludes that the thoroughness of informed consent documentation is crucial, especially for medical procedures that carry high risks. This thoroughness serves as a legal safeguard for medical professionals, ensuring their protection in case of disputes. Enhanced attention to the completeness of informed consent is necessary to mitigate the risks for doctors and provide legal security within the medical field at state university hospitals.
Barriers to Familial Consent in Deceased Organ Donation among Racialized and Indigenous Communities in Canada: A Qualitative Study
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.
Center for Informed Consent Integrity 