Knowledge about and attitudes toward medical informed consent: a Lebanese population survey
Research Article
Mary Deeb, Dana Alameddine, Rasha Abi Radi Abou Jaoudeh, Widian Laoun, Julian Maamari, Rawan Honeini, Alain Khouri,F adi Abou-Mrad, Nassib Elia, Aniella Abi-Gerges
Ethics & Behaviour, 19 December 2022
Abstract
As Medicine shifts from a paternalistic practice to a patient-centered approach, the concept of medical informed consent (IC) has evolved to safeguard patient autonomy. However, its current implementation still presents many challenges in clinical practice. We assessed the knowledge and attitudes of the general Lebanese population regarding the IC process as well as their sociodemographic and medical correlates. An anonymous online survey was distributed to the Lebanese population using social media channels. A sample of 500 adults with an average age of 36.2 ± 13.5 years, including 319 females and 181 males, was recruited. Most of the respondents had a university degree (85.8%), reported previous hospital admissions (75.9%) and had signed an IC for surgical procedures (40.7%). Few participants were knowledgeable about IC Lebanese law. Variability in knowledge level was significantly related to gender and a previous hospitalization history. Positive attitudes toward patient autonomy (53.1%) and shared decision-making (57.5%) correlated with older age, female gender, graduate education, and a previous history of signing an IC document. Males were more likely to believe that IC has positive effects on health than females. This is the first study that provides novel findings regarding Lebanese peoples’ awareness of the ethico-legal components of medical IC.

Analyzing online public commentary responding to the announcement of deemed consent organ donation legislation in the Canadian province of Nova Scotia
Alessandro R. Marcon, Darren N. Wagner, Christen Rachul, Matthew J. Weiss
Plos One, 15 December 2022
Open Access
Abstract
Background
The Canadian province of Nova Scotia recently became the first jurisdiction in North America to pass deemed consent organ donation legislation. The announcement of this legislation generated substantial online discussion, which we analyzed to provide insights on public perception.
Methods
We performed directed content analysis on 2663 user-generated comments appearing on two widely-shared Canadian Broadcasting Company (CBC) articles published online in April 2019. We determined levels of support and opposition in comments and described the specific rhetoric used for doing so. We also performed one-way ANOVA and Pearson chi-square tests to determine how the comments were being received and engaged by other users.
Results
A range of commentary was present in both support and opposition to the changes in legislation. There were more negative than positive comments, and negative commentary generated more replies. Positive comments were received more positively by other users while negative comments were received more negatively. The total sum of negative comments was greatly influenced by a small number of very active participants. Negative commentary focused more on broad concepts and principles related to government, power, and individual rights rather than specific issues in the Nova Scotian context. Substantial issues of trust in the government and healthcare system were evident.
Conclusions
There were strong positive and negative sentiments expressed in the comments, but the total sum of negativity in the comments was significantly influenced by a small number of commentators. Analysis on the presumed consent concerns can be helpful to inform public outreach efforts.

Nurse knowledge and attitudes towards organ donation and deemed consent: the Human Organ and Tissue Donation Act in Nova Scotia
Reports of Original Investigations
Robin Urquhart, Nelofar Kureshi, Jade Dirk, Matthew Weiss, Stephen Beed
Canadian Journal of Anesthesia, 1 December 2022
Abstract
Purpose
In April 2019, the Human Organ and Tissue Donation Act (HOTDA) in Nova Scotia was modified to incorporate a deemed consent model. In this study, we sought to understand intensive care unit (ICU) and emergency department (ED) nurses’ knowledge of and confidence around organ donation and transplantation, experiences with organ donors and recipients, attitudes toward organ donation and deemed consent, and perceived opportunities and barriers to a deemed consent approach in view of the legislative change.
Methods
We sent an electronic, self-administered survey to all ICU and ED nurses in Nova Scotia. The survey queried respondents on their knowledge of, experience with, and attitudes around organ donation and HOTDA, and opportunities and barriers to the implementation of HOTDA in clinical practice. Survey results were analyzed using descriptive statistics.
Results
One-hundred and ninety-four nurses responded to the survey. Nearly all (98%) supported organ donation, with 86% having signed an organ donor card to donate organs and/or tissues after death. A considerable majority (89%) also supported the new legislation. Nevertheless, a minority of respondents (13%) believed that deemed consent legislation would be considered a violation of the general principles of freedom and autonomy. The three most identified topics for ongoing training were coordination of the donation process (70%), clinical management of donors (70%), and family issues in decision-making (70%).
Conclusion
Intensive care unit and ED nurses had positive attitudes toward organ donation, including deemed consent model. The findings should inform educational initiatives in Nova Scotia and beyond to optimize organ donation processes and outcomes.

Estimated Impact of Deemed Consent Legislation for Organ Donation on Individuals With Kidney Failure: A Dynamic Decision Analytic Model
Koto P., Vinson A. J., Kiberd B. A., Beed S., Krmpotic K., Dirk J., Weiss M. J., Karthik K. Tennankore
Canadian Journal of Kidney Health and Disease, 25 November 2022
Abstract
Background
There is little data modeling the impact of deemed consent legislation (eligible individuals who do not register their decision to decline to be a donor are presumed to consent after death) on outcomes for individuals with kidney failure.
Objective
To estimate the change in life-years (LYs) and quality-adjusted life-years (QALYs) resulting from different changes in the rate of deceased donor kidney transplantation associated with deemed consent legislation and health system transformation.
Design
Dynamic Decision Analytic Model.
Setting
This modeling study included kidney failure patients in Atlantic Canada (all of whom receive their kidney transplants in Halifax, Nova Scotia). The adoption of deemed consent legislation was the intervention, and opt-in (the status quo) was the reference comparator.
Patients
Prevalent kidney failure patients at the end of 2019 in all of Atlantic Canada (N = 3615) served as the starting population.
Methods
We compared expected outcomes between the intervention and comparator. Changes in QALYs and total LYs were modeled under different changes to the proportion of patients receiving a deceased donor kidney transplant (from –10% to 20%) resulting from deemed consent relative to the status quo. Changes in QALYs and LYs were reported for 3 different time horizons (5, 10, and 30 years). Uncertainty around QALYs and total LYs was reported using 95% confidence intervals (CIs) constructed from a probabilistic sensitivity analysis using 1000 Monte Carlo Simulations.
Results
The increase in QALYs ranged from 7 QALYs (95% CI: 5-10) with a 5% increase using a 5-year time frame to 882 QALYs (95% CI: 619-1144) with a 20% increase over a 30-year time frame. Parallel changes in total LYs were also observed. In contrast, decreases in deceased donor kidney transplantation resulted in a loss of QALYs (for example, –463 QALYs; 95% CI: –633 to –306 for a 10% decrease over a 30-year time frame). Using the most optimistic scenario (a 20% increase), there was an 18% increase in the cumulative number of deceased donor kidney transplant recipients over a 30-year observation period.
Limitations
The results are subject to uncertainty depending on changes to the dialysis or transplant population that were not modeled and that may not be fully captured with probabilistic sensitivity analysis.
Conclusions
Deemed consent legislation will lead to variable changes in QALYs and total LYs for the kidney failure population, depending on the degree to which deceased donor transplantation rates change and the time horizon of observation. This modeling study may serve as a baseline to monitor the future impact of deemed consent legislation.

Assent, parental consent and reconsent for health research in Africa: thematic analysis of national guidelines and lessons from the SickleInAfrica registry
Research
Nchangwi Syntia Munung, Victoria Nembaware, Lawrence Osei-Tutu, Marsha Treadwell, Okocha Emmanuel Chide, Daima Bukini, Hilda Tutuba, SickleInAfrica ELSI WG, Ambroise Wonkam
BMC Medical Ethics volume, 8 December 2022; 23(130)
Open Access
Abstract
The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries.

Guardians and research staff experiences and views about the consent process in hospital-based paediatric research studies in urban Malawi: A qualitative study
Research Article
Mtisunge Joshua Gondwe, Neema Mtunthama Toto, Charity Gunda, Markus Gmeiner, Ian J. C. MacCormick, David Lalloo, Michael Parker, Nicola Desmond
BMC Medical Ethics, 5 December 2022; 23(125)
Open Access
Abstract
Background
Obtaining consent has become a standard way of respecting the patient’s rights and autonomy in clinical research. Ethical guidelines recommend that the child’s parent/s or authorised legal guardian provides informed consent for their child’s participation. However, obtaining informed consent in paediatric research is challenging. Parents become vulnerable because of stress related to their child’s illness. Understanding the views held by guardians and researchers about the consent process in Malawi, where there are limitations in health care access and research literacy will assist in developing appropriate consent guidelines.
Methods
We conducted 20 in-depth interviews with guardians of children and research staff who had participated in paediatric clinical trial and observational studies in acute and non-acute settings in the Southern Region of Malawi. Interviews were audio-recorded, transcribed verbatim, and thematically analysed. Interviews were compared across studies and settings to identify differences and similarities in participants’ views about informed consent processes. Data analysis was facilitated by NVIVO 11 software.
Results
All participants across study types and settings reported that they associated participating in research with therapeutic benefits. Substantial differences were noted in the decision-making process across study settings. Guardians from acute studies felt that the role of their spouses was neglected during consenting, while staff reported that they had problems obtaining consent from guardians when their partners were not present. Across all study types and settings, research staff reported that they emphasised the benefits more than the risks of the study to participants, due to pressure to recruit. Participants from non-acute settings were more likely to recall information shared during the consent process than participants in the acute setting.
Conclusion
The health care context, culture and research process influenced participants’ understanding of study information across study types and settings. We advise research managers or principal investigators to define minimum requirements that would not compromise the consent process and conduct study specific training for staff. The use of one size fits all consent process may not be ideal. More guidance is needed on how these differences can be incorporated during the consent process to improve understanding and delivery of consent.

Informed Consent Implementation at Leona Hospital in Kupang City
Debi F. Ng. Fallo, Heryanto Amalo
South East Asia Journal of Contemporary Business, Economics and Law, August 2022; 27(1)
Abstract
Informed Consent is a patient’s approval on medical action that will be performed on one after one has received a complete explanation of it. It is done to protect patients against all medical actions that are carried out without the patient’s knowledge and at the same time provide legal protection to doctor against unexpected negative consequences, for example against the risk of inevitable treatment even though the doctor has tried his/her best and acted circumspect. Therefore, the principle of informed consent doctrine is a patient’s autonomy right to himself to decide what is desired in the matter of treatment. It is an empirical legal research or non-doctrinal legal research. The data required is primary data obtained directly from respondents/informants, and secondary data obtained from the literature with data collection techniques are in the form of observations, interviews, document studies and group discussions. This study resulted in information regarding informed consent implementation at the Leona Hospital, Kupang City, and the obstacles faced in the informed consent implementation in the form of patient/patient’s family being heterogeneous groups patient’s perceptions of her/his illness, doctors’ explanations contain medical technical terms, and the limited time. This study suggests that doctors are still obliged to provide information to patients either orally or in writing form and that doctors need to improve their communication skills with patients from different backgrounds so that the goal of delivering information to patients is achieved.

Capacity to consent to research among adolescent-parent dyads in Rakai, Uganda
Philip Kreniske, Susie Hoffman, William Ddaaki, Neema Nakyanjo, Esther Spindler, Charles Ssekyewa, Dauda Isabirye, Rosette Nakubulwa, Nabakka Proscovia, Lee Daniel, Nao Haba, Mahlet Maru, Julia Thompson, Ivy S. Chen, Fred Nalugoda, Robert Ssekubugu, Tom Lutalo, Mary A. Ott, John S. Santelli
The Journal of Pediatrics, 17 November 2022
Abstract
Objectives
To assess the cognitive capacity of early, middle, and late adolescents, and their parents or guardians to provide informed consent to a population-based cohort study.
Study design
Adolescent-parent/guardian dyads including 40 early (N = 80; 10-14 years), 20 middle (15-17 years), and 20 late (18-19 years) adolescents were recruited from the Rakai Community Cohort Study (RCCS), an open demographic cohort in Uganda. Participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured open-ended assessment; interviews were recorded and transcribed. Twenty transcripts were scored independently by two coders; the intraclass correlation coefficient (ICC) was 0.89. The remaining interviews were scored individually. We compared mean scores for early and middle/late adolescents using a one-sided t-test and score differences between parent/guardian and adolescent dyads using two-sided paired t-tests.
Results
Early adolescents (mean score, 95% confidence interval (CI)) (28.8, 27.1-30.5) scored significantly lower (p<.01) than middle/late adolescents (32.4, 31.6-33.1). In paired dyad comparisons, we observed no statistically significant difference in scores between parents/guardians and middle/late adolescents (difference=-0.2, 95% CI=-1.0-0.6). We found a statistically significant difference in scores between parents/guardians and early adolescents (difference=3.0, 95% CI=1.2-4.8).
Conclusions
The capacity of adolescents of different ages and in diverse settings to comprehend risks, benefits, and other elements of informed consent is a critical but understudied area in research ethics. Our findings support the practice of having middle and late adolescents provide independent informed consent for sexual and reproductive health studies. Early adolescents may benefit from supported decision-making approaches.

Status of medical information and patient consent in orthopedic surgery and traumatology at the University Hospital of Burgos (period 2017-2018)
Original Article
Jacobo Salvat Dávila, Juan Salvat Puig, Jesús María Gonçalves Estella, Secundino Vicente González
Spanish Journal of Legal Medicine, 17 November 2022
Abstract
Introduction
The principle of autonomy is the basis of the informed consent concept. Informed consent is a patient´s right consisting in prior to the medical intervention being carried out on his body, he must express his agreement that it must be preceded by the proper information that allows him to decide according to his interests. In this work, our objective was to know the status of medical information and informed consent of the patient in the Traumatology and Orthopedic Surgery Service of the University Hospital of Burgos.
Material and methods
An anonymous questionnaire was prepared and distributed among 647 orthopedic surgery and trauma patients at the University Hospital of Burgos. Subsequently, a descriptive, cross-sectional, observational quantitative study was carried out. The association of sociodemographic variables with the responses to the questionnaire items was studied.
Results
Only 28.9% of the patients know that information is a right, but the majority (97.3%) expressed the need to receive information on risks and complications of the treatment and consider that the information does not increase fear or anxiety (63.4%). The majority stated that they were informed about the care performance (98.1%), understanding the explanations received (98.0%). The time used was sufficient (73.7%). In general, the information received was rated as sufficient (89.8).
Conclusions
Most of the patients felt informed and considered that the time that the doctor had had for this was sufficient.

A qualitative exploration of obtaining informed consent in medical consultations with Burma-born women
Anna Power, Amita Tuteja, Lester Mascarenhas, Meredith Temple-Smith
Australian Journal of Primary Health, 7 November 2022
Abstract
Background
Conciliatory attitudes, respect for medical professionals and avoidance of being direct can make health consultations with Burma-born patients difficult to navigate. Coupled with linguistic barriers, this may make the sensitive nature of many women’s health consultations challenging. Little is known about current practices for obtaining informed consent in this context. The objectives of this study were to explore current practices, barriers and strategies to obtaining informed consent in medical consultations with women born in Burma.
Methods
Purposive and snowball sampling was used to recruit health practitioners (n=15, 2 male, 13 female) of different ages, years of professional experience, and country of origin, from clinics in Victoria that see a high volume of Burma-born patients. Thirty to sixty minute semi-structured interviews were conducted with 4 general practitioners, 8 nurses and 3 interpreters, and deidentified audio recordings were transcribed for inductive thematic analysis.
Results
Five key themes were generated (i) cultural cognisance; (ii) influence of community (iii) skilful navigation of communication; (iv) favourable consultation attributes; and (v) individual tailoring of consent conversations. Differing cultural expectations, and linguistic and educational barriers, were highlighted as challenges to obtaining informed consent, while thoughtful utilisation of non-verbal communication, and intentional customisation of consent conversations were identified as facilitators.
Conclusion
The findings of this study provide practical ways to optimise the informed consent process within the Australian primary healthcare context, and reinforce that accepted Western-based practices for obtaining informed consent are not a ‘one-size-fits-all’.