Consent through art: a critique of a visual method developed with peer-researchers in southern Nepal
Joanna Morrison, Awantika Priyadarshani, Abriti Arjyal
International Journal of Social Research Methodology, August 2023
Abstract
Obtaining informed consent can be challenging during peer research when the boundaries between researcher and participant are blurred. We developed a novel visual consent method with illiterate artists in Nepal who conducted peer interviews in their communities. Artists discussed and sketched images related to ethical principles to create a visual consent form. This improved comprehension about research ethics and developed the confidence of artists to conduct peer interviews, but we found that artists memorised the form; they did not engage participants in looking at the pictures with them; and they did not use the pictures that they disagreed with. In future research, the visuals should be developed in consultation with participants and be used to explain the study to participants. The tool development process can be used to establish a joint understanding about the research, its harms, and benefits, and to develop relational and iterative consent processes in participatory action research.

An examination of the moral conundrum of informed consent within the framework of African values and belief systems : a case study
Jamila Kathoon Adam, Francis Fabian Akpa-Inyang
Interdisciplinary Journal of Economics and Business Law, 2023; 12(1)
Abstract
The notion of bio-medical ethics, which places a strong focus on individual autonomy when considering informed consent, is mostly inspired by western European medical and moral traditions, leaving African traditions and values out of the practice of medical ethics. This is due to the fact that African customs and values favour communitarianism above individualism. In African culture, your strong relationships with people in the community which include sharing everything, including decision-making are what define you as a human being. As a result, it is clear that when applied to the majority of Africans, the idea of individual liberty in informed consent is inapplicable. This is because African communitarian ethics focuses on the interests of the family, community and society and not the individual. Thus, there might be a conflict in the application of the western principle of medical ethics in the general population in Africa. This review paper intends to use published articles, reports, case studies, and ethical principles to explore this potential conflict.

Accessibility of the consent form in Brazilian clinical research
Research
Renan Emilio Kintopp, Sergio Surugi de Siqueira, José Eduardo de Siqueira, José Humberto Guerreiro Tavares Fregnani
Revista Bioética, 2023
Abstract
The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.

Co-producing culturally responsive consent in research
Emily Oliver, Sandy Chaar, Imad Abou Khalil
Humanitarian Practice Network, 12 June 2023
Excerpt
What happens when approaches for consent are co-produced by communities with local researchers and mental health and psychosocial support workers responding to their values, instead of embedding Western concepts that can have unintended consequences far beyond this first formal step of participation? GOAL partners at the Lebanese National Mental Health Programme, War Child and BeyondText are curious about whether more participatory approaches to consent, beyond traditional text-based materials, might be more effective at developing trust, understanding and participation, ultimately helping to create the conditions for more relevant research and interventions and a stronger mental health and psychosocial support (MHPSS) system in Lebanon…

Adequacy of Informed Consent in Elective Surgical Procedures: A Study in a Navi Mumbai Tertiary Care Centre
Amit Patil, Shreyas Chawathey, Adel Malim
Cureus, 12 July 2023; 15(7)
Abstract
Background
Informed consent (IC) is a voluntary authorisation given by a patient or research subject after fully comprehending the risks involved in various procedures and treatments. Though a patient may fulfill all the aspects of consent by completing an informed consent form (ICF), research indicates poor execution of the IC process by ill-informed patients with little comprehension. The present study was done on patients to assess their understanding and involvement in the consenting process, thereby providing insight into the adequacy and sufficiency of the IC process.
Materials and methodology
Patients undergoing elective surgical procedures were surveyed using a questionnaire to study whether the written informed consent (IC) process was adequately used in elective surgeries and to assess the patient’s understanding of the IC and whether the informed consent forms (ICF) used met the ethical and legal standards for this purpose. The questionnaire was administered to the patients by two surveyors. As per the inclusion/exclusion criteria, data was collected from 221 admitted patients who were planned to undergo or recently underwent various elective surgical/operative procedures. Descriptive analysis using frequency and percentages of the positive and negative responses was used to analyse the data.
Results
In 219 (99%) of the cases, informed consent was taken. Two hundred-eight patients (94.1%) understood the knowledgeable consent information, while 13 (5.9%) did not. Of the total 221 patients, more than 90% of patients were informed about the nature and indication of the surgery. The expected benefits were told to 83.25% of patients, while possible complications of the procedure were reported to 91 patients (41.2%). Of the total, 58.37 % of patients knew the type of anaesthesia used for elective surgery. Two hundred and sixteen (97.73%) patients favoured the informed consent process, and 213 (96.38%) were satisfied with the information provided in the consent form. The education status of the patient varied, with nearly 15.5% being illiterate while 35.3% being educated till high school. Patients undergoing surgical procedures must be explained the nature and indication of the proposed surgical treatment, including its benefits and risks. About 208 (94.1%) of the patients stated that they understood all the information provided in the ICF, and 213 patients (96.3%) were satisfied with it. Most patients (88.7%) exercised autonomy in deciding to undergo surgery. Ninety-seven percent of patients favoured the IC process, of which 38.46% believed informed consent has a medicolegal significance.
Conclusion
The present study revealed that a better understanding of the informed consent by the patients is a vital component of the process as it helps exercise autonomy in the decision-making process. However, the lack of information in the informed consent forms critically affects the quality and adequacy of the IC, thus posing ethical and legal challenges to genuinely informed consent.

How informed is informed consent?—Evaluating the quality of informed consent among surgical patients in a tertiary care hospital in Nepal
Research Article
Sunil Basukala, Oshan Shrestha, Niranjan Thapa, Sagun Karki, Ayushma Pandit, Bikash Bikram Thapa, Anup Thapa
PLOS One, 10 July 2023
Open Access
Abstract
Background
Informed consent-taking is a part of clinical practice that has ethical and legal aspects attached to it. This protects the autonomy of the patients by providing complete information regarding the rationale, modality, potential risks, benefits, and alternatives of the planned procedure to the patients. This enables the patients to make the right decision for themselves and their care. This study aims to find out if the informed consent-taking process has ensured the active participation of the patients or the next of kin in the decision-making.
Materials and methods
This is a prospective cross-sectional study conducted in a military healthcare institution among patients undergoing major surgical procedures from July 2022 to October 2022. Ethical clearance was obtained before the commencement of this study. A structured questionnaire was prepared, and the collected data was refined in Excel and imported into SPSS for analysis.
Results
A total of 350 individuals of mean age 47.95 ± 16.057 years were part of this study. The majority of the respondents were married, literate, and family by beneficiary category. All of the respondents received and signed the consent form. About 77% of the respondents read it completely, and 95.4% of them reported that it was understandable. The majority of the patients did not know who was going to perform the surgery, the alternatives to the planned treatment, the benefits of the surgery, or the outcome of non-treatment. On the patient satisfaction scale, 16.28% of the participants agreed that they were satisfied with the informed consent-taking process.
Conclusion
Deficiencies in the informed consent-taking process were the lack of dissemination of adequate information on the nature, duration, pros and cons, post-operative state, and alternative of the planned procedure. A well-structured format of the consent form that is specific to a particular procedure should be adopted, and various alternatives to it must be disseminated to the patient or the next of kin to improve the quality of the informed consent-taking process.

Informed consent in cancer clinical drug trials in China: a narrative literature review of the past 20 years
Review
Xing Liu, Xiaoran Lu, Wei Zhou, Jessica Hahne, Kaveh Khoshnood, Xiaoting Shi, Yuqiong Zhong & Xiaomin Wang
Trials, 7 July 2023; 24(445)
Open Access
Abstract
Background
Although the number of cancer clinical drug trials is increasing rapidly in China, issues concerning informed consent in this research context are understudied. By performing a narrative literature review, we aim to describe the current situation and identify the most salient challenges affecting informed consent in cancer clinical drug trials among adult patients in China since 2000.
Methods
We searched Web of Science (WOS), PubMed, Scopus, EMBASE, the Cochrane Library databases, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database on Disc (CBMdisc), Chinese Scientific Journals Fulltext Database (CQVIP), and WANFANG Data to identify relevant publications since 2000. Data were extracted by three reviewers on six items pertaining to study type, theme, and challenges.
Results
We identified 37 unique manuscripts, from which 19 full texts were obtained and six were included in the review. All six studies were published in Chinese journals, and the publication years of the majority (five out of six) of the studies were 2015 or later. The authors of the six studies were all from clinical departments or ethical review committees at five hospitals in China. All of the included publications were descriptive studies. Publications reported challenges related to the following aspects of informed consent: information disclosure, patient understanding, voluntariness, authorization, and procedural steps.
Conclusion
Based on our analysis of publications over the past two decades, there are currently frequent challenges related to various aspects of informed consent in cancer clinical drug trials in China. Furthermore, only a limited number of high-quality research studies on informed consent in cancer clinical drug trials in China are available to date. Efforts toward improvement of informed consent practice, in the form of guidelines or further regulations in China, should draw on both experience from other countries and high-quality local evidence.

Impact of mHealth on Informed Consent for General Anaesthesia in a Low to Middle-Income Country: A Double- Blind Randomized Control Trial
Vitalis Mung’ayi, David Nekyon, Jasmit Shah
International Journal of Anesthetics and Anesthesiology, June 2023
Open Access
Abstract
Background
Complimentary methods to support the anaesthesia consent process are underutilized in low and middle-income countries (LMICs).
Objective
To establish whether patients who access a mobile health (mHealth) application following a preanaesthesia review have better knowledge of the anaesthetic process and higher satisfaction overall than those who receive a patient information leaflet.
Study population
Adult patients for elective surgery under general anaesthesia at the Aga Khan University Hospital, Nairobi.
Methodology
This was a double-blind randomized control trial conducted between January and May 2019, with patients randomized to either an mHealth application or an information leaflet. The proportion of patients in each arm who achieved a set score of 9 on a survey designed to test knowledge was evaluated.
Results
A total of 72 patients were recruited. While there was no difference in baseline knowledge between the two groups, 71.8% of those in the mHealth group and 17% in the leaflet group achieved the set score of 9 (p < 0.001). A greater proportion of patients without previous anaesthetic experience were very satisfied with the information given.
Conclusions
mHealth is a viable tool for information dissemination for patients in LMICs scheduled for surgery under anaesthesia, and a useful adjunct to the preanaesthesia review.

Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review
Nkosi Busisiwe, Janet Seeley, Ann Strode, Michael Parker
BMC Medical Ethics, 21 June 2023; 24(1) pp 1-16
Open Access
Abstract
Background
Literature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.
Methods
From November 2021 to January 2022, we conducted a literature search using a PRISMA tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.
Results
Out of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.
Conclusion
Our review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process.

A survey on current practice of informed consent process in surgical specialties of a Portuguese tertiary teaching hospital center: What is the state of play?
Original Article
A.L. Vieira, C. Infante, S. Santos, M. Asseiro, C. Ferreira
Ethics, Medicine and Public Health, June 2023
Open Access
Summary
Background
Informed consent is essential in current medical practice and should be a gold standard to be sought in all instances when doctors interact with patients. The aim of this study was to evaluate compliance to the guidelines of the Portuguese health entity regarding the correct filling process of informed consent.
Methodology
An audit was conducted at the operating rooms of a tertiary teaching hospital center in Portugal, in March 2021, in order to verify the presence of informed consent in the clinical file of surgical patients. A representative cohort of 202 clinical files was collected.
Results
An informed consent document was found in only 47% of the clinical files. Merely 21.8% of the informed consent documents included all the items recommended by the guidelines of the Portuguese health entity. Most of these informed consent documents (SIC) included only basic information, with only a small minority including reports about the surgical procedure, information regarding treatment, possible consequences of a missed treatment or complications and possible treatment alternatives. These results do not conform to the standard regulations of the Portuguese health guidelines regarding SIC.
Conclusion
Even though improvements in SIC were attained in recent years, our study suggests that the implementation of SIC is still suboptimal in surgical practice. It is important to raise awareness for the obtention of SIC by the healthcare team, given the ethical importance of such a document in the context of any invasive procedure.