Examining Informed Consent Processes for Indigenous families in Research: A Scoping Review Protocol
Cindy Peltier, Lorrilee McGregor, Mia Bourque, Irina Oltean, Nancy Young
Open Science Forum, 4 April 2022
Abstract
Introduction
Though numerous research pursuits in Indigenous communities have been undertaken, very few have consistently addressed community priorities, or collaborated with Indigenous peoples throughout the research process. This scoping review protocol proposes to explore the existing wise consent processes that respect the rights of Indigenous families (parents, children), and Indigenous community protocols.
Methods and analysis
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for conducting scoping reviews will be followed closely. All primary and theoretical studies of any design written in English from January 1st 2000 to March 31st 2022 examining Indigenous approaches to obtaining informed consent among parents or families and/or children and youth, will be included. Two reviewers will independently review the literature in order to apply the inclusion and exclusion criteria. Data from studies will be extracted and charted in NVivo, following the Arksey and O’Malley’s (2005) framework. The Critical Appraisal Skills Programme (CASP) checklists, depending on the study design of each included study, and the original and modified Aboriginal and Torres Strait Islander Quality Appraisal Tool (ATSI) versions, will be used to assess study quality. A narrative synthesis of the informed consent literature will be reported.
Dissemination
This scoping review will evaluate the existing informed consent processes, barriers to consent, and alternative consent processes in the literature. Results will be shared via conferences, reports and social media with our Indigenous communities, and disseminated through a peer-reviewed publication. This scoping review may prove useful to others who are investigating informed consent processes among Indigenous families in research.

Comparative analysis of informed consent for spine surgery in patients in Ethiopia and Poland and the importance of verbal contact with patients based on the medical mission “Polish Medical Team Helping Hand”
Zygmunt Siedlecki, Abat Sahlu, Adu Sileshy, Surafel Mekonnen Mendere, Amanuel Firew Dilnesaw, Yemisirach Bizuneh, Sebastian Grzyb, Bizuayehu Mengesha Tegene, Abenezer Tirsit, Maciej Śniegocki
Journal of Education, Health and Sport, 3 April 2022; 12(2)
Abstract
The authors present a comparative analysis of the issue of legal consents for surgical procedures between Ethiopia and Poland. The analysis is based on the procedures performed as part of the Polish medical mission “Polish Medical Team Helping Hand”. As part of this project, the authors performed ten surgical procedures for percutaneous spine stabilization in soldiers injured during the war with gunshots of the spine and after falling from a height. All soldiers signed informed written consent to the procedure. However, the authors noticed a significant role of additional oral/ verbal (not written) information in discussing the details of the procedure, which in Polish hospitals must be in writing for formal and legal reasons. The authors conclude that while the written consent for surgical treatment is key and necessary both in Poland and in Ethiopia, in the case of medical procedures performed in Ethiopia, oral communication between the doctor and patients and oral explanations are more binding even regardless of the language barrier.

Informed consent in dentistry and medicine in Spain: Practical considerations and legality
M Otero, N Oishi, F Martínez, M-T Ballester, J Basterra
Medicina oral, patología oral y cirugía buccal, 3 April 2022
Abstract
Background
The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any action performed on them and dental or medical doctors are obliged to obtain their patient’s prior written informed consent (IC) before undertaking any healthcare procedures.
Material and methods
Here we reviewed the legality and jurisprudence in Spain regarding IC. We also used INFLESZ text readability analysis software to analyse a sample of official Spanish informed consent documents (ICDs) from different surgical and interventional procedures related to dentistry and oral cavity interventions.
Results
It is a mistake to confound IC with ICDs. This error prevents physicians from considering the former as a care process in which the patient’s authorisation signature is the last link in a chain formed, almost in its entirety, by the informative process and deliberation alongside the patient. Multiple factors can influence communication between practitioners and their patients. Importantly, treatment adherence is greater when patients feel involved and autonomous in shared decision-making and when the circumstances of their lives are adequately considered. We concluded that although the ICDs we analysed conformed to the requirements set out in international law, they were somewhat difficult to read according to the reading habits of the general Spanish population.
Conclusions
Knowledge about the legality of IC helps professionals to understand the problems that may arise from their non-compliance. This is because the omission or defective fulfilment of IC obligations is the origin of legal responsibility for medical practitioners. In this sense, to date, there have been more convictions for defective ICs than for malpractice. The information provided in ICs should include the risks, benefits, and treatment alternatives and must be tailored to the needs and capabilities of the patient to enable autonomous decision-making.

Factors affecting willingness to participate in vaccine clinical trials in an underdeveloped country: perspective from Nepal
Research Paper
Ram Hari Chapagain, Santosh Adhikari, Bishnu Rath Giri, Pankaj Ray, Nisha Jyoti Shrestha, Bina Prajapati, Prakash Joshi, Sunita Pokharel, Suresh Man Tamang, Birendra Prasad Gupta, T. Anh Wartel, Sushant Sahastrabuddhe, Ganesh Kumar Rai, Tarun Saluja
Human Vaccines & Immunotherapeutics, 6 March 2022
Open Access
Abstract
Due to the inherent complex nature of clinical trials, individual’s willingness to participate and hence, enrollment in a clinical trial maybe challenging. When it comes to vaccine clinical trial in children, informed consent needs to be secured from the parents or legally acceptable representatives (LARs). Some of the factors which contribute to hesitancy in taking part in clinical trials are based on the level of education, living standards, part of the world they live, associated burden of disease, fear of different procedures in clinical trial, side effects, limited understanding, limited time, and mistrust with Investigational product. This study included 201 parents/LARs, who approached Kanti Children Hospital site in Kathmandu with the interest to get their children enrolled in a vaccine clinical trial with objectives of describing the reasons for agreeing or disagreeing to participate in the vaccine clinical trial, factors affecting decision making, and finding the major concerns of parents/LARs. The acceptance for the study vaccine was 136 (67.7%) whereas denial was 65 (32.3%). This study showed that age, education level, family structure, advice from family and friends, and medical guidance play important roles in willingness of parents to get their child enrolled in the trial. If a proper counseling is done, fear of blood sampling is not a big factor which is contrary to the belief among clinical researchers. Safety of vaccine, frequency of injections, and cost of vaccine were the main concerns of the parents, which need to be addressed extensively while planning for any clinical trial in children.

Informed consent forms for gynecologic cancer surgery: recommendations from the Korean Society of Gynecologic Oncology
장하균, 심승혁, 이마리아, Won Moo Lee 오경진, 유헌종, 김미경, 김민규, 이광범, 소경아, 김영태, 이대우, Doo-Yoon Hyun 이종민
Obstetrics & Gynecology Science, March 2022; 65(2) pp 105 – 112
Abstract
The sociomedical environment is changing. In the traditional physician-patient relationship, the physician was authoritative and the patient was obedient. The contractual relationship featured patient consent to the physician’s decision. Today, the physician must explain fully the planned medical treatment, and any alternative, to the patient, who has the right to choose her treatment after considering the benefits and side-effects. The Korean Society of Gynecologic Oncology thus decided to standardize the surgical consent forms to meet the legal requirements of modern medicine, improve patient understanding of the surgical details, and protect medical staff from legal disputes. To determine the format and content, subcommittees for each cancer type collected and reviewed all relevant articles and the current consent forms of domestic medical institutions. After several meetings, 16 basic items to be included for each type of gynecologic cancer were selected. Also, to help patients understand the surgical details, figures were included. The revised forms were legally reviewed in terms of the appropriateness of the format and content. We also developed English versions to provide adequate information for foreign patients. We hope that these efforts will promote trust between patients and physicians, and contribute to effective treatment by laying a foundation of mutual respect.

Health care users’ acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda
Research Article [awaiting peer review]
Hellen Nansumba, Mugalula Flaviano, Semanda Patrick, Ssewanyana Isaac, Douglas Wassenaar
Wellcome Open Research, 1 March 2022
Abstract
Background
Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Bio-repository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a short informed consent statement (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda.
Methods
A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental draft ICF for this study was developed and attached to the Laboratory investigation form.
Results
Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. HCUs who did not understand the draft ICF were 90% less likely to accept broad consent compared to those who understood (OR=0.10, CI [0.03-0.32] while those who partly understood the ICF were 73% less likely to accept broad consent compared to those who understood (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health.
Conclusion
Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.

Informed consent in a patient with aortic dissection and mild intellectual impairment
Wafa Abdelghaffar, Elyes Lagha, Fares Azaiez, Nadia Haloui, Rym Rafrafi
QScience, 19 January 2022
Open Access
Abstract
Informed consent is an ethical and legal requirement in modern medicine. A valid consent implies that the patient can decide on treatment after receiving adequate information from his doctor. In case of incapacity and specific conditions, doctors can administer treatments without patient consent. Nonetheless, some cases are borderline, such as the patient presented in this paper who had a mild intellectual impairment and refused to undergo urgent intervention for aortic dissection. In this case, psychiatrists and cardiologists collaborated to check whether the patient could consent and decided to respect his choice. He was not operated, and the local ethical committee agreed with this decision. In Tunisia and developing countries, the paternalistic approach is still prevalent in the doctor-patient relationship. This paper highlights that ethical considerations should be universal and applied to all patients in all cultures and discusses ethical and legal aspects.

Editor’s note: QScience is the online publishing platform from Hamad bin Khalifa University Press, Qatar.

Meaningful Digital Consent in Canada: Recommendations from Pan-Canadian Consent Management Workshops
Nelson Shen, Iman Kassam, Daria Ilkina, Sarah Wickham, Abigail Carter-Langford
Healthcare Quarterly, January 2022; 24(4) pp 40-47
Abstract
The digital health landscape is rapidly evolving with regard to how society accesses and interacts with digital information and technologies. With a largely commercial marketplace, there are growing concerns that users are not fully informed about how their data are used. Canadian privacy legislation is currently undergoing modernization to improve the transparency of commercial information handling practices through the introduction of meaningful consent. This paper reports on workshops held across Canada, exploring the implications of meaningful consent in a digital health context. Recommendations focus on measures to promote transparency, improve digital literacy and foster public trust in digital health innovations.

Consent to Research in Madagascar: Challenges, Strategies, and Priorities for Future Research
Elysée Nouvet, Simon Grandjean Lapierre, Astrid Knoblauch, Laurence Baril, Andry Andriamiadanarivo, Mihaja Raberahona, Chiarella Mattern, LorieDonelle, Jean Rubis Andriantsoa
Canadian Journal of Bioethics, 2022; 5(1) pp 33-44
Open Access
Abstract
The ethical conduct of research in any setting hinges on the voluntary and informed consent of research participants. Working towards consent that is truly voluntary and informed, however, is far from straightforward, and requires attention to contextual factors that may complicate achievement of this ideal in specific research settings. This paper is based on Madagascar’s first “Consent complexities in health research in Madagascar” workshop, held in Antananarivo, Madagascar, in October 2018. It identifies a number of challenges encountered by individuals responsible for the conduct or oversight of health research in Madagascar related to informed and voluntary consent. Key challenges identified included: adaptation of consent tools into local dialects and for limited literacy populations; perceived acquiescence of potential participants regardless of actual preference based on cultural norms; perceived time pressures within tight project timelines to collect data as quickly as possible, limited time for consent processes; fears and taboos related to specific research procedures or topics; and, uncertainty about how best to approach and verify the validity of individual consent in contexts where traditional leaders’ influence is conventionally sought out and respected. Potential strategies for responding to each of these challenges are proposed, as are key questions meriting further study.

Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns
Research Article
Ferdinand Chinedum Maduka-Okafor, Onochie Ike Okoye, Ngozi Oguego, Nnenma Udeh, Ada Aghaji, Obiekwe Okoye, Ifeoma R Ezegwui, Emmanuel Amaechi Nwobi, Euzebus Ezugwu, Ernest Onwasigwe, Rich E Umeh, Chiamaka Aneji
Research Ethics, 8 September 2021
Abstract
School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents.