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.