Archive for the ‘FABTP Publications’ Category


Who is answerable to whom? Exploring the complex relationship between researchers, community and Community Advisory Board (CAB) members in two research studies in Zambia

Tuesday, March 13th, 2018

Abstract

This paper explores the accountability relationships that arise between researchers, the community and community representative structures known as Community Advisory Boards (CABs). It draws on ethnographic and case study research that documented the history, recruitment, composition and representativeness of two CABs and their relationships with researchers and communities, carried out in two studies in Zambia between 2010 and 2014. The findings revealed contradictions, nuances and imbalances in actual community participation and representation. In both studies, the general population was not given the opportunity to participate in the election of their CAB representatives, and the elected CAB members themselves were initially told to have little or no direct contact with research participants whom they were supposed to represent (unless researchers dictated otherwise). Owing to the researchers’ monopoly of scientific knowledge, literacy and financial resources, power relations were imbalanced. Further, researchers were quick to ask for and formalise community commitment through the CABs whilst reticent about their own accountability to the community. Yet despite these imbalances and CABs lacking formal authority over researchers, CABs did have subtle powers arising from their wider influence in the community, which they could tap into to either support or resist research. To achieve a more balanced and open accountability between research stakeholders, more genuine participatory processes need to be built and sustained.

 

Keywords: Accountability, community engagement, community advisory boards (CABs), power, representation

Research priorities during infectious disease emergencies in West Africa

Tuesday, March 13th, 2018

Abstract

Objectives:

This paper presents the results of the consultations conducted with various stakeholders in Africa and other experts to document community perspectives on the types of research to be prioritised in outbreak conditions. The Delphi method was used to distill consensus.

Results:

Our consultations highlighted as key, the notion that in an infectious disease outbreak situation, the need to establish an evidence base on how to reduce morbidity and mortality in real time takes precedence over the production of generalizable knowledge. Research studies that foster understanding of how disease transmission could be prevented in the future remain important, implementation research that explores how to mitigate the impact of outbreaks in the present should be prioritized. Clinical trials aiming to establish the safety profile of therapeutic interventions should be limited during the acute phase of an epidemic with high fatality-and should preferably use adaptive designs. We concluded that community members have valuable perspectives to share about research priorities during infectious disease emergencies. Well designed consultative processes could help identify these opinions.

Keywords:

Consultation; Epidemic; Infectious disease; Research design; Research priorities; West Africa

“I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa

Thursday, August 31st, 2017

Abstract:

Background

Advances in genetic and genomic research have introduced challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for an H3Africa genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand ethical challenges in obtaining informed consent in the RHDGen study.

Methods

We used a qualitative study methodology involving in-depth interviews and participant observations. Our study participants were RHDGen cases (patients), healthy controls and research staff involved in the recruitment of RHDGen cases and controls. In total, we conducted 32 in-depth interviews with RHDGen cases and controls, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen cases and controls. The interviews were conducted in English, audio-recorded and transcribed verbatim. Data were analyzed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa.

Results

Most healthy controls joined the RHDGen study in order to be screened for rheumatic heart disease (diagnostic misconception). A majority of RHDGen cases decided to join the RHDGen study because of therapeutic misconception.

Conclusion

The ethical challenges that impacted on obtaining informed consent in the RHDGen study were complex. In this study, the main challenges were diagnostic misconception among RHDGen controls and therapeutic misconception among RHDGen cases.

 

Masiye, Francis, Bongani Mayosi, and Jantina de Vries. ““I passed the test!” Evidence of diagnostic misconception in the recruitment of population controls for an H3Africa genomic study in Cape Town, South Africa.” BMC Medical Ethics 18.1 (2017): 12.

Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs

Thursday, August 31st, 2017

Abstract: Heightened global commitment to research on diseases such as HIV/AIDS, tuberculosis, and malaria has led to increased research over the past decade in many African countries, including Nigeria. This increase in research has led to debates about the ethics of health research in resource-poor or developing countries and has drawn further attention to existing ethical review processes. This study was undertaken to describe and benchmark the operational and organizational structures as well as functions of research ethics committees (RECs) in Nigeria. The article explores the factors that contribute to REC conformity with the Nigerian National Ethics Code and World Health Organization (WHO) guidelines for RECs. Data were collected using a self-administered, semistructured questionnaire. A descriptive analysis was conducted, and Fisher’s exact tests performed to assess associations between selected REC characteristics and the degree of conformity to applicable national and international requirements. Eighty percent of RECs (20 out of 25) had standard operating procedures, while 68% (17 out of 25) met at least quarterly and provided final review determinations within three months. RECs with committee chairs who had prior bioethics training were more likely to have operations conforming to the WHO and the Nigerian ethics guidelines. Overall, this study suggests that there is variability in the degree to which operations and functions of RECs in Nigeria conform to the Nigerian National Code and WHO guidelines.

 

Research Ethics Committees in Nigeria: A Survey of Operations, Functions, and Needs,. Aminu A. Yakubu, Adnan A. Hyder, Joseph Ali, and Nancy Kass. IRB: Ethics & Human Research. 2017. May-June 2017 Volume: 39, Issue: 3

A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana

Monday, November 7th, 2016

Abstract Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country (LMIC) settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana (UB) about the review of research protocols by local IRBs. Data were collected using a web-based survey (SurveyMonkey). This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced high rates of approval at government ministries and UB, and generally believed that ethics review processes can help researchers themselves better understand and appreciate research ethics in general. Though only about one-quarter of respondents reported a more positive view of research ethics after interacting with the UB IRB, 56.5 percent reported no change. In contexts where IRBs have recently been established, it can be particularly important to document the perspectives of researchers in order to align expectations with capabilities, and identify areas where IRBs can improve operations. Future efforts to advance research ethics and ethical review in Botswana should include establishing research ethics training requirements and courses for researchers, increasing investment in IRBs and their training, further developing institutional and national research ethics policies, and formalizing agreements between IRBs and others involved in research oversight in the country to support coordinated review.

Silent voices: Current and future roles of African research ethics committee administrators

Thursday, November 3rd, 2016

Efforts to strengthen the capacity of research ethics committees in Africa to date have largely targeted their chairs and members, neglecting an explicit focus on research ethics committee administrators, who often manage the reviews and the review committees. The concept of an administrator as a key role player in research ethics review in Africa is only now emerging. No empirical studies have been conducted to describe their position, roles, and responsibilities or their potential to affect positively the quality and responsiveness of ethics review. This questionnaire-based study found that research ethics committee administrators vary greatly in expertise and responsibilities, identifies the administrators’ potential to improve research ethics review performance in Africa, and outlines specific requirements to realize this potential.

Implementing Community Engagement for Combination Prevention: Lessons Learnt From the First Year of the HPTN 071 (PopART) Community-Randomized Study

Thursday, November 3rd, 2016

Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative

Thursday, September 29th, 2016

Ethical challenges in designing and conducting medicine quality surveys

Wednesday, April 27th, 2016

Objectives

 

To identify and discuss the main ethical challenges related to the conduct of surveys and make suggestions on how to address them.

Method

 

Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented.

Results and conclusions

 

It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These are: impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed.