The role of community advisory boards in community-based HIV clinical trials: a qualitative study from Tanzania

Background Community Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania. Methodology We adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1. Results The findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. Conclusion The study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants.

Capacity of community advisory boards for effective engagement in clinical research: a mixed methods study

Background Community engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda. Methods We conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis. Results Seventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24–70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity. Conclusion Though CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants.

Critérios de seleção de patologias para investigação em Saúde

Procuramos identificar os critérios que conduzem à seleção para investigação de determinadas patologias. O objetivo é verificar se tais critérios são adequados às necessidades de investigação em saúde e respondem aos problemas globais de saúde pública. Tentámos confrontar o que diz a informação científica publicada com a nossa experiência na Comissão de Ética para a Investigação Clínica. Na maioria dos repositórios consultados, há poucas referências a prioridades ou seleção de prioridades, reportando-se a aspetos concretos de patologias específicas. O motor de busca EuropePMC identifica perto de 40 mil entradas, sendo o mais significativo que encontrámos. Analisámos alguns dos artigos pela abordagem ética, metodológica para a investigação médica e suas prioridades, nomeadamente, a participação dos pacientes. A interação entre medicamentos antirretrovirais e o consumo de drogas injetáveis e a inclusão de pacientes UDI em ensaios clínicos só foram investigadas pelas companhias farmacêuticas (e pelos próprios investigadores), pelo confronto e pressão dos principais Community Advisory Boards (CAB), nomeadamente o European CAB. A seleção e arbitragem entre patologias para a investigação não parecem despertar muito interesse por parte de investigadores e da Academia. São os financiadores da investigação, entidades, públicas ou privadas, com ou sem fins lucrativos, que selecionam as áreas a investigar. Nas empresas farmacêuticas, é o retorno económico: doenças de países e regiões de baixos recursos ou raras não têm um mercado. Têm sido as organizações multilaterais e fundações de âmbito global, com os seus financiamentos, a definir as prioridades das investigações em áreas de maior impacto global e social.

Capacity of Community Advisory Boards for Effective Engagement in Clinical Research; a Mixed Methods Study

Background: Community engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda.Methods: We conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis. Results: Seventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR: 24-70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity.Conclusion: Though CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, independence, guidelines for their operations and limited knowledge.

Building an Effective and Empowered Community Advisory Board for Veterans

Although many successful Community Advisory Boards (CABs) are discussed in the literature, some articles report that community members feel they are treated as token participants, or that their voices are not heard. This article describes the initial steps we took in designing an effective and empowered CAB, the underlying group dynamics principles we employed to formulate this CAB, and the structure and processes we instituted. We focused on how to build decision-making procedures that support and enhance the group’s function and effectiveness over the long term. Additionally, we considered how we might intervene when these features become out of balance. Though the literature on CABs often talks about power dynamics, explanations of what is meant by this label are rare. We resolved to explore these dynamics and to design a CAB that would operate successfully in full recognition of power dynamics.

4554 Researchers’ Experiences Working With Community Advisory Boards: How Community Member and Patient Stakeholder Feedback Impacted The Research

OBJECTIVES/GOALS: To assess researchers’ experiences working with community advisory boards (CABs) and how community member/patient stakeholder feedback impacted the research. METHODS/STUDY POPULATION: Researchers (N = 34) who presented their research to a Mayo Clinic CAB (at MN, AZ, or FL) from 2014-2017 were invited to participate in an interview in-person or by phone averaging 10-15 min. Researchers were asked “In what ways did the feedback you received from the CAB influence your research?” The validated structured 7-item interview included domains assessing potential influence that CABs had on the research: 1) Pre-research (e.g., generated ideas), 2) Infrastructure (e.g., budget preparation), 3) Research design, 4) Implementation (e.g., research recruitment), 5) Analysis, 6) Dissemination, and 7) Post-research (e.g., assist in formulating next steps). RESULTS/ANTICIPATED RESULTS: 17 interviews were completed (8 no longer at Mayo, 9 no response). Researchers presented their study to a CAB a mean of 4 years (range 3-5) before the interview. Researchers reported that the CAB had influenced their research in the following domains: 24% in pre-research, 24% infrastructure, 41% study design, 41% implementation, 6% analysis, 24% dissemination, and 18% for post-research activities. The mean total score was = 1.8 (SD = 1.7, range 0-6), of a possible range of 0-7. DISCUSSION/SIGNIFICANCE OF IMPACT: Impact of CAB feedback on the research was moderate. Ways to enhance impact could include follow-up with researchers and CAB members.

How do community advisory boards fulfil their ethical role in HIV clinical trials? A protocol for a systematic review of qualitative evidence

IntroductionCommunity advisory boards (CABs) continue to gain wide use and acceptance in global health research including in HIV clinical trials. They provide means through which community concerns regarding the trial can be considered by the research team, and provide an important platform of communication between the researchers and the community about study goals. Therefore, this systematic review protocol will guide the review of qualitative evidence on the ethical roles of CABs in HIV clinical trials based on the three fundamental ethical principles: respect for the person, beneficence and justice.Methods and analysisThis systematic review of qualitative evidence will involve searching four medical databases: PubMed, ScienceDirect, CINAHL and Cochrane Library. Additionally, other relevant evidence will be obtained through hand searching and grey literature. Searches will be limited to studies published in the English language from 1989 (the year that CABs were first established in HIV clinical trials) to 2019. Articles searched will be screened by two independent authors based on inclusion and exclusion criteria. Included articles will be appraised for quality using the Critical Appraisal Skills Programme checklist and followed by qualitative data extraction. Findings will be analysed based on the meta-aggregative approach with the aid of EPPI-Reviewer 4 web-based software.Ethics and disseminationEthical approval does not apply to this review. Data will be disseminated through scientific conferences and peer-reviewed journals to inform policies and stake-holders about the ethical role of CABs.PROSPERO registration numberCRD42019133787.