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

ABSTRACT: INTRODUCTION:Community 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 ANALYSIS:This 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 DISSEMINATION:Ethical 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 NUMBER:CRD42019133787.

SUBMITTER: Pancras G

PROVIDER: S-EPMC7213848 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Pancras Godwin G Amour Maryam M Mwakyandile Tosi T Morris Baraka B Sunguya Bruno F BF Mmbaga Blandina B

BMJ open 20200430 4

<h4>Introduction</h4>Community 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 ...[more]

PMID: 32354781

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Project description:National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of "knowledge production" is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR.

Project description:BackgroundPatient participation is highlighted as an important facilitator for patient-centered care. Patient participation organised as patient advisory boards (PABs) is an integral part of health care institutions in Norway. More knowledge is needed on how PAB representatives experience patient engagement (PE) with regard to organisation, influence, and impact. The objective was to describe how PAB representatives experience their tasks, roles, and impact on decision-making processes and service delivery in the setting of rehabilitation institutions.MethodsPAB representatives recruited from rehabilitation institutions completed the Norwegian version of the generic Public and Patient Engagement evaluation tool (Norwegian abbreviation EBNOR). EBNOR is tested for reliability and validity with good results and comprises 35 items within four main domains, policies and practices, participatory culture, collaboration, and influence and impact that provide responses about PE-levels. The domain items are scored from "strongly disagree" to "strongly agree" on a five-point scale, in addition to a don't know category. Items in the domain "influence and impact" are scored from "never" to "all of the time" on a four-point scale. Categorical data were summarized using frequencies and percentages, and response categories were collapsed into three PE-levels: barrier, intermediate, and facilitating level. Free-text responses were analysed according to principles of manifest content analysis, summed up, and used to elaborate the results of the scores.ResultsOf the 150 contacted PAB representatives, 47 (32%) consented to participate. The results showed that approximately 75% agreed that the organisation as a whole was strengthened as a result of patient participation. Four out of five domains were scored indicating a facilitating level; policies and practices (53%), participatory culture (53%), collaboration and common purpose (37%), and final thoughts (63%). The modal score in the domain influence and impact was in the intermediate PE-level (44%). Of a total of 34 codes from free text analyses, barriers to PE were coded 26 times, and PE facilitators were coded 8 times.ConclusionsThe findings indicate that most PAB representatives are satisfied with how rehabilitation institutions organise their PAB, but they still experience their impact as limited.

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

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

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