Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa

Tsoka-Gwegweni, Joyce Mahlako; Wassenaar, Douglas

doi:10.1177/1556264614553172

Cited by 33 publications

(58 citation statements)

References 27 publications

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“…[15] They grouped ethics queries to applicants by eight principles in a framework described for the ethics review of biomedical research. [16] The rates per principle are shown in Table 4.…”

Section: Discussionmentioning

confidence: 99%

What changes are there in decisions by the Wits Human Research Ethics Committee (Medical) and in process errors by research applicants between 2003 and 2015?

Cleaton‐Jones

2016

S Afr J BL

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Objective. A retrospective examination of numbers of applications, decision rates, and process errors in 2015 was done for comparison with earlier studies to understand current ethics secretariat workload. Methods. In December 2015 information from committee minutes of all the meetings (N=11) in 2015 (January -November) was collected to quantify change in application numbers and process errors. Statistical analysis used SAS for Windows (version 9.4). Statistical significance was set at p<0.05. Results. There were 809 new general research applications considered in 2015. Monthly approvals at first evaluation ranged from 4 to 30% with an overall approval rate of 16%. Minor revision was required in 72%, major revision in 11% and 1% of applications were not approved. The χ 2 test for trend for initial approval showed a statistically significant decrease across the study periods (p<0.0001). However, the χ 2 test for trend for pending responses from applicants was also statistically significant (χ 2 =29.64). Informed consent and missing information process errors were the most frequent. There were statistically significant increases in lapses of confidentiality methods (p<0.0001) and discrepancies on application forms (p<0.005). Conclusion. Applications to the Wits Human Research Ethics Committee (Medical) (HREC (M)) for ethics clearance almost doubled between2003 and 2015 while approvals at first evaluation approximately halved. This has increased the workload on the HREC (M) secretariat. Process error rates are similar to those in an earlier study except that confidentiality and discrepancies have shown a statistically significant increase. Given limitation on the number of secretariat staff in the current stringent financial circumstances of South African universities, applicants need to improve the quality of their applications to increase approval at first review and reduce secretariat workload.S Afr J Bioethics Law 2016;9(2):69-72.

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Section: Discussionmentioning

confidence: 99%

What changes are there in decisions by the Wits Human Research Ethics Committee (Medical) and in process errors by research applicants between 2003 and 2015?

Cleaton‐Jones

2016

S Afr J BL

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“…Norman Daniels employed benchmarks in health care reform that have been widely discussed and used for policy guidance [ 32 , 33 ]. Similarly, Emanuel et al developed an ethics framework that combines principles and benchmarks to assess the ethical acceptability of clinical trials in developing countries [ 30 ], an approach also embraced by others [ 34 ].…”

Section: An Ethics Assessment Of An Innovative Ahcipmentioning

confidence: 99%

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest

Meslin

Rager

Schwartz

et al. 2015

Clinical & Translational Med

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Relationships between industry and university-based researchers have been commonplace for decades and have received notable attention concerning the conflicts of interest these relationships may harbor. While new efforts are being made to update conflict of interest policies and make industry relationships with academia more transparent, the development of broader institutional partnerships between industry and academic health centers challenges the efficacy of current policy to effectively manage these innovative partnerships. In this paper, we argue that existing strategies to reduce conflicts of interest are not sufficient to address the emerging models of industry-academic partnerships because they focus too narrowly on financial matters and are not comprehensive enough to mitigate all ethical risk. Moreover, conflict-of-interest strategies are not designed to promote best practices nor the scientific and social benefits of academic-industry collaboration. We propose a framework of principles and benchmarks for “ethically credible partnerships” between industry and academic health centers and describe how this framework may provide a practical and comprehensive approach for designing and evaluating such partnerships.

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“…Renewal forms (progress reports) should enable researchers to describe progress in the preceding year, to promote 'sustained' engagement. This might impact the percentage of inquiries that RECs raise about engagement [32][33][34].…”

Section: Discussionmentioning

confidence: 99%

Strengthening stakeholder engagement through ethics review in biomedicalHIVprevention trials: opportunities and complexities

et al. 2018

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IntroductionClinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for HIV prevention researchers to implement “stakeholder engagement” are increasingly common. Such engagement is held to benefit inter‐stakeholder relations, stakeholders themselves and the research itself. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in HIV prevention trials. However, this is not necessarily straightforward. In this article, we consider several complexities. First, is stakeholder engagement a legitimate component of what Research Ethics Committees (RECs) should review for HIV prevention trials? Second, what are the core features of engagement that should be under ethics review? Third, what are the key practices that should be highlighted in ethics review?MethodsTo address these questions, we examined the international ethics guidelines specialized for such trials (UNAIDS 2012, UNAIDS‐AVAC GPP 2011) and directly applicable to such trials (CIOMS 2016; WHO 2011). Thematic analysis was used to code and analyse these guidelines.Results and discussionEthics guidelines support REC review of engagement. Guidance recommends that engagement be broad and inclusive; early and sustained; and dynamic and responsive. Broad engagement practices include evaluating the context, planning in writing, and resourcing. RECs should assess engagement as part of a comprehensive review, and recommend revisions where necessary. Researchers should profile key elements of engagement valued in ethics guidance, when they draft ethics submissions. Importantly, the ethics review process should not undermine the ‘dynamic responsiveness’ required for excellent engagement in this field.ConclusionsAs evidence‐informed engagement strategies emerge, these should inform the ethics submission and review process. Both parties in the review process should strive to avoid a superficial, check‐list type approach that caricatures what should be a thorough, nuanced ethics review of a rich, responsive engagement process.

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Using the Emanuel et al. Framework to Assess Ethical Issues Raised by a Biomedical Research Ethics Committee in South Africa

Cited by 33 publications

References 27 publications

What changes are there in decisions by the Wits Human Research Ethics Committee (Medical) and in process errors by research applicants between 2003 and 2015?

What changes are there in decisions by the Wits Human Research Ethics Committee (Medical) and in process errors by research applicants between 2003 and 2015?

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest

Strengthening stakeholder engagement through ethics review in biomedicalHIVprevention trials: opportunities and complexities

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