Do research ethics committees identify process errors in applications for ethical approval?

Angell, Emma; Dixon‐Woods, Mary

doi:10.1136/jme.2008.025940

Cited by 29 publications

(34 citation statements)

References 17 publications

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“…They reported that 6.0% of the researchers believed that the FICF was not necessary, 44.0% of the research subjects were not informed on the existence of ethical committees and 12.0% of the researchers believed that the quality of research monitoring could be improved. Angell et al 10 reported a high rate of errors identified by the REC, which corroborates the importance of submitting a project to the assessment of a REC before initiating the research.…”

Section: Discussionsupporting

confidence: 49%

Ética em pesquisas com seres humanos: do conhecimento à prática

Lima¹,

Lima²,

Macedo³

et al. 2010

Arq. Bras. Cardiol.

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Section: Discussionsupporting

confidence: 49%

Ética em pesquisas com seres humanos: do conhecimento à prática

Lima¹,

Lima²,

Macedo³

et al. 2010

Arq. Bras. Cardiol.

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“…The process errors were: procedural violation, missing information, slip-ups and discrepancies -all four were devised by Angell and Dixon-Woods; [7] and an additional four are my categories, namely: informed consent, confidentiality, study sample, and legal.…”

Section: Methodsmentioning

confidence: 99%

“…[2] Briefly they comprise: • procedural violations [7] -failure to comply with application procedures • missing information [7] -inadequate information to understand an application • slip-ups [7] -minor errors • discrepancies [7] -inconsistencies • informed consent [2] -inadequate or poorly written consent documents ARTICLE • confidentiality [2] -inadequate protection of participants • study sample [2] -inappropriate choice, missing permission from relevant authorities • legal [2] -contrary to SA law, potential incrimination.…”

Section: Methodsmentioning

confidence: 99%

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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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“…It is important to spend time getting this right as many committee members begin by reading this part, and most feedback involves changes to the information sheet 7. NRES provide substantial guidance on writing these, and I would suggest that you use their sample templates for guidance, although these should be modified to suit the specifics of your project vi…”

Section: Application Processmentioning

confidence: 99%

A hands-on guide on obtaining research ethics approval

Hunter

2011

Postgraduate Medical Journal

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It is an uncontested truth that many medical students and practising clinicians dread having to get their research proposal through a research ethics committee. In this paper, the author, a long-standing member of a research ethics committee, offers a practical guide on applying for research ethics approval, detailing common mistakes and flaws in applications, and giving specific guidance on getting through what can seem a daunting process.

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Do research ethics committees identify process errors in applications for ethical approval?

Cited by 29 publications

References 17 publications

Ética em pesquisas com seres humanos: do conhecimento à prática

Ética em pesquisas com seres humanos: do conhecimento à prática

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?

A hands-on guide on obtaining research ethics approval

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