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A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

Nicholls SG, Hayes TP, Brehaut JC, McDonald M, Weijer C, Saginur R, Fergusson D - PLoS ONE (2015)

Bottom Line: No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses.To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional.A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

View Article: PubMed Central - PubMed

Affiliation: School of Epidemiology, Public health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.

ABSTRACT

Background: To date there is no established consensus of assessment criteria for evaluating research ethics review.

Methods: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.

Results: Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.

Discussion: Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

No MeSH data available.


Flowchart of screening process
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pone.0133639.g001: Flowchart of screening process

Mentions: The electronic search resulted in 2939 citations for review. Review of bibliographies for initially retained papers yielded a further 1304 articles. After de-duplication a total of n = 4234 titles and abstracts were reviewed. Screening by both reviewers achieved 94% concordance. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. The main reasons for exclusion were: not research ethics review (n = 3594), not empirical research (n = 420), not human (n = 14). In addition we were unable to locate the full text of 18 articles. Consequently, a total of 198 articles were included for final data extraction (see Fig 1).


A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

Nicholls SG, Hayes TP, Brehaut JC, McDonald M, Weijer C, Saginur R, Fergusson D - PLoS ONE (2015)

Flowchart of screening process
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4520456&req=5

pone.0133639.g001: Flowchart of screening process
Mentions: The electronic search resulted in 2939 citations for review. Review of bibliographies for initially retained papers yielded a further 1304 articles. After de-duplication a total of n = 4234 titles and abstracts were reviewed. Screening by both reviewers achieved 94% concordance. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. The main reasons for exclusion were: not research ethics review (n = 3594), not empirical research (n = 420), not human (n = 14). In addition we were unable to locate the full text of 18 articles. Consequently, a total of 198 articles were included for final data extraction (see Fig 1).

Bottom Line: No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses.To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional.A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

View Article: PubMed Central - PubMed

Affiliation: School of Epidemiology, Public health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.

ABSTRACT

Background: To date there is no established consensus of assessment criteria for evaluating research ethics review.

Methods: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.

Results: Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.

Discussion: Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

No MeSH data available.