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Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers

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Title: Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers
Language: English
Authors: Sarven S. McLinton (ORCID 0000-0001-9125-3860), Sarah N. Menz (ORCID 0000-0001-5139-2129), Bernard Guerin (ORCID 0000-0002-2773-0746), Elspeth McInnes (ORCID 0000-0002-1677-572X)
Source: Journal of Academic Ethics. 2024 22(4):735-758.
Availability: BioMed Central, Ltd. Available from: Springer Nature. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: customerservice@springernature.com; Web site: https://www.springer.com/gp/biomedical-sciences
Peer Reviewed: Y
Page Count: 24
Publication Date: 2024
Document Type: Journal Articles
Reports - Research
Education Level: Higher Education
Postsecondary Education
Descriptors: Ethics, Informed Consent, Research Committees, Research Methodology, College Role, Self Evaluation (Groups), Evaluation Research, Research Design, Feedback (Response), Research Training
DOI: 10.1007/s10805-024-09523-w
ISSN: 1570-1727
1572-8544
Abstract: Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. We collected every instance (N = 4,195) of feedback made on N = 197 'low-risk' protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including 'Risk to Researchers', 'Commercial benefit, scope and scale', 'Diversity' (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research.
Abstractor: As Provided
Entry Date: 2024
Accession Number: EJ1446900
Database: ERIC
FullText Text:
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  Data: Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers
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  Data: <searchLink fieldCode="AR" term="%22Sarven+S%2E+McLinton%22">Sarven S. McLinton</searchLink> (ORCID <externalLink term="http://orcid.org/0000-0001-9125-3860">0000-0001-9125-3860</externalLink>)<br /><searchLink fieldCode="AR" term="%22Sarah+N%2E+Menz%22">Sarah N. Menz</searchLink> (ORCID <externalLink term="http://orcid.org/0000-0001-5139-2129">0000-0001-5139-2129</externalLink>)<br /><searchLink fieldCode="AR" term="%22Bernard+Guerin%22">Bernard Guerin</searchLink> (ORCID <externalLink term="http://orcid.org/0000-0002-2773-0746">0000-0002-2773-0746</externalLink>)<br /><searchLink fieldCode="AR" term="%22Elspeth+McInnes%22">Elspeth McInnes</searchLink> (ORCID <externalLink term="http://orcid.org/0000-0002-1677-572X">0000-0002-1677-572X</externalLink>)
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  Data: <searchLink fieldCode="SO" term="%22Journal+of+Academic+Ethics%22"><i>Journal of Academic Ethics</i></searchLink>. 2024 22(4):735-758.
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  Data: BioMed Central, Ltd. Available from: Springer Nature. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: customerservice@springernature.com; Web site: https://www.springer.com/gp/biomedical-sciences
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  Data: <searchLink fieldCode="DE" term="%22Ethics%22">Ethics</searchLink><br /><searchLink fieldCode="DE" term="%22Informed+Consent%22">Informed Consent</searchLink><br /><searchLink fieldCode="DE" term="%22Research+Committees%22">Research Committees</searchLink><br /><searchLink fieldCode="DE" term="%22Research+Methodology%22">Research Methodology</searchLink><br /><searchLink fieldCode="DE" term="%22College+Role%22">College Role</searchLink><br /><searchLink fieldCode="DE" term="%22Self+Evaluation+%28Groups%29%22">Self Evaluation (Groups)</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation+Research%22">Evaluation Research</searchLink><br /><searchLink fieldCode="DE" term="%22Research+Design%22">Research Design</searchLink><br /><searchLink fieldCode="DE" term="%22Feedback+%28Response%29%22">Feedback (Response)</searchLink><br /><searchLink fieldCode="DE" term="%22Research+Training%22">Research Training</searchLink>
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  Data: 10.1007/s10805-024-09523-w
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  Data: 1570-1727<br />1572-8544
– Name: Abstract
  Label: Abstract
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  Data: Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. We collected every instance (N = 4,195) of feedback made on N = 197 'low-risk' protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including 'Risk to Researchers', 'Commercial benefit, scope and scale', 'Diversity' (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research.
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  Data: EJ1446900
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