Research approvals iceberg: helping it melt away
Simon E Kolstoe1, David Carpenter2
1School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, PO1 2UP, UK. simon.kolstoe@port.ac.uk.
BMC Medical Ethics
|December 25, 2019
Summary
The UK's health research regulatory system faces criticism for its complexity. However, a new analysis suggests this complexity arises from conflating ethics review with governance and funding, not just ethics approval.
Area of Science:
- Health research regulation
- Research ethics and governance
Background:
- Critique of the UK health research regulatory environment by Petrova and Barclay.
- Highlighting the significant number of professionals (89) required for a single "low-key" study approval.
Discussion:
- Authors, experienced in NHS research ethics, share frustration with the UK regulatory process.
- Argue Petrova and Barclay's analysis is misleading by conflating research ethics with governance and funding.
- Emphasize the need to distinguish between Health Research Authority, local governance, and sponsor interactions.
Key Insights:
- The UK's health research approval process is complex and requires significant professional input.
- Misinterpretation of regulatory components can lead to inaccurate critiques of the system.
- Clearer differentiation between ethics, governance, and funding is crucial for accurate assessment.
Outlook:
- Potential for streamlining regulatory processes by clarifying distinct functions.
- Need for improved understanding and communication regarding research oversight mechanisms.
- Future improvements depend on accurately identifying and addressing specific bottlenecks in the research approval pathway.
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