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Research governance: where did it come from, what does it mean?
Sara Shaw1, Petra M Boynton, Trisha Greenhalgh
1Open Learning Unit, Department of Primary Care and Population Sciences, University College London, Holborn Union Building, Highgate Hill, London N19 5LW, UK. s.shaw@psps.ucl.ac.uk
Journal of the Royal Society of Medicine
|November 2, 2005
Summary
Research formalization offers benefits like reduced misconduct but also drawbacks such as increased paperwork and delayed timelines. Navigating research governance requires human judgment due to contextual variations in approval processes.
Area of Science:
- Social Sciences
- Research Ethics
- Science Policy
Background:
- Research has become increasingly formalized and regulated due to historical and social factors.
- This formalization presents both advantages, such as preventing misconduct and protecting participants, and disadvantages, including administrative burdens and restricted research freedom.
- The interpretation of 'research' and 'governance' varies across contexts, necessitating human judgment even with guidelines.
Purpose of the Study:
- To analyze the impact of research formalization and regulation.
- To explore the complexities and variations in research governance and approval processes.
- To highlight the role of human judgment in resolving ambiguities in research oversight.
Main Methods:
- Qualitative analysis of research regulation frameworks.
- Review of historical and social factors influencing research governance.
- Examination of contextual elements affecting research approval decisions.
Main Results:
- Formalization yields benefits (e.g., fraud reduction, participant protection) and drawbacks (e.g., paperwork, delays).
- Ambiguities in research and governance terms necessitate human judgment for decision-making.
- Approval requirements are contingent upon study specifics: research questions, methods, context, analysis, and dissemination plans.
Conclusions:
- Research governance is a complex, context-dependent process.
- Human judgment remains crucial for effective and ethical research oversight.
- Balancing regulation with research freedom is essential for scientific advancement.