Abstract
Research governance refers to the processes used by institutions to ensure that they are accountable for the research conducted under their auspices. It includes the broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality. Research governance must ensure that the rights of participant patients are paramount at all times. Medical administrators need to be part of their institution’s research governance, and have a full understanding of all components, as well as having an oversight that includes performance reports.
To ensure that confidence by all stakeholders in research occurs, the research governance processes should be transparent and publically available. The roles and responsibilities of all involved should be clearly identified, with systems for monitoring and reporting of fraud and deceit in place. Researchers should receive training in Good Clinical Practice or similar guidelines.
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Further Reading
Australian Code for the Responsible Conduct of Research: https://www.nhmrc.gov.au/guidelines-publications/r39.
FDA Clinical Trials and Human Subject Protection. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/.
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Research Governance Framework for Health and Social Care: Second Edition: https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition.
Salman R, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet. 2014;383(9912):176–85.
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Lowthian, P. (2019). Research Governance. In: Loh, E., Long, P., Spurgeon, P. (eds) Textbook of Medical Administration and Leadership. Springer, Singapore. https://doi.org/10.1007/978-981-10-5454-9_14
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