Improving the process of research ethics review
- PMID: 29451537
- PMCID: PMC5803582
- DOI: 10.1186/s41073-017-0038-7
Improving the process of research ethics review
Abstract
Background: Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.
Main body: Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.
Conclusion: Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.
Keywords: Applied ethics; Institutional Review Boards; Medical research; Research Ethics Boards; Research Ethics Committees; Research ethics.
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References
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- Canadian Institutes of Health Research, Natural Sciences and Engineering Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2014. http://www.ethics.gc.ca/eng/index/. Accessed 21 Jun 2017.
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- World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects as amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013 U.S. Department of Health. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-pr.... Accessed 21 Jun 2017.
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- U.S. Department of Health and Human Services, HHS.gov, Office for Human Research Protections. 45 CFR 46. Code of Federal Regulations. Title 45. Public Welfare. Department of Health and Human Services. Part 46. Protection of Human Subjects. Revised January 15, 2009. Effective July 14, 2009. Subpart A. Basic HHS Policy for Protection of Human Research Subjects. 2009. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/. Accessed 21 Jun 2017.
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