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Local Research Ethics Committees can audit ethical standards in research
1Princess Royal Hospital, Haywards Heath, West Sussex.
Journal of Medical Ethics
|February 6, 1998
Summary
A Local Research Ethics Committee (LREC) successfully audited research ethics, finding that ethical standards for subject recruitment and consent were partly met. This demonstrates LRECs
Area of Science:
- Medical Ethics
- Clinical Research Governance
Background:
- Local Research Ethics Committees (LRECs) play a crucial role in overseeing research conduct.
- Ensuring ethical standards in clinical trials is paramount for participant protection and data integrity.
Purpose of the Study:
- To demonstrate the capability of an LREC to conduct an audit of research ethical standards.
- To assess adherence to ethical guidelines in subject recruitment and informed consent processes within clinical trials.
Main Methods:
- A postal questionnaire was employed as the primary data collection tool.
- The audit focused on clinical research conducted by a single physician over a one-year period, involving eleven patients.
Main Results:
- The audit was successfully executed by the LREC, demonstrating its capacity for such oversight.
- Partial achievement of ethical standards was noted in the recruitment of subjects and the process of obtaining informed consent.
Conclusions:
- LRECs are capable of auditing the ethical conduct of research projects they have approved.
- Proactive planning for potential audits can be integrated into the initial application process for research ethics review.
- The audited research met acceptable ethical standards as determined by the reviewing committee.
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