Regulation on the Local Bioethics Committee
Standard Operating Procedures (SOPs)
- Writing, Reviewing, Disseminating and Revising SOPs
- Maintaining Confidentiality in the Work of the LEC
- Selection of Independent Consultants
- Process for Submitting an Application for Review of a Research Document Package (protocol, etc.)
- Evaluation of a Research Application
- Initial Review of Research Documentation (applications, study protocols)
- Expedited Review of a Research Document Package
- Review of Resubmitted Applications
- Review of Amendments to Research Documents
- Oversight of the Research Process
- Interim Monitoring
- Handling Current Study Documentation
- Noncompliance or Protocol Violations
- Termination of a Study
- Responding to Participants’ Requests
- Notification of Adverse Events and Reactions
- Conduct of LEC Meetings
- Extraordinary LEC Meetings
- Maintaining Confidentiality of LEC Documentation
- Archiving of LEC Documents