Standard Operating Procedure (SOP) for Bio Medical and Health Research involving Human participants


0. Introductory

1. Preparing Standard Operating Procedures (SOPs): Writing, Reviewing, Distributing and Amending SOPs

2. Constitution of Institutional Ethics Committee (IEC), Selection, Roles and Responsibilities of Members of the IEC

3. Handling Confidentiality and Conflict of interest among Ethics Committee Members

4. Selection and Responsibilities of Independent Consultants

5. Procedures for allowing Guest/Observer to visit Institutional Ethics Committee or attend IEC meeting

6. Management of Submission of Research Study Protocol and Study Related Documents

7. Categorization of Submitted Protocols for Ethics Review

7A. Initial Full-Board Review of Research Study Protocols

7B. Expedited Review of Research Study Protocols

7C. Exemption from Ethics Review of Research Study Protocols

8. Agenda Preparation, Meeting Procedures and Recording of Minutes

9. Review of Amended Protocol, Protocol-related Documents and Resubmitted protocol

10. Continuing Review of Study Protocols

11. Review of Protocol Deviations/Violations/Non-compliance

12. Review of Serious Adverse Events (SAE) Reports

13. Review of Study Completion Reports

14. Management of Premature Termination/Suspension/Discontinuation of the Study

15. Request for Waiver of Written Informed Consent and Waiver of Consent

16. Site Monitoring and Post-Monitoring Activities

17. Dealing with Participants’ Requests and Complaints Coming to Ethics Committee

18. Maintenance of Active Study Files, Administrative Records of the Ethics Committee, Archival of Closed Files and Retrieval of Documents

19. Reviewing Proposals involving Vulnerable Populations

20. Preparing for Ethics Committee Audit/Inspection

21. Training and Assessment of Ethics Committee Members

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