SOPS OF ETHICS COMMITTEE

MODULE 3

The objective of the SOPs is to contribute to the effective functioning of the Institutional Ethics Committee (IEC) so that a quality and consistent ethical review mechanism for health and biomedical research is put in place for all proposals dealt by the Committee as prescribed by the Ethical guidelines for biomedical research on human subjects of ICMR. An ethics Committee should have well defined SOPs for reviewing and approval of any proposal submitted to them. Below is the list of SOPs categorized as per activity of an ethics committee.

  1. Preparing Standard Operating Procedures (SOPs) for the Independent Ethics Committee (IEC).
  2. Standard Operating Procedures for Constituting the Independent Ethics Committee.
  3. Standard Operating Procedures for Confidentiality /Conflict of Interest Agreements
  4. Standard Operating Procedures for Selection and Responsibilities of Independent Consultants
  5. Standard Operating Procedures for Management of Protocol Submissions
  6. Standard Operating Procedures for Initial Review of Submitted Protocol
  7. Standard Operating Procedures for Projects Submitted to Expedited Review
  8. Standard Operating Procedures for Review of Resubmitted Protocols
  9. Standard Operating Procedures for Review of Amended Protocol/Protocol related documents
  10. Standard Operating Procedures for Continuing Review of Study Protocols
  11. Standard Operating Procedures for review of Study Completion Reports
  12. Standard Operating Procedures for Protocol Deviation/Non-Compliance/Violation
  13. Standard Operating Procedures for Management of Premature Termination of the Study
  14. Standard Operating Procedures for Review of Serious Adverse Event (SAE) Reports
  15. Standard Operating Procedures for Site Monitoring Visit by EC
  16. Standard Operating Procedures for Agenda Preparation, Meeting Procedures and Recording of Minutes
  17. Standard Operating Procedures for Conduct of Emergency Meeting
  18. Standard Operating Procedures for Maintenance of Active Project Files
  19. Standard Operating Procedures to Archive and Retrieve Documents
  20. Standard Operating Procedures for Maintaining Confidentiality of IEC Documents
  21. SOP for correspondence to the PI and communication for the decisions of EC to the PI
  22. SOP for training of SOPs and revision of SOPs

There is training conducted by FERCAP in collaboration with ICMR and provided standard operating procedure handbook for Ethics Committee which is available online as guidance for framing SOP.

Further ICMR has provided lot of training content for ethics committee which is useful for preparation and updation of their SOP. Below is the web-link for the same.

http://icmr.nic.in/human_ethics.htm

Web-link of openly available IEC SOPs:

Many of the hospital sites IEC has provided their SOPs on their website. Few of them is listed below

Forms for Principal Investigator/Research staffs can be viewed from link below
http://www.actrec.gov.in/IRB_main.htm