FERCI has developed model SOPs for use by IECs. These are generic and need to be personalized by committees according to their own requirement. Effective dates have also been kept blank. The SOPs from KEM Hospital, Mumbai, Tata Memorial Hospital, Mumbai PSG Medical College, Coimbatore, and FERCAP have been used for guidance.
Click on the following links for the SOPs.
List of Standard Operating Procedures
SOP 1 Preparation of Standard Operating Procedures for Institutional Ethics Committee
SOP 2 Constitution of Institutional Ethics Committee
SOP 3 Handling Conflict of Interest among Ethics Committee Members
SOP 4 Selection and responsibilities of Independent Consultants
SOP 5 Procedures for allowing Guest or Observer
SOP 6 Management of Submission of Research Study Protocol and Study related documents
SOP 7 Categorization of Submitted Protocols for Ethics Review
SOP 7A Initial Full Board Review of New Research Study Protocols
SOP 7B Expedited Review of Research Study Protocols
SOP 7C Exemption from Ethics Review of Research Study Protocols
SOP 8 Agenda Preparation, Meeting Procedures and Recording of Minutes
SOP 9 Review of Resubmitted and Amended Protocols and Protocol- related Documents
SOP 10 Continuing Review of Study Protocols
SOP 11 Review of Protocol Deviations/violations
SOP 12 Review of Serious Adverse Events (SAE) reports
SOP 13 Review of Study Completion Reports
SOP 14 Management of Premature Termination, Suspension, Discontinuation of the Study
SOP 15 Waiver of Written or Verbal Informed Consent
SOP 16 Site monitoring visit
SOP 17 Dealing with Participants’ Requests and Complaints Coming to Ethics Committee
SOP 19 Reviewing Proposals involving Vulnerable Populations