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 18 Maintenance of Active Study Files, Administrative Records of the EC, Archival of Closed Files and Retrieval of Documents

SOP 19 Reviewing Proposals involving Vulnerable Populations 

 SOP 20 Preparing for Ethics Committee Audit Inspection

SOP 21 Training and Assessment of Ethics Committee Members