Text Box: Preface

SGPGI constituted its first Ethics Committee in 1988. The only guidelines then available for its functioning were the ICMR Policy Statement on Ethical Considerations involved in Research on Human Participants issued in 1980 and the1983 version of WMA Helsinki Declaration. The Committee gradually evolved its own conventions and practice to review the research proposals and to ensure that the rights, dignity, privacy and safety of the research subjects were protected.
 
A number of important National and International Documents were published during the next 10-15 years laying down more detailed guidelines for clinical studies. The work of the Ethics Committee of the Institute also increased and it was facing difficulty in reviewing the project because the submissions were in different formats and several revisions often became necessary.

The Ethics Committee, hence, decided in 2006 to standardize the project submission and review process to facilitate approval and to ensure that no essential component was overlooked. The SOP guidelines were finally approved and published in August 2007 and have been used since then. They have been helpful in achieving uniformity in project submission, reducing revision and time taken for their approval.

Operational problems have been noticed occasionally and appropriate changes have been incorporated. It was, however, being felt that major revision was now necessary because of availability of more focused National and International guidelines and also because of varied nature of projects coming to IEC for review. Hence a SOP Team was constituted by the IEC under the leadership of the Member Secretary to prepare a draft document. IEC has approved it after detailed discussion and appropriate modifications at its meeting in 27th August 2011. It has been accepted by the Director on 17th September 2011 and implemented from 2nd October 2011. We hope this will not only facilitate and expedite project approval but also ensure that no important facets of participants’ safety and privacy are overlooked.

I would like to thank the members of the SOP Team for their dedicated effort in preparing an excellent initial draft and Faculty and IEC members for constructive suggestions. I hope the document is ‘user friendly’ and we would welcome suggestions for improvement in future versions.

Prof. B.N. Dhawan
Chairman IEC, SGPGI

Sanjay Gandhi Postgraduate Institute of Medical Sciences

 

Standard Operating Procedures  of Institutional Ethics Committee (SOPs, IEC)

 

Useful link (Form/template)

 

 

Forms 1-Project submission

 

Form 2-Intimation of start of study

 

Forms 3-Annual status report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 4-Study Completion Report form

 

A. For Interventional study

 

B. For non Interventional study

 

Form 5-Amendment Reporting

 

Form 6-SAE reporting  

 

A. Onsite

                         

B. Offsite

 

Form 7-Deviation-Waiver-Violation-Reporting

 

Form 8-Premature Termination/Suspension/Discontinuation Report

 

Form 9-Review exemption application

 

Form 10-Request for Waiver of Written Informed Consent

 

Form 11-Formulation of New/Revision of SOP

 

Form 12-List of IEC Members

 

Appendices (Policy and Guideline)

Click here to download

Complete SOPs of IEC, SGPGI

 

Useful link (Form/Template)

 

 

Forms 1-Project Submission-Word / PDF

 

Form 2-Intimation of start of Study

 

Forms 3-Annual status Report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 4-Study Completion Report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 5-Amendment Reporting

 

Form 6-SAE Reporting          

 

A. Onsite

                      

B. Offsite

 

Form 7-Deviation-Waiver-Violation-Reporting

 

Form 8-Premature Termination/Suspension/Discontinuation Report

 

Form 9-Review exemption application

 

Form 10-Request for Waiver of Written Informed Consent

 

Form 11-Formulation of New/Revision of SOP

 

Form 12-List of IEC Members

 

Appendices (Policy and Guideline)

Click here to download

Complete SOPs of IEC, SGPGI