Institutional Ethics Committee-CHARUSAT (IEC-CHARUSAT)
The Institutional Ethic Committee-CHARUSAT (IEC-CHARUSAT) is a formally designated independent entity which reviews, approves and monitors all research projects involving human participants. The primary aim of the IEC-CHARUSAT is to protect the rights and welfare of all the participants of the biomedical /clinical research.
The mandate of IEC-CHARUSAT is to ensure participants be exposed to minimum risk or no risk i.e which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of the general population or during the performance of routine physical or psychological examination, procedure or tests.
The mandate of IEC-CHARUSAT is to ensure the volunteer participation, dignity, rights, safety and well being of participants during the biomedical or clinical study and to provide transparent assurance of protection that the research is carried out upholding the ethical values. IEC-CHARUSAT will keep all emerging ethical issues keeping in the view of social, cultural, economic, legal and religious concerns of the society. Ethics is a subject of discussions and debates and each and every word and line will be deliberated by the IEC-CHARUSAT.
Ethical Clinical research and practice must respect all four of the basic prima facie moral commitments: autonomy, justice, beneficence and Non-maleficence - plus concern for their scope of application. These “four principles plus scope” approach provides a simple, accessible, and culturally neutral approach for considering ethical issues.
IEC-CHARUSAT is constituted in line of ICMR guideline 2017 for National Ethical Guidelines for Biomedical and Health Research involving Human Participants, and registered successfully with Department of Health and Research (DHR), Govt. of India, New Delhi, Central Drugs Standard Control Organisation (CDSCO), Govt. of India, New Delhi and U.S. Department of Health and Human Services (HHS) & Registration of an Institutional Review Board (IRB).
| Sr. No | Name of Member | Designation & Affiliation | Position at IEC-CHARUSAT |
|---|---|---|---|
| 1 | Dr. Swapnil S. Agarwal | Professor & Head, Department of Forensic Medicine & Toxicology, Bhaikaka University, Karamsad | Chair Person |
| 2 | Dr. Hemant Tiwari | Assistant Professor, NHL Municipal Medical College, V.S Hospital, Ahmedabad | Basic Scientist |
| 3 | Dr. Shivpriya Kirubakaran | Associate Professor, Dean, Students Affairs, IIT Gandhinagar | Basic Scientist |
| 4 | Dr. Bhavtosh Anilkumar Kikani | Assistant Professor, PDPAIS, CHARUSAT | Basic Scientist |
| 5 | Dr. Praveen R Singh | Professor, Pramukhswami Medical College, Karamsad | Basic Medical Scientist |
| 6 | Dr. Devang Rana | Assistant Professor, Smt. NHL Medical College, V S Hospital | Basic Medical Scientist |
| 7 | Dr. Sandip B Patel | Assistant Professor, L. M Pharmacy College, Ahmedabad | Basic Scientist |
| 8 | Dr. Reshma Pujara | Consultant Neonatologist and Paediatrician, Shree Krishna Hospital, Karmsad. | Clinician |
| 9 | Dr. Manishkumar Patel | Professor, J S Ayurveda College, Maganbhai Adenwala Mahagujarat University, Nadiad | Basic Medical Scientist |
| 10 | Dr. Udayshankar Singh | Professor, Pramukhswami Medical College, Karamsad | Clinician |
| 11 | Mayur Khunti | Advocate, Gujarat High Court, Ahmedabad | Legal Expert |
| 12 | Dr. Shivani D Mishra | Director, Department of Social Work, Sardar Patel University, Vallabh Vidyanagar, Anand. | Social scientist |
| 13 | Mr. Bharatbhai Dave | Graduate from Aardi | Layperson |
| 14 | Dr. Deepak K | Associate Professor, MTIN, CHARUSAT | Joint Member Secretary |
| 15 | Ms. L Surbala | Assistant Professor, ARIP, CHARUSAT | Member Secretary |
- 1. authority for formation
- 2. sop for sops
- 3. ec composition
- 4. review of clinical trial protocol
- 5. process of review
- 6. Decision Making and Post Review Activities
- 7. Monitoring of Research Projects
- 8. Administrative Support
- 9. Record Keeping and Archival
- 10. Master Training & Self-Assessment
- 11. Amendment-1
- 12. Amendment-2
- 2. confidentiality coi agreement for members
- 2.1 format for declaration of conflict of interest for iec members or investigators
- 3. rights responsibilities of research participants
- 4. application format for investigator initiated full committee or exempt review project
- 4.1 protocol format for investigator initiated full committee or exempt review project
- 4.2 participant information sheet
- 4.4 informed consent form
- 5. application format for industry or government initiated full committee review project
- 5.1 participant information sheet
- 5.3 informed consent form
- 6. application format for investigator initiated case reports reveiw
- 6.1 protocol format for investigator initiated case reports reveiw
- 6.2 case report consent or assent form
- 7. project submission check lists for investigators
- 8. format of response to query letter by investigator
- 8.1 Suggestion letter
- 9. Approval letter - Academic Research
- 9. Format of approval letter by institutional ethics committee - Clinical Trials
- 10. Format for Site Monitoring Report
- 10.1 av consenting monitoring report - regulated trial
- 11. who tool for causality assessment-converted
- 12. reviewer format institutional ethics committee
- 13. format of iec report to CDSCO in SAE
- 14. Format for Detailed Summary of Protocol Changes
- 15. Approval letter of Clinical Trials
- 16. Checklist informed consent document-converted
- 17. GCP Inspection Checklist
- 18. Documents Checklist for Clinical Trial
- 19. Checklist_review_of_sae-converted
- 20. Apendix_xi_-_schedule_y_0-converted
- 21. Appendix_xii_-_schedule_y_0-converted
- 22. Research_participant_interview_guide_english (1)-converted (1)
- 23. Format_for_project_report_submission
- 24. Declaration_by_PI_participant_recruitmentn
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