Ethics Committee

Compliance with best practices for Biomedical & Health Research (BHR) and Clinical Trials (CT)

Tanvir Hospital Institutional Ethics Committee
for Biomedical and Health Research

Ethics Committee
Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure.

The Ethics Committee consists of educational, clinical, bio medical research and administrative activities. At Tanvir hospital we have two separate Ethics Committees –

  1. Biomedical & Health Research (BHR)
  2. Clinical Trials (CT).

Both the committees commonly comprise of 11 qualified members with their details as attached

List of the Ethics Committee Members

Name of MemberQualificationRole/Designation in EC
Dr. Rakesh SahayMBBS (Endocrinology)Chair Person
Dr. Meeta SinghMBBS (MD OBG)Member Secretary - Clinician (Dual Role)
Dr. KanhaRam PatelMBBS (MD-Pharmacology)Basic Medical Scientist
Dr. Prasanna VMBBS (MD-Pharmacology)Basic Medical Scientist
Dr. Spandana NuthakkiMBBS (MD - Obstetrics & Gynaecology)Clinician
Dr. Tanvir SinghMBBS (MD - Obstetrics & Gynaecology)Clinician
Dr. Akanshi SinghMBBS (MD - Obstetrics & Gynaecology)Clinician
Ms. Rubina MajidBSc (MBA)Social Scientist
Mr. Vamshi Krishna GLLB (Civil and Criminal Law)Legal Expert
Ms. Harpreet KaurBA (M.A.)Lay Person
Ms. Reshma KaurB. COM (MBA)Member
Dr. Sarada C VMBBS (Biochemistry)Scientific Member
Ms. Chandini KuncheOther (Computer Sciences Engineering)Other Supporting Staff

List of SOPs

  1. SOP-001: GUIDANCE FOR PREPARING STANDARD OPERATING PROCEDURE DOCUMENT
  2. SOP-002: LIST OF DOCUMENTS
  3. SOP-003: FORMING TH-IEC & STATEMENT OF COMPLIANCE
  4. SOP-004: TH-IEC AUTHORITY AND SIGNATORY
  5. SOP-005: DISSOLVING TH-IEC
  6. SOP-006: ADDING A MEMBER TO TH-IEC
  7. SOP-007: REMOVING A MEMBER FROM TH-IEC
  8. SOP-008: RESIGNATION BY A MEMBER FROM TH-IEC
  9. SOP-009: IEC ROSTER
  10. SOP-010: TERMS OF APPOINTMENT FOR IEC MEMBERS
  11. SOP-011: TERMS OF APPOINTMENT FOR EC COORDINATOR
  12. SOP-012: OBLIGATIONS OF AN INVESTIGATOR
  13. SOP-013: TRAINING AND EDUCATION
  14. SOP-014: EXPECTATIONS FROM IEC MEMBERS’ PRIOR TO MEETING
  15. SOP-015: EVALUATING AND MANAGEMENT OF FINANCIAL INTEREST
  16. SOP-016: LEGALLY AUTHORIZED REPRESENTATIVE AND GUARDIAN FOR CHILDREN
  17. SOP-017: DESIGNATING ‘REVIEWER’ FOR REVIEWING HUMAN RESEARCH STUDY PROTOCOL
  18. SOP-018: OBTAINING CONSULTATION ON PARTICIPANT MATTER FROM AN EXTERNAL INDIVIDUAL/ AGENCY
  19. SOP-019: FEES FOR REVIEWING RESEARCH STUDY PROPOSALS AND HANDLING FINANCES
  20. SOP-020: PREPARING FOR IEC MEETING
  21. SOP-021: MONITORING IEC MEETING FOR QUORUM AND EXPERTISE
  22. SOP-022: REVIEWING BIOMEDICAL & HEALTH RESEARCH STUDY PROTOCOLS THAT DO NOT REQUIRE CDSCO APPROVAL
  23. SOP-023: REVIEWING RESEARCH STUDY PROTOCOLS THAT INVOLVE VULNERABLE POPULATION
  24. SOP-024: REVIEWING MISCELLANEOUS RESEARCH (GENETIC TESTING, HUMAN EMBRYO, FETAL AUTOPSY,
    BIOREPOSITORY SERVICES, STORED BIOSAMPLES, AND HUMANITARIAN EMERGENCIES AND DISASTERS)
  25. SOP-025: REVIEWING PUBLIC HEALTH RESEARCH
  26. SOP-026: REVIEWING SOCIAL AND BEHAVIORAL SCIENCES RESEARCH FOR HEALTH
  27. SOP-027: CONTINUING REVIEW OF BIOMEDICAL & HEALTH RESEARCH STUDY
  28. SOP-028: USE OF SOCIAL NETWORKING SITES OR MOBILE DEVICES FOR HUMAN PARTICIPANT RESEARCH
  29. SOP-029: WAIVER FOR OBTAINING INFORMED CONSENT
  30. SOP-030: ASSENT
  31. SOP-031: CALCULATING END OF STUDY APPROVAL DATE
  32. SOP-032: DOCUMENTING IEC PROCEEDINGS
  33. SOP-033: COMMUNICATING IEC’S DECISION TO INVESTIGATOR
  34. SOP-034: APPEAL OF TH-IEC DECISION
  35. SOP-035: MANAGING NEW INFORMATION
  36. SOP-036: STATUS AND TRANSITIONS OF RESEARCH STUDIES
  37. SOP-037: MANAGING ALLEGATIONS OF UNDUE INFLUENCE ON IEC
  38. SOP-038: CONVENING UNSCHEDULED MEETINGS
  39. SOP-039: HANDLING RECORDS
  40. SOP-040: HANDLING MAJOR PROTOCOL DEVIATION/ VIOLATION
  41. SOP-041: REVIEW OF SAE REPORTS
  42. SOP-042: SELF-ASSESSMENT AND POST-APPROVAL MONITORING OF RESEARCH STUDIES
  43. SOP-043: COMPASSIONATE USE OF INVESTIGATIONAL PRODUCT AFTER COMPLETION OF THE RESEARCH STUDY
  44. SOP-044: PROMPT REPORTING REQUIREMENTS
  45. SOP-045: RESPONDING TO RESEARCH PARTICIPANT’S REQUEST OR COMPLAINT
  46. SOP-046: AUDIT/ INSPECTION BY REGULATORY AGENCY
  47. SOP-047: REPORTING TO SPONSOR/ FUNDING AGENCY REGARDING HUMAN PARTICIPANTS’ RESEARCH

Ethics Committee Certificate

Ethics Committee cover letter

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    Co-Ordinator information

    Chandini.K

    Ethics Committee Co Ordinator
    Mobile no

    +91 7799222150, +91 9642757000