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


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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

List of Projects

  1. DIVERSITY OF MICROBIOME IN THE URINE OF PREMENOPAUSAL WOMEN WITH ACUTE UNCOMPLICATED URINARY TRACT INFECTION : A CASE CONTROL STUDY
  2. A SINGLE CENTER EXPERIENCE OF CERVICAL CANCER SCREENING IN AN URBAN PRIVATE HOSPITAL OF TELANGANA STATE.
  3. COVID 19 VACCINATION: PERCEPTIONS, EFFICACY AND SAFETY- A CROSS SECTIONAL OBSERVATIONAL STUDY
  4. PROTOCOL FOR INDIAN MID-LIFE REGISTRY FOR INDIAN MENOPAUSE SOCIETY
  5. DOES PREOPERATIVE VIRTUAL REALITY EXPOSURE HELP IN REDUCING ANXIETY IN WOMEN POSTED FOR OFFICE HYSTEROSCOPY? A PILOT RANDOMIZED CONTROLLED TRIAL.
  6. A PAN SOUTH ASIA STUDY- RELATION OF MENOPAUSE AND METABOLIC SYNDROME
  7. A NATIONAL REGISTRY TO GENERATE REAL WORLD EVIDENCE ON POLYCYSTIC OVARIAN SYNDROME (PCOS) IN INDIA – PCOS INDIA REGISTRY – THE STUDY PROTOCOL
  8. DOES PROCEDURE TIME AND SIZE MATTER FOR IN-OFFICE HYSTEROSCOPY TREATMENT OF RETAINED PRODUCTS OF CONCEPTION TO ACHIEVE THE HIGHEST PATIENT SATISFACTION?
  9. KNOWLEDGE, ATTITUDE AND PRACTICE OF MENOPAUSE HORMONAL THERAPY: CLINICIANS AND CONSUMERS PERCEPTION
  10. AGE AT MENOPAUSE AND ITS DETERMINANTS IN INDIA– A POPULATION BASED STUDY
  11. STATE OF HEALTH MAPPING – A DESCRIPTIVE STUDY TO ASSESS CURRENT STATE OF HEALTH, WELLBEING AND LIFESTYLE OF THE INDIAN PHYSICIAN
  12. A RANDOMIZED CONTROL TRIAL TO EVALUATE THE EFFICACY OF NANO VITAMIN D3 BUCCAL SPRAY SUPPLEMENTATION DAILY FOR 3 MONTHS AND COMPARE IT WITH SIMILAR DOSE OF NANO D3 AND CONVENTIONAL FAT SOLUBLE D3 PREPARATIONS IN TABLET FORMS IN ELDERLY POPULATION
  13. PREVALENCE OF SUBCLINICAL HYPOTHYROIDISM IN INDIAN PATIENTS WITH TYPE 2 DIABETES MELLITUS – A REAL WORLD MULTI-CENTRIC STUDY
  14. REAL WORLD EVALUATION OF USAGE PATTERNS, OUTCOMES, SAFETY AND SYMPTOM RESOLUTION OF ACUTE ISCHEMIC STROKE MANAGEMENT WITH TENECTEPLASE IN INDIA
  15. GENETICS OF DIABETIC RETINOPATHY: INDIAN PERSPECTIVE
  16. PREVALENCE OF ANEMIA
  17. ALKEM – RID-IR STUDY
  18. ESI – SYNDROMIC OBESITY REGISTRY
  19. ESI –  DSD REGISTRY
  20. WIN REGISTRY
  21. REAL WORLD OBSERVATIONAL STUDY ON THE USAGE, SAFETY AND EFFECTIVENESS OF EVOGLIPTIN IN T2DM PATIENTS IN INDIA
  22. VALIDATION OF GENOTYPE-PHENOTYPE ASSOCIATIONS IN INDIAN POPULATION
  23. REAL WORLD OBSERVATIONAL STUDY ON THE USAGE, SAFETY AND EFFECTIVENESS OF EVOGLIPTIN IN T2DM PATIENTS IN A MULTICENTRIC, CROSS SECTIONAL STUDY TO ASSESS AWARENESS OF RISK FACTORS AND CURRENT BEHAVIOR AMONGST TYPE 2 DIABETES MELLITUS PATIENTS IN INDIA
  24. A MULTICENTRIC, CROSS SECTIONAL STUDY TO ASSESS AWARENESS OF RISK FACTORS AND CURRENT BEHAVIOR AMONGST TYPE 2 DIABETES MELLITUS PATIENTS IN INDIA
  25. DOES PREOPERATIVE VIRTUAL REALITY EXPOSURE HELP IN REDUCING ANXIETY IN WOMEN POSTED FOR OFFICE HYSTEROSCOPY? A PILOT RANDOMIZED CONTROLLED TRIAL.
  26. A STUDY TO EVALUATE THE SUBSIDENCE OF TIBIAL BASE PLATE IN POST TOTAL KNEE ARTHROPLASTY PATIENTS
  27. ROLE OF BLOOD UREA NITROGEN TO SERUM ALBUMIN RATIO IN PREDICTING OUTCOMES OF CRITICALLY ILL ICU PATIENTS
  28. EARLY DIAGNOSTIC MARKERS IN PREDICTING SEVRITY OF DENGUE DISEASE
  29. DETERMINE THE RESISTANCE PATTERN OF ENTEROBACTERIACEAE IN A TERTIARY CARE CENTER
  30. GENERATION OF NORMATIVE REFERENCE RANGES FOR SERUM TESTOSTERONE MEASURED USING LC-MS/MS ASSAYS IN HEALTHY ADULT INDIAN POPULATION
  31. THE STUDY ON ASSOCIATION OF SERUM URIC ACID LEVEL WITH URINE ALBUMIN LEVEL IN TYPE-II DIABETES MELLITUS
  32. CORRELATION OF SERUM GAMMA GLUTAMYL TRANSFERASE AND HS-CRP LEVELS IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH GOOD AND POOR GLYCEMIC CONTROL
  33. INDIAMET(INDIAN METABOLIC PROFILE) STUDY – A CROSS SECTIONAL NATION-WIDE STUDY OF CARDIOMETABOLIC PROFILE OF INDIAN ADULTS
  34. ARTIFICIAL INTELLIGENCE-ENABLED REFERRAL PATHWAYS FOR EARLY DIAGNOSIS OF COMPLICATIONS ARISING FROM DIABETES: APPLICATION TO DIABETIC RETINOPATHY
  35.  RELATION BETWEEN DIAMETER OF FEMORAL HEAD  AND DISTANCE BETWEEN CENTRE OF FEMORAL HEAD TO UPPER END OF LESSER TROCHANTER.

Ethics Committee Certificate


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Ethics Committee cover letter


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Co-Ordinator information

FAWZIYA

Ethics Committee Co Ordinator
Mobile no

+91 8106469461, +91 9642757000

Email Id

tanvirhospitalecbhr@gmail.com