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 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 –

Biomedical & Health Research (BHR)
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 Member	Qualification	Role/Designation in EC
Dr. Rakesh Sahay	MBBS (Endocrinology)	Chair Person
Dr. Meeta Singh	MBBS (MD OBG)	Member Secretary - Clinician (Dual Role)
Dr. KanhaRam Patel	MBBS (MD-Pharmacology)	Basic Medical Scientist
Dr. Prasanna V	MBBS (MD-Pharmacology)	Basic Medical Scientist
Dr. Spandana Nuthakki	MBBS (MD - Obstetrics & Gynaecology)	Clinician
Dr. Tanvir Singh	MBBS (MD - Obstetrics & Gynaecology)	Clinician
Dr. Akanshi Singh	MBBS (MD - Obstetrics & Gynaecology)	Clinician
Ms. Rubina Majid	BSc (MBA)	Social Scientist
Mr. Vamshi Krishna G	LLB (Civil and Criminal Law)	Legal Expert
Ms. Harpreet Kaur	BA (M.A.)	Lay Person
Ms. Reshma Kaur	B. COM (MBA)	Member
Dr. Sarada C V	MBBS (Biochemistry)	Scientific Member
Ms. Chandini Kunche	Other (Computer Sciences Engineering)	Other Supporting Staff

List of SOPs

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

List of Projects

DIVERSITY OF MICROBIOME IN THE URINE OF PREMENOPAUSAL WOMEN WITH ACUTE UNCOMPLICATED URINARY TRACT INFECTION : A CASE CONTROL STUDY
A SINGLE CENTER EXPERIENCE OF CERVICAL CANCER SCREENING IN AN URBAN PRIVATE HOSPITAL OF TELANGANA STATE.
COVID 19 VACCINATION: PERCEPTIONS, EFFICACY AND SAFETY- A CROSS SECTIONAL OBSERVATIONAL STUDY
PROTOCOL FOR INDIAN MID-LIFE REGISTRY FOR INDIAN MENOPAUSE SOCIETY
DOES PREOPERATIVE VIRTUAL REALITY EXPOSURE HELP IN REDUCING ANXIETY IN WOMEN POSTED FOR OFFICE HYSTEROSCOPY? A PILOT RANDOMIZED CONTROLLED TRIAL.
A PAN SOUTH ASIA STUDY- RELATION OF MENOPAUSE AND METABOLIC SYNDROME
A NATIONAL REGISTRY TO GENERATE REAL WORLD EVIDENCE ON POLYCYSTIC OVARIAN SYNDROME (PCOS) IN INDIA – PCOS INDIA REGISTRY – THE STUDY PROTOCOL
DOES PROCEDURE TIME AND SIZE MATTER FOR IN-OFFICE HYSTEROSCOPY TREATMENT OF RETAINED PRODUCTS OF CONCEPTION TO ACHIEVE THE HIGHEST PATIENT SATISFACTION?
KNOWLEDGE, ATTITUDE AND PRACTICE OF MENOPAUSE HORMONAL THERAPY: CLINICIANS AND CONSUMERS PERCEPTION
AGE AT MENOPAUSE AND ITS DETERMINANTS IN INDIA– A POPULATION BASED STUDY
STATE OF HEALTH MAPPING - A DESCRIPTIVE STUDY TO ASSESS CURRENT STATE OF HEALTH, WELLBEING AND LIFESTYLE OF THE INDIAN PHYSICIAN
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
PREVALENCE OF SUBCLINICAL HYPOTHYROIDISM IN INDIAN PATIENTS WITH TYPE 2 DIABETES MELLITUS - A REAL WORLD MULTI-CENTRIC STUDY
REAL WORLD EVALUATION OF USAGE PATTERNS, OUTCOMES, SAFETY AND SYMPTOM RESOLUTION OF ACUTE ISCHEMIC STROKE MANAGEMENT WITH TENECTEPLASE IN INDIA
GENETICS OF DIABETIC RETINOPATHY: INDIAN PERSPECTIVE
PREVALENCE OF ANEMIA
ALKEM - RID-IR STUDY
ESI - SYNDROMIC OBESITY REGISTRY
ESI - DSD REGISTRY
WIN REGISTRY
REAL WORLD OBSERVATIONAL STUDY ON THE USAGE, SAFETY AND EFFECTIVENESS OF EVOGLIPTIN IN T2DM PATIENTS IN INDIA
VALIDATION OF GENOTYPE-PHENOTYPE ASSOCIATIONS IN INDIAN POPULATION
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
A MULTICENTRIC, CROSS SECTIONAL STUDY TO ASSESS AWARENESS OF RISK FACTORS AND CURRENT BEHAVIOR AMONGST TYPE 2 DIABETES MELLITUS PATIENTS IN INDIA
DOES PREOPERATIVE VIRTUAL REALITY EXPOSURE HELP IN REDUCING ANXIETY IN WOMEN POSTED FOR OFFICE HYSTEROSCOPY? A PILOT RANDOMIZED CONTROLLED TRIAL.
A STUDY TO EVALUATE THE SUBSIDENCE OF TIBIAL BASE PLATE IN POST TOTAL KNEE ARTHROPLASTY PATIENTS
ROLE OF BLOOD UREA NITROGEN TO SERUM ALBUMIN RATIO IN PREDICTING OUTCOMES OF CRITICALLY ILL ICU PATIENTS
EARLY DIAGNOSTIC MARKERS IN PREDICTING SEVRITY OF DENGUE DISEASE
DETERMINE THE RESISTANCE PATTERN OF ENTEROBACTERIACEAE IN A TERTIARY CARE CENTER
GENERATION OF NORMATIVE REFERENCE RANGES FOR SERUM TESTOSTERONE MEASURED USING LC-MS/MS ASSAYS IN HEALTHY ADULT INDIAN POPULATION
THE STUDY ON ASSOCIATION OF SERUM URIC ACID LEVEL WITH URINE ALBUMIN LEVEL IN TYPE-II DIABETES MELLITUS
CORRELATION OF SERUM GAMMA GLUTAMYL TRANSFERASE AND HS-CRP LEVELS IN PATIENTS OF TYPE 2 DIABETES MELLITUS WITH GOOD AND POOR GLYCEMIC CONTROL
INDIAMET(INDIAN METABOLIC PROFILE) STUDY – A CROSS SECTIONAL NATION-WIDE STUDY OF CARDIOMETABOLIC PROFILE OF INDIAN ADULTS
ARTIFICIAL INTELLIGENCE-ENABLED REFERRAL PATHWAYS FOR EARLY DIAGNOSIS OF COMPLICATIONS ARISING FROM DIABETES: APPLICATION TO DIABETIC RETINOPATHY