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