Introduction:

Ethics Committee comprises of medical, scientific, non-medical and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial.  The committee is responsible for reviewing and approving the protocol including the methodology, adequacy of information and adequacy of confidentiality safeguards. In the case of any serious adverse harm to the clinical trial participant during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per the 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 follows

S.No.Name of Member  QualificationRole
1.Dr.RakeshSahayMBBS, MD (Medicine), DNB, DM (Endocrinology, FICP, FACEIEC Chairperson
2.Dr.Meeta  MBBS, MD (OBG)Clinician
3.Ms.ReshmaKaur  BCom, MBA, LLBVice-Chairperson
4.Dr.Akanshi Singh  MBBS, MS (OBG)Member Secretary
5.Dr.Tanvir  MBBS, MS (OBG)Clinician
6.Ms.HarpreetKaur  BA, MA, MPhilLay person
7.Ms.RubinaMajid  BSc, MBA, MALay person
8.Mr. G. Vamshi Krishna  B.Tech, MBA, LLBLegal Expert
9.Dr.Prasanna V.  MBBS, MD (Pharmacology)Medical Scientist
10.Dr.Kanharam Patel  MBBS, MD (Pharmacology)Medical Scientist
11.Dr. CV Sarada  MBBS, MD (Biochemistry)Basic Medical Scientist

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 CDSCOAPPROVAL
  • 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

Ethics Committee Co-Ordinator Information:

  • Name: Chandini.K
  • Mobile no.:+91 7799222150
  • Email Id: tanvirhospitalecbhr@gmail.com

Registration certificates– BHR, CT

Application letter & covering letter: