ETHICS COMMITTEE

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Objectives

• Ensure protection of the rights, safety and well-being of the Human subjects involved in research projects on drugs, Devices, procedures etc.

• A quality and consistent ethical review mechanism for research for all proposals dealt by the committee as prescribed by the International Conference on Harmonization of Good Clinical Practice.

( DCGI Reg No- ECR/354/Inst/MH/2013)

  • The Ethics Committee shall always be known and referred to as, by and in the name of “Ethics Committee Inamdar Multispeciality Hospital” Pune (IMHEC)
  • The Ethics Committee Inamdar Multispeciality Hospital is constituted as per ICMR Guidelines & Schedule-Y. It consists of 11 members.
  • Ethics Committee Inamdar Multispeciality Hospital works as per its SOP.
  • The EC meeting follows the Quorum as per ICMR guidelines, schedule-Y, ICH-GCP.
  • ECIMH is registered at OHRP Office for Human Research Protection) and FWA (Federal Wide Assurance).
  • It can function as institutions ethics Committee
  • It is the responsibility of the Ethics Committee to review for and accord its approval to the trial protocol, SAEs/CIOMS/SUSAR (if require) with a view to safeguard the dignity, rights, safety and wellbeing of all actual and potential research participants.
  • Ethics Committee will conduct continuing review of each ongoing trial at intervals, appropriate to the degree of risk to human subjects.
  • Ethics Committee Inamdar Multispeciality Hospital works as per its SOP. The Ethics Committee Meeting should be held as per the requirement. The committee will hold a regular meeting at least once in a Month and less frequently if there are no research proposals to review but not less than once every Three Months.
  • Proposals will be sent to all members Eight days prior to the meeting.
  • The date of the meeting will be intimated to the researcher, to be present, to explain the protocol, and to offer the clarification if necessary.
  • During the EC meeting; members will discuss both on-site and off-site SAEs /CIOMs/SUSARs etc. If appropriate, specific action or a combination of actions will be taken, based on the consensus decision of the Ethics committee. This will be communicated to P.
Please contact us for any other information

Ethics Committee Inamdar Multispeciality Hospital
Hospital Building, S.No.15, Fatima Nagar . Pune 411040.

Inamdar Multispeciality Hospital: +91 020 – 66812475