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  • Checklist For Ethics Committee Registration For Biomedical and Health Research

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    avinash
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    This document provides a checklist for ethics committee registration for biomedical and health research. It contains 14 items that must be submitted, including an application letter, documents establishing the committee's authority and membership requirements, standard operating procedures for general committee functions and reviewing research involving vulnerable populations, policies for training members and preventing conflicts of interest, and an undertaking form. The checklist ensures ethics committees applying for registration submit all necessary documentation to demonstrate they meet standards for reviewing research ethics.

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    This document provides a checklist for ethics committee registration for biomedical and health research. It contains 14 items that must be submitted, including an application letter, documents establishing the committee's authority and membership requirements, standard operating procedures for general committee functions and reviewing research involving vulnerable populations, policies for training members and preventing conflicts of interest, and an undertaking form. The checklist ensures ethics committees applying for registration submit all necessary documentation to demonstrate they meet standards for reviewing research ethics.

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    © All Rights Reserved
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    23 views1 page

    Checklist For Ethics Committee Registration For Biomedical and Health Research

    Uploaded by

    avinash
    This document provides a checklist for ethics committee registration for biomedical and health research. It contains 14 items that must be submitted, including an application letter, documents establishing the committee's authority and membership requirements, standard operating procedures for general committee functions and reviewing research involving vulnerable populations, policies for training members and preventing conflicts of interest, and an undertaking form. The checklist ensures ethics committees applying for registration submit all necessary documentation to demonstrate they meet standards for reviewing research ethics.

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    © All Rights Reserved
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    of 1

    Checklist

    for
    Ethics Committee Registration for Biomedical and Health Research

    S.No. Checklist Item


    1 Application for registration in accordance with the requirements as
    specified in ICMR National Ethical Guidelines (Upload signed copy
    of Covering Letter/Application for registration of ethics committee )
    2 Authority under which the ethics committee has been
    constituted(upload authority letter from authorized person of
    hospital/Institute)
    3 Memberships requirements of the ethics committee(upload
    relevant SOP/Document)
    4 The terms of reference of the committee (upload relevant
    SOP/Document)
    5 Conditions of appointment and the quorum required (upload
    relevant SOP/Document)
    6 Procedure for resignation ,replacement or removal of
    members(upload relevant SOP/Document)
    7 Documents, proving that the members of the committee are
    conversant with the provisions as specified in latest edition of
    National ethical guidelines for biomedical and health research
    involving human participants. (upload copy of BIO Data & training
    certificates showing that all members are convergent with
    provisions of GCP and relevant guidelines)
    8 The standard operating procedures to be followed by the
    committee in general (upload copy of policy/ SOP).
    9 Standard operating procedures to be followed by the committee for
    vulnerable population (upload relevant SOP)
    10 Policy regarding training for new and existing committee members
    along with standard operating procedures (upload relevant SOP)
    11 Policy to monitor or prevent the conflict of interest along with
    standard operating procedures (upload relevant SOP)
    12 If the committee has been audited or inspected before, give
    details(upload relevant Document, if No, upload justification)
    13 Undertaking by the committee as per the format annexed (upload
    filled undertaking)
    14 Upload Form CT-01

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