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    NEC Form 05 - ICF Checklist

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    Rhem Rick Corpuz
    This document contains a checklist for reviewing informed consent forms and processes. It includes questions about whether informed consent is necessary, whether participants are provided sufficient information about the study purposes and procedures, risks and benefits, confidentiality, voluntary participation, and recommendations for approval or revisions. The reviewer would use this checklist to assess whether an informed consent form adequately addresses these important components or requires minor/major revisions before being approved.

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    NEC Form 05 - ICF Checklist

    Uploaded by

    Rhem Rick Corpuz
    72 views2 pages
    This document contains a checklist for reviewing informed consent forms and processes. It includes questions about whether informed consent is necessary, whether participants are provided sufficient information about the study purposes and procedures, risks and benefits, confidentiality, voluntary participation, and recommendations for approval or revisions. The reviewer would use this checklist to assess whether an informed consent form adequately addresses these important components or requires minor/major revisions before being approved.

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    This document contains a checklist for reviewing informed consent forms and processes. It includes questions about whether informed consent is necessary, whether participants are provided sufficient information about the study purposes and procedures, risks and benefits, confidentiality, voluntary participation, and recommendations for approval or revisions. The reviewer would use this checklist to assess whether an informed consent form adequately addresses these important components or requires minor/major revisions before being approved.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    72 views2 pages

    NEC Form 05 - ICF Checklist

    Uploaded by

    Rhem Rick Corpuz
    This document contains a checklist for reviewing informed consent forms and processes. It includes questions about whether informed consent is necessary, whether participants are provided sufficient information about the study purposes and procedures, risks and benefits, confidentiality, voluntary participation, and recommendations for approval or revisions. The reviewer would use this checklist to assess whether an informed consent form adequately addresses these important components or requires minor/major revisions before being approved.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    NATIONAL ETHICS COMMITTEE

    STANDARD OPERATING PROCEDURES


    NEC Form No. 5
    CHECKLIST TO INFORMED CONSENT SOP No. 5&6
    FORM AND PROCESS Version No. 2
    Version Date 15 July 2014

    Title of
    Study

    Type of
    NEC Code
    Review
    Principal
    Institution
    Investigator
    Primary
    Reviewer
    reviewer
     Yes  No
    Guide questions for reviewing the informed consent process and form
    Is it necessary to seek the informed consent of the participants?  Unable to Assess  Yes  No
    If NO, please explain.

    If YES, are the participants provided with sufficient information regarding:


     Purpose of the study?  Yes  No
     Expected duration of participation?  Yes  No
     Procedures to be carried out?  Yes  No
     Discomforts and inconveniences?  Yes  No
     Risks (including possible discrimination)?  Yes  No
     Random assignment to the trial treatments?  Not applicable  Yes  No
     Benefits to the participants?  Yes  No
     Alternative treatments/ procedures?  Not applicable  Yes  No
     Compensation and/or medical treatments in case of injury?  Yes  No
     Who to contact for pertinent questions and / or for assistance in a research-
     Yes  No
    related injury?
     Refusal to participate or discontinuance at any time will not involve
     Yes  No
    penalty or loss of benefits to which the subject is entitled?
     Extent of confidentiality?  Yes  No
    Is the informed consent written or presented in lay language that participants can understand?
     Yes  No
    Does the protocol include an adequate process for ensuring that consent is voluntary?
     Yes  No
    Do you have any other concerns?
    Recommendation:  Approved
     Minor revisions required

    _____________________________________________________

    _____________________________________________________

    _____________________________________________________

     Major revisions required

    _____________________________________________________

    _____________________________________________________

    _____________________________________________________

    _____________________________________________________

     Disapproved

    Reasons for disapproval:

    _____________________________________________________

    _____________________________________________________

    _____________________________________________________

    _____________________________________________________

    ________________________________ ________________________
    Name and Signature of Reviewer Review Date

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