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    Ethical Clearance: Prof. Dr. Delfi Lutan, MSC., Spog (K)

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    Monika Ayuningrum
    The document discusses ethical clearance for reproductive health research from the Ethics' Committee on Reproductive Health Research at the Medical School of Sumatera Utara University. It explains that ethical clearance is needed to ensure research meets legal and ethical standards. Researchers must submit their protocol and credentials to the committee for review at least one month before starting research involving humans or animals. The committee's role is to protect participants and researchers by approving only research that follows applicable guidelines.

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    Ethical Clearance: Prof. Dr. Delfi Lutan, MSC., Spog (K)

    Uploaded by

    Monika Ayuningrum
    73 views12 pages
    The document discusses ethical clearance for reproductive health research from the Ethics' Committee on Reproductive Health Research at the Medical School of Sumatera Utara University. It explains that ethical clearance is needed to ensure research meets legal and ethical standards. Researchers must submit their protocol and credentials to the committee for review at least one month before starting research involving humans or animals. The committee's role is to protect participants and researchers by approving only research that follows applicable guidelines.

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    The document discusses ethical clearance for reproductive health research from the Ethics' Committee on Reproductive Health Research at the Medical School of Sumatera Utara University. It explains that ethical clearance is needed to ensure research meets legal and ethical standards. Researchers must submit their protocol and credentials to the committee for review at least one month before starting research involving humans or animals. The committee's role is to protect participants and researchers by approving only research that follows applicable guidelines.

    Copyright:

    © All Rights Reserved
    73 views12 pages

    Ethical Clearance: Prof. Dr. Delfi Lutan, MSC., Spog (K)

    Uploaded by

    Monika Ayuningrum
    The document discusses ethical clearance for reproductive health research from the Ethics' Committee on Reproductive Health Research at the Medical School of Sumatera Utara University. It explains that ethical clearance is needed to ensure research meets legal and ethical standards. Researchers must submit their protocol and credentials to the committee for review at least one month before starting research involving humans or animals. The committee's role is to protect participants and researchers by approving only research that follows applicable guidelines.

    Copyright:

    © All Rights Reserved
    of 12

    Ethical Clearance

    Ethics’ Committee on Reproductive Health Research


    Medical School, University of Sumatera Utara

    Prof. dr. Delfi Lutan, MSc., SpOG(K)


    WHO Collaborating Center for Research in
    Human Reproduction
    Medan, October 2017
    1
    What is the ethical clearance ?

    Ethical Clearance is an approval of the ethic’s


    committee on reproductive health research
    based on the certainty of ethics that have both
    of the international and national quality.

    2
    Why should the ethical clearance is needed
    by every researcher on Reproductive Health
    Research ?
    Because the ethical clearance (approval to
    implement the research) is needed to meet the
    legal aspect’s procedure of research on medical/
    reproductive health that have already agreed as
    a global (not in-contradiction to the legislation
    rule that has obtained, the suitability, and the
    morality).

    3
    What is an importance to get the Ethical
    Clearance from the Ethic’s Committee to
    implement reproductive health research ?

    Having the ethical clearance is one of the


    protection mechanisms toward the subject and
    researcher that are involved in the reproductive
    health research.

    4
    When and how long the process to get an
    ethical clearance ?

    Ethical clearance has to be gotten before the


    research is started and the process to get it
    has to be waited for one month.

    5
    What is the requirement to get an approval
    (ethical clearance) ?
    1. Requested by researcher who have a competency to implement
    the reproductive health research (as individually and group).
    2. Give two copies of research protocol.
    3. Attach two copies of researcher’s CV and the budget estimation.
    4. Fill in the two copies of standard form that is given by the ethic’s
    committee on reproductive health research.
    5. Attach two copies of the explanation of research’s activity
    concern all the aspect of research that will be done with the
    clearly language that could be understood by the subject of
    research.
    6
    What kind research should attach an ethical
    clearance ?

    Every research on reproductive health that is


    involves a human (even as group or individually)
    or animal as the subject of research)

    7
    What kind research that is included on the
    reproductive health research ?

    Reproductive health research is the biomedical


    research which is included research on the
    pharmaceutical, medical apparatus, radiation
    and imaging, medical record, biological material,
    also research on epidemiological, social and
    psychology (WHO).

    8
    What is the institution that has a capability to
    give an ethical clearance ?

    The institution that has a capability to give an


    ethical clearance is the Ethics’ committee on
    Reproductive Health Research.

    9
    What is the ethic’s committee on
    reproductive health research ?
    • The ethic’s committee on reproductive health
    research is an independent organization that has a
    member both of the non-expert and the entire
    different scientist.
    • This committee has a duty to give an assessment
    and review/consideration toward the research
    protocol on reproductive health which using a
    human and other as the research subject.

    10
    What is the duty of the ethic’s committee on
    reproductive health research ?

    • Their duty is to helping the researcher whose


    doing the medical/reproductive health research,
    in or outer the environment of Sumatera Utara
    University, to give the assessment,
    consideration, and approval to implement the
    research.

    11
    WIRHDC MEDAN 12

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