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    Governance

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    merrileeanne
    The document provides updates from a research governance office meeting including: 1. New guidelines require a Site Specific Assessment be submitted and approved before research can begin at a hospital to ensure proper authorizations and resources. 2. The assessment is approved by the research governance office, not a committee, and should be submitted around two weeks after the ethics application. 3. Other new guidelines include timeframes for responding to amendments, submitting annual reports, registering annual reports, and getting continued clearance if research goes past 12 months. Archiving requirements also follow certain time periods.

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    Governance

    Uploaded by

    merrileeanne
    32 views2 pages
    The document provides updates from a research governance office meeting including: 1. New guidelines require a Site Specific Assessment be submitted and approved before research can begin at a hospital to ensure proper authorizations and resources. 2. The assessment is approved by the research governance office, not a committee, and should be submitted around two weeks after the ethics application. 3. Other new guidelines include timeframes for responding to amendments, submitting annual reports, registering annual reports, and getting continued clearance if research goes past 12 months. Archiving requirements also follow certain time periods.

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    The document provides updates from a research governance office meeting including: 1. New guidelines require a Site Specific Assessment be submitted and approved before research can begin at a hospital to ensure proper authorizations and resources. 2. The assessment is approved by the research governance office, not a committee, and should be submitted around two weeks after the ethics application. 3. Other new guidelines include timeframes for responding to amendments, submitting annual reports, registering annual reports, and getting continued clearance if research goes past 12 months. Archiving requirements also follow certain time periods.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    32 views2 pages

    Governance

    Uploaded by

    merrileeanne
    The document provides updates from a research governance office meeting including: 1. New guidelines require a Site Specific Assessment be submitted and approved before research can begin at a hospital to ensure proper authorizations and resources. 2. The assessment is approved by the research governance office, not a committee, and should be submitted around two weeks after the ethics application. 3. Other new guidelines include timeframes for responding to amendments, submitting annual reports, registering annual reports, and getting continued clearance if research goes past 12 months. Archiving requirements also follow certain time periods.

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    Download as PDF, TXT or read online from Scribd
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    of 2

    RESEARCH SESSION FEEDBACK

    GOVERNANCE OFFICE
    UPDATE
    Site Specific Assessment submissions (SSA)
    3/2010
    - Research should not be undertaken at the hospital until a
    Site Specific Assessment form has been lodged and
    approval given.
    Summary:
    - The purpose of this assessment is to ensure that
    the Department of Health has authorisations have been obtained and that the site has the
    released new Standard resources to support the research.
    Operating Procedures for both - The SSA is approved by the RGO, not a committee, so they
    Ethics and Research can be submitted at any time. It was suggested they be
    Governance. submitted about 2 weeks after the NEAF has been lodged,
    because the authorisation will only be given once the NEAF
    The meeting was addressed by okay is received.
    Maggie Piper SWAHS
    Research Governance Officer New Guidelines

    Where: Nepean Hospital There are some new guidelines coming into force and old guidelines
    that are still applicable will be more strongly enforced. These
    When: October 15 2010 include:

    - The RGO must ensure that the process to get Research


    Governance clearance must not take more than 60 days,
    however, any time required for required amendments isn’t
    counted in the time.

    - Investigators have to respond to requests for amendments


    within 3 months of notification or the application will be
    discontinued.

    - Annual research reports must be given within 1 month of a


    researcher receiving the letter. For multiple site research,
    ARs must be consolidated within 1 report, listing each site,
    not a separate report for each site. The research CIA is
    responsible for this.

    - ARs will be registered.

    - If research goes past a 12 month period the researcher


    must complete the forms to get clearance to continue.

    Local Area Health clusters

    Prepared by: Merrilee Kessler, Local Health Network (LHN) is splitting. NSW will have 18 LHNs in
    Administration Officer, Research and
    Ethics
    place from 1 January 2011. Nepean is in the Nepean Blue
    Mountains Cluster.
    Disclaimer: this document provides a
    limited overview of the session.
    It is anticipated that the restructure will have low or negligible
    Transcripts or other recording means
    made available by the host organisation effect on the SSA process. An advantage will be the introduction of
    should be used as the primary source of
    information on this session.
    a simpler process for easy projects eg if the research is just a questionnaire you will not need to do a
    NEAF.

    Archiving time requirements

    - Governance requirements follow the NHMRC and any state retention requirements.

    - Documents must be held until a study is finalised and whatever time period required after
    that. If a site is one of many it must keep its documents for the length of time the research is
    running at all sites, ie the holding period is counted from when the study closes at the final
    site.

    - This has an impact on archive fees and researchers need to budget for these.

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