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.