FAQs

Can I start my SSA while my project is still under review by the HREC?

Yes.  NALHN supports dual submission of governance and ethics, this allows the review to occur in parallel.  Governance authorisation can only be given to those projects approved by ethics.  If any documents change as a result of ethics queries you will need to re-submit these for governance review along with the ethics approval letter.  Alternatively, you are encouraged to work on your governance application before the HREC has approved your project so that it is ready to submit to the RGO as soon as you receive your HREC approval letter.

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My project covers multiple SA Health sites, how do I find the other RGOs?

RGO Contact List

http://www.sahealth.sa.gov.au/wps/wcm/connect/768b3f004aaf37e19d83fd7633bbffe0/SA+Health+RGO+List+-+Aug+17.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-768b3f004aaf37e19d83fd7633bbffe0-lZH.-Qa

 

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Do I need to add the RGO Contact details for complaints in the Participant Information & Consent Form (PICF)?

Only if the approving HREC is not an SA Health Committee. The approving SA Health HREC contact details should be used in the first instance should the participant want to speak with someone independent of the project or make a complaint about the study/investigators.

Example (wording for use in the PICF): when the reviewing HREC is an SA HREC
“If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact”:
Reviewing HREC approving this research and HREC Executive Officer details:

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Reviewing HREC name Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
HREC Executive Officer Heather O’Dea
Telephone 8222 6841
Email Health.CALHNResearchEthics@sa.gov.au

Example (wording for use in the PICF): when the HREC is interstate
“For matters relating to research at the site at which you are participating, the details of the local site complaints person are”
Complaints contact person:

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Name Alison Barr
Position NALHN Research Governance Officer
Telephone 8182 9346
Email healthnalhnrgo@sa.gov.au
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Before you submit documentation to the RGO please consider the following:

Do all your documents/attachments have version numbers/dates in the footers?

The RGO can only endorse HREC approved documents for use on site i.e. the version number or date in the footer of your documents should match the version listed on the HREC approval letter?  Without evidence of HREC approval your document i.e. PICF or protocol will not be accepted for use at LMH.

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Have you changed your file names so the titles reflect the document name and version?

You should not use the file name automatically generated by your scanner.  Changing the file name allows the RGO to quickly identify your attachments for review.

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Do your file names follow the same format?

Please use consistent file names when submitting electronic documents i.e. PICF_Version1.0_20160607, Protocol_Version1.2_20161011

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