Andrew Thornton Chairman, HREC Royal Adelaide Hospital Ethics Forum – May 2012

Types of studies >Drug Trials >Device Trials >Other clinical studies which require full committee review >Low and negligible risk research >Audits

Full studies conducted at single site (RAH) >The study should be submitted through on- line forms designating RAH committee. >The ethics/science of study should be reviewed at RAH. >A Site Specific Assessment must be completed for RAH. >Amendments, IBs should be submitted to RAH through on-line forms. >Annual Reports, SUSARs, SAEs etc should be submitted to RAH as normal

Full studies conducted at multiple sites within SA Health >Only one application and one ethical review is necessary. >The main PI (coordinating CPI) may choose a committee to review the study but this should generally be at the CPI’s institution. >The study should be submitted through on- line forms designating the lead committee. >A separate Site Specific Assessment must be completed at each site. >Amendments, IBs, SUSARs, Annual Reports, etc should be submitted to the approving HREC only.

On line HREC submission Researcher HREC Office HREC Submission Code Connections: On-line Forms and AU-RED AU-RED Database On line SSA submission Researcher Governance Office SSA Submission Code HREC Submission Code

Completing the HREC process – RAH Submissions >Complete the IDSC checklists. >The REC checklist and yellow ethics form and not required but all the documents you want approved must be listed in the cover letter (electronic submission) >Submit 2 hard copies of the cover letter protocol and PIS. >Submit all documents electronically as searchable (not scanned) PDF documents (CD preferred) >Complete the CTN (as appropriate). >Let the HREC know that you have submitted the study and quote the submission code.

Completing the HREC process – Other documents >Amendments: Submit on-line plus one hard copy plus electronic version (CD preferred) >IBs: Submit on-line plus one hard copy plus electronic version (CD preferred) >SUSARs: submit as now including one electronic copy (CD preferred) >SAEs, Annual reports: submit as now including one electronic copy (CD or ) >General advice: if the submission is large, submit on a CD so that it can be filed.

Completing the submission process - SSA >Obtain an SSA submission code from the on-line forms website. >Let the Governance Officer know that there is an SSA for RAH and quote the submission code and the HREC reference number which has been allocated. >Complete the CTA >Complete the CTN (as appropriate).

Warning! Warning!! Warning!!! >Submitting through on-line forms does not alert Heather or Bernadette to the fact that something has been submitted. >For any on-line submission (Protocol, Amendment, IB, etc) you must let Heather know by . >For any governance submission through on line forms you must let Bernadette know.

Low and negligible risk research (LNR) At this time… >Studies may be submitted through on-line forms. >Studies may also be submitted in the traditional way (hard copy plus electronic submission by or CD). >The HREC Chair will decide if the study qualifies as LNR. >The HREC Chair will decide if the study requires an SSA. >Heather will complete the entry onto the ethics database (AU-RED).

Audits At this time… >Studies should be submitted in the traditional way (electronic submission by or CD). >The HREC Chair will decide if the study qualifies as an Audit >Audits are not required to be entered into ethics research database.

Future >We will publish the updated instructions on the intranet/internet. >We will review the IDSC checklists. >We will work with SA Health to iron out some issues with on-line forms. >A simple on-line LNR ethics form will be developed to allow on-line submission >A simple on-line LNR SSA form will be developed. >The system will be available Australia- wide to all single submission.