Women's and Children's Hospital, Adelaide
General information on the submission of documentation to the WCHN Human Research Ethics Committee

Research at the WCHN

Human Research Ethics Application (HREA) Submissions at WCHN - for Full and Low Negligible Risk (LNR) applications

Whether the study is an LNR or Greater than Low Risk (Full) the WCHN HREC requires completion of the Human Research Ethics Application (HREA) - via GEMS. Together with the HREA:

  • All associated or supporting documents should also be uploaded on to GEMS as attachments (e.g. cover letter, protocol, participant information sheet/s, consent form, questionnaires/surveys, investigator brochure, etc). The name of the document, version and date should be included.
  • A protocol outlining background information (including references), aims, study design, participants (including selection criteria, participant cohort/s, randomisation) study procedures, recruitment, risks/benefits etc should be provided. Alternatively, you may use this Word iconProtocol template.
  • For guidance on the requirements of the WCHN HREC on the information to be included in the information sheets and consent forms, refer to:

Please refer to the Word icon HREC Submission Checklist for guidance for applicable supporting documentation.

Research GEMS does not currently support LNR applications. This functionality will be available in tranche 2. Until then, for LNR applications using the Ethics and Governance Assessment (EGA) Form, a shell application should be created on Research GEMS. For these applications, the free text fields in the HREA can be populated with “See EGA/Protocol”.

Enquiries may be emailed to: HealthWCHNResearch@sa.gov.au

Or telephone:

Mr Luke Fraser on 8161 6521

Ms Mary Thorne on 8161 6936

Applicants are reminded of the requirements for WCH page link iconResearch Governance review and approval before commencement of the research project. Please contact the Research Governance Officer, Dr Carmel Murone on 08 8161 6688 for further information.

 

The management of the study will also be conducted through GEMS. This includes:

  • Responses to issues raised by the HREC
  • Study amendments
  • Extension requests
  • Relevant safety reports such as Serious Adverse Events (SAEs), Serious Unexpected Serious Adverse Reactions (SUSASs), Data Safety Monitoring Board (DSMB) reports etc.
  • Annual and Final Reporting

 

Audit applications should continue to be submitted outside of GEMS by using the Audit Application Form.

 

Audit Submissions and Case Studies

Audit Studies

PDF iconGuidelines for the Preparation of Audit Submissions

Word iconAudit Application Form

The following Corporate Procedure for Audits requiring WCHN human research ethics approval is a guide as to when an audit pertaining to patients/clients requires review by either the WCHN HREC or WCHN HREC Chair.

PDF iconCorporate Procedure: Audits requiring WCHN HREC approval

An audit is an "activity where the primary purpose is to monitor, [evaluate], or improve the quality of service delivered by an individual or an organisation... Terms such as 'peer review', 'quality assurance', 'quality improvement', 'quality activities', 'quality studies' and 'audit' are often used interchangeably." (Ethical Considerations in Quality Assurance and Evaluation Activities. NHMRC March 2014 – Link iconhttp://www.nhmrc.gov.au/guidelines-publications/e111).

Audit review falls into one of two categories i) Full committee review ii) Chair only review.

For information about these two categories and more general information about the submission of audits please see Guidelines for the Preparation of Audit Submissions.

Those wishing to undertake an audit will need to complete the Audit Application Form.

 

Case Studies

For case studies at the WCHN, the below processes should be followed:

  • If case notes or other identifying information is not accessed, all information is de-identified and the case has not been lodged with the WCHN Clinical Governance Unit, submission of an audit application to the WCHN HREC is not required. An appropriate consent process should be followed and documented in the medical records.  Prior to seeking consent the WCHN Safety and Quality Unit should be contacted to determine whether the patient/case has been lodged with the Unit.
  • If case notes or other identifying information is being accessed for the purpose of the case study then the standard audit application process should be followed.  In addition, case studies should be de-identified.  An appropriate consent process should be followed and documented in the medical records.  Prior to seeking consent the WCHN Safety and Quality Unit should be contacted to determine whether the patient/case has been lodged with the Unit and WCHN HREC approval obtained. 

Word iconAudit Application Form

 

Enquiries regarding submission may be emailed to: HealthWCHNResearch@sa.gov.au

Or telephone:

Mr Luke Fraser

08 8161 6521

Ms Mary Thorne

08 8161 6936

 

Applicants are reminded of the requirements for WCH page link iconResearch Governance review and approval before commencement of the research project.  Please contact the Research Governance Officer, Dr Carmel Murone on 08 8161 6688 for further information.

 

last modified: 17 Mar 2021