Types of Human Research Submissions
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.
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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 Research GEMS.
Together with the HREA:
- All associated or supporting documents should also be uploaded on to Research 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 protocol 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:
- Information Sheet Guidelines
- Consent Form template
- Alternatively, you may find the NHMRC Standardised participant information and consent forms (PICFs) templates useful (scroll to the bottom of the linked webpage)
- If you will be using alternate contacts for research studies, please include the additional text outlined on this information sheet.
- If you are not a WCHN employee, please ensure that a WCHN employee obtains a Consent-to-Contact prior to you contacting the potential participant
- Waiver of consent is acceptable under certain circumstances (Chapter 2.3 of the NHMRC National Statement). If you wish HREC to consider a waiver of consent, please submit this Request for Waiver of Consent form.
Please refer to the HREC Submission Checklist for guidance on applicable supporting documentation.
NOTE: 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”.
The management of the study will also be conducted through Research 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.
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.
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).
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.
For case studies at the WCHN, the following processes should be followed:
- If casenotes 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 casenotes or other identifying information is being accessed for the purpose of the case study, 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.
- Audit Application Form
- Mr Luke Fraser – 8161 6521
- Ms Mary Thorne – 8161 6936
Applicants are reminded of the requirements for Research 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.