Expedited review panel submissions

Low risk research is where the only foreseeable risk to participants is discomfort. Examples of discomfort may include minor medication side-effects, discomfort with measuring blood pressure or anxiety induced by an interview. All low risk applications must be submitted through email.

The ERP provides low risk research review for the following institutions:

• joint ethics and governance review for all CALHN sites
• ethical review for any SA Health sites as per SA Health Research Ethics and Governance Policy
• some private sites, requiring a fully executed external entities agreement (EEA).

1. Prepare all documentation for submission including:
   1. CALHN Ethics and Governance Application Form (EGA) with signatures from all research personnel
   2. approval from all relevant heads of department (either as signatures on the EGA form or through email)
   3. project resourcing approval from the relevant CALHN business manager
   4. CVs for all investigators
   5. study protocol containing sufficient detail for ethical and scientific review
   6. blank draft of the data collection spreadsheet if data is extracted from records
   7. data collection sheet/survey/questionnaire if new data is collected
   8. recruitment documentation (e.g. advertising material, telephone scripts etc)
   9. participant information and consent form (if applicable)
   10. interview schedule (if applicable)
   11. approval for use of externally held data/samples (if applicable)
   12. grant funding documentation (if applicable).
2. Submissions will first be reviewed by CALHN Research Services for validity (completeness). Researchers may be asked to provide further documentation or approvals. Incomplete submissions will not proceed to ERP review.
3. Following review by the ERP researchers will be sent any requests for further information required for both ethical and governance approval. Depending on the response to a request, it may be reviewed by the ERP at the meeting following receipt of the response or out of session.

• Ensure document footers including dates and versions are correct.
• Clarify CALHNs participation in the project.
• Ensure you have attached the correct documentation for your submission and have organised the required signatures and approvals.

Research projects that involve conducting research procedures (including retrospective patient data collection) without participant consent are not eligible for expedited review, and must be reviewed by the full committee of the CALHN HREC. Researchers may use the EGA form however the study protocol must clearly outline how the project meets all criteria in chapter 2.3.10 of the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research 2023.