The NHMRC National Statement on Ethical Conduct in Human Research (2007) defines low risk research as “research where the only foreseeable risk is one of discomfort”. Discomfort may include minor side-effects of medication, discomfort related to measuring blood pressure or anxiety induced by an interview. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.
The National Statement provides that institutions may have ethical review processes other than full committee review for low/negligible risk studies.
Central Adelaide Local Health Network (CALHN) Research Services holds joint ethics and governance review of application for approval of low/negligible risk research projects at its weekly Expedited Review Panel.
The Expedited Review Panel comprises the CALHN HREC Chair and representatives from CALHN research governance office.
The Expedited Review Panel meets weekly on Tuesdays. Submissions are due by 4:00 pm the previous Thursday.
The Research GEMS system does not support expedited review applications for low/negligible risk research. Submissions must be made via email.
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 be reviewed by the Panel.
At a minimum submissions should include:
- CALHN Ethics and Governance Application Form with signatures from all research personnel
- Approval from all relevant heads of department (either as signatures on the CALHN Ethics and Governance Application Form or in email form)
- Project resourcing approval from the relevant CALHN business manager
- CVs for all investigators (if not provided within previous 12 months)
- Study protocol (note: must contain sufficient information for ethical and scientific review)
- Participant Information and Consent Form (if applicable)
- Draft (blank) data collection spreadsheet (if data is extracted from records)
- Data collection sheet/survey/questionnaire (if new data is collected)
- Interview schedule (if applicable)
- Recruitment documentation (e.g. advertising material, telephone scripts etc)
- Approval for use of externally held data/samples (if applicable)
- Grant funding documentation (if applicable)
Following review by the Panel researchers will be sent any requested changes/further information required for both ethical and governance approval. Responses to these requests may either be reviewed by the Panel at the meeting following receipt of response, or out of Panel session.
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 2007 (Updated 2018).
For further information, contact CALHN Research Services on 08 7117 2224, or via email at Health.CALHNResearchLNR@sa.gov.au.