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.[1]

Formal determination of whether a study is low/negligible risk and/or is eligible for expedited review is made by the Chair of the Ethics Committee upon receipt of an application.

Low and Negligible Risk (LNR) Studies require both ethical approval from the relevant HREC and governance authorisation to commence at SA Health sites.

[1] Paragraphs 5.1.18 to 5.1.23 NHMRC National Statement on Ethical Conduct in Human Research (2007).

Submitting an Application

Effective from 7 January 2020 CALHN Research Services is implementing scheduled weekly joint ethics and governance review of applications for approval of low/negligible risk research projects.

The Expedited Review Panel comprises the CALHN HREC Chair and representatives from CALHN and NALHN research governance offices.

The Expedited Review Panel meets weekly on Tuesdays. Submissions are due by 4:00pm the previous Friday.

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:

  1. Ethics and Governance Application (EGA) form with signatures from all research personnel
  2. Approval from all relevant heads of departments (either as signatures on the EGA form or in email form)
  3. Project resourcing approval from the relevant CALHN business manager
  4. Approval for use of externally held data/samples (if applicable)
  5. Grant funding documentation (if applicable)
  6. CVs for all investigators (if not provided within previous 12 months)
  7. Study protocol (note: must contain sufficient information for ethical and scientific review)
  8. Participant Information and Consent Form (if applicable)
  9. Draft (blank) data collection spreadsheet (if data is extracted from records)
  10. Data collection sheet/survey/questionnaire (if new data is collected)
  11. Interview schedule (if applicable)
  12. Recruitment documentation (e.g. advertising material, telephone scripts etc.)

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.

Please note: research projects that involve conducting research procedures (including retrospective patient data collection) without participant consent require review by the full committee of the CALHN HREC. Researchers can continue to use the Ethics and Governance Application (EGA) form however the study protocol must clearly outline how the project meets all criteria in chapter 2.3.10 of the NHMRC National Statement on Ethical Conduct in Human Research.

CALHN Ethics and Governance Application Form

CALHN LNR Ethics and Governance Application Form Guideline

Guidelines for drafting a Study Protocol and Participant Information and Consent Form are available below:

PICF Guideline

LNR Study Protocol Guideline

It is recommended that you consult with the CALHN Researcher Support Officer prior to completing your submission.

Email: Health.CALHNResearchLNR@sa.gov.au

Email: HealthNALHNRgo@sa.gov.au