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Southern Adelaide Clinical Human Research Ethics Committee

The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC) is a joint committee of the Southern Adelaide Local Health Network (SALHN) and Flinders University. See committee membership.

The committee is constituted under the requirements of National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) and is a fully accredited lead HREC within SA Health.

Since 2 April 2012, SA Health has mandated a streamlined approach to ethical review within the SA public health system resulting in a single review model. This approach has resulted in a single scientific and ethical review by a chosen lead HREC for multi-site research being undertaken across the SA public health system.

As a chosen lead HREC, the SAC HREC reviews multi-site and single site clinical research being undertaken within SA Health (including the Southern Adelaide Local Health Network) and Flinders University, which involves: patients, staff or visitors; research involving the administration of drugs; and applications from external organisations which have requested the SAC HREC review studies on their behalf.

SAC HREC Standard Operating Procedures (PDF 189KB)

SAC HREC Terms of Reference (PDF 143KB)

SAC HREC Meeting Dates 2017 (PDF 72KB)

Guidance

Authorised Prescriber Application Guidelines (PDF 166KB)

Contact Details for Participant Information Sheet/Consent Form (PDF 139KB

National Ethics Application Form (NEAF) Application Guidelines (PDF 230KB)

Qualitative Research Application Guidelines (PDF 69KB)

Low and Negligible Risk (LNR) Application Guidelines (PDF 107KB)

Office for Research Document Naming Guidelines (PDF 93KB)

Ionising Radiation in Clinical Research Guidelines (PDF 155KB)

Reporting and Monitoring Guidelines for Research Applications (PDF 140KB)

Serious Adverse Events Guidelines (PDF 187KB)

Quality Assurance versus Research Project Exemption Guidelines (PDF 172KB)

SAC HREC Project Evaluation Form (DOC 325KB)

 

Forms

Cover Letter for Ethics and Governance Submissions (DOC 235KB)

Authorised Prescriber Application Form (DOCX 331KB)

Qualitative Research Application Form (DOCX 316KB)

Annual Review and Extension Request Form (DOCX 304KB)

Final Report Form (DOCX 327KB)

Project Amendment Form (DOCX 129KB)

Protocol Violation Deviation Form (DOCX 114KB)

Withdrawal of Research Form (DOCX 321KB)

Serious Adverse Events Report Template (DOCX 411KB)

Declaration of Safety Documents Form (DOCX 319KB)

 

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