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Calvary Health Care Adelaide

Human Research and Ethics Committee

Research and Ethics Governance at Calvary Wakefield Hospital

Calvary Wakefield Research and Ethics Committee (REC) considers research and ethical issues that may arise at Calvary Wakefield Hospital. The Committee demonstrates a strong commitment and attention to detail in its research and ethics governance.

The REC is fully compliant with all directives and obligations of the National Medical Research Council (NHMRC) / Australian Health Ethics Committee (AHEC) in terms of committee composition, committee conduct, reporting, and monitoring, and is fully compliant with The National Statement on Ethical Conduct in Research involving Humans 2007.

The REC Chair provides a comprehensive Annual Report to NHMRC/AHEC and subsequently receives an annual 'compliance confirmation' letter, without which an REC may not consider nor conduct any research. Calvary Wakefield REC has been certified compliant for over 10 years.

The current process for research activity approval and conduct at Calvary Wakefield Hospital (CWH) is as follows:

  • If a researcher / investigator enquires about conducting research at a CWH, he/she is given the REC Ethics Submission Guidelines and Declaration 2007. This document is stored at CWH: J:Executive/Research and Ethics WH guidelines.
  • The researcher/investigator forwards the completed documents (2 copies) with a covering letter to the CEO requesting REC consideration and research proposal approval. In addition, a copy of the proposal may also be sent electronically to the Chair. These documents are considered 'in-confidence' and are managed and stored securely. A Consent Form and separate Patient Information Sheet (plain language) must be included. Both must contain declaration of any and all patient risks.
  • CEO forwards proposal to Chair/Secretary who arranges copies and distribution to all REC members in a timely manner.
  • CEO forwards copy of research proposal to insurance agents where as required.
  • REC members must have minimum of two weeks to consider proposals before they are considered formally at the next REC meeting. REC meetings are conducted approximately 6 weekly. The Meeting Date schedule is available from REC Chair/Secretary or the CEO Executive Assistant.
  • Once research proposals are considered by the REC, a recommendation is made to the CEO regarding approval status of the study. This approval may be 'subject to minor amendments as outlined to the principal investigator by the REC Chair', or approval may be granted for the original submitted version.
  • Researchers are requested to ensure they include relevant version numbers in order to track any requested amendments and for archival purposes.
  • The CEO notifies the principal researcher/investigator as soon as practicable by letter as to the approval status of the research.
  • The REC Chair/Secretary maintains complete records and has monitoring obligations for the study duration as stated in the governing document, The National Health and Medical Council (NHMRC) National Statement on Ethical Conduct of Research involving Humans. 2007.
  • It is the responsibility of the REC Chair to guide members through the research consideration process and to be informed and updated on all relevant legislative and jurisdictional documents and obligations.

Contact REC Chair – Amanda Rischbieth at or 0417 200 883

Or the CEO's Executive assistant - Sue Cross at or 08 - 8405 3301

Documents

Links

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