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Home » Certification scheme handbook

Certification scheme handbook

Thankyou for your interest in the Certification Scheme Handbook. Please read and accept the disclaimer below to access the current version.

Executive Summary

Certification is a voluntary scheme.  Certification provides assurance that the policies, processes and procedures of an institution¹ and its Human Research Ethics Committee (HREC) comply with an agreed set of national criteria² for the conduct of an ethical review³ of multi-centre health and medical research.

The certification of an institution’s ethical review processes will be recognised in all States and Territories.  Institutions with certified ethical review processes may accept research proposals from any jurisdiction and any institution.  In New South Wales, public health organisations may also be accredited for ethical review of multi-site intra-state research

The institutional ethical review process will be independently assessed by a certifying body; NHMRC will be the certifying body in the initial round of certification.  It is expected that NHMRC, and other certifying bodies (as required), will be accredited through the Joint Accreditation System of Australia and New Zealand (JAS-ANZ).  This accreditation will provide assurance to institutions in all jurisdictions that the certifying body and the certification scheme comply with international standards.

Certification begins with the institution carrying out a self assessment of its ethical review processes and supporting structures against agreed national criteria. This is followed by a desktop audit by the certifying body before an on-site visit to verify institutional claims and practices.  No fee will be charged for NHMRC’s services as the certifying body.

Certification is dependant on a satisfactory demonstration of institutional conformance with specified criteria which, in part, are based on the National Statement on Ethical Conduct in Human Research (2007) or any document that complements, supplements or succeeds it.

It is also anticipated that national certification of the process of ethical review of multi-centre research will evolve over time and will be informed by the practical implementation of the scheme in late 2009-early 2010. Institutions should check this page to ensure they are using the latest guidance documents to prepare themselves for certification.

Document version 2.1

Note: the self assessment (Appendix 4.2), nomination (Appendix 4.3) and declaration forms (Appendix 4.4) are interactive PDF documents. Please contact the Project Officer at homer@nhmrc.gov.au if you have any questions about using these forms.

Submitting your nomination for certification of institutional ethical review processes

Email your completed self assessment, nomination form, declaration form and checklist, along with mandatory supporting documentation*, to homer@nhmrc.gov.au with “HoMER Certification Nomination” in the subject line.

*Mandatory supporting documentation

Please note that nomination for certification only requires the following mandatory supporting documentation to be included with the institutional self assessment, nomination form and declaration form and checklist:

Footnotes

1. In this document, ‘institution’ means the decision making responsibility and accountability of the Head of an institution (e.g. Chief Executive Officer, Vice-Chancellor, Chief Executive or their delegate determined by the governance arrangements of the institution).
2. The ‘agreed set of criteria’ includes demonstration of  conformance with the National Statement on Ethical Conduct in Human Research
3. In this document, ‘ethical review’ means both the ethical and scientific review of an application for a particular research proposal.