National Health and Medical Research Council

Organisations that have established Human Research Ethics Committees are encouraged to register with the NHMRC, and report annually to the NHMRC. There are many benefits for registering HRECs with the NHMRC.

Registering a HREC with NHMRC

When do you need to establish a HREC?

The National Statement on Ethical Conduct in Human Research (2007) (the National Statement) requires that all research involving human participants be reviewed and approved by a Human Research Ethics Committee (HREC).

Organisations that regularly undertake research involving humans may establish an HREC to review this research. Organisations should be aware, however, that establishing and maintaining an HREC requires significant resources. It is the establishing organisation's responsibility to ensure that its HREC is adequately resourced and maintained. The organisation must also accept legal responsibility for decisions and advice received from the HREC and must appropriately indemnify its members. For these reasons, an organisation should only contemplate establishing an HREC if it is confident that it can adequately meet these ongoing requirements.

Organisations that choose not to establish an HREC may approach another organisation with an established HREC with a request for the HREC to review research proposals on its behalf, on a regular or ad hoc basis. Independent researchers may also approach HRECs with such requests. An HREC's relationship with non-affiliated researchers should be specified in its terms of reference, which should be determined by the establishing organisation. It should be noted, however, that organisations are not obligated to agree that their HREC will undertake reviews on behalf of other organisations or independent researchers. Organisations agreeing to provide ethical reviews on behalf of other organisations or for independent researchers sometimes require indemnification and/or charge a fee for service.

Alternatively, organisations may wish to contact other organisations to consider jointly establishing an HREC. Organisations jointly establishing an HREC can arrange to share the responsibility for resourcing and maintaining the HREC. The National Statement does not restrict how many organisations can share an HREC, however, it should be noted that it is the responsibility of the organisations involved to establish the terms of reference of the HREC and determine legal aspects of their relationship.

Why should you register your HREC with NHMRC?

The National Statement on Ethical Conduct in Human Research (2007) (the National Statement) requires that organisations and their HRECs report annually to the NHMRC information relevant to its procedures. For this reason, the NHMRC requires that HRECs register with the NHMRC.

HRECs registered with the NHMRC are required to comply with, and demonstrate their on-going compliance with, the National Statement. Although compliance with the National Statement is not required by law, there are compelling reasons why your HREC should comply with these guidelines and verify this compliance by registering with the NHMRC. Some of these reasons are listed below.

Funding

The NHMRC requires organisations that receive NHMRC funding to ensure that research involving humans, whether relating to health or not, has been reviewed and approved by an HREC that has been established and operates in accordance with the National Statement. Therefore, the NHMRC requires that organisations that receive this funding have, or have access to, an HREC registered with the NHMRC.

The Australian Research Council (ARC) - the major Australian funding body for research outside the fields of clinical medicine and dentistry - also requires that research proposals involving humans have approval from an HREC established and operating in accordance with the National Statement, in order to qualify for funding.

Clinical Trials

The Therapeutic Goods Administration (TGA) requires ALL clinical trials of unregistered therapeutic goods conducted under the Therapeutic Goods Act 1989 to be reviewed and monitored by an HREC that is notified to the NHMRC and compliant with the National Statement.

Human Embryo Research

The Research Involving Human Embryos Act 2002, Section 22, requires HRECs that approve research involving excess human embryos to be registered with the NHMRC and compliant with the National Statement.

Privacy Legislation

HRECs that apply the Guidelines under Section 95 and the Guidelines approved under Section 95A of the Privacy Act 1988 are required to be registered with the NHMRC and compliant with the National Statement.

Recognition

Registration with the NHMRC demonstrates that an HREC is established in accordance with the National Statement, and has appropriate procedures in place to meet the ongoing operational requirements of the National Statement. Being assessed by the NHMRC as compliant with the National Statement (together with the Section 95 and 95A Guidelines) indicates that an organisation operates according to, and promotes, the highest standards of academic integrity and ethical practice in research.

Quality Improvement

Adhering to the high ethical standards and practices prescribed by the National Statement is a good quality assurance measure. Registering with the NHMRC enables an organisation to monitor its performance against these standards.

Publication

It is becoming increasingly common for professional journals to only publish research that has had approval by an HREC at the proposal stage.

Information

By registering with the NHMRC, the NHMRC's Australian Health Ethics Committee (AHEC) will ensure that you be made aware of all relevant NHMRC guidelines, discussion papers, quarterly NHMRC E-News , Research Ethics Guidance Notes and other relevant publications.

Assistance

By registering with the NHMRC, an HREC will have access, by e-mail or telephone, to assistance and guidance from the Secretariat of the NHMRC's Australian Health Ethics Committee on interpreting and using the National Statement and other relevant guidelines in reviewing human research proposals.

The HREC registration form

You can apply for registration of a Human Research Ethics Committee (HREC) with the NHMRC by completing a Registration Form. Applications for registration should be completed with reference to the National Statement on Ethical Conduct in Human Research (2007) (the National Statement), with particular reference to Chapter Two 'Human Research Ethics Committees'.

Please note that an application for registration of an HREC must be completed and signed by the head of the organisation(s) responsible for the HREC (eg. the CEO(s)).

 How to close a HREC

Organisations considering closing their HREC(s) must take into account the need for ongoing research projects to be monitored until completion. Either the HREC should continue to operate until all current research projects have been completed, albeit not taking responsibility for any new research projects, or the organisation should make arrangements so that the responsibility for monitoring the research projects is transferred to another HREC.

Organisations intending to close their HREC(s) should ensure that the principal researchers of all current projects are notified of the proposed closure and should work cooperatively with the researchers to ensure the transfer of current projects to another HREC. Principal researchers and organisations which conduct research must ensure that all current research is being conducted under the auspices of an HREC.

For HRECs registered with the NHMRC, organisations must complete a HREC Registration Closure Form form to advise the NHMRC of this closure and demonstrate that responsibility for ongoing research projects has been addressed appropriately.

An Annual Report Form must be completed for the HREC for any part of the reporting period (financial year) that it was in operation. An Annual Report Form will be provided to the organisation at the end of the reporting period. For more information about the Annual Report, please see HREC Annual Reporting to NHMRC.

If an organisation chooses to terminate the registration of its HREC with the NHMRC for reasons other than the closure of the HREC, it is still required to complete a HREC Registration

and to complete an Annual Report Form for any part of the reporting period (financial year) that the HREC was in operation and registered with the NHMRC. An Annual Report Form will be provided to the organisation at the end of the reporting period.

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