Criteria for referral of research to the DH HREC

Page contents: Minimizing the duplication of review | Access to data held by DH

Organisations that conduct human research are required to ensure that their research is approved by an HREC which is constituted in accordance with the National Statement (Section 5.1.24). Such organisations usually have their own institutional HREC.

The DH HREC is an institutional HREC and the following criteria determine whether a research proposal involving more than ‘low or negligible risk’, as defined in the National Statement (p. 16), should be referred to the DH HREC for consideration:

1. Where research involving human subjects is being undertaken by the Department of Health and the research cannot be considered by another Human Research Ethics Committee which is properly constituted in accordance with the National Statement (see section 2.3.1).



2. Where the Department of Health is providing funding to other organisations for the provision of services, the research relates to the clients of such an organisation, that organisation does not have its own Ethics Committee, and the research cannot be considered by another properly constituted Human Research Ethics Committee.



3. Where research to be conducted by another organisation has been funded by the Department of Health, that organisation does not have its own Ethics Committee, and the research cannot be considered by another properly constituted Human Research Ethics Committee.



4. Where there is a formal agreement signed by an authorised delegate to accept research proposals for consideration by this committee when the organisation does not have its own committee.

Minimizing the duplication of review

The National Statement on Ethical Conduct in Human Research (2007) requires that organisations minimize the duplication of ethical review of research proposals (5.3 National Statement).

Research which will receive ethics approval by a Human Research Ethics Committee constituted in accordance with the National Statement (Sections 5.1.26 - 5.1.37), does not require additional approval from the DH HREC.*

Approval should be sought from the primary ethics committee, i.e. the committee which has review responsibilities (5.3 National Statement) and which accepts responsibility for the scientific and ethical review of the research. For example, if research is being conducted in hospitals or requires access to hospital data, researchers will need to seek approval from the relevant hospital HREC(s). Alternatively, if the researcher is a member of staff at a University, the research will need to be approved by that organisation.

* It is the responsibility of individual HRECs from which DH accepts ethical review to ensure that they meet the obligations and responsibilities set out in 5.1.9 of the National Statement in relation to legal protection for all individuals involved in the ethical review of research proposals.

Access to data held by DH

All researchers wishing to access data held by DH will need to seek departmental support prior to the submission of their proposal to an ethics committee. Researchers must comply with the standard release conditions imposed by the Heads of the relevant DH program areas, who have ultimate responsibility for the appropriate storage, handling of, access to and use of the data of which they are custodians (3.2 National Statement).

Research that involves the use of data held by DH does not require ethics consideration by the DH HREC in the following circumstances:

• The Principal Researcher is external to DH and will be seeking approval from the HREC of the organisation of which they are a member of staff. External researchers are required to submit to their ethics committee and will therefore not have access to the DH HREC.



• The Principal Researcher is a DH member of staff but has already been granted approval for the conduct of the research by another HREC (e.g. a hospital HREC or an HREC accessed via a Co-Researcher on the same research project).



• The data are non-identifiable, as determined by the Head of the relevant DH program area.

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