Procedures

Procedures for human research proposals involving both the University of Newcastle and Hunter New England Health

The University of Newcastle (University) and the Hunter New England Health (HNEH) have an agreement whereby the decision of the Human Research Ethics Committee (HREC) of one institution will be accepted by the other institution. The agreement became effective on 1 January 2006 and applies to applications for ethics approval lodged after that date.

For the most part, human research which previously would have required submission to, and approval from, the HRECs of both the University and HNEH will now require a full submission to one HREC only. However all such approvals from one institution’s HREC must be reported to and noted by the other’s HREC and each HREC reserves the right to request a review of the approval.

NOTE: researchers must ensure the HREC approval is registered with their respective institution for cover under their institution’s insurance and for linkage of the ethics approval to research grants being administered by the University. See below.

A. Staff or students of the University conducting research in HNEH

A full application is to be made to the HNEH Human Research Ethics Committee (HNEHREC) for research in the following categories. That is, the HNEHREC will be the ‘lead’ committee and take primary responsibility for reviewing and, where appropriate, approving the research.

Staff, clients or patients of HNEH will be recruited as participants in the research; and/or
Records held by HNEH will be accessed; and/or
Human tissue samples held by HNEH will be accessed.

When approved, it is the responsibility of the Chief Investigator or Project Supervisor to register the approval with the University by lodging the following with the University’s Human Research Ethics Officer within 14 days of written notification of HNEHREC approval:

The completed Registration of HNEHREC Approval .
Three (3) copies of the approval notification from the HNEHREC.
Three (3) copies of the full application submitted to the HNEHREC.
Three (3) copies of any correspondence with the HNEHREC between submission of the application and final approval.

Monitoring of the approved research, reviewing applications for variations to the approved protocol, and receipt and review of serious adverse events will be the responsibility of the HNEHREC.

B. Staff or students of the University using facilities of the HNEH for their research

The University HREC will be the ‘lead’ committee and take primary responsibility for reviewing and, where appropriate, approving the research if:

The involvement of HNEH is restricted to University staff or students accessing facilities, services or equipment in HNEH, and no patients, clients or staff of HNEH will be participants in the research. Examples of such research might be the use of medical imaging or pathology services.

In this case, researchers must:

Submit a full application to the University HREC.
Submit with that application, written confirmation from the management of the relevant HNEH facility that the research may proceed in that facility once ethics approval is obtained.
When approval is granted by the University HREC, submit to the Professional Officer (Research Ethics) of the HNEH within 14 days of written notification of the University HREC approval:

One copy of the HREC Certificate of Approval.
One copy of the full application submitted to the University HREC.
One copy of any correspondence with the University HREC between submission of the application and final approval.

C. Staff of HNEH with research grants administered by the University of Newcastle

Staff of HNEH with research grants that will be administered by the University, and who have approval from the HNEHREC for the research proposal described in the grant application need to lodge the following with the University’s Human Research Ethics Officer:

The completed Registration of HNEHREC Approval.
Three (3) copies of the approval notification from the HNEHREC.
Three (3) copies of the full application submitted to the HNEHREC.
Three (3) copies of any correspondence with the HNEHREC between submission of the application and final approval.

D. Staff of HNEH conducting research at the University of Newcastle

The University HREC will be the ‘lead’ committee and take primary responsibility for reviewing and, where appropriate, approving the research if staff of the HNEH wish to conduct research at the University involving:

Staff or students of the University as participants in the research; and/or
Access to records held by University.

In these cases, researchers must:

Submit a full application to the University HREC.
When approval is granted by the University HREC, submit to the Professional Officer (Research Ethics) of the HNEH within 14 days of written notification of the University HREC approval:
- One copy of the HREC Certificate of Approval.
- One copy of the full application submitted to the University HREC.
- One copy of any correspondence with the University HREC between submission of the application and final approval.

E. When application to both the University and HNEHREC is required

In some cases it may still be necessary to obtain approval from both the University HREC and HNEHREC. For example, where the research involves both staff/clients/patients/records/tissue at HNEH and staff/students/records at the University.