Conducting Research at Newcastle Private Hospital
Any research project that impacts directly or indirectly on Newcastle Private Hospital (NPH) patients (inpatients and outpatients), or that will use significant NPH resources, must have both Human Research Ethics Committee (HREC) and Research Governance approval in place.
Research Ethics (HREC)
The National Health and Medical Research Council (NHMRC)’s National Statement on Ethical Conduct in Human Research 2007 (updated 2018) sets the national standards for any individual, institution or organisation conducting human research in Australia.
All research projects to be completed at NPH requires ethics review. As part of the National Mutual Acceptance initiative, NPH accepts ethical review from NHMRC Certified Lead HRECs, providing the HREC is willing to extend their ethical oversight to NPH.
NB: NPH has agreements in place with a number of different NHMRC approved HRECs, noting their acceptance to provide ethical review on behalf of NPH. In the situation where an agreement is not in place, a copy of the executed HREC indemnity (noting NPH as a site) must be obtained as evidence that the lead HREC agrees to proceed with monitoring responsibilities for NPH.
Please contact the NPH Regulatory Coordinator for further information.
A streamlined governance process has been implemented at NPH to ensure that all ethical, regulatory and logistical requirements of research being conducted at NPH are being fulfilled.
The process of research governance at NPH includes consideration of:
- the suitability of the investigators to conduct the research;
- the assessment and management of site risk;
- the identification of actual and in kind resources required to conduct the research;
- ensuring clinical research is conducted in compliance with national and institutional SOPs on research and clinical trials, as well as national and international research guidelines (eg. NHMRC National Statement, ICH GCP).
For further information and queries, please contact the NPH Regulatory Coordinator:
Phone: 02 4941 8718
Newcastle Private Hospital
14 Lookout Road
New Lambton Heights, NSW 2305
Applying for Research Governance at Newcastle Private Hospital
All new Research projects that impact directly or indirectly on Newcastle Private Hospital (NPH) patients (inpatients and outpatients), must undergo review by the:
- Hospital Medical Advisory Committee (MAC)
- NPH Research Governance Unit
The purpose of the NPH research governance application form is to outline the requirements of the proposed research project and to assess the legal, financial, regulatory, and contractual matters related to the impact of the research at NPH.
The Principal Investigator of a research project is responsible for ensuring that any site-specific documents (including any Participant Information and Consent Form, PICF) are submitted, and that these are based upon the current HREC approved Master documents and appropriately amended to include NPH site specific information.
The information submitted as part of the NPH research governance application form will be used as part of the governance review completed by both the MAC and NPH Research Governance Unit.
N.B: NPH MAC meetings are held every 3 months (February, May, August, November)
Both a MAC acknowledgment AND NPH Governance approval letter are required before a research study can commence at Newcastle Private Hospital.
In order to facilitate a timely review, Research Governance applications may be submitted for studies pending HREC approval. Please note, however, that final NPH Research Governance Approval will not be granted until evidence of ethical approval has been provided.
The Principal Investigator of a research project is responsible for notifying the NPH Research Governance Unit of all HREC approved amendments to a research project. These amendments include the submission of any:
- change to authorised documents, such as study protocol, Investigator Brochure, Participant Information and Consent Form (PICF);
- new study document requiring NPH approval;
- amendments to study agreements or Indemnity.
All HREC approved amendments are to be submitted for governance review prior to implementation at NPH.
The NPH research governance amendment form is to be completed and submitted to the NPH Research Governance Unit for review and approval.