New Applications
Steps to submitting a new project for ethical review:
In order to apply for ethical approval for a proposed research project, the investigators must complete the following steps
| 1 | Write a research protocol |
| 2 | Arrange a pre-submission peer review of the protocol |
| 3 | Conduct a risk assessment to determine which application process to follow in the next step |
| 4 | Follow the instructions on the relevant page to complete and submit an application to the Ethics Office |
A research protocol is the document that outlines the study plan for a human research project. The study plan must be carefully designed to safeguard the health and safety of the participants, as well to as answer specific research questions. A protocol gives written evidence for the necessity and feasibility of a research study. It provides a full and detailed description of the objectives, design, methodology, statistical considerations and organisation of the study, including specific details on how the research will be conducted and evaluated. A complete, detailed protocol allows the Human Research Ethics Committee (HREC) and other reviewers to make a judgement about the scientific and ethical aspects of the study. HREC approval will only be granted to studies with an adequate protocol. Following approval by the HREC, the protocol becomes the legally binding, definitive document for the study conduct, evaluation and reporting. Once a protocol is approved, it is essential that the study is carried out in accordance with the details in the document, as the investigators only have approval to do the research as described in the protocol.
For further information, guidance & templates please see the Clinical Research Development Office (CRDO) website.
2. Arrange a pre-submission peer review of the protocol
All clinical research protocols require peer review before submission to the RCH Ethics Office, and evidence of this review must be submitted with the application. Pre-submission peer review is a key process to assure quality in research to ensure that relevant and scientifically sound research is undertaken under the approval of the RCH HREC.
For further guidance please see the Pre-submission (Peer) Review Process.
Please download the Pre-submission (Peer) Review Proforma for use.
3. Conduct a risk assessment to determine which application process to follow
Different research projects carry different degrees of risk. For the RCH Ethics Office, the application and review process for each project is determined by which level of risk applies to the research.
For further guidance on how to assess the risk of your project and determine the correct application process, please consult the Risk Assessment Page.