Submitting a Proposal
A research proposal is submitted for review using the Research Ethics and Governance Information System (REGIS) website at: https://regis.health.nsw.gov.au/. (First time users of the site must create an account before proceeding).
When to submit
DOCUMENTS TO BE SUBMITTED
For both single and multi-site research, the documents listed below are required to be uploaded into REGIS when completing the HREA.
Additional documentation for clinical drug or device trials. Please see the Clinical Trials page
a) RESEARCH PROTOCOLS INVOLVING IONIZING RADIATION
Under NSW legislation, research studies must follow the guidelines set out by the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) in its "Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes" (2005) which can be downloaded from www.arpansa.gov.au/pubs/rps/rps8.pdf
Age Where practicable, participants should be aged over 40 years, and preferably over 50. Persons under the age of 18 are not permitted to be exposed to radiation as volunteers in medical research unless the research is related to conditions of childhood and the information sought cannot be obtained using adult participants.
Exclusions Pregnant women and women who are breastfeeding must be excluded except when a condition specific to these groups is being investigated. An estimate of the likely dose to a fetus will be required. If the pregnancy status of a woman of reproductive age is uncertain, a pregnancy test should be performed to exclude pregnancy if the dose to the uterus would exceed 0.1 millisieverts.
Radiation DoseThe radiation dose must be kept to the minimum level practicable. Dose constraints (upper levels) apply to exposures additional to those which are received for normal clinical management. Dose constraints are specified for Effective Dose according to age and life expectancy and for Equivalent Dose to skin and any other organ. Where these dose levels will be exceeded, the ERC will closely review the justification for the exposures and may obtain further authoritative advice.
The CRGH Radiation Safety Officer (Nicholas.Forwood@health.nsw.gov.au) should be consulted about the study during its preparatory stages in order to ensure that the appropriate radiation safety clearances are obtained.
b) GUIDE TO WRITING A RESEARCH PROTOCOL
A Research Protocol is mandatory for all applications to the Ethics Committee. A list of Protocol templates can be accessed in the Forms section under "Suggested Protocol Templates".
c) DATA MANAGEMENT FOR RESEARCH
The SLHD encourages researchers to practice and be familiar with good data management practices. Spreadsheets like Excel or Google Sheets should be avoided and can be poor tools for data management. The SLHD provides one such tool in the REDCap data management software. It is provided free of charge to researchers and offers a secure, encrypted database option with regular back-ups which are stored within the SLHD ICT Services environment. It has a wide variety of features and functions to support high quality data collection and reduce the potential for the above mentioned data catastrophes. More information can be found on the SLHD REDCap home page https://redcap.sswahs.nsw.gov.au.
Please see the Data Management in Research page for further information.