Submitting your 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).

1. The first step is to register your project in REGIS. More information is available here.
   
   
2. Once the project registration is complete, the Human Research Ethics Application (HREA) must be completed in REGIS. The HREA is used for all research submissions regardless of the level of risk and regardless of whether the research is single-site or multi-site. More information is available here.
   
   
3. Once the ethics application has been submitted, you can commence the Site Specific Assessment Application (NSW SSA) in REGIS. More information on completing an SSA application and obtaining Head of Department support is available here. More information on submitting the SSA application is available here.
   
   
4. When uploading document files onto REGIS during project registration, please refer to the REGIS guide available here. 
   
   
5.  Before you submit your ethics application in REGIS please ensure that there is ONE person who is in the Role “Coordinating Principal Investigator” at question 1.9.10 in the HREA:

When to submit

Low or negligible risk ethics applications may be made submitted at any time. 

Greater than low or negligible risk ethics applications must be submitted no later than the HREC's monthly submission dates (see link below).

Important note:

• Meeting dates for full Ethical review 
  
• Low or Negligble Risk Review pathway applications may be submitted at any time.
  
• SSA applications may be submitted at any time. 
• Studies involving cell therapy should be discussed in advance with the Director of the Department of Cell and Molecular Therapies, c/o: gabrielle.osullivan@health.nsw.gov.au                     

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.

1. Cover letter
2. Study Protocol (note: studies received without a protocol will not be approved)
3. Privacy Compliance Form
4. Data Collection Form for multiple sources, Data Collection Form fo single data source and Master Code Sheet for Medical Review studies (click here for guidance on how to complete a HREA for MR studies)
5. Research Data Management Plan (RDMP)
6. For research involving medical records review: create a data collection form. This should contain a version number and date.
7. Participant Information Sheet & Consent Form. A pro-forma is available here. For multi-site research this should be a Master Version from which all sites can prepare their own local version. It should contain a version number and date.
8. Separate Participant Information Sheet and Consent Form for genetic sub-studies.
9.  For all forms and templates, please click here
   
10. For all NSW Health Pathology staff or researchers collaborating with NSW Health Pathology staff, services or facilities, additional requirements apply. Please click here for further information. 

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

• Research participants should be selected according to the following criteria:

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 Dose The 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 RPAH Radiation Safety Officer (Alice Caldwell, 02 9515 6023) should be consulted about the study during its preparatory stages in order to ensure that the appropriate radiation safety clearances are obtained.

•  All procedures involving ionizing radiation should be listed in the protocol. Those procedures which are additional to normal clinical management should be identified and the radiation dose must be estimated for these procedures.

• Dose estimates must be assessed or verified by a medical physicist approved by the regulatory authority, in NSW the Department of Environment and Conservation. If a dose estimate exceeds the dose constraints, the medical physicist must obtain verification of the dose by a second medical physicist independent of the investigator.

•  For PET studies, the Information for Participants and the Participant Consent Form should be in the standard PET format and, where appropriate, should include specific information about the insertion of an arterial line and the associated risks. Contact the RPAH Radiation Safety Officer.

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.