Full Ethics (NEAF) and Low Risk (LNR) submissions
The following application forms are available at the “Online Forms” website at: www.ethicsform.org/au. (First time users of the site must create an account before proceeding).
- Human Research Ethics Application (HREA) for both multi-centre, single-site and Low/Negligible Risk research from 1st September 2017. NB: NEAF and LNR forms will still continue to be accepted if an application was created prior to this date.
- Site Specific Applications (NSW SSA)
- Meeting dates for HREA
- Low 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, Professor John Rasko c/o: firstname.lastname@example.org
1. COMPLETING THE ONLINE FORM
For researchers: When you log in to Online Forms after 31 August 2017, select ‘Create New
Project’ and then ‘HREA’. The Online Forms HREA is used in exactly the same way as the NEAF; complete the form, upload supporting documents, create SSAs, electronically authorise, and submit the application to the reviewing organisation. The Online Forms User Manual, which provides guidance on how to complete application forms and supporting documents required for making an application, will be updated to reflect the HREA. Under the Help menu, select User Manual.
Low Risk research to be reviewed under the National Mutual Acceptance (NMA) scheme or interstate research must be submitted using the HREA. These applications cannot currently undergo expedited review and will be reviewed at a meeting of the HREC.
2. DOCUMENTS TO BE SUBMITTED
For both single and multi-site research, the documents listed below are required. A pdf (or Word) of each document should be emailed to: email@example.com and one paper copy of each document should be provided to the RPAH Research Ethics and Governance Office.
- Study Protocol (note: studies received without a protocol will not be approved)
- For research involving medical records review: create a data collection form. This should contain a version number and date.
- 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.
- Separate Participant Information Sheet and Consent Form for genetic sub-studies.
- Site Specific Assessment (SSA) Form – one hard copy with submission code and all signatures. This form should be submitted after ethics has been approved. See the SSA page for further information.
- For all forms and templates, please click here
NB: ALL SUBMITTED DOCUMENTS SHOULD BE SINGLE-SIDED AND UNSTAPLED.
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:
AgeWhere 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.
ExclusionsPregnant 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 RPAH Radiation Safety Officer (Jocelyn Towson, 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. Guidance on writing a Research Protocol is available here.
c) DATA MANAGEMENT FOR RESEARCH
The SLHD encourages researchers to practice and be familiar with good data management practices. Spreadsheets like Exvel 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 IM&TD 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.
The Ethics Officer
Research Development Office
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
RPA Medical Centre
Cnr Missenden Road and Carillon Avenue
NEWTOWN NSW 2042