SCHN HREC: GREATER THAN LOW AND NEGLIGIBLE RISK SUBMISSION GUIDELINES
APPLICATIONS VIA REGIS
This submission guideline provides advice to any person, staff member or student who intends on submitting a greater than low risk ethics application for review by the Sydney Children’s Hospitals Network Human Research Ethics Committee (SCHN HREC).
It is important to note that in addition to ethical approval, Site Specific Authorisation (SSA) from the Research Governance Office of each site is required before a research project can commence at that site. For further information regarding the process of obtaining of SSA, please contact the relevant Research Governance teams.
Greater than Low Risk Research Projects
In accordance with the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018), the following types of human research must be ethically reviewed by the full Committee and not through an expedited process.
Research that involves more than a low risk to participants.
Research that includes any of the following:
· Interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities;
· Active concealment or planned deception of participants;
· Exposure of illegal activities.
Research specifically targeting Aboriginal or Torres Strait Islander peoples.
Research that includes any of the following, except where the project uses collections of non-identifiable data and involves only negligible risk to participants:
· Human genetics;
· Human stem cells;
· Women who are pregnant and the human foetus;
· People who are highly dependent on medical care who may be unable to give consent;
· People with a cognitive impairment;
· People with an intellectual disability or a mental illness; and,
· People who may be involved in illegal activities.
Submission & Review Processes for Greater than Low risk Resarrch Ethics applications
The SCHN HREC has two different submission and review processes for greater than low risk applications. Please refer to the following table to identify the relevant submission instructions for your application.
Type of Project
Investigator Initiated Studies
The investigator takes the overall responsibility for the conduct of a study and usually initiates, organises and supports the study.
Peer Review required
please refer to pages 3 to 6
Other Funded Studies
A for-profit company (e.g. Pharmaceutical or Device Company) takes the overall responsibility for the design and conduct of a study.
large collaborative group:
A well-established, non-commercial collaborative or cooperative group external to NSW Health takes the overall responsibility for the design and conduct of the study (e.g. COG)
limited other funded studies:
· NHMRC project grants, partnership projects, development projects and TCR grants
· Project grants that have been assessed via NHMRC peer review process, e.g. Cancer Council PdCRSS and Cancer Council NSW
· NSW Health Translational Research Grants Scheme
Exempt from Peer Review
Please refer to pages 7 to 10
Investigator Initiated Studies
An investigator initiated study is a research project in which the investigator takes the overall responsibility for the conduct of a study and usually initiates, organises and supports the study.
Submission Requirements & Process:
Step 1 – Obtainment of Peer Review
· Investigators must source an appropriate peer reviewer/s (at least one peer reviewer is required) and send to them their final study protocol and the SCHN HREC Peer Reviewer Report Form available on SCHN Research Ethics website. The peer review must be:
· Independent: the reviewer must be independent of the project. The reviewer may be internal and may be a member of the same department as the investigators; however the reviewer must not be in a dependent relationship (i.e. must not report to the Principal Investigator) and should be sourced from another department if the Principal Investigator is the Head of Department
· Expert: The peer reviewer must have adequate research experience, and understanding of the research methodology and outcomes of the proposed study.
· Documented: clear, written evidence of the review and the researchers’ response to any reviewer comments is to be submitted with the research ethics application.
Note - If you have difficulty finding an appropriate peer reviewers, please contact the Research Ethics Office for assistance.
· For studies that involve statistical components, investigators must also send their protocol for review to the SCHN SAC Statistician, Ms Liz Barnes. It is strongly recommended that investigators engage Ms Barnes as early as possible in the development of their protocol. Instructions for how to make an appointment with Ms Barnes is available on the SCHN Research Ethics website.
· The peer reviewer will complete the SCHN HREC Peer Reviewer Report Form and return the form to the investigators. The SAC Statistician will provide her written feedback via email.
It is important to note that the investigators can only submit their final research ethics application following receipt of endorsement from their peer reviewer and the SAC statistician.
Step 2 – Submission Closing Date
Following endorsement from the Peer Reviewer/s and the SAC statistician, the investigators can submit their final application on the SAC & HREC submission closing date.
The final submission by the investigators should be via REGIS as per the following instructions:
1. Register Project on REGIS
· The first step is to register your project on REGIS. To do this, please access the REGIS website: https://regis2.health.nsw.gov.au (which requires log in details. Please register for these details if you do not already have log in details).
· Please refer to the REGIS Quick Reference Guide (QRG) “Completing Project Registration” available via this link (https://regis.health.nsw.gov.au/how-to/) for instructions on how to register your project.
!!! Important Notes !!!
· Ensure all details are correct before you complete registration. The project registration CANNOT be edited or changed after submission.
· Incorrect site selection at project registration will have a major impact on the application process. Please ensure that in part C, all the correct sites have been selected under the relevant ACT / NSW / Other tabs.
2. Complete HREA Application Form (via REGIS)
After project registration, REGIS will automatically generate a HREA form for completion. Please refer to the QRG “Competing an Ethics Application” available via this link (https://regis.health.nsw.gov.au/how-to/) for instructions on how to complete your HREA form on REGIS.
3. Documents Required in Addition to HREA Form
In addition to the HREA form, the following documentation is required and must be uploaded onto REGIS for your application before it is submitted. Please note that incomplete applications will be rejected requiring a full resubmission.
· SCHN HREC’s Peer Reviewer Report Form
SCHN HREC’s Peer Reviewer Report Form completed by the peer reviewer/s. If the peer reviewer had requested further information / modifications prior to endorsing the application for submission, a copy of the investigator’s response to the peer reviewer and the peer reviewer’s subsequent endorsement should also be provided.
· Written endorsement form the SAC Statistician, Liz Barnes (if the study involved statistical components)
· Protocol including a data management plan as per the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018), section 3.1.45.
Note: It is mandatory that the SPIRIT Protocol Template is utilised for investigator initiated studies. Please refer to the SCHN Research Ethics website for a copy of the template.
· Investigator Brochure/Product Information (if applicable)
· Master Participant/Parent Information Sheets and Consent Forms (link to NHMRC templates)
· A one page executive summary for Participant/Parent Information Sheets longer than 10 pages.
· All Research Tools that will be used (for example, questionnaires, focus group questions, surveys)
· All Advertising Materials that will be used (if applicable)
· For applications involving radiation in excess of Clinical Care, a report from the Radiation Safety Officer at each site requiring ethical review and approval from SCHN HREC.
· Invoicing Authorisation Form (if applicable)
Please refer to the fee schedule on the last page for further information. The Invoicing Authorisation Form is to be downloaded from the SCHN Research Ethics Website.
· For all Victorian sites - The Victorian Specific Module
· For all Western Australian sites - Western Australian Specific Module (WASM) via RGS website
· Application for Waiver of Consent form if applicable
If you wish to apply for a waiver of consent, complete the Waiver of Consent Application Form.
· Submission Checklist including signatures on the declaration pages from both the CPI/PI and Head of Department
NOTE: If your submission checklist is incomplete (including missing endorsements, versions and dates, etc.) then your application will be considered invalid and will require a full resubmission.
Once all the documents are finalised and