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:

o Interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities;

o Active concealment or planned deception of participants;o 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:

o Human genetics;o Human stem cells;o Women who are pregnant and the human foetus;o People who are highly dependent on medical care who may be unable

to give consent;o People with a cognitive impairment;o People with an intellectual disability or a mental illness; and, o People who may be involved in illegal activities.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 1

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 Submission Instructions

Investigator Initiated StudiesThe 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

commercially sponsored: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:o NHMRC project grants, partnership projects, development projects

and TCR grantso Project grants that have been assessed via NHMRC peer review

process, e.g. Cancer Council PdCRSS and Cancer Council NSWo NSW Health Translational Research Grants Scheme

Exempt from Peer Review

Please refer to pages 7 to 10

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 2

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.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 3

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.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 4

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.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 5

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.

4. Submission Once all the documents are finalised and you have obtained all the required

endorsements and uploaded them onto REGIS, please submit your application by

clicking on “Generate HREA document”. For more information please refer to the

QRG “Completing an Ethics Application” available on:

https://regis.health.nsw.gov.au/how-to/.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 6

Other Funded StudiesThe following projects are exempt from the peer review requirement:

A commercially sponsored study is a research project in which a for-profit company (e.g. Pharmaceutical or Device Company) takes the overall responsibility for the design and conduct of a study.

A large collaborative group study is a research project in which 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. Examples of large collaborative groups are the Children’s Oncology Group (COG) and the Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL).

The SCHN HREC has also exempted limited other funded studies from peer review. These are:

o NHMRC project grants, partnership projects, development projects and TCR grants

o Project grants that have been assessed via NHMRC peer review process, e.g. Cancer Council PdCRSS and Cancer Council NSW

o NSW Health Translational Research Grants Scheme

Submission Requirements & Process:

Submit application via REGIS 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).

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 7

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 website)

After project registration, REGIS will automatically generate a HREA form for

completion. Please refer to the QRG “Completing 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.

Protocol including a data management plan as per the National

Statement on Ethical Conduct in Human Research, 2007 (updated

2018), section 3.1.45.

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.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 8

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 .

For all the aforementioned funded studies exempt from peer review –

the grant approval letters

For commercially sponsored, multi-centre studies that involve non-

SCHN sites - Medicines Australia Form of Indemnity (HREC review only)

Please refer to this link for Medicines Australia indemnity forms and guidelines: https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/. The indemnity form must be provided by an Australian corporate entity. This may be:

o An Australian company; oro An Australian company that is subsidiary of an overseas parent

company; oro An Australian contract research organisation (CRO) that has been

engaged by an overseas or Australian company to conduct the trial in Australia.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 9

The indemnified party details must be completed as per the following:

“The Sydney Children’s Hospitals Network (Randwick and Westmead) (incorporating The Royal Alexandra Hospital for Children), ABN: 53 188 579 090; a Statutory Health Corporation incorporated under the Health Services Act 1997 of Hawkesbury Rd and Hainsworth St, Westmead, NSW, 2145 (“the Health Service”).”

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.

4. Submission Once all the documents are finalised and you have obtained all the required

endorsements and uploaded them onto REGIS, please submit your application by

clicking on “Generate HREA document”. For more information please refer to the

QRG “Completing an Ethics Application” available on:

https://regis.health.nsw.gov.au/how-to/.

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 10

Fees for Review of Research Ethics Applications

The NSW Ministry of Health has established minimum fees for the review of Research Ethics applications by the Human Research Ethics Committee. In accordance with this Policy Directive, the SCHN Research Ethics Office has established fees for these, and other types of ethics applications as deemed appropriate to ensure service delivery is maintained. Fees are payable on submission of an application with the option to request an invoice for payment. The fees for review of research ethics applications and associated processes are:

Type of Application Sponsor / Financial Support

Fee (GST Inclusive)

Application for Research Project (any form):

Full Commercial / Industry Funding

$3,300.00

Application for Research Project (any form):

Partial Commercial / Industry Funding

0.5% of total (funding) contract value up to $3,300

Application for Research Project (any form):

Collaborative Group Sponsored / Funded

$165.00

Non-GST Amount for internal applications - $150.00

REGIS - Greater than Low Risk Submission Guideline – V2 – Apr 2019 Page 11