Submission Guideline

HREA – Greater than Low Risk Applications

Sydney Children’s Hospitals Network Human Research Ethics Committee

Table of Contents

Introduction

Research with greater than low risk

Submission & Review Processes for greater than Low risk Resarrch Ethics applications

Step by step submission Instructions

Investigator Initiated Studies

Commercially Sponsored, Large Collaborative Group and Limited Other Funded Studies

Fees for review of research ethics applications

Introduction

This submission guidelineprovides advice to any person, staff member or student who intends on submitting a greater than low risk ethics applicationfor review by the Sydney Children’s Hospitals Network Human Research Ethics Committee (SCHN HREC).

SCHN HREC is responsible for ensuring ethical and scientific acceptability of human research conducted at sites within the Sydney Children’s Hospitals Network (SCHN) and for paediatric specific research referred by any Public Health Organisation from NSW, ACT, VIC, QLD, SA and WA as part of the National Mutual Acceptance of scientific and ethical review of multi-centre human research.Human research is research conducted with or about people, or their data or tissue.

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 ofobtaining of SSA, please contact the relevant Research Governance teams.

Research with greater than low risk

In accordance with the National Statement on Ethical Conduct in Human Research (2007), the following types of human research must be ethically reviewed by the full Committee and not through an expedited process.

  1. Research that involves more than a low risk to participants.
  1. Research that includes any of the following:
  2. Interventions and therapies, including clinical and non-clinical trials and innovations or new treatment modalities;
  3. Active concealment or planned deception of participants;
  4. Exposure of illegal activities.
  1. Research specifically targeting Aboriginal or Torres Strait Islander peoples.
  2. Research that includes any of the following, except where the project uses collections of non-identifiable data and involves only negligible risk to participants:
  3. Human genetics;
  4. Human stem cells;
  5. Women who are pregnant and the human foetus;
  6. People who are highly dependent on medical care who may be unable to give consent;
  7. People with a cognitive impairment;
  8. People with an intellectual disability or a mental illness; and,
  9. 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. These processes are briefly outlined in the below tables. Please ensure that you read the full step-by-step submission instructions following the tables before preparing and submitting your application.

Investigator Initiated / Commercially Sponsored
Large Collaborative Studies
NHMRC funded studies
Project grants that have been assessed via NHMRC peer-review process
NSW Health Translational Research Grants Scheme
Step 1 – Obtainment of peer review prior to submission to the SCHN HREC.
Researchers to obtain peer review from at least one independent, expert reviewer and the SCHN SAC Statistician. / Exempt from peer review
Step 2 – Sub. Closing Date
Researchers to submit their final application following endorsement from their peer reviewer/s. Final applications will include a completed SCHN HREC’s peer reviewer report form. / Step 1 – Sub. Closing Date
Researchers to submit their final application.
Step 3 – SAC and HREC meetings. / Step 3 – SAC and HREC meetings.
Step 4 – Combined SAC and HREC feedback issued to applicants. / Step 4 – Combined SAC and HREC feedback issued to applicants.

Step by step submission Instructions

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.

The National Statement on Ethical Conduct in Human Research (NHMRC 2007) requires each institution to be satisfied that human research receiving ethical approval meets relevant scholarly or scientific standards. An important aspect of this assurance is evidence of peer review of the scientific basis of a research protocol. Peer review is seen as a key indicator of quality assurance in research and is an essential process to ensure that relevant and scientifically sound research is undertaken within the network. Peer review should also be seen as a useful opportunity to improve the quality of the project.

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

Followingendorsement 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 email to and include the following documentation. The submission email should be from a valid organisational email address (e.g. not Gmail/Hotmail).

  • HREA – completed online at downloaded and emailed as an original PDF (i.e. not scanned). Please ensure that you select ‘Greater than Low Risk’ to question 4.5 in the HREA.
  • Electronic signatures or scanned signature page
  • SCHN HREC’s Peer Reviewer Report Form completed by the peer reviewer/s. If the peer reviewer had requested for 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 - 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.
  • For all Victorian sites - The Victorian Specific Module
  • For all Western Australian sites - Western Australian Specific Module (WASM)
  • Application for Waiver of Consent form if applicable
  • Submission Checklist

Step 3 – SAC and HREC Meetings

The application will be listed for review by the SAC and HREC on consecutive meeting days.

Step 4 – Combined SAC and HREC Feedback

A single combinedSAC and HREC feedback letter is issued to investigators within one week of the published HREC meeting date.

Commercially Sponsored, Large Collaborative Group and Limited Other Funded Studies

The 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:
  • 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

Step 1 – Submission Closing Date

Submit application via email to the SAC & HREC submission closing date. The application should contain the following documentation (please see next page). The submission email should be from a valid organisational email address (e.g. not Gmail/Hotmail).

  • HREA– completed online at downloaded and emailed as an original PDF (i.e. not scanned).Please ensure that you select ‘Greater than Low Risk’ to question 4.5 in the HREA.
  • Electronic signatures or scanned signature page.
  • Protocol
  • 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.
  • Application for Waiver of Consent form if applicable
  • Submission Checklist
  • For all the aforementioned funded studies exempt from peer review – the grant approval letters
  • For all Victorian sites - The Victorian Specific Module
  • For all Western Australian sites - Western Australian Specific Module (WASM)
  • 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: The indemnity form must be provided by an Australian corporate entity. This may be:

  • An Australian company; or
  • An Australian company that is subsidiary of an overseas parent company; or
  • An Australian contract research organisation (CRO) that has been engaged by an overseas or Australian company to conduct the trial in Australia.

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”).”

Step 2 – SAC and HREC Meetings

Your application will be listed for review by the SAC and HREC on consecutive meeting days.

Step 3 – Combined SAC and HREC Feedback

A single combinedSAC and HREC feedback letter is issued to investigators within one week of the published HREC meeting date.

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

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Submission Guideline – HREA: Greater than Low Risk – V1 – August 2017