Resources | Templates
This page provides resources and templates to assist with your research ethics application. We are continuously updating this page with new resources and templates!
In addition, this document provides a brief guide on how to prepare & submit a successful research ethics application: Guide to a Successful Research Ethics Application
The National Statement on Ethical Conduct in Human Research 2007 (updated in 2018)
The National Statement provides guidelines for ethical design and conduct of human research. The SCHN HREC reviews all research ethics applications in light of the National Statement. Researchers are strongly encouraged to familiarise themselves with the National Statement and utilise it in preparing their research ethics applications. Here is the link to access the National Statement: https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018
Consent & Recruitment
- Policy - SCHN Human Research Consent Policy
- Guide - APREG Guide to child consent in Clinical Trials - February 2017
Lay Language Resources
Parent/Guardian & Adult Participant Information Sheet (PIS) Templates
- Template - Parent Guardian PIS (most suitable for LNRs)
- Template - Adult PIS (most suitable for LNRs)
- Link to NHMRC PIS templates for Greater than Low Risk Applications: https://www.nhmrc.gov.au/research-policy/ethics/ethical-issues-and-resources
- Template - PIS Executive Summary (for PIS longer than 10 pages)
Child and Young Person Participant Information Sheet (PIS)Templates
- Template - Young Person PIS (suitable for all types of applications)
- Template - Child PIS (suitable for all types of applications)
Consent Form Templates
- Template - Parent Guardian Consent Form (with space for child/young person consent)
- Template - Adult Consent Form
Participant Invitation Letter Template
Follow Up Phone Script
Waiver of Consent
- Waiver of Consent Application Form - Data
- Waiver of Consent Application Form - Samples
- Guide: NSW Privacy Statutory Guidelines on Research - 2002
- Guide - Human Tissue Act & Use of Tissue in Research - 2006
- Summary of Consent Requirements for Use of Human Tissue in Research
The opt-out approach is a method used in the recruitment of participants into research where information is provided to the potential participant regarding the research and their involvement and where their participation is presumed unless they take action to decline to participate.
An opt-out approach to participant recruitment to research may be appropriate when it is feasible to contact some or all of the participants, but where the project is of such scale and significance that using explicit consent is neither practical nor feasible.
While an opt-out approach makes it possible for people to make an informed choice about their participation, this choice can only be made if participants receive and read the information provided, and they understand that they are able to act on this information in order to decline to participate.
An opt-out approach, should not be used in genomic research.
Before approving the use of an opt-out approach for research, an HREC must be satisfied that:
Involvement in the research carries no more than low risk
The public interest in the proposed activity substantially outweighs the public interest in the protection of privacy
The research activity is likely to be compromised if the participation rate is not near complete, and the requirement for explicit consent would compromise the necessary level of participation
Reasonable attempts are made to provide all prospective participants with appropriate plain language information explaining the nature of the information to be collected, the purpose of collecting it, and the procedure to decline participation or withdraw from the research
A reasonable time period is allowed between the provision of information to prospective participants and the use of their data so that an opportunity for them to decline to participate is provided before the research begins
A mechanism is provided for prospective participants to obtain further information and decline to participate
The data collected will be managed and maintained in accordance with relevant security standards
There is a governance process in place that delineates specific responsibility for the project and for the appropriate management of the data
The opt-out approach is not prohibited by State, federal, or international law.
Identifiability of Data & Privacy Protection
- Guide: NSW Privacy Statutory Guidelines on Research - 2002
- Guide: De-identification and the Privacy Act
Data may be collected, stored or disclosed in three mutually exclusive forms:
Individually identifiable data, where the identity of a specific individual can reasonably be ascertained. Examples of identifiers include the individual’s name, image, date of birth or address; Patients' identifiable information cannot be taken off SCHN server / site without their consent.
Re-identifiable data, from which identifiers have been removed and replaced by a code, but it remains possible to re-identify a specific individual by, for example, using the code or linking different data sets;
Non-identifiable data, which have never been labelled with individual identifiers or from which identifiers have been permanently removed, and by means of which no specific individual can be identified. A subset of non-identifiable data are those that can be linked with other data so it can be known that they are about the same data subject, although the person’s identity remains unknown.
Program of Research and Data Registries Guidelines
Invoicing Authorisation Form
Forms, Templates & Resources Specific to Greater than Low Risk Applications
- SPIRIT Drug/device protocol template – mandatory for investigator initiated studies
- SPIRIT Non drug device protocol – mandatory for investigator initiated studies
- Peer Reviewer Report Form - V1 - August 2017
- Booking an appointment with the CHW Biostatistician
- CHW Radiation Safety Report Application Form (word version)
- CHW Radiation Safety Report Application Form (pdf version)
- SCH Radiation Safety Report Application Form