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 

Lay Language Resources

Parent/Guardian & Adult Participant Information Sheet (PIS) Templates

Child and Young Person Participant Information Sheet (PIS)Templates

Consent Form Templates

Participant Invitation Letter Template

Follow Up Phone Script

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

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