Resources and templates

Resources and templates

Guide to a successful Research Ethics application

National Statement

Consent and recruitment

Templates for Participant Information Sheets (PIS) and Consent Forms

The CT:IQ InFORMed Project has developed templates and user guides for simplified Participant Information Sheets for use by researchers. We encourage researchers to use these resources.

These templates, user guide and feedback portal can be found on the InFORMed website.

Lay Language Resources

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

Child and Young Person Participant Information Sheet (PIS)Templates

Consent Form Template

Participant Invitation Letter Template

Follow Up Phone Script

Waiver of consent

Opt-out consent

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.

LNR protocol template

Identifiability of data and 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 forms

Peer review template

Protocols

Radiation safety assessment

Research that involves the use of ionising radiation for any purpose (standard of care or additional to standard of care) requires a completed radiation safety assessment form. Please ensure the below forms are completed and approved by the relevant Radiation Safety Officer before you submit your Research Ethics and Governance application. Please ensure the radiation statement/s in your site specific documents are also represented appropriately. If your research project will involve the use of ionising radiation under the purpose of standard of care only, please provide written evidence from the supporting department that clearly confirms this. 

Note for The Children’s Hospital at Westmead (CHW) applications

There is a fee of $250.00 per report associated with the generation of these reports as an external consultant is required. Please allow up to 1 month for the review and generation of a radiation dosimetry report from the date of your submission. If the report needs an independent review due to exceeding dose constraints, please allow for additional time. The following documents listed below must be submitted with this request form. The request will not be processed until all relevant documents are received:

  • Study protocol
  • Imaging manual (if available)
  • Medical physicist radiation report from the lead site (if CHW is not the lead site)
  • Participant and Information Consent Forms (PICFs)