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. Ensure the radiation statement/s in your site specific documents are also represented appropriately.

Standard of care

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.

For projects involving standard of care procedures, allow up to 10 business days for request applications to be reviewed.

Additional to standard of care

If your research project will involve radiological procedures where radiation exposure exceeds what is typically required for the condition being treated and is specifically requested for the purpose of the trial, they are considered additional to standard care. Examples include:

  • Use of different modalities to perform imaging (i.e. CT instead of X-ray)
  • More frequent radiological examinations than typically required
  • Additional ionising radiation procedures to track adverse outcomes
  • Examinations conducted solely to determine a volunteer’s eligibility for a clinical trial
  • Imaging of additional body regions

The Radiation Safety Officer/Medical Physicist will provide a radiation dose estimate and risk assessment for the study scans that are additional to standard of care.

These documents must be submitted with your Research Ethics and Governance application, in line with the ARPANSA RPS 8 Code of Practice for Exposure of Humans to Ionizing Radiation for Research Purposes (The Code). If the radiation dose from these procedures exceeds the limits set in The Code, the proposal must undergo an independent assessment by a second medical physicist. This will be organised by the Radiation Safety Officer.

For projects involving additional to standard of care procedures, allow up to 4-6 weeks for request applications to be reviewed.

Protocol amendments

Note that protocol amendments that leads to a change in the participant’s radiation exposure where the radiation exposure exceeds what is considered standard care will require a re-assessment.

Requests cannot be processed until all relevant documents are received. These include:

  • Completed radiation research assessment form (incomplete form will not be considered)
  • Finalised protocol (a protocol that is not finalised will not be accepted)
  • Imaging manual
  • Participant information statement
  • Participant consent form
  • Medical physicist radiation report from lead site

Queries

The Children’s Hospital at Westmead

Sydney Children's Hospital, Randwick

Aboriginal Health and Medical Research Ethics (AH&MRC) resources