NSW Health has developed an important new, standardised NSW Health Consent Toolkit to support broad-based, ethical and truly informed consent.
We recognise that obtaining informed consent for future unspecified biobanking research is a recognised challenge for the international research community.
By developing this standardised, plain English approach, NSW Health hopes to lead the way in biobanking consent and provide greater support to those undertaking vital translational research.
A collaborative research asset that is accessible and easy to use, the Consent Toolkit provides support, guidance, expertise and templates for those seeking consent from participants to:
- donate a sample for future health and medical research
- link health and personal information (data) to the sample now and into the future
Participant Consent Materials
To help support and guide your conversations with patients and participants around consent, a range of plain English Participant Consent Materials have been developed for your use. These include:
- Participant Information Sheet Cover Page
- Participant Information Sheet
- Adult consent form
- Child consent form – directed at child
- Child consent form – directed at parent/guardian
- Frequently Asked Questions
- Research examples
When building your consent process and documentation, there are two versions of Participant Consent Materials to select from.
Fixed Participant Consent Materials
It is a NSW Health policy for the following collection types to use the Fixed Participant Consent Materials:
- prospective Strategic Collections (funded by OHMR)
- prospective open access collections housed at the NSWHSB
- fixed PDF versions of the Participant Information Sheet, consent forms, FAQs and research examples
- Participant Information Sheet Cover Page for biobankers/researchers to tailor the consent materials to their specific collection and research project
- free access to standard linked datasets (via the Centre for Health Record Linkage – CheReL)
- pre-approval of fixed consent materials by human research ethics committees
Flexible Participant Consent Templates
The Flexible Participant Consent Templates are available to:
- Strategic Collections that are retrospective or part of a broader collection (e.g. national collection or clinical trial)
- all other collections in the NSWHSB
- all other collections in NSW
- editable versions of the Participant Information Sheet and Cover Page, consent forms and FAQs
- Consent Compliance Checklist to demonstrate to the requisite HREC that the key principles and elements in the NSW Health Consent Toolkit have been adhered to
Research projects using this version of the consent materials do not have:
- access to free access to standard linked datasets
- pre-approval from human research ethics committees
Download the Participant Consent Templates
Complete the form below to download the full range of consent materials templates. Please indicate which version is best suited to your needs.