All the HDEC Participant Information Sheet/Consent Form (PIS/CF) templates have been updated.
A summary of the revisions are as follows:
- All gendered pronouns (e.g., he/she, his/her, etc.) have been amended for gender neutrality (they, them, their).
- All references to “mother” have been amended to “pregnant parent” for gender neutrality.
- Options have been added to the Pregnancy PIS/CFs to account for the circumstance in which the pregnant parent is the participant in the trial.
- All references to gendered contraception have been amended for gender neutrality (e.g., “Male/female condom” becomes “external/internal condom”).
- The statement “If you decide not to be in the study, no one will be angry with you” has been removed from the child assent form as this claim is not a certainty, nor is it within the researchers’ control.
- The HDEC exemplar cultural statement has been added to the main PIS/CF template.
- A section on Māori Data Sovereignty has been added to the main PIS/CF template.
- The following statement has been added under ‘What Will Happen to my Information’ in the main PISCF template: “Your GP [will / may] be notified of your participation in this study with your consent.”
- Advocacy email and HDEC email updated.
- Version number and date added to every template for version tracking.
- Some headers have been reformatted for readability.
Use of the HDEC templates are not mandatory but are helpful resources for adaption as they contain the level of detail required of the National Ethical Standards. Older templates may be used for new applications but some may find items from the above summary of changes being highlighted for amendment.