New Participant Information Sheet/Consent form (PIS/CF) templates
New Participant Information Sheet/Consent form (PIS/CF) templates for: Pregnant Partners, Pregnancy Follow-Up and an updated: standard main PIS/CF form template are now available.
New PIS/CF templates for Partners of Participants who become pregnant, and for their follow up after the baby is born, have been added to our list of PIS/CF templates. It is the expectation of the HDECs that a partner-pregnancy PISCF should be developed for all studies involving a medicine where the effect on a foetus is not known.
There is no template for pregnant participants, nor is a pregnant participant PISCF required for new studies, due to the difficulties in writing a PIS in advance for pregnant participants (as the information depends greatly on the study and where it is up to when the pregnancy occurs). Participant Pregnancy PISCFs should instead be created and submitted for review with a Post-Approval Form (amendment) after a pregnancy has occurred.
The pregnancy follow-up PISCF is also intended to be used after a pregnancy is confirmed, and submitted for review through a Post-Approval Form as an amendment.
In addition, the standard PISCF template has been updated to include considerably greater information regarding the use of data. This ensures that PISCFs will align with the National Ethics Standards and should be helpful for researchers to meet the expectations of the committees.
View the new form templates.