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Table 1 PICF wording for (a) GenV to work with and (b) trials to work with GenV

From: Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort

(a) Wording in the GenV PICF that is specific to supporting trials:
• “You may be offered the chance to take part in future ethically approved studies working with GenV …. You can always choose whether to take part.”
• “GenV’s data can only be used for ethically approved research to improve health, development, or wellbeing for children and adults. Over time, researchers will use lots of different methods to answer new and important questions. Therefore, the value of your information will keep growing for many years.”
• “Some GenV participants may join research trials testing new approaches. All trials need ethical approval. Who is offered the new approach is randomly picked, like tossing a coin. In some trials, only people offered the new approach are contacted about taking part. GenV data can be used to compare the outcomes of people who do and do not receive the new approach.”
• “Trials … may ask your consent to share data with GenV, with ethics approval. We support this.”
(b) Suggested wording for trials to include in their PICF, as appropriate to its degree of integration with GenV (Fig. 2):
• “This trial is working with [Model 2]/part of [Model 1] the Generation Victoria (GenV) program. GenV is a research program open to all children living in Victoria and born over two years starting in 2021, and their parents. People in GenV can also be in trials testing new approaches to prevent, predict and treat important issues. This cuts down cost, effort and duplication. It also increases the value of trials. For example, by drawing on GenV data, a trial can look at more outcomes over a longer time than it could otherwise. You can read more about GenV here, and about the trials working with GenV here.”
[Model 2 only] “We ask that you consent to allow your trial data to be joined up with your GenV data, [Model 2c] if you are in both. Then both studies can answer more questions about health and other outcomes. Under strict conditions and ethical approval, data from this trial can enter GenV’s dataset, and data from GenV can enter this trial’s dataset.”
[Model 2c only] “It is possible that [you/your child] [are/is] eligible for GenV but not enrolled in it. We encourage you to enroll in GenV (Generation Victoria). This increases the value of this trial, without adding to your time. You can join GenV by … [trial enrolls participant; trials passes contact details to GenV; parent contacts GenV directly].”
[Model 2c only – choose relevant wording] “You can be in this trial and not in GenV, but we will be missing some information about you/your child or You can only take part in this trial if you are also in GenV.”