In paediatric medical research, across jurisdictions, parental consent and the assent of their child will usually come from a shared conversation between the researcher and family. This is how a study is introduced, information delivered, uncertainties addressed and understanding confirmed. Evidence indicates the crucial importance of the dialogue1 yet it currently goes unguided, undocumented, and often unchecked as review and research design continue to focus on the Participant Information Sheets (PIS).2 We propose that it’s time to move our focus on to this conversation to help families make their decision and in this viewpoint we suggest how this can be realised working within the constraints that researchers face. We address consent to research, but would contend that this idea has equal applicability in clinical practice.

Recognising the importance of this dialogue, the UK Oxford ‘A’ Research Ethics Committee has developed and published a framework for consent and a summary information decision aid with input from researchers and patient representatives.3 We propose that this could be adapted for paediatric practice to make a shared template for the conversation between researchers and families when they discuss a research study (see online supplemental file 1).

[archdischild-2023-326454supp001.pdf]

We would envisage this should be no more than four sides of A4 as a longer document would be unwieldy and difficult to use within a consultation. Detailed material would be provided in links, including the full PIS. We propose this simple document would provide a shared …