Objective 1: Ethics of data sharing in child health research

• The collection and sharing of patient/caregiver-reported outcomes (PROs) in care-based child health research raises unique ethical and practical questions, including 1) whether and when PRO data collected in health care may be used for research purposes, 2) whether there is an obligation to share PRO data collected for research with the health care team, 3) whether sharing PRO data is ethically permissible or desirable, and 4) how patients and families should be involved in decisions about PRO data collection and sharing.

• We explored the above questions with a team of researchers, providers, patient partners, and ethicists and published a paper (see Publications) outlining three models for managing pediatric PRO data sharing. We endorsed the model in which children and families have access to and control over how their data is used and clinical providers are also involved in decisions about their commitment to reviewing research data with patient/caregiver consent. These recommendations have informed discussions and protocols regarding ethical data sharing within the Canadian MPS and PKU patient registries.