Ethical Considerations for Clinical Data Sharing in Craniofacial Research: Recommendations From a Multidisciplinary Working Group

Abstract

Objective

To propose recommendations for ethical, participant-centered clinical data sharing in craniofacial research.

Design

Series of deliberative multidisciplinary expert working group meetings to develop recommendations.

Setting

Two 1-h virtual meetings; one all-day hybrid meeting.

Patients, Participants

Working group (n = 16) comprised individuals with expertise in craniofacial research, bioethics, and patient/caregiver advocacy, as well as lived experience of craniofacial conditions.

Interventions

The working group first reviewed prior empirical data about research participant attitudes about data sharing then drafted initial recommendations that were built on the data and the group's collective expertise. Recommendations were iteratively refined until the group agreed upon their final presentation.

Main outcome measures

Working group endorsement of recommendations.

Results

The working group produced 16 recommendations that addressed considerations for primary and secondary researchers, data repositories, and the craniofacial research community across 5 domains. These domains address: (1) research team communication with participants, (2) data collection and protections, (3) data governance, (4) education for researchers, and (5) remaining research gaps. Recommendations highlight the importance of prioritizing the experiences of those with lived experience of craniofacial conditions in decision-making about data sharing, navigating varied perspectives on privacy protections for facial images, and striving to implement trustworthy data sharing and governance practices.

Conclusions

This summary of recommendations offers guidance for the craniofacial research community to advance participant-centered clinical data sharing practices. Ethical data sharing that accounts for participants’ experiences and values has potential to advance scientific research and improve outcomes for individuals with craniofacial conditions, their families, and their communities.