Events

Informed consent in research is an expression of the duty of respect for persons.  The practice of informed consent includes both effective delivery of relevant information and a valid, voluntary consent.  Current and rapidly accelerating trends in medical science center around expansive access to very large collections of carefully de-identified patient data. Consent is seen as both impossible to manage given the necessary scope of the data collection and irrelevant because the process of de-identification disconnects the patient from the data, minimizes risk and removes the duty to human subjects.  What is left, however, is the duty to inform as a manifestation of respect for persons

Use of large sets of unconsented health data offers a powerful tool for research and is widely seen as imperative for access to the full promise of medical science, especially as use of artificial intelligence and machine learning (AI/ML) expand.  While sharing of data is not new, the vastness of the data sets and the expansion of access to groups outside traditional academic medicine create an obligation to re-align patient and community expectations around data use, privacy and control of participation in research.  The obligation reflects both the ethical duty of respect for persons and a very practical duty to protect the research mission of the institution by avoiding a rupture of trust between the institution and its communities of patients and other stakeholders.

This symposium will create an opportunity for collaboration among experts in data science, research, community experience, ethics, law and education to forge a path forward to transparent, patient and community-centered communication about unconsented data. The aim is not to decide whether broad use of unconsented data is valid, but to create plans to manage the persistent obligation to inform.