SEMINAR: Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research

Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. This seminar will describe international, consensus-based, PRO-specific ethical guidelines for clinical research, published JAMA 2022, including the management of PRO Alerts and issues of equality, diversity and inclusivity in PRO data collection.

Melanie Calvert, PhD is Professor of Outcomes Methodology, University of Birmingham, National Institute for Health and Care Research Senior Investigator, member of National Research Ethics Advisory Panel, Director of Birmingham Health Partners Centre for Regulatory Science and Innovation. She leads the Centre for Patient Reported Outcomes Research which aims to optimise use of patient reported outcomes (PROs) in clinical trials and routine care, improve service delivery, enhance patient care/outcomes and ensure the patient perspective is central to healthcare research/decision-making.