Return of Individual Research Results to Participants in Observational Cohort Studies

Dates: 

Wednesday, June 26, 2024: 10:00 AM - 5:00 PM (EST)

Thursday, June 27, 2024: 10:00 AM - 3:00 PM (EST)

Description

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) is hosting a two-day virtual workshop titled "Return of Individual Research Results to Participants in Observational Cohort Studies” - scheduled for June 26 and 27, 2024, from 10:00 AM to 4:30 PM (EST). This workshop, organized in collaboration with the National Human Genome Research Institute (NHGRI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the All of Us Research Program, aims to explore best practices for observational cohort studies to ethically return individual research results, with a focus on genetic and genomic findings. 

Workshop Co-Chairs

NHLBI Chairs

Co-Chairs

Dr. Iftikhar J. Kullo, MD, Mayo Clinic College of Medicine and Sciences

Overview

This workshop will address the critical need for developing best practices in returning incidental genetic and genomic findings to research participants. Returning results involves complex ethical, legal, logistical, and economic considerations. This process requires understanding the diverse perspectives of stakeholders including patients/participants who seek to access their personal data and participate in shared decision-making. By convening experts in the field of Return of Results (RoR) and engaging research study participants, the workshop aims to foster collaborative discussions on best practices for return of incidental genetic and genomic findings in research settings. 

Key areas of focus will include the principles and guidance for RoR, the classification of individual genetic and genomic results, and the ethical and clinical implications for returning results in culturally diverse communities. Additionally, the workshop will explore participants' perspectives, and examine methods, outcomes, and lessons learned from previous studies. It will conclude with discussions on emerging technologies and other types of results that can be returned to participants, thereby broadening the scope beyond genetics and genomics. 

Key Objectives

1. Identify best practices for the ethical return of genetic and genomic results to individual participants, from observational cohort studies, including types of results, methods for evaluating effectiveness, and lessons learned. 
2. Address the ethical and legal challenges associated with returning individual research results, and implications for families, diverse communities, minorities, and underserved populations while ensuring compliance with existing regulations. 
3. Understand participant perspectives and preferences on receiving research /actionable results, their perceived value and contribution to follow-up care and outcomes.  
4. Assess the feasibility of returning additional individual results to participants, such as information on environmental exposure risks, and new technologies including digital and AI tools.