The Return of Individual Research Results Within a Multi-site Cohort Study of Young Adults

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Abstract Rationale: The return of individual research results (IRR) to participants presents opportunities and challenges. As the National Academy of Science, Engineering and Medicine (NASEM) published, there is potential value in sharing clinically relevant results with participants. However, with minimal guidelines and no best practices for how to return IRRs, research teams face complex ethical, logistical, and practical considerations. This multi-site study describes the return of IRRs (e.g., lab, spirometry, chest CT) within a NHLBI funded study, Lung Health Cohort (LHC) (U01 HL146408-01). The LHC study is conducted by the American Lung Association, Airways Clinical Research Centers. Methods: Members of the LHC research team were invited to complete a 15-question online survey about the return of IRRs at their research site. Team members from 27 sites (N=100) were invited to participate (e.g., investigators, study coordinators) if they were involved in the return of IRRs for the LHC study. Individuals not involved in reviewing or returning IRRs within the LHC were excluded. Results: Fifty-one individuals from all twenty-seven research sites completed the survey on the return of IRRs. Response rates did not differ greatly between investigators, resulting in a sample of about 1/3 investigators (17/51) and 2/3 other study staff (34/51). LHC results were more often returned if they were abnormal results. The most common method for returning IRRs was phone (84%) followed by the electronic health record (68%) (table 1). Most results were returned to participants within ten days of the results being available (82%). Team members reported that participants often have questions about their IRRs (76% sometimes/often/always). Yet, 30% of team members reported they did not feel they had answers to questions LHC participants asked. Conclusions: This study offers valuable insights into the current practices and challenges of returning IRRs in a multi-site cohort study. The findings highlight the variability in returning IRRs across research sites (e.g., types of results returned, methods for returning results). These results also underscore the need for standardization and added support for research teams. Future efforts should focus on developing best practices for the return of IRRs, addressing participant questions, and streamlining the process to ensure consistent and effective communication of results across all study sites. These improvements could enhance the overall value of the return of IRRs for both participants and researchers in large-scale cohort studies.

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