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Innovative Study Aims to Standardize Return of Individual Research Results in Lung Health Cohort

7 months ago2 min read

Background and Significance

Clinical research in the United States is fraught with challenges, including slow participant enrollment and high costs, which are exacerbated by a lack of diversity among participants. The Lung Health Cohort (LHC) study, funded by the National Heart, Lung, and Blood Institute (NHLBI), aims to establish a national cohort of young adults to define lung health and intercept chronic lung disease early. As part of this study, participants undergo chest computed tomography (CT) tests, with a significant number of results identifying new health findings.

The RECEIVE Study

Embedded within the LHC, the RECEIVE study focuses on the process of returning individual chest CT results to participants. It aims to develop a tool that educates participants on the benefits and risks of receiving individual research results (IRRs), assesses their healthcare preparedness, and improves the overall experience for study teams, participants, and healthcare providers.

Objectives

  • Engage with LHC study teams, participants, and healthcare providers to understand the process and satisfaction with returning or receiving chest CT results.
  • Develop a tool for returning IRRs using a human-centered design framework, guided by a participant advisory council.

Methodology

The study employs a mixed-methods approach, including surveys and interviews with stakeholders. It seeks to gather comprehensive insights into the current processes and challenges of returning IRRs, with the goal of establishing best practices that can be adapted for other studies.

Expected Outcomes

  • A deeper understanding of the challenges and processes related to returning IRRs.
  • Development of a user-friendly tool for communicating chest CT results effectively.
  • Establishment of best practices for returning IRRs that can be applied beyond the LHC study.

Implications for Future Research

The RECEIVE study represents a significant step forward in addressing the ethical obligation to return actionable research findings to participants. By standardizing the process of returning IRRs, the study aims to improve participant satisfaction and engagement, potentially influencing the broader landscape of clinical research.
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