Ethical Excellence: Returning Computed tomography rEsults to actIVE Lung Health Cohort participants (RECEIVE)

Denise A. Kent, PhD
Credit: American Lung Association

Background and Significance

Clinical research in the United States faces substantial barriers, including fragmented processes, slow enrollment, and high costs.¹ Approximately 40% of clinical research sites struggle with inadequate participant enrollment, leading to delays or even terminations of studies.² This issue is exacerbated by a lack of representation from minority communities, which not only limits the diversity of clinical research but also contributes to health inequities.³ Participants often express a desire to receive their individual results from studies⁴; however, the current practice of returning these results is inconsistent and lacks established best practices. The National Academy of Sciences, Engineering, and Medicine (NASEM) has emphasized that returning valid and actionable Individual Research Results (IRRs) is an ethical obligation for research teams.⁵ Despite this call to action, best practices for returning IRRs remain undeveloped.

The RECEIVE study (UIC IRB 2024-0782) is an ancillary study embedded within the Lung Health Cohort (LHC) study (U01 HL146408-0).⁶The LHC, funded by the National Heart, Lung, and Blood Institute (NHLBI), is a study of 4000 healthy individuals between the ages of 25 and 35 years. The overarching objective of the LHC is to establish a national cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages. The LHC is being conducted by the American Lung Association’s Airways Clinical Research Centers (ALA-ACRC) across 27 clinical sites. To date, 2400 LHC participants have completed a chest computed tomography (CT) test as part of the study. Thousands more are still to complete their CT test. Of the chest CT tests completed, a third of the results identify a new health related finding, and 11% are medically actionable requiring follow-up with a healthcare provider.⁷

The RECEIVE study aims to elucidate the processes and experiences of returning or receiving chest CT results from the perspective of three stakeholders: study teams, participants, and healthcare providers whose patients are enrolled in the LHC study. The overall objective of the RECEIVE study is to develop a tool to support the return of chest CT results to LHC participants. The rationale for the tool is to educate participants on the benefits and risks of receiving IRRs, assess participants' healthcare preparedness (e.g., health literacy, insurance status, access to care), reduce the burden on research teams to develop their own processes, and improve all stakeholders’ experiences and satisfaction with the return of IRRs. The long-term goal is to establish a process by which the return of IRRs is standardized for participants in the LHC. Our approach could inform how other studies return IRRs across a range of conditions (e.g., lung cancer) across multiple studies.

Objectives

The primary objectives of the RECEIVE study are twofold:

1. Engage with LHC study teams, LHC research participants, and their healthcare providers to describe the process, experiences, and satisfaction with returning or receiving individual LHC chest CT research results.
2. Develop a return of IRRs tool for individual chest CT results utilizing a human centered design framework for implementation in the LHC. An LHC participant advisory council will be established to guide the development of the tool.

Methodology

The study employs a mixed methods approach that includes surveys and interviews with stakeholders involved in the LHC. The LHC consists of healthy young adults who undergo extensive clinical testing, including chest CT scans. Findings are classified as normal, abnormal, and medically actionable. Currently there is no standardization around what LHC chest CT results are returned and how they are provided. Data collection will include:

1. Surveys targeting study team members, participants, and healthcare providers to gather insights into their experiences with IRRs.
2. Virtual interviews to explore stakeholder experiences in greater depth.
3. Establishment of a participant advisory council (PAC) to guide tool development based on stakeholder feedback.

Expected Outcomes

The anticipated outcomes of the RECEIVE study include:

• A comprehensive understanding of the current processes and challenges related to returning IRRs from multiple stakeholder perspectives.
• Development of a user-friendly tool designed to facilitate effective communication of LHC Chest CT results.
• Establishment of best practices for returning IRRs that can be adapted for use in other studies beyond the LHC.

Implications for Future Research

By addressing the critical barrier of inconsistent return practices of IRRs in clinical research, the RECEIVE study has the potential to enhance participant engagement and retention.⁸ The findings could inform broader applications across various conditions and studies, ultimately contributing to improved health outcomes and reduced disparities in research participation. The RECEIVE study represents an innovative approach to improving clinical research practices through stakeholder engagement and human-centered design.^{9, 10} By focusing on the return of IRRs as a means to enhance participant experience and satisfaction, this initiative aims to set new standards for ethical responsibilities within clinical research while promoting inclusivity and diversity in medical research.