Denise Kent, PhD, APRN, is an assistant professor for the department of biobehavioral nursing science at the University of Illinois Chicago.

Denise Kent, PhD, APRN

Enhancing Standards for Ethical Responsibilities within Clinical Research

A set of challenges have been identified in clinical research within the United States given inefficiencies in different processes, slow participant enrollment, and high costs. In an interview featured in the second issue of 

, the quarterly pulmonology research newsletter powered by the American Lung Association Research Foundation, Denise Kent, PhD, APRN, discussed her team’s research in this area.

Kent serves as an assistant professor for the department of biobehavioral nursing science at the University of Illinois at Chicago. Kent spoke in the latest issue of The Respiratory Report about the Returning Computed tomography rEsults to actIVE Lung Health Cohort participants (RECEIVE) study and its aims.

“The received study is an ancillary study embedded within the Lung Health Cohort study, also referred to as the LHC,” Kent said. “The LHC is funded by the National Heart, Lung, and Blood Institute, and is a study of 4000 healthy individuals between the ages of 25 and 35 years. It is the first ever study to focus on millennials. The overarching objective of the LHC is to establish a cohort of young adults for the purpose of defining lung health and developing targets to intercept chronic lung disease at its earliest stages.”

Kent went on to describe additional details regarding the RECEIVE study’s objectives and the implications of her team’s work.

“The overall objective of the received study is to develop a tool to support the return of chest CT results within the LHC,” Kent said. “The long term goal is to establish a process by which the return of individual research results is standardized for participants. Hopefully, our approach will inform how other studies return individual research results across a range of diseases and conditions across multiple studies.”

To learn more about Kent's research, view the interview above or read her contribution to the second issue of The Respiratory Report here:

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

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This summarizes the latest in our pulmonology research quarterly newsletter powered by the American Lung Association Research Institute.

Denise A. Kent, PhD
Credit: American Lung Association

Clinical research in the United States faces substantial barriers, including fragmented processes, slow enrollment, and high costs.

Approximately 40% of clinical research sites struggle with inadequate participant enrollment, leading to delays or even terminations of studies.

 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.

 Participants often express a desire to receive their individual results from studies

; 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.

 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).

The 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.

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.

The primary objectives of the RECEIVE study are twofold:

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.

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.

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:

Surveys targeting study team members, participants, and healthcare providers to gather insights into their experiences with IRRs.

Virtual interviews to explore stakeholder experiences in greater depth.

Establishment of a participant advisory council (PAC) to guide tool development based on stakeholder feedback.

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.

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.

 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.

 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.

Articles

Clinical research in the U.S. faces challenges like slow enrollment and high costs, with many sites struggling to enroll participants, especially from minority communities. The RECEIVE study, part of the Lung Health Cohort, aims to improve the return of individual research results (IRRs) from chest CT scans to participants. It seeks to develop a standardized tool for returning IRRs, enhancing participant education and healthcare preparedness. The study employs a mixed methods approach, including surveys and interviews, to gather insights and establish best practices for returning IRRs.

The RECEIVE study develops tools to standardize returning chest CT results in the Lung Health Cohort, improving engagement and ethical practices.