Return of Value in the New Era of Biomedical Research—One Size Will Not Fit All

Abstract

Background: There is a growing interest in creating large-scale repositories that store genetic, behavioral, and environmental data for future, unspecified uses. The All of Us Research Program is one example of such a repository. Its participants will get access to their personal data and the results of the studies that used them. However, little is known about what researchers should return to participants and how they should do it in a way that is valuable and meaningful to participants. Methods: To better understand the concept of “return of value” and the practice of returning valuable study information, we conducted semi-structured telephone interviews with 44 stakeholders with diverse perspectives on this topic. All interviews have been transcribed and coded thematically to identify the most salient themes, to explore differences between returning different types of study results, and to describe differences and similarities in perspectives of different stakeholder groups. Results: We found that one size does not fit all when it comes to returning value to participants: the decisions about return of results are affected by participant preferences, researchers’ concerns about feasibility, the types of data collected, their level of granularity, and available options for supporting result interpretation. Conclusions: Our findings suggest that the key to operationalizing return of value and to identifying ways to return valuable information to study participants may be to find a point of equilibrium between criteria that may affect usefulness and feasibility. The point of equilibrium may vary by study, by participants’ backgrounds and preferences, by their health literacy and access to regular healthcare, and by the resources available to professionals controlling the data. Future studies should explore the factors that determine the point of equilibrium between feasibility and usefulness.

Key Words:

• All of us research program
• data repository
• research ethics
• research participants
• return of results
• return of value

Ethical approval

Both the RAND and Scripps Institutional Review Boards (IRBs) determined this study to be exempt from review.

Acknowledgments

The authors would like to thank all study participants for sharing their perspectives, Steven Steinhubl for useful suggestions on earlier versions of this manuscript, Mary Vaiana for editorial assistance, Ingrid Maples for helping with reference formatting, and two anonymous reviewers for their careful reviews of the manuscript.

Conflicts of interest

The authors report no conflicts of interest.

Notes

1 This interviewee is referring to patients making rash clinical decisions, like getting a double mastectomy, based on results of elevated risks from genome sequencing.

Additional information

Funding

This work was supported by the National Institutes of Health under Grant 1U24OD023176-01.

Notes on contributors

Dmitry Khodyakov

DK, SB, and EB designed the study. DK and EB co-developed the interview guide. CN and SB offered suggestions for improving the protocol. DK, EB, and AM-G conducted the interviews and analyzed the data. DK drafted the manuscript. All coauthors revised the draft manuscript, provided critical revisions, and have reviewed and approved the final version before publication.