The Past, Present, and Future of the Debate Over Return of Research Results and Incidental Findings

Abstract

In this introduction to a symposium on managing incidental findings and individual research results in genomic research involving biobanks and archived data sets, the principal investigator of the underlying National Institutes of Health (NIH)-funded project discusses the roots, current state, and likely future of this debate. The roots lie in the recognition that research participants are not mere means to scientific progress but vulnerable individuals. After key position papers on return of incidental findings and individual research results by investigators, the debate has now turned to the more complex question addressed in this symposium — how large-scale research using biobanks and archived data sets should approach incidental findings and individual research results. Where is the debate headed next? The answer lies in the history itself, a history of progress toward recognizing the humanity and informational needs of research participants. Increasingly, participants will be offered individual information. Limits will be set, to preserve the capacity to perform research and to protect participants from faulty information. And not all studies and biobanks will undertake individual return. It will take research and work to tailor return to serve participants’ needs and research realities. But debating return is the next step toward recognizing those who contribute specimens and data as partners in the research process.

Keywords: biobank, bioethics, genetics, genomics, incidental findings, research ethics, return of results