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 (IFs) and individual research results (IRRs) in genomic research involving biobanks and archived datasets, the principal investigator of the underlying 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 IFs and IRRs by investigators, the debate has now turned to the more complex question addressed in this symposium--how large-scale research using biobanks and archived datasets should approach IFs and IRRs. 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.