Return of individual research results and incidental findings: facing the challenges of translational science

Abstract

The debate over return of individual research results and incidental findings to study participants is a key frontier in research ethics and practice. This is fundamentally a problem of translational science-a question of when information about an individual that is generated in research should be communicated for clinical attention, particularly as technologies such as whole-genome sequencing and whole-exome sequencing are increasingly used in clinical care. There is growing consensus that investigators should offer participants at least those individual findings of high clinical importance and actionability. Increasing attention to what information biobanks and secondary researchers owe people who provide data and specimens offers an opportunity to treat these source individuals as research partners. Cutting-edge issues include return of results in pediatric populations and return to kin and family, both before and after the death of the proband, as well as how to manage incidental findings in clinical sequencing. Progress will require an understanding of the continuum linking research and clinical care and developing standards and models for return.

Figure 1

A biobank research system. (Reprinted with permission from Wolf et al. 2012 (19))