BOX 4-2Previous Expert Groups and the Return of Research Results

Previous expert groups have analyzed and offered guidance on which criteria to apply to investigator decisions when determining whether to return research results to participants. Many of these expert groups have offered clear criteria for when results should be offered to participants, but the issue of when results may or should not be returned is less clear and frequently is delegated to review boards to help decide whether return is appropriate. Below is a list of the common criteria identified by previous expert groups for deciding on return.

Results should be returned to participants when participants are consented and results are

• Analytically valid (Bookman et al., 2006; Fabsitz et al., 2010; Jarvik et al., 2014; National Bioethics Advisory Commission, 1999; Wolf et al., 2012, 2015)
• Clinically actionable or able to be used in significant life planning decisions (Bookman et al., 2006; Fabsitz et al., 2010; Jarvik et al., 2014; National Bioethics Advisory Commission, 1999; Wolf et al., 2008, 2012, 2015)
• Indicative of significant health risks or implications (Bookman et al., 2006; Fabsitz et al., 2010; Jarvik et al., 2014; National Bioethics Advisory Commission, 1999; Wolf et al., 2008, 2012, 2015)
• Legal to return (Wolf et al., 2012, 2015)

Results may be returned to participants when participants are consented and the results are

• Analytically valid (Fabsitz et al., 2010; Wolf et al., 2012, 2015)
• May or may not be clinically actionable, but the information is of significance to the individual, for example, with regards to reproductive decision making (Wolf et al., 2008, 2012, 2015)
• IRB approved for return with an appropriate disclosure plan, and the benefits outweigh the risks (Fabsitz et al., 2010)
• Legal (Fabsitz et al., 2010; Wolf et al., 2012, 2015)

Results should not be returned if results are

• Unlikely to provide a net benefit to the participants (Wolf et al., 2012)
• Of unknown importance or personal utility (Wolf et al., 2008, 2012)

Additional work is ongoing to determine best practices for the return of genetic results with funding from by the National Institutes of Health's National Human Genome Research Institute. It is exploring the ethical, legal, and practical aspects of returning research results, including the incorporation of genetic and genomic data into electronic health records (CSER Consortium, 2018; Mjoseth, 2012; NHGRI, 2017b).