Table 2.

Themes concerning how researchers make decisions concerning return of incidental findings

Assessing multiple factors jointly

Assessing “the bulk of the data”

Providing uncertain results and explaining the uncertainty

Making judgment calls

Interpretations may vary over time

Who should decide

Leave it up to the participant

But they may decide without fully understanding the complexities

Leave it to PI discretion

Override patient preferences?

Offer possibility, not promise of return

Err on side of giving results versus err on “conservative” side

Maintain “willful ignorance”

Seek external expertise

Within study team

External to study team

Contextual factors/roles of institutions and other governing bodies

Biobanks

Biobank has preestablished parameters or not

IRBs

Experienced with this issue or not

In agreement with researcher or not

Can provide a rationale not to return results (“The IRB said no”)

Governmental policies

In the United States, many laboratories are not CLIA-approved, and CLIA confirmation is costly

Policies differ in other countries

In the developed world

In the developing world

CLIA, Clinical Laboratory Improvement Amendments; IRB, institutional review board; PI, principal investigator.