Table 3

Ethics Tool Kit in action—Essential Element 8: Return of Research Results and Management of Incidental Findings

Points to consider	Scenarios
Address any planned disclosure of general (aggregated) research results, for example, posting of research results on ClinicalTrials.gov Address any planned disclosure of individual research results (IRRs) to subjects and the criteria or framework under which IRRs will be evaluated for returnability (or justify a ‘no-return’ approach, if applicable) Address any planned disclosure of incidental findings (IFs) to subjects and the criteria or framework under which IFs will be evaluated for returnability (or justify a ‘no-return’ approach, if applicable) If appropriate, include any proposed referral policies (ie, for confirmation of the IRRs or IFs and/or any necessary clinical care that might flow from the finding) Describe whether participants will have the ability to opt-in or opt-out of receiving IRRs and/or IFs, and any circumstances in which a participant's stated general preference to receive results will govern and/or a participant's preference not to be informed of IRRs and/or IFs will be overruled	A spinal tumour detected through a research MRI where the protocol calls for the analysis of the image of an unrelated part of the body A genetic variant indicating a high risk of a certain type of cancer found during a whole-genome sequencing protocol where the focus of the research is limited to a different portion of the genome Genetic variants uncovered in the analysis of banked specimens and data under circumstances where the significance of the variant may have been unknown at the time the materials were banked, and the retrospective research was not targeting such variants

Points to consider

Scenarios

Address any planned disclosure of general (aggregated) research results, for example, posting of research results on ClinicalTrials.gov
Address any planned disclosure of individual research results (IRRs) to subjects and the criteria or framework under which IRRs will be evaluated for returnability (or justify a ‘no-return’ approach, if applicable)
Address any planned disclosure of incidental findings (IFs) to subjects and the criteria or framework under which IFs will be evaluated for returnability (or justify a ‘no-return’ approach, if applicable)
If appropriate, include any proposed referral policies (ie, for confirmation of the IRRs or IFs and/or any necessary clinical care that might flow from the finding)
Describe whether participants will have the ability to opt-in or opt-out of receiving IRRs and/or IFs, and any circumstances in which a participant's stated general preference to receive results will govern and/or a participant's preference not to be informed of IRRs and/or IFs will be overruled

A spinal tumour detected through a research MRI where the protocol calls for the analysis of the image of an unrelated part of the body
A genetic variant indicating a high risk of a certain type of cancer found during a whole-genome sequencing protocol where the focus of the research is limited to a different portion of the genome
Genetic variants uncovered in the analysis of banked specimens and data under circumstances where the significance of the variant may have been unknown at the time the materials were banked, and the retrospective research was not targeting such variants