Table 2.

Practical challenges in returning individual genetic research results

Practical QuestionsWhat Is Entailed?
What
 Which results to return? How to ensure that participants receive what they value and can decline what they wish not to receive, now and in the future?Researchers need to solicit participant preferences and identify results suitable for return, ensure respect for preferences to decline results, and determine whether secondary findings will be obtained and reported
How
 Where/in what setting?Researchers in collaboration with IRBs need to determine who will return results and in what setting, and they need to develop appropriate information for participants receiving results and their health care providers
 Who can provide the result to the participant?Avoiding therapeutic misconception (i.e., the mistaken perception that the participant is receiving medical care) is an important consideration
 When will results be returned?Researchers need to determine the timing of return of results. For example, will results be returned shortly after testing or at a later point/the end of the study? Does this information influence the study? In the case of genotype-driven recruitment, will researchers disclose during the recruitment process or during/after the study?
 For how long after the study will results be updated?Will results be reinterpreted after the study closes if new information is learned? What happens to the data after the study is completed?
Feasibility and resources needed
 What is the burden on the clinic and staff?Researchers in collaboration with clinicians need to address workload concerns related to discussion, potential confirmation, and follow-up of research results
The staff and other resources required to develop appropriate education materials for participants and for clinicians providing follow-up counseling need to be assessed to ensure that participants are understanding their results and any implications for family members
 What does a clinician need to do to prepare for a patient bringing a result and asking for help to interpret or follow-up?Clinicians must have information about the nature of the research, degree of uncertainty in the research results, and potential medical interventions related to the results
 What costs are involved in returning results?Researchers and clinicians need to determine resources to comply with any validity standards (e.g., CLIA or recommended alternative standards), including additional cost for confirmatory testing if research test does not reach analytic validity standards, and provide appropriate follow-up care. Allocation of costs to research versus clinical sources needs to be addressed
 What resources are needed to follow-up on the patient’s test result?Clinicians and researchers need to consider the range of specialty care required for medically actionable results (such as well characterized incidental findings), including financial or geographic burden involved in access