Table 1.

Questions Addressed in Return of Results Workshop

1. What criteria should be used to evaluate which results to return?

2. Should CLIA confirmation be required?

3. What is the best way to empower research participants to make the best decisions for themselves about which results to receive?

a. What processes should be used to document participant preferences for return of results (which was not done originally) and obtain informed consent?

b. What is the role of pre-test genetic counseling?

c. What approaches should be used for genetics education?

4. What processes should be used to communicate results to the participants?

a. What is the role of the physician?

b. What is the role of disclosure/post-test genetic counseling?

5. How should the multi-site nature of the project be handled, given that multiple IRBs are involved and contact information for many participants is maintained at the sites?

6. How should changes in interpretation of the results over time be handled? Should they be communicated to research participants and if so, how?

7. What approaches can/should be used to provide ongoing information and support?

8. How should costs be handled, given that the project’s budget did not include funds for return of results?