Table 4.
| a. Role of the IRB in consideration of specific genetic results (n=65) | ||||||
|---|---|---|---|---|---|---|
| IRB should have: | ||||||
| Consideration of Specific Results | Full authority |
Input only |
No role |
|||
| n | (%) | n | (%) | n | (%) | |
| Determining whether an actual genetic result meets the criteria for disclosure to participants and/or family members (Example: Whether the CDKN2A result found in the pancreatic research scenario should be offered) |
30 | (46) | 21 | (32) | 10 | (15) |
| Determining the specific process by which participants and/or family members are contacted and offered an actual genetic result (Example: Within the range of potentially acceptable approaches to family members, determining the specific process that should be used to contact and offer the CDKN2A result found in the pancreatic research) |
36 | (55) | 22 | (34) | 4 | (6) |
| b. If not the IRB, who should have authority for considering disclosure of specific individual genetic research results? | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Consideration of Specific Results | The researcher |
Existing institutional entity |
Ad hoc institutional entity |
National entity |
Unsure | |||||
| n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
| Determining whether an actual genetic result meets the criteria for disclosure to participants and/or family members (n=31) | 11 | (35) | 4 | (13) | 7 | (23) | 5 | (16) | 4 | (13) |
| Determining the specific process by which participants and/or family members are contacted and offered an actual genetic result (n=26) | 11 | (42) | 0 | (0) | 5 | (19) | 5 | (19) | 5 | (19) |
Percentages may not sum to 100% due to missing data, as well as “unsure” answers not shown
Percentages may not sum to 100% due to missing data