Table 4.
Consent for Genetic Testing among Interviewed Participants by Visit Type and Institutional Review Board Consent Modification Level
P1 | Father | T1 | T3-First | T3-Prior | Total | |
---|---|---|---|---|---|---|
Level 1* | 154/162 (95.1%) |
256/269 (95.2%) |
380/397 (95.7%) |
97/103 (94.2%) |
250/253 (98.8%) |
1137/1184 (96.0%) |
Level 2* | 71/85 (83.5%) |
112/128 (87.5%) |
160/170 (94.1%) |
37/42 (88.1%) |
116/119 (97/5%) |
496/544 (91.1%) |
Level 3* | 43/48 (89.6%) |
42/43 (97.7%) |
44/48 (91.7%) |
20/20 (100%) |
26/26 (100%) |
175/185 (94.6%) |
Total | 268/295 (90.8%) |
410/440 (93.2%) |
584/615 (95.0%) |
154/165 (93.3%) |
392/398 (98.5%) |
1808/1913 (94.5%) |
Level 1 = no alterations to NICHD IRB-approved consent process; Level 2 = minimal alterations to NICHD IRB-approved consent process; and Llevel 3 = significant, substantive changes to consent process, particularly as applied to genetic testing.