Example 5. The IRB discussed and clarified with the researcher a number of issues related to whether recruitment was likely, whether recruitment target children from lower socioeconomic backgrounds, why the vaccine was originally withdrawn from use, and the anticipated likelihood of a small pox bioterrorism attack. The IRB disagreed about the appropriateness of approving under category 46.405 the study of a vaccine with known side effects whose likelihood of providing direct benefit to an individual child depended on an assessment of the likelihood of a terrorist-inspired smallpox attack, and ultimately the IRB decided that category 46.405 was inappropriate. Example 6. The IRB discussed several possible ways that the researcher could meet the FDA requirement for community notification about this emergency medicine study. The IRB decided, because of opposing viewpoints among the members, to have a HSD staff member call the FDA for discussion and possible recommendations. Example 7. The IRB disagreed and could not establish how many investigational devices are being used in the study. The researcher will be asked to clarify this issue. Example 8. The IRB had different viewpoints over the likelihood of some subjects becoming incarcerated during the study, and decided to approve the study except for the use of prisoners. The researcher will be told to submit a Modification if she anticipates subjects becoming incarcerated so that prisoner involvement and procedures can be reviewed by the IRB and a prisoner advocate.
Example 5. The IRB discussed and clarified with the researcher a number of issues related to whether recruitment was likely, whether recruitment target children from lower socioeconomic backgrounds, why the vaccine was originally withdrawn from use, and the anticipated likelihood of a small pox bioterrorism attack. The IRB disagreed about the appropriateness of approving under category 46.405 the study of a vaccine with known side effects whose likelihood of providing direct benefit to an individual child depended on an assessment of the likelihood of a terrorist-inspired smallpox attack, and ultimately the IRB decided that category 46.405 was inappropriate. Example 6. The IRB discussed several possible ways that the researcher could meet the FDA requirement for community notification about this emergency medicine study. The IRB decided, because of opposing viewpoints among the members, to have a HSD staff member call the FDA for discussion and possible recommendations. Example 7. The IRB disagreed and could not establish how many investigational devices are being used in the study. The researcher will be asked to clarify this issue. Example 8. The IRB had different viewpoints over the likelihood of some subjects becoming incarcerated during the study, and decided to approve the study except for the use of prisoners. The researcher will be told to submit a Modification if she anticipates subjects becoming incarcerated so that prisoner involvement and procedures can be reviewed by the IRB and a prisoner advocate.