iv. Assurance of IRB review 21 CFR 312.66

The sponsor-investigator is responsible for:

1. Assuring that a qualified IRB will be responsible for initial and continuing review and approval of the investigation.
2. Providing a letter or email from the FDA (as an attachment to the HawkIRB new project application) giving the IND number assigned by the FDA.
3. Assuring that he/she will report to the IRB all changes and unanticipated problems involving risk to human subjects or others.
4. Assuring that he/she will not make any changes in the investigation without prior IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.