Section 1580.60  Additional Review Requirements

a)         Research projects are subject to IRB review and approval whenever changes are proposed to the research project. Changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subjects.

b)         For research projects that already have IRB approval, the IRB must perform continuing, periodic reviews at intervals commensurate to the degree of risk the research poses, but at least once a year.

c)         Research that is subject to this Part may be subject to further review and approval or disapproval by the executive director of the Authority. Research reviewed by the executive director of the Authority shall be conducted in a manner consistent with the provisions of Section 1580.40. However, the executive director of the Authority may not approve the research if it has not been approved by an IRB.