www.fdanews.com/articles/122255-ohrp-irbs-may-approve-studies-with-conditions
OHRP: IRBs May Approve Studies With Conditions
November 16, 2009
When
an IRB approves a clinical study with conditions, those conditions would have to be satisfied before the study could begin in most cases, according to
a new draft guidance. If an IRB grants conditional approval, it can usually give
the board chairperson or another qualified expert the authority to sign off on the conditions once they’ve been met, the HHS Office of Human Research
Protections (OHRP) says in the guidance.
Clinical Trials Advisor
Clinical Trials Advisor