What procedures must be described in an agreement called an “assurance of compliance” with OHRP?
A) Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.
B) Procedures in place to outline how subjects will be randomized.
C) Procedures in place to ensure that the research complies with ethical principles (such as the World Medical Association’s Declaration of Helsinki).
D) Procedures in place to outline how unanticipated problems will be reported to the local IRB.