what procedures must be described in an agreement called an “assurance of compliance” with ohrp?
- procedures in place to ensure that the research complies with ethical principles (such as the world medical associations declaration of helsinki)
- 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
- procedures in place to outline how unanticipated problems will be reported to the local irb. procedures in place to outline how subjects will be randomized?