what procedures must be described in an agreement called an \assurance of compliance\ with a u.s. federal…

what procedures must be described in an agreement called an \assurance of compliance\ with a u.s. federal agency? procedures in place to ensure that the research complies with ethical principles (such as, the world medical associations declaration of helsinki). procedures in place to outline how subjects will be randomized. 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.

what procedures must be described in an agreement called an \assurance of compliance\ with a u.s. federal agency? procedures in place to ensure that the research complies with ethical principles (such as, the world medical associations declaration of helsinki). procedures in place to outline how subjects will be randomized. 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.

Answer

Brief Explanations:

An "assurance of compliance" with a U.S. federal agency must describe procedures that protect subjects as per the Common Rule, including review by an appropriate independent - like an IRB. The World Medical Association's Declaration of Helsinki is more of an international ethical guideline not the core requirement for a U.S. federal agency assurance. Randomization procedures are not the main focus of such an assurance. Reporting unanticipated problems to local IRB is part of the overall protection but the broader protection under the Common Rule is the key.

Answer:

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.