What procedures must be described in an agreement called an “assurance of compliance” with OHRP?
A: Procedures in place to ensure that the research complies with ethical principles (such as the world medical associations declaration of Helsinki)
B: 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.
C: Procedures in place to outline how unanticipated problems will be reported to the local IRB.
D: Procedures in place to outline how subjects will be randomized?
The correct answer is option B.
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.
Assurance of compliance:
An assurance of compliance is a written agreement submitted by an institution that is engaged in research, which is non-exempt human subjects. An Institutional Review Board does not write it. The non-exempt human subjects are supported or conducted by HHS.
The federal assurance (FWA) is the only assurance of compliance, which is approved and accepted by OHRP.
The OHRP is the government office that falls under the US department of health and human services. It protects the individuals that are involved in research studies.
The essential function of the OHRP is to provide information and guidance to the institutional review boards. These review committees are required by those scientists who are involved in research studies.
The OHRP is also responsible for ensuring that rules and regulations are followed in clinical drug trials which are involving people.
An assurance of compliance makes sure that individuals follow the rules and regulations, especially when research studies concern human subjects.
Researchers are required to handle human subjects in an ethical manner. The human subjects who are part of the research should be treated with dignity and respect. Their welfare should be kept in mind.
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