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Do clinical screening procedures require IRB oversight?

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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

Clinical screening procedures for research eligibility are considered part of the subject selection and recruitment process and, therefore, require IRB oversight. If the screening qualifies as a minimal risk procedure, the IRB may choose to use expedited review procedures. The IRB should receive a written outline of the screening procedure to be followed and how consent for screening will be obtained. The IRB may find it appropriate to limit the scope of the screening consent to a description of the screening tests and to the reasons for performing the tests including a brief summary description of the study in which they may be asked to participate.

Unless the screening tests involve more than minimal risk or involve a procedure for which written consent is normally required outside the research context, the IRB may decide that prospective study subjects need not sign a consent document. If the screening indicates that the prospective subject is eligible, the informed consent procedures for the study, as approved by the IRB, would then be followed.

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