Exploring the Common Rule: A Guide for Beginners

Compliance/Regulatory Issues

  • 1.  Compliance/Regulatory Issues

    Posted Fri February 16, 2024 01:18 PM

    We were just approached by our Legal Department with a few issues in regards to compliance with regulatory issues associated with research. Our office searched majority of their answers but was wondering if any other institutions/universities came across this or something similar and if have any policy/procedures/standards of practice in place for your IRB Department they would not mind sharing. We are a small safety net hospital with minimal clinical trial research but hoping to expand. Thanks in advance.

    Billing  policies and procedures for Clinical Research Services, Items and Tests

    • Billing for Investigational Devices and Drugs Policy
    • Clinical Trial Agreement
    • HIPAA Authorization Forms for Clinical Research Involving Serum/Tissue Banking
    • Informed Consent for Off-Label Use of a Drug or Device
    • Informed Consent to Participate in Research
    • Insurance Coverage Analysis for Patients Enrolled in a Clinical Trial
    • Policy for the Recruitment of Subjects


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    AMANDA HONG
    IRB COORDINATOR
    AMANDA HONG Household
    Skokie IL
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