The University of Tennessee Graduate School of Medicine, Knoxville

The Institutional Review Board

Standard Operating Procedures

(2018 Common Rule regulations for studies approved after January 21, 2019)

In an effort to foster research integrity and safety the Institutional Review Board (IRB) of the University of Tennessee Graduate School of Medicine (UTGSM) hereby establishes the following policies and procedures. These policies and procedures will be interpreted and enforced in accordance with the principles outlined in the Belmont Report, Federal and State laws, rules and regulations, general principles of Medical Ethics, and applicable policies and procedures of the University of Tennessee.

Number Title
001 IRB Authority, Membership and Permanent Positions
002 IRB Member Education
003 Review of Research
004 Criteria for Approval
005 Informed Consent
006 Informed Consent - Non-English Speaking Subjects
007 Emergency Exemption from Informed Consent
008 Privacy and Confidentiality
009 HIPAA Authorization For use of PHI
010 HIPAA Use of PHI Without Authorization
011 Additional Protections-Pregnant Women, Neonates and Fetuses
012 Additional Protections- Prisoners
013 Additional Protections- Children and Minors
014 Exempt Applications
015 Expedited Review
016 Continuing Review
017 Serious Adverse Event Reporting
018 Review of Safety Alerts
019 Protocol Deviation Reporting
020 Review of Advertisements
021 Conflict of Interest
022 Significant Risk / Non-Significant Risk Determinations
023 Emergency Use
024 Compassionate Use
025 Humanitarian Use Devices
026 Certificates of Confidentiality
027 Responsibilities of Investigators
028 Appeal of IRB Decisions / Request for Re-Review
029 Investigator Non-Compliance
030 Audits of Investigators/Sites
031 Communication From the IRB
032 Study Closure and Record Retention
033 Repositories and Genetic Analysis
034 Case Studies and Reports
035 Cell Lines
036 Reliance Agreements
037 Alternative Procedures During a Public Health Emergency
038 Revisions to Studies

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