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IRB Review

Note: policies with new substantial revisions or newly added policies will have an asterisk (*) beside the date listed on this page.

• Authority, Membership and Permanent Positions - 01/23/2023
• Member Education - 02/28/2013
• Criteria for IRB Approval - 01/21/2019
• Full Board Review - 10/04/2022
• Expedited Review - 10/04/2022
• NHSR or Exempt Status: Determination - 10/04/2022
• International Research - 01/21/2019
• Local IRB Reliance AgreementsÌý- 10/04/2022
• Reliance Agreements - 10/04/2022
• Utilization of the NCI CIRB - 01/10/2022*
• Use of Anonymized Human Cell Lines - 01/21/2019
• Case Studies - 01/21/2019
• NHSR Status for De-identified Repositories - 01/10/2023

Informed Consent & Confidentiality

• Informed Consent - 06/28/2023
• Informed Consent for Genetic Analysis & Repositories - 01/21/2019
• Informed Consent of Subjects Who Do Not Speak English, Illiterate English-Speaking Subjects, and Visually/Hearing Impaired Subjects - 10/04/2022
• Emergency Medicine Research Exemptions from Informed Consent Requirements - 07/12/2017
• Privacy and Confidentiality - 01/21/2019
• HIPAA Authorization for the Use of PHI in Research - 10/04/2022
• Use of PHI Without Subject Authorization - 10/04/2022
• Certificates of Confidentiality -Ìý03/08/2018

Vulnerable Populations in Research

• Additional Protections: Pregnant Women and Fetuses -Ìý01/21/2019
• Additional Protections: Prisoners - 01/21/2019
• Additional Protections: Children - 06/28/2023

Continuing Review/Revisions/Closures/Records

• Continuing Review of Research - 01/21/2019
• Revisions in Approved Studies - 10/07/2022
• Study Closure and Record Retention - 11/30/2022

Safety Reports & Protocol Deviations

• Adverse Event & Unanticipated Problem Reporting - 10/04/2022
• Review of Progress and Safety Reports - 01/21/2019
• Protocol Waivers and Deviations - 01/21/2019

Advertisements & Recruitment Materials

• Review of Advertisements and Recruitment Materials - 04/15/2023

Drug/Biologic/Device

• Significant Risk/Non-significant Risk Determinations - 02/28/2013
• Emergency Use - 10/04/2022
• Compassionate/Treatment Use - 02/02/2024
• Humanitarian Use Devices - 09/01/2018

Regulatory Compliance

• Responsibilities of Investigators - 04/15/2019
• Conflicts of Interest - 01/21/2019
• Appeal of IRB Decisions - 04/29/2021
• Investigator Noncompliance - 04/13/2021
• Auditing of Research Studies - 04/13/2021

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