IRB Policies

IRB Review

Authority, Membership and Permanent Positions - 03/20/14
Member Education - 02/28/13
Criteria for IRB Approval - 12/04/13
Full Board Review - 02/28/13
Expedited Review - 02/28/13
Exemption from IRB Review: Determination - 02/27/13
International Research - 04/30/12
Cooperative Agreement - 02/27/13
Use of the NCI CIRB - 02/11/14
Use of Anonymized Human Cell Lines - 02/27/13

Informed Consent & Confidentiality

Informed Consent - 04/07/14
Informed Consent for Genetic Analysis & Repositories - 02/27/13
Informed Consent of Subjects Who Do Not Speak English - 02/27/13
Emergency Medicine Research Exemptions from Informed Consent Requirements - 02/27/13
Confidentiality - 02/28/13
HIPAA Authorization for the Use of PHI in Research - 04/07/14
Guidance on Use of PHI Without Subject Authorization - 02/28/13
Certificates of Confidentiality - 02/28/13

Vulnerable Populations in Research

Additional Protections - Pregnant Women and Fetuses - 05/04/12
Additional Protections: Prisoners - 05/03/12
Additional Protections: Children - 04/07/14

Continuing Review/Revisions/Closures

Continuing Review of Research - 02/27/13
Revisions in Approved Studies - 02/28/13
Study Closure and Record Retention - 02/28/13

Safety Reports & Protocol Deviations

Adverse Event Reporting - 09/10/2013
Review of Progress and Safety Reports - 05/01/12
Protocol Waivers and Deviations - 05/01/12

Advertisements & Recruitment Materials

Review of Advertisements and Recruitment Materials - 02/27/13

Drug/Biologic/Device

Significant Risk/Non-significant Risk Determinations - 02/28/13
Emergency Use - 04/07/14
Compassionate/Treatment Use - 10/18/13
Humanitarian Use Devices - 02/28/13

Regulatory Compliance

Responsibilities of Investigators - 04/07/14
Conflicts of Interest - 02/20/14
Appeal of IRB Decisions - 02/28/13
Investigator Noncompliance - 02/28/13
Auditing of Research Studies - 02/28/13

Updated: 04/10/14