IRB Standard Operating Procedures

Note: the most recently revised policies or newly added policies will have an asterisk (*) beside the date listed on this page.

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 - 10/24/14
International Research - 04/30/12
Cooperative Agreement - 01/29/15
Use of the NCI CIRB - 05/16/14
Use of Anonymized Human Cell Lines - 11/11/14
Case Studies - 10/24/14
Exemption for Use of De-identified Repositories - 04/27/15*

Informed Consent & Confidentiality

Informed Consent - 05/08/15*
Informed Consent for Genetic Analysis & Repositories - 02/27/13
Informed Consent of Subjects Who Do Not Speak English, Illiterate English-Speaking Subjects, and Visually/Hearing Impaired Subjects - 05/08/15*
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
Use of PHI Without Subject Authorization - 05/08/15
Certificates of Confidentiality - 02/28/13

Vulnerable Populations in Research

Additional Protections: Pregnant Women and Fetuses - 05/04/12
Additional Protections: Prisoners – 05/08/15
Additional Protections: Children - 01/29/15*

Continuing Review/Revisions/Closures/Records

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 & Unanticipated Problem Reporting - 09/10/2013
Review of Progress and Safety Reports - 05/01/12
Protocol Waivers and Deviations - 01/29/15

Advertisements & Recruitment Materials

Review of Advertisements and Recruitment Materials - 07/09/14

Drug/Biologic/Device

Significant Risk/Non-significant Risk Determinations - 02/28/13
Emergency Use - 01/21/15*
Compassionate/Treatment Use - 05/08/15
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 - 11/14/14

Updated: 05/25/15