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 - 04/20/16
Member Education - 02/28/13
Criteria for IRB Approval - 12/04/13
Full Board Review - 02/12/16
Expedited Review - 02/12/16
NHSR or Exempt Status: Determination - 02/12/16
International Research - 02/12/16
Cooperative Agreement - 02/08/16
Use of the NCI CIRB - 05/16/14
Use of Anonymized Human Cell Lines - 12/08/15
Case Studies - 12/08/15
NHSR Status for De-identified Repositories - 12/08/15

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 - 12/03/15
HIPAA Authorization for the Use of PHI in Research - 04/07/14
Use of PHI Without Subject Authorization - 05/08/15
Certificates of Confidentiality - 12/03/15

Vulnerable Populations in Research

Additional Protections: Pregnant Women and Fetuses - 12/08/15
Additional Protections: Prisoners - 01/12/16
Additional Protections: Children - 01/29/15

Continuing Review/Revisions/Closures/Records

Continuing Review of Research - 08/01/16*
Revisions in Approved Studies - 02/12/16
Study Closure and Record Retention - 08/01/2016*

Safety Reports & Protocol Deviations

Adverse Event & Unanticipated Problem Reporting - 02/12/16
Review of Progress and Safety Reports - 02/12/16
Protocol Waivers and Deviations - 02/12/16

Advertisements & Recruitment Materials

Review of Advertisements and Recruitment Materials - 01/29/15

Drug/Biologic/Device

Significant Risk/Non-significant Risk Determinations - 02/28/13
Emergency Use - 10/16/15
Compassionate/Treatment Use - 05/08/15
Humanitarian Use Devices - 11/03/15

Regulatory Compliance

Responsibilities of Investigators - 04/07/14
Conflicts of Interest - 08/01/16*
Appeal of IRB Decisions - 02/28/13
Investigator Noncompliance - 02/28/13
Auditing of Research Studies - 08/11/15

Updated: 8/01/16