The list below consists of the current policies and procedures for the protection of human subjects at Rush.

HIPAA Privacy Procedures for Research- April 2011

HIPAA - What is Considered Protected Health Information and/or Identifiable Information

RA-IRB-100 Scope and Purpose of the Rush Institutional Review Board

RA-IRB-101 Appointment of IRB Members, Alternates, and Chairs

RA-IRB-102 Initial and Ongoing Training of Rush IRB Members and Administrative Staff

RA-IRB-102A Rush IRB Training Checklist

RA-IRB-103 Disclosure and Management of Conflicts of Interest by IRB Members

RA-IRB-103A IRB Member Conflict of Interest Disclosure Agreement

RA-IRB-104 Review of Research Activity that May Meet the Regulatory Criteria for Exempt Status

RA-IRB-105 Expedited Initial Review of Research

RA-IRB-106 Initial Review of Research by the Full IRB

RA-IRB-107 Process of Obtaining Additional Expertise for IRB Review

RA-IRB-108 Requests for Third-Party Verification of Study Information

RA-IRB-109 IRB Authority to Impose Study Restrictions

RA-IRB-110 Modification or Amendment of IRB Approved Research

RA-IRB-111 Continuing Review of Approved, Ongoing Studies

RA-IRB-112 Lapse of IRB Approval for Ongoing Studies

RA-IRB-114 Research Involving Investigational Devices

RA-IRB-115 Research Involving Investigational Drugs

RA-IRB-116 Review and Approval of Study Advertisements and Other Recruitment Materials

RA-IRB-117 Finder's Fees and Bonus Payments

RA-IRB-118 Determining Whether an Activity is Research Involving Human Subjects

RA-IRB-118A Determination of Whether an Activity Constitutes Human Subjects Research Form

RA-IRB-200 Elements and Documentation of Informed Consent for Research Subjects

RA-IRB-201 Alteration or Waiver of Informed Consent for Research Subjects

RA-IRB-202 Use of Translated Consent Documents for Research, Including 'Short Form' Consents

RA-IRB-203 Research Involving Pregnant Women or Fetuses

RA-IRB-204 Research Involving Neonates of Uncertain Viability or Non-Viability

RA-IRB-205 Research Involving Stem Cells and Fetal Material, including Dead Fetuses and Placenta

RA-IRB-206 Research Involving Children (Minors)

RA-IRB-207 Research Involving Prisoners or Other Legally Restricted Persons

RA-IRB-208 Research Involving Adults with Questionable Capacity to Consent

RA-IRB-209 Reporting and Review of Unanticipated Problems, Including Adverse Events

RA-IRB-210 Protocol Exceptions and Deviations

RA-IRB-211 Emergency Use of a Test Article

RA-IRB-212 Review of a Humanitarian Use Device

RA-IRB-213 Suspensions and Terminations of Approved Research

RA-IRB-300 Documentation and Storage of Minutes

RA-IRB-301 Maintenance of IRB Regulatory Files

RA-IRB-400 Training and Education Policy for Investigators and Relevant Research Personnel

RA-IRB-401 Reporting and Investigating Research Non-Compliance

RA-IRB-402 EQuIP Policy

RA-IRB-403 Policy on Governmental and Sponsor Audits