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| Research at Rush > Research Affairs Policies and Procedures | ||||||
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Research Affairs Policies and ProceduresThe list below consists of the current policies and procedures for the protection of human subjects at Rush. To see the policies and procedures, click the "More" link or the document links below. |
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| HIPAA Privacy Procedures for Research- April 2011 (updated June 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 Finders 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 |
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