101. Biomedical (IRB-01) and Social-Behavioral (IRB-02) Boards
102. About the IRB
102.1 Disclosure of Financial Relationship for Sponsored Projects
103. IRB Member Confidentiality
103.1 IRB Confidentiality Acknowledgement
104. Federal-wide Assurance/IRB Registration
104.1 IRB Statement of Compliance
105. IRB Review Process
105.1 Definitions for Human Subjects Research
105.2 Human Subject Regulation Decision Charts
105.3 Checklist for Member Review
105.4 Biomedical Application for Initial IRB Review (IRB-01)
- Attachment A: Expedited Review Categories
- Attachment B: Research Involving Children
- Attachment C: Research Involving Pregnant Women or Fetuses
- Attachment D: Research Involving Prisoners
- Attachment E: Research Involving Adults with Diminished Decision-Making Capability
- Attachment F: Research Involving Investigational New Devices
- Attachment G: Request for Waiver of Consent/Permission/Assent or Documentation of Consent/Permission/Assent
105.5 Social-Behavioral Application for Initial IRB Review (IRB-02)
- Attachment A: Expedited Review Categories
- Attachment B: Research Involving Children
- Attachment C: Research Involving Pregnant Women or Fetuses
- Attachment D: Research Involving Prisoners
- Attachment E: Research Involving Adults with Diminished Decision-Making Capability
- Attachment G: Request for Waiver of Consent/Permission/Assent or Documentation of Consent/Permission/Assent
105.6 Application for Response to IRB Requests
105.7 Creighton University Human Research Protection Program Letter of Agreement
105.8 Guidance: Criteria for Consideration in Risk Assessment
106. Duties of IRB Members
106.1 IRB Member Evaluation
107. Evaluating Sound Study Design
108. Scientific/Methodological Review of Investigator-Initiated Research
108.1 Reporting Form for Scientific/Methodological Review
108.2 Guidance on Conducting Scientific/Methodological Reviews
108.3 Guidance on Writing a Research Protocol
109. Expedited Categories
110. Medical Devices
110.1 IRB Administrative Checklist for Research Involving Devices
110.2 Examples of Non-Significant Risk Devices and Significant Risk Devices
111. Sponsor-Investigator Research Requirements (When a CU Investigator Holds the IND)
111.1 IRB Administrative Checklist for Research Involving Drugs
112. Guidelines for Genetic Research
113. Recruiting Research Subjects
113.1 Application for Web Posting of Recruitment Advertisement
114. Exempt (from the Codes of Federal Regulations) Research
114.1A Application for Determination of Exempt Status: Educational Research
114.1B Application for Determination of Exempt Status: Observation, Survey, Interview
114.1C Application for Determination of Exempt Status and HIPAA Authorization Waiver for Medical Record Review
114.1D Application for Determination of Exempt Status: Use of Biological Specimens in Research
114.2 Exempt Application Checklist
114.3 Guidelines for Quality Assurance Projects vs Research
114.4 Information Letter Template (When Consent Documentation is Waived)
114.5 IRB Guidelines for Student/Classroom Research Projects
114.6 Guidelines for Identifying Studies That Are Not Human Subjects Research (Do Not Need IRB Review)
115. External Studies
115.1 Application for External Review
116. Vulnerable Research Populations
116.1 IRB Member Checklist for Projects Involving Children
116.2 IRB Member Checklist for Projects Involving Neonates
116.3 IRB Member Checklist for Projects Involving Pregnant Women and Human Fetuses
117. Prisoners in Research
117.1 IRB Member Checklist for Projects Involving Prisoners
118. Informed Consent (Including Permission/Assent)
118.1 IRB Member Checklist for Informed Consent
118.2 Consent/Permission Template
118.3 Assent Template (age 7-11)
118.4 Assent Template (age 12-18)
118.5 Consent for Genetic Testing for Research Purposes
118.6 Addendum Consent for Optional Protocol-Defined Genetic Research
118.7 Addendum Consent for the Storage of Tissue or Blood for Undefined or Unspecified Future Genetic Testing
118.8 Tips on Informed Consent-OHRP
118.9 Glossary of Lay Terms for Use in Preparing Consent Forms
118.10 Checklist for Waiver/Alteration of Consent or Authorization
118.11 Bill of Rights for Research Participants
119. HIPAA for Researchers
119.1A HIPAA Authorization Template Without Instructions
119.1B HIPAA Authorization Template With Instructions
119.2 Elements of a Valid HIPAA Authorization
119.3 De-identified Health Information Under HIPAA
119.4 Revocation of Authorization to Use and Disclose Health Information for Research Purposes
119.5 Creighton University Notice of Privacy Practices
119.6 DOCu Track for PHI
119.7 Application for Waiver of HIPAA Privacy Authorization
119.8 HIPAA Authorization Flow Chart
120. Unanticipated Problems Involving Risks to Participants or Others
120.1 Unexpected Event Algorithm
120.2 Replaced by 134.1, Reporting Form for Reportable New Information
120.3 Examples of Violations and Deviations to an Approved Protocol
121. Continuing Review/Project Termination
121.1 Continuing Review or Project Termination Application IRB-01
121.2 Continuing Review or Project Termination Application IRB-02
121.3 Continuing Review or Project Termination Application for Projects Determined to be Exempt
122. Modification of Approved Research
122.1 Samples of Modifications and Type of Review Required
122.2 Request for Modification of Approved Research
122.3 Application for Request for Review of Supplemental Documents
123. Human Subjects Research Education Program
123.1 Mandatory Educational Requirements for IRB Members
124. Review of Human Subject Research Activities by Other Creighton University Committees
125. Registering Clinical Trials (clinicaltrials.gov)
126. Additional DOD Regulations
127. Engaged in Research
128. Emergency Use of Unapproved Drugs/Devices/Biologics
129. Expanded Access to Investigational New Drugs
131. Noncompliant Conduct
132. Data and Safety Monitoring Plans
134. Reportable New Information
134.1 Reporting Form for Reportable New Information
135. Suspensions and Terminations
Confidential Research Hotline (402-280-3200)
Research Personnel are expected to report any known or suspected noncompliant conduct related to research or sponsored program activities conducted and/or approved through Creighton University. The confidential Research Compliance Hotline (402-280-3200) is available for any individual who wishes to remain anonymous and/or has found other available reporting mechanisms to be ineffective. Research Personnel may also address their research compliance-related questions or concerns to Kathy Taggart, Associate Vice President for Research and Compliance, at 402-280-2360.
