Policies
- 103 - IRB Member Confidentiality
- 105 - IRB Review Process
- 107 - Evaluating Sound Study Design
- 110 - Medical Devices
- 118 - Informed Consent
- 119 - HIPAA for Researchers
- 123 - Human Subject Research Education Program
- 127 - Engaged in Research
Required Documents
- 102.1 - IRB Member Financial Disclosure Form
- 103.1 - IRB Member Confidentiality Acknowledgement
- 106.1 - IRB Member Evaluation
Information to Assist in Reviews
- 105.2 - Human Subject Regulations Decision Charts
- 105.3 - Checklist for Member Review
- 105.8 - Guidance: Criteria for Consideration in Risk Assessment
- 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
- 117.1 - IRB Member Checklist for Projects Involving Prisoners
- 118.1 - IRB Member Checklist for Informed Consent
- 118.10 - Checklist of Waiver/Alteration of Consent or Authorization
- 119.8 - HIPAA Authorization Flow Chart
- FDA Information Sheet
- OHRP Guidance
Education
- Web-based PRIM&R "Ethical Oversight of Human Subjects Research" course
- OHRP General Informed Consent Requirements Video
- OHRP IRB Membership Video
- OHRP Research Use of Human Biological Specimens and Other Private Information Video
- OHRP Reviewing and Reporting Unanticipated Problems and Adverse Events Video
- OHRP Research Involving Vulnerable Populations Video
- OHRP Webinars: "When the Regs Come a Knockin': Nuts and Bolts of 45 CFR Part 46" and "When the Feds Come a Knockin': How to Prepare for an OHRP Compliance Evaluation of Your Program"
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.
