Investigators' Manual for the Use of Human Subjects in Research
The Investigators' Manual for the Use of Human Subjects in Research was developed to provide the Creighton University research community with an overview of the federal regulations and institutional policies governing the use of human subjects in research. These policies and procedures are based on federal regulations published by the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protection (OHRP) and the U.S. Food and Drug Administration (FDA).
**Please note: Updated policies and procedures approved 10-06
If you would like to update the hard copy of your manual please print these and replace the policies and procedures section.
The following are links to all of the components of the Manual:
- Creighton University Institutional Review Board Investigators' Manual for the Use of Human Subjects in Research policies and procedures (pdf) (in revision)
- NEW POLICY:
1.1 Unanticipated problems involving risks to participants or others
- Appendix A - Application and Reporting Forms
- Appendix B - Model Consent/Permission Documents (Word document)
- Appendix C - Model Assent Documents (Word document)
- Appendix D - Examples of Non-Significant and Significant Risk Devices (Word document)
- Appendix E - De-identified Health Information and Elements required in a HIPAA Authorization (Word document)
- Appendix F - Fee Schedule (Word document)
- Appendix G - OHRP Decision Charts (Word document)
- Consent/witness requirement
- External Studies Policy
- Application for External Review