Office of Research and Innovation
University of Louisville
Louisville, Ky. 40202
502.852.6512, 502.852.8361 (Fax)
Looking for a unit within the Office of Research and Innovation? Contact information here.
Policy Manual/Guides
Policy and Procedures Manual
Human Subjects Protection Program Policy Manual
Below are a list of guides from frequently visited policies from the manual linked above.
Informed Consent and HIPAA
- #015 Informed Consent- Electronic Consent, Electronic Signature
- #016 HIPAA and PHI
- #017 Informed Consent- Dos and Don’ts
- #018 Informed Consent- Minors
- #019 Informed Consent- Required Criteria
- #020 Informed Consent- Waiver of Consent
- #021 Informed Consent- Optional Consent within Main Consent
- #023 Short Form Consent with Non-English Speaking Participants
Local Policy/Procedures
- #005 Definitions
- #006 Approved Sources of Public Use Data
- #007 Common Terms and Acronyms
- #008 Research with Databases, Registries, and Specimen Repositories
- #024 External Research Collaborations
- #029 Recruitment Tools
- #033 Documents Stamped by the IRB
- #037 Data Research
- #039 Studies Involving the Robley Rex VA Medical Center
- #040 Corrective And Preventive Action Plan (CAPA)
- Controller's Office: Payments for Research Study Participants
Vulnerable Populations
- #001 Additional Protections for Minors – FDA
- #002 Additional Protections for Minors- OHRP
- #003 Additional Protections for Pregnant Women, Fetuses, and Neonates
- #004 Additional Protections for Research Involving Prisoners
OHRP & Federal Guidance
- #010 Exempt Review Categories (exempted prior to 1/20/2019)
- #010a Revised Common Rule Exempt Categories (exempted on/after 1/21/2019)
- #011 Expedited Review Categories
- #014 Federal Agencies- Additional Reporting Requirements
- #022 IRB- Approval Criteria
- #025 Is My Project Research?
- More information on OHRP site
- NIH Certificate of Confidentiality
- Belmont Report
FDA
