Policies & Guidance
Sidebar
The HSPP has developed guidance materials and compiled documentation from outside sources to aid UofL researchers in conducting compliant research. The full HSPP policy manual is located at the top of the page.
The materials below contain local guidance, outline federal policies from sources such as the Office of Human Research Protection (OHRP) and Food and Drug Administration (FDA). It is important for research teams to utilize these resources when conducting research.
Departmental Signoffs for Initial Submissions
IRB applications for studies under full board review require sign off in iRIS by the departmental assigned Scientific and Scholarly Merit Reviewer and Department Chair.
- Scientific Reviewer and Department Chair List (by department)
- Instructions for routing an initial submission for Scientific and Department Chair review in IRIS
- Scientific Reviewer and Department Chair Paper Form (if not routed in iRIS for review)
Policies and Guidance Materials
- #015 Informed Consent- Electronic Consent, Electronic Signature [PDF]
- #016 HIPAA and PHI [PDF]
- #017 Informed Consent- Dos and Don’ts [PDF]
- #018 Informed Consent- Minors [PDF]
- #019 Informed Consent- Required Criteria [PDF]
- #020 Informed Consent- Waiver of Consent [PDF]
- #021 Informed Consent- Optional Consent within Main Consent [PDF]
- #023 Short Form Consent with Non-English Speaking Participants [PDF]
- #005 Definitions [PDF]
- #006 Approved Sources of Public Use Data [PDF]
- #007 Common Terms and Acronyms [PDF]
- #008 Research with Databases, Registries, and Specimen Repositories [PDF]
- #024 External Research Collaborations [docx]
- #029 Recruitment Tools [PDF]
- #033 Documents Stamped by the IRB [docx]
- #037 Data Research [PDF]
- #039 Studies Involving the Robley Rex VA Medical Center [PDF]
- #040 Corrective And Preventive Action Plan (CAPA) [PDF]
- Controller's Office: Payments for Research Study Participants
- IRB/HSPPO Emergency Preparedness Plan
- Screening Enrollment Log
- #010 Exempt Review Categories [PDF] (exempted prior to 1/20/2019)
- #010a Revised Common Rule Exempt Categories (exempted on/after 1/21/2019) [PDF]
- #011 Expedited Review Categories [PDF]
- #014 Federal Agencies- Additional Reporting Requirements [PDF]
- #022 IRB- Approval Criteria [PDF]
- #025 Is My Project Research? [PDF]
- More information on OHRP site
- NIH Certificate of Confidentiality
- Belmont Report
Research studies involving ULP, UofL Health Hospitals, and UofL Health Outpatient Centers require approval from the UofL Health Research Office (ULHRO) prior to research being conducted in a UofL Health facility.
Email: research@uoflhealth.org
Research studies conducted at Norton Healthcare facilities must obtain site approval from the Norton Research Institute prior to starting. For more information, review the Norton Children's Research Institute website.
Email: ro@nortonhealthcare.org