Human Research Protection Program (HRPP)
The University of Iowa IRBs interact with other University of Iowa committees and programs that review research projects involving human subjects. None of these entities are a formal part of the University of Iowa IRB structure, but there is communication between the committees/programs regarding status of review and/or conditions of approval. These entities are considered part of the Human Research Protection Program (HRPP). The HRPP is made up of UI boards, committees, core facilities and programs that have an interest in the research enterprise and are involved with the review of research projects involving human subjects. Many of them review information included in the HawkIRB application and attached documents. Others have a separate application form or process. The UI IRB provides some tools to help researchers learn about and obtain approval from these other entities, as necessary. The Other Committee Tool includes:
- The first graphic illustrates the relationship of these entities to the UI IRB review process.
- The Other Committee Graphic helps researchers identify which committees need to review and approve a research project.
- The HRPP Committee Regulatory Mandates includes references to the regulatory entities and laws that guide each committee.
The overall Human Research Protection Program Review process is outlined in this flowchart. IRB approval can be issued prior to any HRPP committee approval. Approval must be issued by all applicable HRPP committees prior to release of the project in the HawkIRB system. In the event an HRPP committee has required changes after the IRB has issued approval, one modification can be submitted to address any HRPP required changes.
For more information about an individual review entity, click on the corresponding link below.
Additional Institutional Approvals
Under the direction of the Institute for Clinical Translational Science (ICTS), the Clinical Research Unit (CRU) provides clinical resources for studies.
The University of Iowa Cooperating Schools Program (CSP) is a university-wide service to facilitate the placement of research projects conducted by faculty, staff, and students in public schools throughout Iowa. The purpose of the CSP is to provide information needed to obtain permission to conduct research in Iowa schools and school districts.
The Conflict of Interest in Research Office provides processes and guidance for studies with a potential or actual conflict of interest in research.
The Division of Sponsored Programs (DSP) provides resources and support for studies with external funding or in-kind contributions.
The Holden Comprehensive Cancer Center's Protocol Review and Monitoring Committee (PRMC) requires oversight and guidance for studies including cancer center patients or resources.
The Institutional Biosafety Committee (IBC) is responsible for ensuring that recombinant DNA (rDNA) activities comply with federal regulations.
The Medical Radiation Protection Committee (MRPC) provides technical support, professional guidance and radiation safety training.
The Nursing Research and Evidence-Based Practice Committee (NRC) must give its approval for research to be done within the Department of Nursing Services and Patient Care.
Researchers wishing to utilizing Department of Pathology services for a study need to obtain prior approval from the department.
The Pharmacy and Therapeutics (P&T) Safety Subcommittee has been established to provide the UI Health Care administration and its clinical leadership with information and advice concerning the proper use of drugs and related products.
Pharmacy and Therapeutics (P&T) Investigational Drug Service (IDS) reviews studies involving approved or investigational drugs with a focus on drug disbursement, storage, preparation, and inventory control.
UIHC Research Billing Compliance (RBC) - Research Billing has two approval processes in which they oversee:
- Billing charges - UIHC studies that involve any of the following activity at UI Health Care, even if subjects or their insurance will not be billed for the item or service, and regardless of the study funding source (including studies with departmental or no funding)
- Procedures, tests, examinations, hospitalizations, use of Pathology services, use of clinic facilities or clinical equipment, or any patient care services, including services conducted in the Clinical Research Unit; or
- Physician services or services provided by non-physicians who are credentialed to bill (ARNPs, Physician Assistants, etc.
- CMS investigational device approval - UIHC studies with an IDE (investigational device exemption) which require approval from CMS (Centers for Medicare and Medicaid Services)
Oversees research conducted at the VAHCS.