Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 178
AAHRPP Elements: II.2.D.
- The UIC Clinical Research Center (CRC) reviews research to be performed at or by the staff of the UIC CRC. The purpose of the CRC is to make clinical translational research happen in a predictable and reproducible fashion. In addition, the CRC offers expertise and resources that help bring to fruition study protocols for investigators who might lack certain research resources or personnel needed for a particular protocol, as the CRC has or can obtain physical resources needed to perform specialized studies. The CRC emphasizes the safe and ethical conduct of clinical research, while at the same time fostering education of future clinical translation research scientists.
- The CRC performs a feasibility, risk/safety, and utilization assessment of all new clinical research studies that will utilize the CRC. Final IRB approval of new protocols will not occur until documentation of CRC review has been received.
- Initial Protocol Review.
- Investigators who will be utilizing the CRC submit their proposed research studies to the CRC prior to submission of the IRB application to OPRS for IRB review.
- Investigators includethe Appendix G signed by CRC leadership or documentation of conditional CRC approval with their protocol application to the IRB.
- OPRS staff screens the initial protocol applications to determine whether the study involves the use of the CRC and is subject to the CRC review. If so, OPRS staff ensures that the application includes the Appendix G signed by CRC leadership or documentation of conditional CRC approval .
- OPRS staff denotes in the RiSC database (under “Additional Reviews”) that the research protocol is subject to “CRC” approval. This action ensures that the CRC is included as a copy on correspondence from the IRB (OPRS) to the investigator.
- If the protocol application does not include the signed Appendix G or acknowledgement, OPRS staff may return the protocol submission without review back to the investigator.
- Although a protocol application may be scheduled for review prior to CRC approval, final IRB approval will not be issued without final CRC approval. OPRS staff will ensure that the investigator has submitted this documentation before issuing IRB approval.
- OPRS provides the CRC a copy of the IRB approval notice.
- Continuing Protocol Review.
- For CRC research studies, in addition to the IRB, investigators must submit a continuing review to the CRC. The CRC review cycle is based upon the approval period (no less than once a year) established by the IRB.
- The investigator submits the CRC Continuing Review Form to the CRC in parallel to submission of the Continuing Review application to the IRB. In contrast to initial review, CRC approval is not required for the issuance of Continuing IRB approval.
- Following the issuance of continuing review approval, copies of the approval notices are exchanged between CRC and OPRS, and retained in the respective file.
- Other Submissions (amendments, final reports, complaints, protocol violations, unanticipated problems and other events requiring prompt reporting, and non-compliance findings)
- The OPRS handles the submission (amendments, final reports, complaints, major protocol violations, unanticipated problems and other events requiring prompt reporting, and allegations of non-compliance) in accordance with the respective UIC HSPP policies and procedures.
- For CRC research studies, following IRB review of the submission, the OPRS sends the CRC a copy of the correspondence sent to the investigator.
- CRC Personnel
- The CRC maintains a protocol with the IRB which outlines the purpose, goals, and ideals of the CRC.
- As all CRC personnel are listed as research personnel on the CRC research protocol, including documentation of training and credentials, the principal investigator of each specific protocol that utilizes the CRC may refer to the CRC research personnel list on the CRC protocol rather than list all CRC personnel as members of their research team.
- However, if a member of the CRC will be conducting specialized procedures (e.g., activities outside those designated on the Appendix P of the CRC master protocol that require specialized certification or UIC Medical Staff approval) for an individual protocol, then the person is to be specifically listed on the personnel list for the individual protocol.
- In addition, if a particular member of the CRC personnel is to have OPRS Live access, then the person is to be specifically listed on the personnel list for the individual protocol.
- If a member of the CRC is also a member of the IRB, the member is not considered to have a conflict of interest as the member is providing a service (similar to the member of IDS). However, if the member is listed separately on the Appendix P, as the member is conducting specialized procedures, then the member is considered to have a conflict of interest.
- The CRC is responsible for ensuring that the Appendix P of the CRC master protocol is kept up to date. An amendment adding new personnel should be submitted at the time of staff additions. Removal of staff no longer employed by the CRC may occur at the time of continuing review.
- The CRC is responsible for maintaining personnel files supporting the training (including UIC IRB training), qualifications and credentialing of CRC staff. A signed and dated copy of their CV or NIH biosketch should be in the file.
- As per UIC HSPP policy, the principal investigator of each protocol is responsible for ensuring that all changes to the research, including but not limited to personnel changes, are reported to the IRB. Therefore, the principal investigator of the CRC protocol is ultimately responsible for ensuring that the list of CRC research personnel is complete, accurate, and approved by the IRB.
- The CRC is responsible for reviewing and documenting any potential conflicts of interest for each specific protocol that utilizes the CRC.
- Institutional Reporting
- In accordance with UIC HSPP policy Reporting of Unanticipated Problems, Suspensions, Terminations, and Non-Compliance, for CRC research studies, the CRC also receives a copy of the report sent to institutional officials, supporting agency heads, and regulatory agencies, including but not limited to:
- Unanticipated problems and other events requiring prompt reporting;
- Continuing and/or serious non-compliance;
- IRB suspension; and/or
- IRB termination.
- Quality Assurance/Improvement Findings
- If the OPRS conducts a directed or routine Quality Improvement audit of a CRC protocol, a copy of the final report is disseminated to the CRC.
- If the CRC conducts an audit or inspection of an IRB approved study, a copy of the final report will be provided to the OPRS Director. The Director forwards the report to the IRB.
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Deleted reference to SAC since disbanded;
clarified that institutional reporting includes but
is not limited to the examples listed.
||Updated to reflect name change for CRC.
||Updated to reflect name change back to CRC. Updated to include section regarding CRC Personnel.
Updated to clarify conflicts of interest of CRC personnel who are also IRB members Upating of logo