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The Clinical Translational Research Center at Cincinnati Children’s Research Foundation provides the following frequently asked questions (FAQs) and answers.
Projects utilizing the research center may be either investigator-initiated or industry-sponsored. Investigators from many Children's Hospital divisions and Departments of the University of Cincinnati utilize the services of the Clinical Translational Research Center.
Projects may be carried out on the inpatient unit, the outpatient unit, scatter beds, or utilize the services of the Core Laboratories (including the Biochemistry Core, Sample Processing and the Body Composition Core), or bionutrition services.
A “scatter bed” is a term used to describe the use of an inpatient bed for research purposes that is not located on the Clinical Translational Research Center unit. When a patient who is admitted clinically to the hospital also is enrolled in a CTRC-approved research study, the Research Nursing Core or the Bionutrition Core can provide research services on the patient’s clinical unit, including a General Medical/Surgical floor, the Newborn Intensive Care Unit, the Pediatric Intensive Care Unit, or any other unit in Cincinnati Children’s Hospital or UC Medical Center. For scatter beds, the CTRC can provide support for ancillary costs (costs of research tests), nursing services, lab processing, and bionutrition services.
It would be ideal for all studies utilizing the Clinical Translational Research Center to have external support from the National Institutes of Health (or some public health service funding agency) or foundations, such as the American Heart Association, Cystic Fibrosis Foundation or others.
In fact, although a significant portion of studies do have external funding, many do not. And the Clinical Translational Research Center serves as a site where pilot work can be developed with the goal to submit these projects for external funding. Many entry-level faculty utilize the CTRC for the development of pilot work. Established faculty may use it to develop different directions for their research activities.
The Clinical Translational Research Center is funded for an average cost for ancillary costs (lab tests, X-rays, etc.) for each outpatient visit and each inpatient bed day. The average ancillary costs from the NIH are $50 for each outpatient visit and $71.23 for each inpatient bed day. This is the average. There are many studies in which there are no ancillary costs while others have higher than average costs / visit. It is safe to say that requests for ancillaries that approximate the average cost per visit will be approved without problem. Higher amounts may be considered but rarely exceed $200 to $300 / visit for small studies. Remember: the CTRC is not a funding agency; we provide infrastructure that supports research, and high research costs should be borne by investigators’ grants.
The SAC accepts projects for review prior to or concurrent with IRB approval. No project may be started at the CTRC prior to IRB approval.
Each project is given a priority score on the basis of scientific merit when the CTRC Scientific Advisory Committee reviews it. Should there be budgetary restraints placed upon the Clinical Translational Research Center, use of resources will be determined by priority score.
If you have an Institutional Review Board-approved project and you plan to submit to the Clinical Translational Research Center for utilization, you may receive administrative approval to start prior to full review by the CTRC Scientific Advisory Committee.
This would only be considered if awaiting final approval by the committee would mean missing a rare research opportunity. It would also be understood that the protocol might need to be modified because of comments by the committee prior to final approval. For questions regarding administrative approval, contact Amy Hartkemeyer, business manager, 513-636-4273, firstname.lastname@example.org.
It is not necessary to have external funding for the project that will use the Clinical Translational Research Center. Although it is ideal to have National Institutes of Health or public health service funding for projects, many have foundation funding, and many do not have funding. For the unfunded projects, it is understood that the CTRC is a resource to develop pilot results that may lead to future funded projects utilizing the center.
Yes. Projects should be approved by the IRB at UC first. With the new federal assurance, review by the IRB at Cincinnati Children’s should be handled by an expedited review process or the CCHMC IRB may establish reliance on the UC IRB as the IRB of record.
Yes. If one or more investigators need specific assays that may be used by multiple CTRC users, the Biochemistry Core Laboratory can provide these tests. Assays for analyses such as ELISAs or RIAs may be provided for single investigators since these technologies are already available within the laboratory. Check the comprehensive test menu for the lab, or contact the lab supervisor, Theresa Kenney, 513-636-2229, to discuss your needs.
The mechanism for use of CTRC resources at the outpatient facility at Bethesda Oak is the same as for use of outpatient / inpatient / scatter bed usage. Protocols must be reviewed and approved by the IRB and SAC. The CTRC will provide personnel for DXA measurements and nursing support on a limited basis at Bethesda Oak.
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