Frequent Questions
The General Clinical Research Center at Cincinnati Children's Research Foundation provides the following frequently asked questions (FAQs) and answers.
Answers
- What sort of projects utilize the General Clinical Research Center?
- 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 General Clinical 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), biostatistical services, bionutrition services or informatics. Traditionally the most popular resources have been inpatient, outpatient, scatter bed or the use of the sample processing Laboratory. Other services are used in conjunction with inpatient, outpatient or scatter bed usage.
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- What are scatter beds and how can I use them for my research project?
- A scatter bed is a term used to describe the use of an inpatient bed for research purposes which is not located on the General Clinical Research Center unit. Typically, these beds are located on the Neonatal Intensive Care Unit or Pediatric Intensive Care Unit because research subjects would be hospitalized there for medical reasons. Also, because of their special needs, the environment of the General Clinical Research Center would be unsuitable. For scatter beds, the General Clinical Research Center can provide support for ancillary costs (costs of research tests) and limited nursing support for studies.
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- What support can I expect to get from the General Clinical Research Center for my project?
- It would be ideal for all studies utilizing the General Clinical 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 General Clinical 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 General Clinical Research Center for the development of pilot work. Established faculty may use it to develop different directions for their research activities.
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- What are reasonable ancillary costs for an outpatient and inpatient project?
- The GCRC 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 $50.00 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 $200-300/visit for small studies. Remember: the GCRC is not a funding agency, we provide infrastructure that supports research and high research costs should be borne by investigators' grants.
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- How do I get approval for use of the General Clinical Research Center?
- For investigator-initiated projects, the protocol must be approved by the Institutional Review Board at Children's Hospital Medical Center of Cincinnati and, if radiation exposure is part of the project, the Radiation Safety Committee of the University of Cincinnati. After these approvals are obtained, a General Clinical Research Center Protocol Submission Form is completed and the Scientific Advisory Committee reviews the project. After the committee review, modifications may be necessary prior to use of the General Clinical Research Center. Once final approval is obtained, the investigator will meet with a nursing staff member who will coordinate and facilitate the General Clinical Research Center portion of the project. Read more....
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- Can projects be submitted to the SAC prior to IRB approval?
- The SAC accepts projects for review prior to or concurrent with IRB approval. No project may be started at the CRC prior to IRB approval.
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- How do I obtain submission materials for the General Clinical Research Center's Scientific Advisory Committee (SAC)?
- The submission materials are available online or by contacting Andrea Smith, andrea.smith@cchmc.org, 513-636-4273.
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- What happens if the General Clinical Research Center budget is insufficient to cover the costs of all projects utilizing it?
- Each project is given a priority score on the basis of scientific merit when the Scientific Advisory Committee reviews it. Should there be budgetary restraints placed upon the General Clinical Research Center, use of resources will be determined by priority score. Read more....
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- What if I have a project that needs to be started before the Scientific Advisory Committee has a chance to review it?
- If you have an Institutional Review Board-approved project and you plan to submit to the General Clinical Research Center for utilization, you may receive administrative approval to start prior to full review by the 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 Prasad Devarajan, M.D., 513-636-8265, or Andrea Smith, 513-636-4273.
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- Do I have to have funding from a grant to use the General Clinical Research Center?
- It is not necessary to have external funding for the project that will use the General Clinical Research Center. Although it is ideal to have Natioanl 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 General Clinical Research Center is a resource to develop pilot results that may lead to future funded projects utilizing the center.
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- Do UC investigators need IRB approval at CCHMC for use of the GCRC at Children's Hospital?
- Yes. Projects should be approved by the IRB at UC first. With the new federal assurance, review by the IRB at CCHMC should be handled by the expedited review process.
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- Is it possible for the Core Laboratory to do assays not already being provided?
- Yes. If one or more investigators need specific assays that may be used by multiple GCRC 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 Theresa Kenney, the lab supervisor to discuss your needs.
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- How can the Bethesda Oak facility be used and what resources are available there?
- The mechanism for use of GCRC 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 GCRC will provide personnel for DXA measurements and nursing support on a limited basis at Bethesda Oak.
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- What is the Clinical Research Feasibility Funds Program (CReFF)?
- This is a program to support junior faculty in the development of research careers. This award (up to $20,000/year) for a maximum of 2 years) may be used for costs of the study not provided by the GCRC. Details of the program may be found under Clinical Research Feasibility Funds (CReFF) Program on this website.
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