1. Who can use the GCRC?
2. Are non-MDs allowed to conduct studies in the GCRC?
3. Does the GCRC provide money for research?
4. What kind of research can be done on the GCRC?
5. Can pharmaceutical studies use the GCRC?
6. How are subjects scheduled?
7. What if there are revisions to the original, approved protocol or consent?
8. Who obtains informed consent of the subject?
9. How is medical care provided on the GCRC?
10. What support can I expect to get from the General Clinical Research Center for my project?
11. How do I get approval for use of the General Clinical Research Center?
12. Can projects be submitted to the GAC prior to IRB approval?
13. How do I obtain submission materials for the General Clinical Research Center's Advisory Committee (GAC)?
14. What happens if the General Clinical Research Center budget is insufficient to cover the costs of all projects utilizing it?
15. What if I have a project that needs to be started before the Scientific Advisory Committee has a chance to review it?
16. Do I have to have funding from a grant to use the General Clinical Research Center?

Who can use the GCRC?
The GCRC is open to all KUMC faculty members, (School of Medicine, School of Nursing, Allied Health) including those with adjunct appointments. The GCRC is open to Ph.D. investigators, but a M.D., D.O, or Nurse Practitioner must be included on the protocol for contact in the event of illness. Fellows, post-doctoral students, and pre-doctoral students are encouraged to use the GCRC, but should identify a faculty mentor.

Are non-MDs allowed to conduct studies in the GCRC?
Yes, however all non-MD investigators such as PharmDs and PhDs must have an M.D., D.O, or Nurse Practitioner collaborator who will assume medical responsibility for the patients.

Does the GCRC provide money for research?
The GCRC is a resource that provides a physical location, nursing support, laboratory, and statistical and data management support for approved protocols. The GCRC has limited funds to assist investigators with the costs of laboratory tests and supplies that are not covered under an investigator’s existing grant. The GCRC is not permitted to pay for recruitment of subjects or subject remuneration, and does not provide grants directly to investigators.

What kind of research can be done on the GCRC?
The GCRC supports investigator - initiated, human - based research. The protocols may be unfunded pilot studies, NIH or other peer-review funded studies, private foundation (American Heart Association, American Diabetes Association, etc) or pharmaceutical funded studies. Investigators with NIH funding have priority when requests for GCRC use exceed available resources, but other projects may receive high priority to achieve a balance of interest areas and investigator demographics, or for investigators new to clinical research. Pharmaceutical industry funded studies must demonstrate that they are investigator initiated or the costs will be charged back to the pharmaceutical account.

Can pharmaceutical studies use the GCRC?
The GCRC is distinct from a clinical trials unit in that priority is given to an investigator’s hypotheses. Other traditional pharmaceutical industry trials may use the GCRC skilled nursing and beds on a space available basis. However, in contrast to investigator - initiated studies, pharmaceutical trials are classified as “D” days by NIH, and must pay all the costs of GCRC use. Investigators who need the skilled nursing or other support of the GCRC are encouraged to contact GCRC Administration by phone at (913) 588-0970 to inquire about the costs and support available. D study budget agreements cannot be finalized until the protocol has been submitted to and approved by the GCRC Advisory Committee (GAC).

How are subjects scheduled?
Investigators should telephone the GCRC Nurse Manager prior to making arrangements with the subject to insure that space on the unit can be reserved. Scheduling depends on the availability of beds, equipment, and staffing on the unit. Scheduling is done by contacting the GCRC Nurse Manager or her designate at (913) 588-0980. The following information is necessary for scheduling: a.) Subject Initials b.) Project title under which the patient is to be admitted, PI, diagnosis c.) Date of birth, ethnicity, race and gender d.) Date of admission or outpatient visit e.) Estimated length of visit f.) Procedures to be completed at the visit g.) Contact information for person making the request.

What if there are revisions to the original, approved protocol or consent?
If a protocol is substantially modified or updated after approval by the IRB and the GCRC Advisory Committee, an amendment must be submitted and approved by the GCRC Advisory Committee before subjects can be enrolled in the revised protocol. All revised consents and appropriate IRB approval letters must be forwarded to the GCRC Administrator and Nurse Manager.

Who obtains informed consent of the subject?
It is the responsibility of the principal investigator or appropriate designate to obtain informed consent from the subject prior to the commencement of a study. The signed consent form must be on the subject's chart at the time of the outpatient visit. The investigator is also required to give the study subject and the GCRC a copy of the consent.

How is medical care provided on the GCRC?
The physician investigator is responsible for the medical care of study subjects. Arrangements for emergency care must be formalized before study implementation.

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.

How do I get approval for use of the General Clinical Research Center?
Additionally, the protocol must be approved by the University of Kansas Human Subjects Committee and, if radiation exposure is part of the project, the Radiation Safety Committee. For investigator initiated studies, it is preferred that approval is obtained from the GCRC fist. A General Clinical Research Center Protocol Submission Form is completed and the GCRC Advisory Committee (GAC) 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.

Can projects be submitted to the GAC prior to IRB approval?
The GAC has accepted projects for review prior to or concurrent with IRB approval. No project may be started at the GCRC prior to IRB approval.

How do I obtain submission materials for the General Clinical Research Center's Advisory Committee (GAC)?
The submission materials are available online (http://gcrc.kumc.edu) .

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, which is assigned by the GAC, using the NIH study section scoring system (1.0 is highest and 5.0 is lowest)

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 Richard Barohn, MD or GCRC Administration by phone at (913) 588-0970.

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 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 General Clinical Research Center is a resource to develop pilot results that may lead to future funded projects utilizing the center.