Frequently Asked Questions

1) What kind of research can be performed at the GCRC?

The GCRC supports investigator initiated, human-based research. The protocols should be NIH or VA funded studies; federal, state, and or local government funded; private nationally recognized foundation (American Heart Association, American Diabetes Association, etc) funded; or investigator initiated 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 in order to utilize the GCRC resources free of charge.

2) Who can use the GCRC?

The GCRC is open to all University of Miami School of Medicine, Miami VA Medical Center and Jackson Memorial Medical Center faculty and non-faculty researchers, including those with adjunct appointments. The GCRC is open to Ph.D. investigators; but a licensed, privileged, credentialed physician (co-investigator on the project) must be included on the protocol for contact in the event of illness and/or treatment needs. Fellows, nurses, post-doctoral students, and pre-doctoral students are encouraged to use the GCRC, but should identify a faculty mentor.

3) Are non-M.D.’s allowed to conduct studies in the GCRC?

A: Yes, however all non-M.D. investigators such as Pharm.D.s, and Ph.D.s must have an M.D. collaborator who is credentialed and privileged to provide medical treatment.

4) Can pharmaceutical investigations/companies use the GCRC?

The GCRC is distinct from a clinical trials unit, in that priority is given to an investigator’s hypothesis. Other traditional pharmaceutical industry trials may use the GCRC skilled nursing staff and space as available. However, in contrast to investigator initiated studies, pharmaceutical trials are classified as “D” days by NIH, and they must pay all the costs of GCRC use, including space cost, supply cost, personnel time cost, etc. Investigators who need skilled nursing, professional biostatistical, informatics, and/or nutritional support from the GCRC are encouraged to contact the administrative director or one of the program directors to inquire about the costs and support available.

5) Does the GCRC provide money for research?

The GCRC is a resource that provides a physical location, nursing support, dietary support, and statistical and data management support for approved protocols. The GCRC has limited funds to assist investigators with the costs of routine 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. However, seed money may be available on a competitive basis from the VA Research Service and University of Miami School of Medicine to assist investigators with these costs.

6) What if there are revisions to the original, approved protocol or consent?

If a protocol is modified or updated after approval by the IRB and the GCRC Advisory Committee, the IRB approved amendment must be submitted to the GCRC for administrative records. If substantial revisions have been made, the projects must be re-approved by the GCRC Advisory Committee before subjects can be enrolled in the revised protocol. All new revised consents and appropriate IRB approval letters must be forwarded to the GCRC administrator and nurse manager prior to the amendments being implemented and must have received IRB and GCRC approval.

7) Who obtains informed consent of the subject?

It is the responsibility of the principal investigator or appropriate designee to obtain informed consent from the subject/parents before the commencement of a study at the GCRC. The signed consent form must be on the subject's chart at the time of the inpatient admission or a copy of a properly executed current IRB stamped consent must be given to the GCRC for its outpatient records at the time of the subjects research visit to the GCRC. The investigator is also required to retain the original signed copy and to give the study subject a signed and dated copy of the most current approved research consent.

8) How is medical care provided at the GCRC?

The principal investigator or his medical co-investigator that has licensed, privileged credentials and staff privileges is responsible for the medical care of study subjects. Arrangements for 24-hour emergency and night care must be formalized before study implementation for inpatient subjects and during business hours for the outpatient subjects. In case of an intercurrent illness, care will be provided according to standard freestanding non-hospital care center practices at the Diabetes Research Institute and Batchelor Children’s Research Institute. The Miami VA Medical Center will provide an emergency care response team and they will stabilize a code blue subject. The subject may or may not remain in the GCRC depending on both the needs of the subject and the space requirements of ongoing research studies.

9) How are physician’s orders handled at the GCRC?

All orders must be typed or in legible handwriting and have the name and pager number of the project’s licensed, privileged, physician. A copy should be made available to the GCRC staff before the scheduled in-service and/or visit for final review and in preparation for the visit. Telephone orders may be accepted by the nursing staff, but must be signed by the medical physician within 24 hours of issue. The GCRC staff has developed outlines and an electronic template for standing orders for your convenience.

Orders must include the following statement: "For GCRC approved research protocol: (title of study and protocol number)"

Orders should also include the name and pager number of a licensed privileged physician providing backup for the principal investigator (if unavailable for any reason). All orders should be detailed. Special diets orders must be coordinated with the research dietitian, Gwen Enfield, at 305-243-5012 at least one week prior to the initiation of the study.

If the physician will not be present at the time of discharge, or prefers to write the order prior to discharge, the following type of statement must be included on orders: "May discharge patient at end of protocol, (date), if stable."

10) What is the purpose of the researchers in-service?

After receiving approval from the IRB and the GCRC Advisory Committee, you will be asked to meet with the GCRC nurse manager and staff to introduce your protocol. This process is commonly referred to as an "in-service". The in-service allows the GCRC staff to obtain a better understanding of your protocol and your exact needs. The GCRC nurse manager will assist you in coordinating the meeting. The in-service will be used to train and educate GCRC staff on the specifics of your protocol prior to its initiation.

11) How are subjects scheduled?

Investigators should telephone the GCRC prior to making arrangements with a subject to ensure that space on the unit is available. The GCRC requests a minimum of a weeks notice on inpatient scatter-bed day admissions at Jackson. Admission depends on the availability of beds, equipment, and GCRC research staffing.

All outpatients scheduling is done through the GCRC nurse manager or her designee. They can be reached at 305-243-5012 during business hours Monday through Fridays from 8 a.m. until 4:30 p.m. The GCRC Patient Demographics form is available from the GCRC staff at the time of the research subject’s visit. The following information is necessary for scheduling:

1. Subject name (first and last)
2. Subjects study ID number
3. Project title under which the patient is to be admitted, the GCRC and IRB number
4. Date of admission or outpatient visit
5. Estimated length of stay
6. Request of personnel, notification of procedures/test, and sample assay processing services to be performed