Frequently Asked Questions
Site for research appointments – Where can I accommodate my clinical trial participants for their research related clinical activity?
The Clinical Translational Research Site (CTRS) has three locations on campus with services for both industry-sponsored and non-industry-sponsored protocols.
Cost of using the CTRS – Is there a cost to use the CTRS?
The CTRS operates on a fee-for-service model with a two-tier rate structure for industry and non-industry sponsored studies. A detailed study-specific budget will be provided following initial discussions of services and resources required for the protocol.
Hours of CTRS Operation – When is the CTRS open?
Hours of operation can be accommodated according to the study protocol including overnight.
CTRS Staff Certification – Does CTRS staff have all necessary certifications to facilitate research studies?
Yes. All CTRS staff have CITI training. In addition, all nurses are ACLS and ONS certified.
Velos and long-term follow-up – Should I de-enroll participants from Velos if my study is in long-term follow-up only?
No, you should not de-enroll participants in long-term follow-up. The MCA should clearly state the activities in the treatment and follow-up phases of the protocol. You should change your study status to “All patients off treatment” when you enter the follow-up phase for all participants. Even though the participant is off treatment there may still be routine services that are billable to the participant’s insurance. Bills have to be reviewed for the Medicare/Managed Care Medicare patients because they need to be billed with the NCT number, the V70.7 Diagnosis Code and Mod Q1 as appropriate.
Participants without insurance – protocol requires no SOC treatment – If a clinical trial participant loses insurance that is accepted at UHealth, do I need to remove this participant from the study? What if this participant has a medical emergency on site?
Removing the participant from the trial should be based on the parameters defined in the IRB-approved protocol or factors related to participant safety and wellbeing. Removal should not be based solely on the fact that the participant lost insurance accepted at UHealth. The PI or someone from the financial services side should have a discussion with the participant regarding his/her financial obligations as it relates to any medical emergencies experienced while at UM and which are deemed unrelated to the trial. According to all agreements with the industry clinical trial sponsors, the sponsor is responsible and expected to pay only for the injury directly related to the study procedures, study article and protocol design, and for nothing else. If the emergency is study-related, the sponsor will cover expenses once the emergency is classified by the PI as study-related adverse or serious adverse event. In case of unrelated injury to such subject who is at the site for the study-related visit, the sponsor is not obligated to pay.
Participants without insurance – protocol is intertwined with SOC procedures - ICF – The research protocol is intertwined with standard of care procedures. The clinical trial participant loses insurance that is accepted at UHealth. Does the ICF cover this situation?
Only insofar as the type of cost or compensation language included in the ICF that might define any additional costs participants may be expected to pay. The PI or someone from financial services should have a discussion with the participant about what implications the loss of insurance may have on his/her continued participation in the trial. If the participant is willing to pay for the costs, it should be so documented.
Participants without insurance – protocol is intertwined with SOC procedures – Sponsor – The research protocol is intertwined with standard of care procedures. The clinical trial participant loses insurance that is accepted at UHealth. May I ask the sponsor to cover SOC expenses to keep the participant in the trial?
Yes, within the following criteria. If the sponsor deems the participant’s study-generated information to be of importance for the trial and/or because it is the right thing to do they may agree. Since this may be considered additional compensation not afforded other participants with insurance, the IRB would expect the PI to submit a modification to explain the issue and what the sponsor is willing to do in the event a study participant loses insurance. Alternatively, if the participant goes elsewhere for SOC treatments, the PI can ask for the information to be disclosed for the research purpose provided the necessary HIPAA issues are addressed with the participant and his/her healthcare providers. A very specific amendment to the contract is written for industry sponsors.
Timing of return to campus – My experiments have specific time-dependent needs. When will I be allowed to return to campus after a shutdown?
You can normally return as soon as your building is cleared, but no sooner. As buildings are cleared, the information is relayed to the Rumor Control Hotline (305) 243-6079.
Equipment / Laboratories
Laboratory Relocation – I am moving my lab but staying within my department’s assigned space. Do I still need to follow the relocation procedures?
Yes, for your safety and the safety of others, you must follow the relocation procedures.
Power loss – What do you do if your equipment experiences a power loss after standard business hours?
Call UM Security at (305) 243-6000 and ask them to visit the location for a quick inspection. Request they contact the on-call Physical Plant Manager to evaluate and resolve the power issue. Have a backup plan for your critical samples. If the power is not resolved immediately, ask Security to coordinate your relocation of your samples to one of RIM’s empty refrigeration units upon availability.
Equipment Failure – Security called me and said my equipment was in alarm. What should I do?
Request they contact the on-call Physical Plant Manager to evaluate and resolve the issue if possible. If the issue persists, call and arrange for one of our approved refrigeration vendors to evaluate the problem and repair the refrigeration unit.
Eligibility – Who is eligible to apply for internal award funding from the Miller School?
All full-time faculty members in MSOM are eligible to apply for internal funding for both the Scientific Award Committee (SAC) and the Administrative Committee programs.
Exclusions – What cannot be funded through the MSOM internal award program?
Travel costs, conference fees, faculty salary support and graduate student stipends are not allowable on internal award budgets.
Letters of Intent – When do I need to submit a Letter of Intent (LOI) prior to submitting an application?
The only program that requires an LOI is the Interdisciplinary Team Science (ITS) Pilot Program.
Equipment – Can equipment be purchased on an internal award?
Typically the purchase of equipment is not supported on internal award budgets. However, in some cases with strong justification, equipment will be allowed if it is an essential component to successful completion of the proposed project and is not available within the University core services or another faculty’s laboratory. An Emergency Equipment award is available to support the repair and/or upgrade of equipment. More information can be found at the following link: LIST LINK WHEN AVAILABLE.
Fringe benefit rate – When budgeting staff salary - what fringe benefit rate should be used?
The Non-Federal rate should be used when calculating fringe benefits for staff on all internal awards.
Proposal/Contract Routing Form – Does my internal application require a proposal transmittal form?
No, this is not required for internal application submissions.
Where to submit – Does my internal application need to be submitted to the Office of Research Administration (ORA) and/or MEDReps?
No, applications should be submitted directly to the Internal Award Program Manager.