What to Know Before Opening a Research Project at Jackson
In the past, initiating clinical research at Jackson Health System (JHS) was often a confusing, cumbersome and time consuming process for University of Miami investigators. With an understanding of these challenges, the Office of Research Administration (ORA) and JHS Clinical Trials Office have been working together to streamline and improve the process to make it easier and more efficient for investigators and their study teams to utilize JHS resources for their projects.
The Network for Clinical Research Professionals seminar on February 14 highlighted the updates in the process in a presentation by the Office of Research Administration’s Directors of Pre-Award Stewart MacIntyre and Tatyana Vikhlyantseva along with JHS Clinical Trials Office Director Katuska Barbery.
One of the biggest bottlenecks that was identified in the clinical research process with JHS was the need for three-party clinical trial agreements. Regardless of who may be involved, when negotiations have to take place and different studies have different processes, it slows the process down.
In February 2017, the Master Research Collaboration Agreement between UM and JHS was signed. It eliminates the need to negotiate a three party clinical trial agreement (between UM, the Sponsor and JHS) and consolidates all study types regardless of funding mechanism into one process.
While the master agreement laid out a faster, more streamlined process for handling the contractual terms, the budget negotiation process does not have a one-size-fits-all solution as each budget is handled on a case-by-case basis.
Both the ORA and JHS Clinical Trials Office, however, are continuing to look at ways they can work more collaboratively in this area. The initiation forms, available on ORA’s and Jackson’s websites have been updated for this purpose to help reduce duplicative analyses.
When getting started with a project that may involve the use of JHS’s facilities or resources, investigators and study teams should first review the flow chart on ORA’s website to understand what information is required and the timeline of events. The necessary forms can be found on the Submitting to ORA web page. In addition, the Jackson related forms can also be found on Jackson’s study submission page. Two important things to keep in mind when beginning are:
- When you know you will be using Jackson resources in your study, you should budget for the costs in your study proposal. Estimating these costs in the front end will help in the long run. The JHS Clinical Trials Office can provide pricing.
- Submit the Jackson Work Order Request Form only when: you have received the notice of award from ORA and you are ready to use Jackson resources.
Answers to Common Questions
Following the NCRP presentation, the presenters gave answers to some common questions that they frequently encounter.
What do I put in the JHS study calendar?
These items are the procedures that will take place at Jackson. Often times it is better to emphasize to people what not to put in the calendar. Don’t put:
- Procedures that only takes place at UM
- Personnel related items
- Informed consent
You can contact the budget analyst at ORA assigned to your study with other questions.
How do I determine the amount to enter into the Jackson Work Order Request Form?
This field is no longer required as sometimes it is not known at the outset. It will be within the main budget that ORA and JHS are negotiating.
How long does it take for ORA to receive a budget from Jackson?
The goal is for it to take 2 weeks, but right now it can be longer if the following happens:
- Application, forms and calendar are missing important information
- ORA doesn’t have latest version of your protocol
- There are many studies in the queue for review
How long does the work order request process take?
It depends on the complexity of the budget. It may take a month or longer.
Where can I find the final Jackson budget? How will I know what I will be billed for?
The final Jackson budget will be in the final Jackson work order. You’ll have your per-patient budget in this work order.
How do we do a feasibility analysis for a new study if it involves Jackson?
The JHS Clinical Trials Office can provide guidance on the costs for labs, procedures and devices. Sponsors, in general, understand the cost of clinical procedures. Departments should look closely at personnel and study specific costs.
The Sylvester Comprehensive Cancer Center has a feasibility review committee, which is very helpful in identifying if studies can happen at Jackson.