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Here's how to improve study budgeting and policies
Administrator offers look at best practices
It's not uncommon for research institutions to lose money on studies because of unexpected expenses, but this problem can be prevented by using a thorough budget worksheet and following budget policies.
"We did a major initiative for budgeting, focusing on how to budget and how to know the true cost for research conducted here," says Jana L. Lacera, RN, BSN, MSA, human protections administrator and director of the IRB and Bio-Ethics at Community Healthcare System in Munster, IN.
"This was one of our main focuses because everybody kind of knew how to budget, but there wasn't a formal process or spreadsheet they could use to identify costs up front," Lacera explains. "And we felt it was very important in negotiating contracts with sponsors to know what it would cost us."
Lacera devised a six-page Excel spreadsheet that lists activity details, hours per activity, total number of hours, dollars per hour, projected expense and expected revenue.
She also wrote an eight-page budget policies and procedures for researchers and research staff to follow.
"I took the budget worksheet and new policies to the clinical research staff, and they tested the budget worksheet, using data from old contracts," Lacera says. "Then we took it to our legal counsel for review, and they thought it was a good idea and approved everything we had done so far."
The institution has used the research budget worksheet for about a year, and there have been no problems with its predictions, so far, she says.
"We just finished revising it to make it more user-friendly," Lacera notes. "It was good to begin with, but it needed those fine revisions."
Here is how Lacera helped the research office improve its budgeting and contract negotiation process:
1. Create a model clinical research agreement.
Policy manuals can describe what is expected, but what if clinical trial professionals have questions about reviewing a clinical research agreement with a sponsor?
Community Healthcare System made this process easier for staff by developing a checklist of items that a clinical research coordinator and principal investigator could look at in a CR agreement, Lacera says.
"And we have a model clinical research agreement we worked on with our legal counsel," Lacera says. "We looked for language in the agreement that they recommended."
The model agreement is meant to help CR staff become familiar with such contracts, she notes.
"I asked our legal counsel to come in and speak with the staff, giving them a few sections on how to examine a clinical research agreement and about negotiation," Lacera says.
The 16-page model agreement includes language, such as the following:
• "Study Conduct:" 1.1 Institution, Investigator, and all sub-investigators agree to use their best efforts and professional expertise to conduct the clinical research described herein (the "Study") in accordance with the Protocol and the terms and conditions of this Agreement, provided however, that Institution and/or Investigator may make such deviations to the Protocol as they deem necessary to protect the health and welfare of Study subjects. Institution will promptly notify Sponsor of any such deviations to the Protocol."
2. Obtain more information and feedback.
"I went to other people's Web sites and found only one budget worksheet," Lacera recalls.
So she read as much as she could about the budgeting process and called some institutions to see if they could help her learn more by sharing their budgeting tools.
Once she obtained a great deal of information on the subject, Lacera began to build a budget worksheet and budgeting policies and procedures that would be suitable for Community Healthcare System.
Lacera also meets, as needed, with clinical trial staff to identify areas that need to be improved, such as the informed consent process.
The meetings are more frequent with departments that are newer to research, and these same departments are the ones that report finding a great deal of value in the budget worksheet and other tools, Lacera notes.
She obtained buy-in by having research staff involved in the process from the beginning.
"They said they found the budget worksheet very helpful," Lacera says. "And since they were in on the process from the beginning, they could see the importance of budgeting and knowing what a budget was because people tend to buy into things if they're involved."
3. Learn as much as possible about the costs of clinical research.
"I started with the study activities, determining how much time it would take for the principal investigator and clinical research coordinator to actually prepare for a study," Lacera says.
She identified a variety of areas that would take time, including the following:
Research coordinators fill out the worksheet from the very beginning, noting the estimated number of subjects, and then they complete information for all of the activities that are listed, Lacera says.
"I tried to capture all of the expenses, such as were they going to solicit the use of pharmaceutical services within the hospital?" Lacera says. "Or, what else would they have to use to do this study that would impact their budgets, including the lab and the radiology department."
Lacera also included a section on the cost of test procedures and treatments, detailing the actual costs and physician interpretation fees.
"There's a place where you can identify whether a test or procedure is the standard of care or related to research," Lacera says. "I did that for the obvious reason that you're identifying which it is right up front so it won't get confused along the way and lead to double billing and fraud problems."
There is an easy reference sheet for clinical research coordinators to review, she adds.
"In our system, it's the clinical research coordinators who fill this out, and if the standard of care versus research care is not evident in the protocol, then the protocol is not written well," Lacera says. "If they don't spell out who is responsible for paying for what then I have a problem taking that protocol to the IRB because if you don't know who pays for what then you can't inform your subjects."
On the last page of the worksheet, there is a budget recapitulation in which all of the totals are listed and there is a 25 percent indirect cost added to it, plus the IRB fees.
"Then it lists what the expected revenue will be from the research," Lacera says. "Hopefully, your expenses are less than your revenue."