Download Overview for Research Budget - St. Michael`s Hospital Research

Research Budgets
Development and Negotiation
Developed by:
Marianna Betro
Business Manager
Research Budgets - An Overview
Effective Budget Development and Negotiation
Budgets from both the Principle Investigator and the sponsor perspectives represent are negotiable.
From the sponsors’ perspective, the goals of the budget are cost effectiveness, pay for value, to avoid
any surprises and compliance with regulations. From the PI’s perspective the goals of the budget are
full recovery of costs and intangible benefits. Both the sponsor and the PI want to conduct a
successful study, which can initiate quickly and minimize any administrative burden. The important
factor is to ensure that it represents a fair and accurate estimate of the actual costs required to
conduct the study. It is not the PI’s responsibility to subsidize the study for the sponsor. The budget
may be an estimate on behalf of the sponsor but institutional costs will vary and they are aware of
this. The person who is most closely linked to the day to day activities of the study should play a
primary role in developing the budget.
Budget Development
In developing a budgets there are important factors which should be considered by the PI.
1.
Determine Activities: What needs to be done for the study or a chart of events. Do not
forget to include any coordinator time or physician time.
2.
Determine time per activity:
3.
Determine who will complete activities: Will the activities be completed by the PI,
Based on your protocol how long will activities take.
Please keep in mind that you can not be an expert in everything and that outside
professionals might be asked to help.
nurse, coordinator, research assistant or a combination of professionals.
4.
Determine Salaries: Follow set HR salary guidelines and do not forget increases and
then once the salaries are set, take into account how long the study is going to run.
5.
Determine per Patient costs: For example, patient training is equal to ½ hour of a
nurse’s time therefore the cost would be time x salary.
6.
Determine Institutional Charges:
7.
Determine other charges: Such charges as office start up costs (equipment and phone
Such charges as overhead, REB fees and other
institutional charges like, Pharmacy, research vivarium, Diagnostic Imaging, Lab costs etc.
lines, recruiting, advertising, stipends, sample processing, shipping of samples, collection
maintenance, protocol amendments, premature termination, record retention, conference
presentation costs, publishing costs, etc.
Budget Review
Once complete review the budget for accuracy, completeness, reasonableness and
compliance with any contract or grant guidelines.
Budget Monitoring and Forecasting
Use your
payments
payments
payments
budget to develop a tracking tool for monitoring payments received versus
owed. For a Clinical Trial, keep track of the payments received to ensure that all
are received for all visits completed. It might be helpful to also keep track of
owed versus payments made to internal departments for services rendered.
Another important part of monitoring is comparing the actual versus the budgeted costs.
This will be helpful for you to develop budgets for future studies and we see whether you
need to make revise your budget.
Steps to the Calculation of your Research Budget
Starting the Budgeting Process
 Review the budget template at http://smhinet/Intranet/index.asp under Finance/
Financial/ Research Budget Template Tool. Must verify how tool will be
distributed.
 Approximately 30% of the time required in a study is non clinical but administrative. 1
Examples are REB submissions, communication with sponsor or Research Business
Analyst, budgeting, preparing grant submission etc.
 Use a program like MS Excel to develop and maintain your budget so that your total
numbers can be moved easily to your Budget Template Tool. This will help you avoid
any errors in calculations and help you capture all expenditures. Insert link to excel
tool attached.
 If the budget is for a Clinical Trail, some tools that you will need are a copy of the
Case Report Form (CRF) in order to determine what is required for data collection,
current interdepartmental fees for departments that may be providing services.
 The main objective when applying for research funding is to obtain sufficient funding
to cover all the proposed costs.
 Identify all direct costs and include provision for indirect costs.
 Examine the sponsors funding guidelines which in some cases will dictate eligible and
ineligible expenses.
1
Costs of Conducting Clinical Research. Journal of Clinical Oncology; 21: 4145-4150, 2003. Emanuel et al.
Direct costs to consider when completing your Budget
Direct costs include actual traceable expenses incurred such as;
1.
Start up costs
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2.
Costs that are incurred before the study is begun and in clinical trails can
represent non refundable costs whether potential participants are enrolled in
the study or not.
REB review fee if applicable of $ 2,500
Medical lab start up for setting up lab specimens
Salaries
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In budgeting for salaries take into account what type of staff will be required to
complete the study and the length of time each staff will spend on the study.
For clinical trials, take into account the informed consent process and estimate
the time required to conduct the process, take into account the complexity of
the study and the length of time the patient will need to fully understand. Also
take into account any increase in length of time if translation services are
required.
Salaries for staff must be within range for the appropriate SMH classifications.
Allowances should be made for increases to the salaries effective April 1 st of
each year. We recommend that you use the hourly rate at the top of the range
and then from year to year the increase would be 3%. If you do not use the
top hourly rate then the increase from year to year should be 8% to include
step increases plus inflationary increases.
Salaries must include benefits.
For clinical trails if there is a salary for the PI take into account the time to
prepare the REB application, meetings, etc.
Also in salaries there could be stipends that are being paid for independent
contractors.
Clinical Trials and Salaries
For Clinical trials there are other factors that need to be taken into consideration
when budgeting for salaries. One should take into account:
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The informed consent process and estimate the time required to conduct the
process which will depend on the complexity of the study and the length of
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3.
time the patient will need to fully understand. Also take into account any
increase in length of time if translation services are required.
There are certain activities that need to be done for patient trials, so the time
required to do some of the following should be taken into account;
i. to take the patient for a test, pre-screening time
ii. pre visit preparation (planning logistics of a visit and booking tests, and
preparing source documents,
iii. transcription from source documents to CRF
iv. communication with PI, study participant
Equipment
You should consider whether a protocol requires equipment that the hospital does
not have. Also if equipment is purchased please ensure that maintenance and
certification of equipment is accounted for in the budget amounts. Other items
that can fall this category are;
 Computers
 Telephone line charges and phone sets
 Other minor equipment required for the study
4.
General Expenses
Items that can fall this category are;
 Inter department printing charges
 Long Distance Charges
 Postage
 Courier
 General supplies
 Conference attendance
 Storage costs
 Travel reimbursement
 Honorariums
 Training courses
 Publication costs
 Sub contract costs which are costs for portions of the projects which are done
by other organizations or institutions.
Allowances should be made for inflationary increases to the expenses from year to
year. We recommend you use 3%.
5.
Research Vivarium costs
If the study requires the use of the vivarium and cost for the animals and the
monthly vivarium maintenance charge should be included in the budget.
6.
Research Supply Costs
Research supplies are special supplies required to equip the lab or to carry out
special procedures as part of the protocol.
7.
For Clinical Trials – Per Patient Costs
For clinical trials, there are also some per patient costs that should be considered
in the budget process. Some of these are:
 Participant reimbursement – ensure the amount is adequate to cover the
patient costs for travel, a meal if necessary
 Sample processing if required – the time for blood draw, or cost of draw tubes,
time for completion of requisition forms and specimen labels, time for preparing
slides, etc
 Laboratory testing – cost of tests required times the frequency
 Pharmacy charges for the dispensing of medications
 Diagnostic Imaging costs if tests required
 Advertising costs – consider whether advertising would be helpful in recruiting
participants
 One time, flat rate & invoiced – these are costs related but not dependent upon
the number of patients enrolled in the study. Before adding those to your
budget consider the financial benefit to the risk of asking for too much from the
sponsor. Such cost may be general supplies such as
i. General supplies such as stamps, paper, photocopying, shredding,
phone charges, computer, fax etc. Consider asking for a lump sum to
cover general costs as long as those costs can be accounted for.
ii. after hours pharmacy dispensation
iii. dry ice
iv. close out visit or study termination costs such as close out visit, data
clarification, REB notification of study closure, account reconciliation and
closure, return of unused study materials and unused drugs, preparation
of study documents and debriefing of participants
Indirect costs to consider when completing your Budget
Indirect costs can not be specifically traced to a particular study and can include;
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building lease
depreciation of equipment
physical plant and maintenance
30% overhead charge if applicable to the study
Other Points to Consider
 Footnotes – insert subscript numbers after budget items that require further
clarification
 Signatures – ensure the budget is signed off on
 Ensure the final Clinical Study Agreement contains the approved budget (and not an
earlier version or sponsor’s version)
 Review your calculations and estimates
 Take into account US dollars or Canadian Dollars in revenue calculations.