Research Budget Considerations
As an Investigator, you are responsible for negotiation of your research budget. To ensure that you are appropriately compensated for your work, you need to calculate how much it costs you to participate in the study. Your cost calculations should include all of the items that you are responsible for paying for in starting up, managing and wrapping up the study. Knowing the true value of your participation in the project and the amount of your minimum acceptable budget will allow you to better negotiate your research budget and determine if its economically feasible for your to participate in the study.
TIPS for Preparing and Reviewing Research Budgets:
- Know your therapeutic area, the phase of the trial, patient population, and items you will need to outsource.
- Read and review the protocol and case report form (if available) to identify any cost-generating activities, or ask if there is a specific study manual for the trial.
- Don’t depend solely on the protocol’s study flow chart as other costs will be found throughout the protocol or not found in the protocol at all but will be incurred (eg: costs associated with record retention, shipping and handling of samples, amendments, time for re-consenting patients, rescheduling visits, and regulatory inspection costs).
- Remember start-up costs (eg: set up fees for pharmacy/lab/radiology/pathology, REB application preparation, SI/SE visits, investigator meetings, monitor needs when visiting) and archiving fees.
- Include overhead and REB fees.
- Identify which procedures are standard of care and which are study specific.
- Consider personnel costs (eg: research team: availability and time of investigator, study coordinator, research assistant).
- Budget for per subject study costs (patient care procedures, tests and labs (pharmacy, lab, radiology), stipend/travel/lodging)).
- If you are participating in a multi-year project, remember prices for supplies or services can change and/or are updated annually. Always ask if there is set annual increase for these items.
- Budget for the unexpected (eg: subject drop out, changes in study staff, longer than expected study duration, screen failures, early termination)
- Review the payment schedule/payment milestones, payment terms and currency of payment.
- Consider expenditures that aren’t always obvious (eg: copying, long distance phone calls, overnight shipping, faxes, materials, specialty equipment, advertising)
The Research Contracts team can provide you with more information on some of these costs. In addition, the following are some common institutional costs:
Archiving fees — $200/box if arranged through Research Administration
HiREB Initial Review — $3,500
HiREB Annual Renewal — $300/year
HiREB Major Protocol Amendment Review Fee – $750/amendment
For costs associated with lab setup please contact: Josephine Baldwin at Hamilton Regional Laboratory Medicine Program. Her email address is: email@example.com
Pharmacy Costs — Contact the Pharmacy Research Support Services (PReSS)
PReSS is responsible for providing comprehensive pharmacy services for clinical trials with McMaster, General and JHCC sites. PReSS’ webpage on the HHS intranet can be found at: http://corpweb.hhsc.ca/body.cfm?id=662
Diagnostic Imaging Costs — Please contact Jane Castelli, Manager, Research, Diagnostic Services at 905-667-1418 or firstname.lastname@example.org