Overhead
Nova Scotia Health charges 30% overhead on industry sponsored research and 15% overhead on investigator driven research funded by industry, government agencies and foundations. This overhead is applied to ALL direct study related costs outside standard of care. Those items not subject to overhead will be listed separately in the line-item study budget.
Research Ethics Board
As a cost-recovery means to support research ethics reviews, the Research Ethics Office charges a required initial review fee of $4,000 for each new study funded by a for-profit entity (industry sponsored and industry funded studies). This fee is charged regardless of the outcome of the review. A new REB annual maintenance fee of $500/year and a protocol amendment fee of $250/amendment is also being implemented for active studies. This fee structure is based on review of national standards, the increase in research studies being reviewed by the REB, inflation, and digital structure. The Research Ethics Office monitors the inclusion of the Research Ethics Board (REB) Invoice Template Billing Form in submissions for all industry sponsored AND industry funded studies and a request for invoice generation sent to Research Finance.
Archiving/Document Storage
As per Good Clinical Practice (GCP), Health Canada regulations, and applicable Nova Scotia Health requirements, research records must be stored for a minimum of 7 (seven) years or a maximum of 15 years. To offset the cost of storage of these records on premised owned or leased by Nova Scotia Health, a record retention fee of $1,500.00 (Phase I-III) or $750 (Phase IV) is required. This fee is directly invoiced by Research Finance at the completion of the study.
Equipment Inspection and Approval
Nova Scotia Health’s Department of Biomedical Engineering is responsible for ensuring that medical devices, equipment and/or technology entering NSH facilities are in compliance with the applicable standards and guidelines established by the Federal and Provincial governments as well as certain policies and procedures of NSH. This inspection could result in an hourly fee depending on the time required. For more information, please see the following link.
Banking/EFT Information, Invoicing and Financial Reporting
All requests for and documentation specific to Nova Scotia Health’s Banking Information and to notify Nova Scotia Health of a payment, please contact NSHAResearch@nshealth.ca .
All other research finance inquiries should be directed to ResearchFinance@nshealth.ca, Room 813 Bethune Building, 1276 South Park Street, Halifax, Nova Scotia B3H 2Y9
Administrative Research Costs
It is an institutional requirement that all direct costs of research, outside standard of care, are covered by the Research Budget. It is the shared responsibility of RID and the Research Team/PI to ensure that all related costs are covered. These costs include administration fees, personnel time, protocol related tests, procedures, institutional departmental service fees, protocol related supplies and institutional fees such as overhead, ethics and archiving. These fees can vary based on the complexity of the research protocol, the expertise and training required by research staff (for example a regulated vs non-regulated research coordinator), training required specific to protocol related activities, creation of internal budgets, quotes, contract review and others. The following is a benchmark of standard fees charged by all research teams at Nova Scotia Health.
Institutional Fees
Budget Item |
Fee |
---|---|
Overhead (applied to all direct study costs) | |
Industry Sponsored Studies | 30% on per patient costs |
Industry Funded Studies | 15% on total funding |
REB Fees | |
Initial review | $4,000.00 |
Annual approval | $500.00 |
Amendment fee (each) | $250.00 |
Archiving fee | |
Phase I-III | $1,500.00 |
Phase IV | $750.00 |
Administrative Study Fees
Budget Item |
Fee: |
||
1. Team Start-up fee* |
$5,000.00 |
$7,000.00 |
$9,000.00 |
2. Annual Admin & Maintenance Fee* |
- |
- |
$1,750.00 |
3. Study Close Out* |
- |
- |
$1,200.00 |
4. Safety & Quality Reporting |
|||
a. Serious Adverse Events (SAEs) |
$150 - $300 (not inclusive of OH) per event** |
||
5. Auditing |
Negotiated based on Sponsor expectation and time involved (hourly or per day) |
||
6. Monitoring |
|||
a. Visit (in-person/remote) |
$520 per day (inclusive of OH) |
||
b. Site update calls |
$97.80 per call (inclusive of OH) |
||
7. Amendment Fees |
|||
a. Major (protocol amendments requiring REB changes and reconsenting participants)
|
$850 each (inclusive of OH) |
||
b. Minor ((protocol amendments requiring REB changes)
|
$300 each (inclusive of OH) |
Shared Services Admin. Fees
Pharmacy Start-up |
$800-1,700 |
Pharmacy Annual Maintenance |
* |
Pharmacy Close Out |
$300.00 |
Lab Start-up |
$500-1,500 |
Lab Annual Maintenance |
$1,000.00 |
Lab Close out |
$100.00 |
Diagnostic Imagin / Radiology Start-up |
$500-1,500 |
Radiologist Fee |
$200/hr |
Diagnostic Imagin / Radiology Amendment Fee |
$275.00 |
Image De-identification and CD |
$85.00 - $110.00 |
Heart Health Start-up (ECHO, ECGs, MUGAs) |
$500.00 |
Med Day Unit Start-up |
$500.00 |
Pulmonary Function Star-up |
$500.00 |
*currently charged quarterly and varies protocol to protocol
Standard Per Patient Fees
Protocol Activity |
Standard Fee |
Assessment of Adverse Events |
$75.00 |
Brief Physical Exam |
$150.00 |
Recruitment |
$25.00 |
Informed Consent |
$150.00 - $250.00 |
Inclusion/exclusion criteria |
$150.00 |
Coordinator Fee per Visit |
$65.00/hr |
Medical History |
$150.00 |
Demographics |
$65.00 |
Vital Signs |
$25.00 - $65.00 |
Concomitant Medications |
$65.00 |
Investigator Fee per Visit |
$250.00 |
Complete Physical Exam |
$250.00 |
Questionnaires |
$50.00 |
Randomization Administration |
$20.00 |
Patient Reimbursement Fee |
$50.00 - $100.00** |
Sample Collection & Processing Fee |
$40.00 - $90.00*** |
On Site drug administration |
$65.00 |
Data Entry Fee |
$65.00/hr |
*fees are based on an average across a representative sample of previously negotiated budgets **may vary/exceed this amount based on visit complexity. Please note: this does not include travel reimbursement as listed below. ***with or without dry ice
Participant Stipend
The standard per visit rate for participant reimbursement is $55 - $100 per visit and is required to be included in the per participant budget.
Participation Reimbursement
Published guidelines generally agree that to protect human subjects, reimbursements specific to participation in clinical research should be limited to compensation for time, lost earnings, travel, and other expenses incurred in taking part in a study; that no payment should be given for the assumption of risk; and subjects may be paid or otherwise compensated for inconvenience. At Nova Scotia Health, these payment amounts are standardized and based on institutional reimbursement policies.
Participation Travel Reimbursement
Any additional funds required to cover long distance travel, overnight stays, additional meals, or support companions will be requested as outlined below and upon approval of the Sponsor/Lead Site prior to such costs being incurred or invoiced for payment.
Gas Mileage if the participant is travelling in excess of 80 Km round trip* |
NSHA Mileage rate 57 cents/km |
Hotel Accommodations |
Accommodations may be applicable for those traveling long distance and will be decided on a visit-to-visit basis |
Breakfast (offsite) |
Hotel breakfast covered up to $20 with receipt |
Dinner (offsite) |
Hotel dinner covered up to $40 with receipt |
Caregiver/ Support person Meals |
Same as Study Participant. See above for applicable amounts. |
*Mileage rate may increase with inflation and institutional directives