Indirect Costs and Budgets
Indirect Costs, also referred to as “Facilities and Administrative (F&A) costs” or “overhead”, are required to be applied to the total direct clinical costs for industry sponsored clinical trials.
Exception – IRB fees are exempt from F&A costs.
The indirect cost rate for Industry Initiated or Sponsored Trials is 35%.
Waiver: If the industry sponsor or other funding source will not pay the current F&A rate, a waiver is required from the Chief Financial Officer (CFO). Requests should be made in writing or email by the Chair or Administrator of the Principal Investigator’s Department. Unless the Chair is also the Principal Investigator (PI) the request should not come from the PI. If the waiver is not granted, the department will need to supplement the difference.
For more information, refer to Policies and Procedures for Charging Indirect Costs to Sponsored Projects Received from Extramural Sponsors, Gifts, Donations, and Other Receipts.
What
FACTS Office – Budget Development & Negotiation Services
The Financial Administration of Clinical Trials Services (FACTS) office provides investigators the option of using their budget development and negotiation services for industry sponsored clinical trials. FACTS will incorporate their fees into the budget and charge sponsors for these costs.
Develop and Negotiate Your Own Budget
If the research team chooses to develop and negotiate their own budgets, please consult with your research administrator for department specific resources and fees. In addition, see the tools listed below to assist researchers with budget development and negotiation.
Tools
Budgeting Guidelines
FACTS – Refer to the section entitled “Budgets” for the following:
- Budget Development Tips
- Budget Templates
- Budget Negotiations Presentation
- Budget Negotiations for Industry Clinical Trials
- Industry Sponsored Device Trials
Institutional Fees
| Service | Fee |
| Clinical Research Unit (CRU) | Fee Schedule |
| Facilities and Administrative (F&A) Costs | Fees |
| FACTS | 2025 FACTS Fees |
| Investigational Drug Service | IDS Information Sheet |
| ISMMS IRB Fees | Refer to the section entitled Information for Sponsored Research |
| Room Rates | Research Overnight rates 2025 |
| Program for the Protection of Human Subjects (PPHS) Fees | PPHS Fees |
Research Fee Schedule Contacts
| Department | Contact |
| Anesthesiology | James Leader, Jamie Kwan-Gorelick |
| BioMedical Engineering and Imaging Institute (BMEII) | BMEII Director |
| Biorepository and Pathology CoRE | Rachel Brody, MD, PhD |
| Cardiology | Debra Fitzpatrick |
| Dermatology | Giselle Singer |
| Hospital Fees | Inna Bender |
| Medicine Divisions | Michele Cohen |
| Neurophysiology Lab | Mary-Catherine George |
| Ophthalmology | Harriet Lloyd |
| Pathology, Molecular and Cell-Based Medicine Clinical Labs |
Beverly Cooper; Clinical Labs Price List |
| Pathology, Molecular and Cell-Based Medicine Transfusion Medicine and Cellular Therapy Laboratory |
Jeffrey Jhang, MD |
| Transplant | Brandy Haydel |
| Translation Fees | Language Assistance Program (LAP) |
Recruitment
Address recruitment and retention challenges early on; earmark funds during budget development/negotiation. For more information, refer to Recruitment and Retention.
How
To use FACTS Budget Development and Negotiation services, email FACTS@mssm.edu or call (646) 605-7251.
When you submit your contract through MediTract (FACTS), you will be asked to indicate who will be negotiating the budget. If the study team chooses to negotiate the budget, the FACTS office will reach out to the study team to obtain the final negotiated budget.
When
Budget development and negotiation should occur concurrently with contract negotiations and IRB submission.
Biomedical Research Alliance of New York (BRANY)
BRANY is a research consortium owned by several New York metropolitan area institutions, including the Icahn School of Medicine. BRANY offers a variety of services, including:
- IRB review
- Budget negotiation and contracting for multisite studies
- Monitoring services for investigator initiated studies
- Medicare Coverage Analysis (MCA)
To use BRANY services, please email FACTS@mssm.edu for more details and for the fee schedule.
Research 411 Portal
Still Need Help?