Industry Initiated Clinical Research

Budget Development and Negotiation

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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.

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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
Administrative Fees (Start-up, Maintenance, Close out)	2022 Institutional Research Fee Schedule
Clinical Research Unit (CRU)	Fee Schedule
Facilities and Administrative (F&A) Costs	Fees
FACTS	2023 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 2023
Medicare Coverage Analysis (MCA) Fee	2022 Institutional Research Fee Schedule

Research Fee Schedule Contacts

Department	Contact
Anesthesiology	James Leader
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.

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