Contract Negotiation Synopsis
Introduction
The negotiation and execution of contracts is a substantial component of the genesis of a clinical trial. Clinical trials at UConn Health cannot commence until a contract has been fully negotiated, approved, and executed and the clinical trial has received final IRB approval.
Historically, the negotiation of clinical trial agreements contributed to the delay in the opening of pharmaceutical/industry clinical trials. OCTR has alleviated many of these issues by redefining the contract procedure to include the following:
- Parallel budget determination
- Standardization of contract templates
- Organization of contract negotiation procedures
- Coordination with the Institutional Review Board (IRB)
- Full execution of contracts after IRB contingent approval
Types of Contracts
The OCTR negotiates industry-sponsored or investigator initiated industry-supported contracts, university-to-university agreements, co-operative group contracts and foundation-supported contracts, which include the following:
- Clinical Trial Agreements (CTA)
- Confidentiality Disclosure Agreements (CDA)
- Contract Amendments
- Letters of Indemnification (LOI)
OCTR does not negotiate:
- Federally funded investigator initiated agreements* **
- Clinical trials or clinical research in which the Prime Award is in response to a public solicitation (e.g., Request for Information (RFI), Request for Application (RFA), Funding Opportunity Announcement (FOA))
* In this instance, the proposals will be negotiated by the staff in the Sponsored Programs Services (SPS). If you are pursuing a federally-funded agreement or a study in which the prime award is in response to a public solicitation, please contact SPS at 860-679-4040 or go to their website.
** Appendix I: The following represent the main types of federally funded grant awards and projects that will continue to be negotiated by the Sponsored Programs Services (SPS) at UConn Health. See listing of all NIH grant mechanisms.
Research Grants:
- R01 – NIH Research Project Grant Program
- R03 – NIH Small Grant Program
- R13/U13 – NIH Support for Conferences and Scientific Meetings
- R15 – AREA: NIH Academic Research Enhancement Award
- R21 – NIH Exploratory/Development Grant Award
- R34 – NIH Clinical Trial Planning Grant
- R41/R42 – STTR: Small Business Technology Transfer
- R43/R44 – SBIR: Small Business Innovative Research
- R56 – NIH High Priority, Short-Term Project Award
- U01 – Research Project Cooperative Agreement
- K99/R00 – NIH Pathway to Independence (PI) Award
Career Development Awards (K series)
Research Training and Fellowships (T & F series)
Program Project/Center Grants
- P01 – Research Program Project Grant
- P02 – Exploratory Grant
- P30 – Center Core Grants
- P50 – Specialized Center Grants
Resource Grants
- R24 – Resource-Related Research Projects
- R25 – Education Projects
- X01 – Resource Access Program
Trans-NIH Program
- BISTI: Biomedical Information Science and Technology Initiative
- Blueprint: NIH Blueprint for Neuroscience Research
- Diversity Supplements
- Administrative Supplements
- ES I: New and Early Stage Investigators Policies
- GWAS: Genome-Wide Association Studies
- NIH Common Fund: NIH Roadmap for Medical Research
- OppNet: NIH Basic Behavioral and Social Science Research Opportunity Network
- PECASE: Presidential Early Career Award for Scientists and Engineers
- Stem Cells
Contract Negotiation Process
Industry Sponsored Clinical Trial Agreements
If an industry sponsor is interested in conducting a clinical trial at UConn Health, the sponsor will initially send a non-disclosure agreement or a confidentiality disclosure agreement (CDA) to the researcher. Once received, the researcher should forward the CDA to the contract specialist in the OCTR. The CDA will then be reviewed, negotiated, approved, and executed. Thereafter, the researcher will review the data and the study components in order to determine whether to participate in the study.
After review of the sponsor’s data and proposed study, the researcher and the sponsor will make a mutual decision whether or not to engage in the study. If the researcher decides to engage in the study, the sponsor will send a clinical trial agreement (CTA) to the researcher or the researcher’s study coordinator. The clinical trial agreement is then forwarded to the contract specialist in the OCTR for review and negotiation. Once the CTA is negotiated, the contract specialist will obtain signatures from an authorized representative of UConn Health, the researcher, and the sponsor.
Another type of CTA is the “University to University” agreement. University to University agreements are subcontracts with a university that has a governing contract with a company sponsor. The negotiation procedure for University to University agreements is similar to the negotiation procedure for industry-sponsored clinical trial agreements.
Investigator-Initiated Clinical Trial Agreements
An investigator-initiated clinical trial is one that is authored by the investigator and financially supported by industry, a foundation, or another university. The funding agency may send its own company contract to OCTR for negotiation, or OCTR may send the funding agency a clinical trial agreement generated by UConn Health. Thereafter, the negotiation procedure is generally tantamount to the process described above for industry-sponsored studies.
Cooperative Group Studies
UConn Health has master agreements with cooperative groups which are designed to promote and support clinical trials. OCTR negotiates all agreements pertaining to the cooperative group studies or its corresponding master contract.
Budget and Institutional Review Board (IRB)
All clinical trials that incur JDH and/or UMG and/or Dental charges will need a completed Budget Workbook before IRB submission. During contract negotiations, OCTR staff reviews the protocol, informed consent, and contract to ascertain that patient costs and patient injury language are in agreement within all documents. At the time of review, the IRB will also assess concordance among the protocol, patient consent, and contract relative to patient costs and patient injury language. If the protocol is contingently approved by the IRB, the contract can be signed by the Director of Sponsored Program Services and sent back to the company while contingencies are being met.
A clinical trial agreement cannot be signed until the study has received contingent approval from the IRB. Thus, an executed contract is not required for IRB submission. However, if a clinical trial agreement contains subject injury language, said language may be required for submission. The subject injury language can be requested from the OCTR.
No clinical trials can open or begin accrual without final IRB approval.