Agreements and Agreement Oversight
Upon award acceptance or final execution of a negotiated contract, a formal agreement has been made. Sponsored agreements set the parameters for specific aims, funding amounts, period of performance, expense reporting or invoicing requirements, and the method of funding transfer. In many cases, sponsors incorporate a standard set of terms and conditions into agreements and create a budget and statement of work for the project. In some cases, the agreement may include project-specific requirements
Below we delineate the multiple types of agreements that Research Operations (RO) oversees in its fiduciary responsibilities on behalf of BMC. Sponsored Programs Administration (SPA) is responsible for agreements resulting from grants awarded by government or foundation sponsors. In addition, SPA oversees transfer agreements and government contracts. The Clinical Trial Office (CTO) is responsible for clinical trial agreement negotiated with industry partners.
For more on sponsor types and funding mechanisms, visit Introduction to Sponsored Programs.
Two Notes on Terminology
1. In legal parlance, "agreement" is another term for "contract." In the parlance of sponsored programs (SP), because governments award both grants and contracts, SP administrators tend to use "agreement" except when referring to government "contracts."
2. The terms "award" and "sponsored agreement" are sometimes used interchangeably by research administrators. Strictly speaking, however, a clinical trial agreement negotiated between a research site and an industry sponsor is not an award.
Agreement Types
Confidentiality/Non-disclosure Agreement (CDA/NDA): Typically an agreement between an industry sponsor and study site (=BMC) to allow study site personnel to review a protocol prior to agreeing to participate in a multi-site study. Collaboration between BMC and an industry sponsor typically commences with CDA/NDA negotiation.
Clinical Trial Agreement (CTA): Usually following upon a signed CDA/NDA and a feasibility assessment indicating that a proposed CT is warranted, the executed CTA is the result of negotiations between an industry sponsor and the site (BMC) for fair, ethical, institutionally acceptable terms.
Data Use Agreement or Data Transfer Agreement (DTUA): The name is virtually self-explanatory. A DUA is a contract that governs the transfer of data that are not publicly available. Because, in the healthcare setting, data are often clinical in nature, a site that agrees to provide data must follow strict protocols to protect patient privacy and confidentiality, following federal, state, and institutional requirements.
Material Transfer Agreement (MTA): The terms and conditions of transfer and acquisition of tangible material are stipulated by an MTA. Biologicals, e.g., cell lines and reagents, are the materials most likely to be transferred to or from a healthcare institution, but material may be chemical, animal, or digital products. Most BMC MTAs are "outgoing" -- we are providing materials to other institutions. The MTA defines the rights both of the provider and the recipient with respect to the materials and any derivatives or inventions following the recipient’s use of the materials.
Subaward Agreements: These agreements may be either outgoing, when BMC is the prime awardee of a grant engaging other sites as subrecipients, or incoming, when BMC is engaged by other prime-awardee sites as their subrecipient. Both "primes" and "subs" have many responsibilities, but the regulations governing outgoing subawards are more extensive. A subaward agreement that is not specified as incoming is typically an outgoing type, and it is typically abbreviated as, simply, "subaward."
See Basics of Subawards for more information on the responsibilities of outgoing subawards.
See the funding mechanism section of Introduction to Sponsored Programs for a description of Cooperative Agreements and Government Contracts.