Pre-Award Grants & Contracts - Contract Definitions

Sep 15, 2026

Pre-Award Grants & Contracts defines key contract types reviewed by the office, including amendments, clinical trial agreements, collaboration agreements, and confidentiality/non-disclosure agreements. It explains HIPAA-related structures for business associate agreements involving protected health information and data use agreements using limited data sets or de-identified data. The guide also covers consulting, investigator-initiated clinical trial agreements, laboratory services agreements, grant agreements, and letters of indemnification, with notes on common terms and typical governance.

LanguageEnglish

CategoryLetters

FormatPDF

Pages2

Reading Time1 min

AccessFree to download

Contract Definitions Overview

Amendment

Business Associate Agreement associated with Clinical Research

Clinical Trial Agreement

Collaboration Agreement

Confidentiality/Non-Disclosure Agreement

Consulting Agreement

Data Use Agreement

Grant Agreement

Investigator Initiated Clinical Trial Agreement

Laboratory Services Agreement

Letter of Indemnification (LOI)

What types of contracts does the Pre-Award Grants & Contracts office review? Amendment An agreement that modifies any aspect of an existing agreement. Common modifications include: adding new terms or conditions, extending the project period, increasing the funding, etc. Business Associate Agreement associated with Clinical Research This is an agreement between a covered entity (the holder of the PHI) and the recipient of the PHI (such as a service provider) in which the covered entity discloses PHI or in which the business associate creates, receives, maintains, or transmits PHI on behalf of the covered entity or another business associate. HIPAA generally requires that covered entities and business associates enter into a Business Associate Agreement to ensure that the business associate will appropriately safeguard protected health information. The business associate contract also serves to clarify and limit, as appropriate, the permissible uses and disclosures of protected health information by the business associate, based on the relationship between the parties and the activities or services being performed by the business associate. A business associate may use or disclose PHI only as permitted by the agreement or as required by law. Clinical Trial Agreement This agreement is between at least two parties and typically includes an industry sponsor, who is designated as the Sponsor per FDA guidelines. Other parties may include a contract research organization (CRO) designated by the Sponsor. Common terms generally include; confidentiality of proprietary information, data rights and HIPAA protections, certain regulatory terms, publication rights, inventions and patents, payment schedules, indemnification, subject protection, research injury and budget. • ACTA – The Accelerated Clinical Trial Agreement was developed to streamline the negotiation process. The ACTA represents a straightforward and unambiguous position that sets forth regulatory and contractual obligations, acceptable to both parties. The ACTA can be chosen when used in template form with no modifications or when slight modifications are made and approved by UH legal. • Work Order – A project specific clinical trial agreement that rolls up under a Master Agreement. Work Orders, or Statements of Work, define the work activities, deliverables, timelines, pricing and other requirements. All terms not defined in the work order are governed by the Master Agreement. Collaboration Agreement A contract between UH and one or more organizations that are cooperating in the conduct of a research program. In these agreements, there is generally no transfer or funds between organizations (referred to as a “No Cost Collaboration”) . Instead, the agreement describes the actions that each organization has agreed to undertake, and defines the obligations each party has to the others participating in the collaborative research effort. Confidentiality/Non-Disclosure Agreement A confidentiality agreement is sometimes referred to as a non-disclosure agreement (NDA) or a confidential disclosure agreement (CDA) . This agreement is between at least two parties and describes confidential material, knowledge, or information that the parties wish to share with one another for a specific purpose, but wish to restrict access to third parties. It is a contract through which the parties agree not to disclose information covered by the agreement. After execution of a confidentiality agreement, the protocol, the clinical trial agreement and other study materials will be released to the participating site. Consulting Agreement An agreement between a consultant and a sponsor in which the sponsor desires to engage the consultant to provide and perform certain services related to a research project in the area of the consultant’s expertise. This ONLY includes consulting agreements that transfer money to Institution. All consulting agreements that pay a physician dir

FAQs

What is an amendment in the context of contract agreements?

An amendment is an agreement that modifies an existing agreement. Typical changes include adding new terms, extending the project period, or increasing funding.

What is the purpose of a Business Associate Agreement in clinical research?

It sets out how a covered entity and a business associate handle protected health information (PHI). HIPAA requires these agreements to clarify and limit permitted uses and disclosures, and to ensure appropriate safeguards.

When are data use agreements (DUAs) used?

Data use agreements govern disclosure of PHI in the form of a Limited Data Set or de-identified data set for research. They restrict use to a specified purpose, require safeguards, and prevent identification of individuals in the recipient’s dataset.

Sep 15, 2026

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