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Research Contracting and Compliance

Research Contracting and Compliance

Many companies are engaged in research–whether performing it themselves or contracting with others to complete it. Research contracting and compliance is an absolute must for companies to protect both their livelihoods and their employees.

What is Research Contracting and Compliance?

Research contracting involves two parties entering into a legal agreement that outlines the obligations of two or more parties engaged in a project. They are common in the situations between:

  • Private Parties. One business pays another to engage in research for the business.
  • Private Parties and the Government. A public agency hires a company for a research project
  • Universities and Private Parties. A company pays the university to conduct research.
  • Universities and the Government. For example, the Department of Defense retains the research services of a university.

Regardless of the parties involved or the research being conducted, compliance is a critical component in establishing and enforcing the contract’s terms as well as any regulations that govern the research being done.

Why It Matters for Your Business

Research contracting provides the mechanism for the exchange of payments and information. The contract protects your vital rights such as ownership of the research and any licensing available if patentable or copyrightable work is performed.

Simply put, the research contract protects you. Without a solid research contract, you expose your organization to extreme risk and liability.

The Research Contract

The details of the specific contract depend on the parties involved and the type(s) of research being performed. Common research contracts include Material Transfer Agreements, Data Use Agreement, Research Agreements, and Collaboration Agreements. However, most contracts contain sections such as:

Preamble

The first section of most research contracts describes the effective dates of the contract, the parties, and fixed names for the parties–such as “Sponsor,” “Research Firm,” or the research company’s name. We’ll use the terms “Sponsor” and “Researcher” on this page for simplicity’s sake.

Definitions

This section defines the terms used throughout the document and provides extra context or clarification when necessary. A common example is an exact definition of the project or industry-specific terminology referenced throughout the contract.

Scope of Work

This section typically covers the research project’s basic details, including:

  • Promise to perform. The Researcher promises to perform the work with due diligence or a similar standard of work.
  • Reporting. This covers the frequency and type of reporting the Researcher provides to the Sponsor.
  • Meetings. The contract outlines when and where meetings will take place and the conditions under which extra meetings may occur.

Budget

This section describes the total compensation amount and establishes a payment schedule. It outlines invoice details, which can be especially important when one of the parties is a government agency or university with strict protocols for processing invoices. This section also details the parameters for processing payments in the event the contract is terminated early.

Publication of Results

Once the research is complete, who is entitled to publishing the results? This section of the contract covers issues like rights to publishing and the Sponsor’s right to preview such work before it is published.

These publishing rights will depend entirely on the parties’ relationship and the terms of their standing agreement. For example, such publications are typically at the core of a research-centric university. A separate publication agreement may also be required by the Sponsor.

This section can be lengthy if the contract is between a federal government agency and a private company since certain federal work may be classified.

Proprietary/Confidential Information

Often, proprietary information is provided by the Sponsor to the Researcher, occasionally information will be exchanged This section provides language on how such information is provided as well as the Researcher’s obligation to protect that sensitive information. If health information is to be provided, how it will be treated will also be addressed in this section.

Intellectual Property

This critical contract component discusses intellectual property rights to future inventions and related works based on the completed research. For example, a Sponsor may be given an option to exclusively license the work product from the research. Regardless of how the rights are conferred, the contract must explicitly outline ownership of the intellectual property to prevent future misunderstandings and legal headaches.

Termination

There are multiple reasons why a research contract could end early. For example, the sponsor may not meet its obligation to pay, the Researcher may miss multiple milestones or deadlines, the quality of the research being performed may not meet quality expectations or any number of other reasons. The agreement specifies the conditions under which the contract can be terminated and the actual termination process itself.

If one party has failed to comply or breached its duty under the contract, the other party has several paths to enforcement. When a material breach of contract occurs, the terms of a research contract generally give that party a timeframe to address the concern. If the issue is not remedied, then the affected party may terminate the contract and seek appropriate remedies,
including damages.

Many, but not all, contracts have mediation or arbitration clauses that require any disagreements to be handled through alternative dispute resolution. However, if this doesn’t remedy the situation, then a lawsuit for breach of contract may be filed against the non-performing party.

Governing Law

This provision identifies the state law governing the contract. It may also cite applicable federal regulations.

Other Relevant Sections

There are other topics discussed, such as insurance, warranties, and modifications.

Research Compliance

Many types of research require strict compliance with a wide range of applicable regulations. With extensive experience in the biotech space, Carson Law is uniquely positioned to address compliance issues with human subject research, export control, data use (including HIPAA and GDPR), and FDA regulations for new devices and new drugs.

How Carson Law Can Help You

If you need help drafting a new research contract or reviewing an existing one, Carson Law is here to assist you. With a background in biotech contracting and research administration, Carson Law can help ensure your research contracts address all project needs.

Contact us today at (832) 621-0766