Majority of scientific research institutions encourage relationships with the corporate and nonprofit sectors. They frequently participate in a wide variety of agreements involving basic and applied research.  In such cases a Research Agreement (or Research Contract) is a legal document detailing the obligations of two or more parties over the course of a research project.  It usually has specific deliverables and milestones to be met and dictates how the contracting parties will interact with each other.  Agreements may be called by a variety of names – contract, purchase order, award, memorandum of understanding, letter agreement – however, if the content of the document includes specific terms and conditions governing the performance of research, it is most frequently considered to be a Research Agreement or Sponsored Research Agreement. Majority of research institutions have their specific templates for Sponsored Research Agreement. It is imperative for research sponsors to analyze the forms very carefully.

There are four major types of Sponsored Research Agreements, given below in gradation from basic, curiosity-driven research to targeted, results-driven research:

Research Grant

This type of funding agreement is typically focusing on basic, curiosity-driven research. Grants typically come from government granting councils, non-profit organizations,  but in some instances also from industry.

Frequent  characteristics include :

-          Research scope and project control lies with the researcher

-          Start and end dates of the project are defined

-          Payment is provided in advance (following acceptance of progress reports)

-          Equipment purchased under the contract is owned by the research institution

-          Researchers have unrestricted rights to publish results

-          Ownership of any intellectual property resides with the researcher/research institution

-          Sponsor is provided with progress reports and the final research report

Research Contract

This type of funding agreement is equally frequent from a government and industry. Research is usually directed at answering questions that are of interest to the Sponsor.

Frequent  characteristics include:

-          Defined scope of work/research plan

-          Start and end date of project are defined

-          Termination provisions are included

-          The intellectual property and ownership are clearly defined

-          Possible provisions for confidentiality of information are clearly defined

-          Insurance and indemnification provisions are included to protect the research institution and researcher

-          Warranty clause: The results cannot be guaranteed

-          Payment may be dependent on milestones/deliverables

-          Equipment purchased under the contract is owned by the research institution

-          Researcher retains the right to publish, but may be dependent on sponsor review for confidential information and/or for intellectual property

-          Researcher/research institution retains ownership of new intellectual property

-          Sponsor may have the option to acquire a license

Collaborative Research Agreement

This type of funding arrangement is often co-funded by both government and industry for strategic research or technology development.

Frequent  characteristics differ from Research Contract by the following:  

-          Ownership of equipment purchased under the contract can be stipulated

-          Researcher/research institution retains ownership of new intellectual property, but share inventorship with sponsors

Research Services Agreement and Consulting Agreement

This type of research funding agreement is set to deliver specialized research services and/or expertise to the sponsor.

Frequent  characteristics include:

-          Start and end dates of project are defined

-          Use of research institution facilities, resources and the existing know-how

-          Possible provisions for confidentiality of information are clearly defined

-          Insurance and indemnification provisions are included to protect the research institution and researcher

-          Warranty clause: The results cannot be guaranteed

-          Payment can be delayed till services are rendered or tied to deliverables

-          Results are the property of the sponsor

-          Know-how developed or utilized by the research institution in provision of services is owned by the institution

Engaging into  Sponsored Research Agreements may be problematic for sponsors due to federal, state and the respective research institution laws and regulations. All sponsors need to be aware of potential conflicts before signing any sponsorship agreement.

The Legal  Issues in Sponsored Research Agreements originate from four major players:

-   Federal law

-   State law

-   Sponsored institution mission

-   Contract administration

When engaging into Research Agreements the sponsored institution administration is bound by Federal and State laws and may see problems when sponsors request:

-   indemnification from liability or request assurance of a legal defense in case research legal problems arise

-  to specify a particular locale or court outside of the institution State of residence, as the “jurisdiction” or “venue” for any lawsuits arising from the agreement

- to specify insurance requirements such as:

            Maintain an insurance policy that contains specified dollar limits for coverage

            Provide sponsor with an insurance certificate or other proof of this insurance;

            Name sponsor as an “additional insured” on the institution policy

-  to keep information regarding the research project confidential.  Including provisions covering  confidential company information,  terms of the sponsored research agreement, or the general existence of the research relationship.

Three very important issues need to be addressed properly in any Sponsored Research Agreements:

1.   Rights to publication of the research results  –  it may be problematic  for sponsors to seek the right to approve publications resulting from the research. 

2.   Confidentiality of research  -  sponsors requests that information relating to the research, including research data,  be considered the sponsor’s confidential information, may be denied. 

3.   Ownership of research data  -  sponsor request for ownership of data arising from the research may be denied.

There are also Federal Law related issues that may affect the outcome of Sponsored Research Agreements. This is especially true when there are multiple funding sources that contribute to the research project or invention, including the Federal sources. The Bayh-Dole Act or Patent and Trademark Law Amendments Act adopted in 1980, may prevent iindustry sponsors from  seeking ownership of or preferential access to inventions arising from the sponsored research where Federal funds were also involved. 

Another Federally regulated issue is the control of export of goods or services to foreign individuals and countries. An agreement may specify that certain information used in the project is subject to US export control laws.  Problems can arise in the following areas: 

-   Presence of export-controlled information may prevent international students or scholars from participating, and may limit international collaborations, what could negatively impact and deter the research institution

-   Contracts for export-controlled research may include provisions that conflict with the institutional research policy, such as publication restrictions or contract terms prohibiting or requiring approval for participation of foreign nationals

-   Export-controlled research may require security precautions

Each State has also their specific laws (which is way beyond the scope of this primer) that can affect Sponsored Research Agreements, and any conflict issues arising from such laws need to be addressed  before signing the agreements.

Research Stir does not participate and is not a side in your communication and agreements with the project PI and the project overseeing institution. Nevertheless, in an attempt to provide help for scientific research supporters, we provide below a listing of useful links to related legal and other resources. We also encourage our visitors to provide a valuable information or links concerning the legal issues of scientific research sponsorship through the comment form at the bottom of the page.

Useful links:

http://www.ncura.edu/content/news/rmr/docs/v18n1_Ferreira.pdf  -  "Academic-Industry Collaboration under Federal Grants and Cooperative Agreements: Financial, Administrative, and Regulatory Compliance" presented by National Council of University Research Administrators.

http://ori.hhs.gov/education/products/clinicaltools/data.pdf  –  Guidelines for responsible data management in scientific research provided by Office of Research Integrity, U.S. Department of Health & Human Services.

http://www.niehs.nih.gov/research/resources/bioethics/whatis/  -  Article on the importance of ethics in research. Codes and policies for research ethics explained.

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm118862.htm  -  Federal Policy for the Protection of Human Subjects.

http://www.justice.gov/atr/foia/divisionmanual/204293.htm  -  National Cooperative Research and Production Act (1993) — relaxed restrictions on cooperative production activities, enabling research joint venture participants to work together in the application of technologies they jointly acquire.

http://www.gpo.gov/fdsys/pkg/PLAW-106publ404/html/PLAW-106publ404.htm  -  Technology Transfer Commercialization Act (2000)—amended the Stevenson-Wydler Act and the Bayh-Dole Act to improve the ability of government agencies to monitor and license federally owned inventions.

http://grants.nih.gov/grants/policy/coi/   -  NIH Financial Conflict of Interest webpage. The U.S. Department of Health and Human Services and the Public Health Service (PHS) have issued new financial conflict of interest (FCOI) disclosure regulations. The new regulations apply to grants and cooperative agreements awarded on or after Aug 24th 2012,

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