Research is the prevalent type of sponsored activity at Northwestern University. Research is commonly characterized as "basic" or "applied", though these terms are not formal designations at Northwestern, or universally agreed-upon terms. Nonetheless, generally speaking, basic research is conducted primarily for the enhancement of public knowledge and typically does not have immediate commercial potential. Applied research is designed to identify and solve particular practical problems in the modern world. Basic and applied research exists on a continuum of research activities that take place at the University.
Research may also be "open" or "classified" depending on the degree to which information may be shared with third parties and the public at large. For instance, if a project involves information related to national security, the sponsoring federal agency or private industry may seek to impose restrictions on the dissemination of information or the participation of foreign nationals.
Under University policy, Northwestern conducts only "fundamental" research, which may be basic or applied but must be open. Northwestern does not enter into agreements to conduct sensitive, secret or classified research, nor does it agree to any requirements that restrict the freedom of a scholar to publish or disseminate findings. Further, under research projects the University must not discriminate on the basis of citizenship status. Entering into a research agreement that violates these freedoms may trigger strict federal regulations and/or bring severe export control penalties.
Common Agreement Types Drafted and Reviewed by the Office for Sponsored Research (OSR)
Sponsored Research Agreements
Northwestern enters into many types of research agreements with sponsors, including the federal government, foundations, other universities, and industry. These relationships are governed by agreements between Northwestern and the sponsor that define each party’s rights and obligations in the relationship. Sponsored research agreements usually require negotiation between the University and the sponsor, and always require the approval/signature of the Office for Sponsored Research (OSR). The list below describes the common types of agreements that the University receives, including (but not limited to) grants, contracts, cooperative agreements, and clinical trial agreements.
A grant is one of several award mechanisms that sponsors use to support projects under the direction of a principal investigator. Grants are the most common award mechanism at Northwestern. A grant typically provides funding to the University to carry out an approved project or activity when the principal objective is to accomplish a public purpose. The sponsoring entity will use a grant (as opposed to a cooperative agreement) when it does not anticipate substantial programmatic involvement with the recipient during performance of the financially assisted activities. Typically, sponsors award grants on a competitive basis to recipients responding to a sponsor's solicitation, funding opportunity announcement, request for applications or program announcement. The scope of work and expected outcomes in a grant are less defined than in a contract. Grants are associated with "assistance" type of funding (wherein the sponsor is "assisting" the University accomplish activities central to its mission); contracts are associated with "procurement" (wherein the sponsor is "procuring" activities at the primary direction and benefit of the sponsor).
A cooperative agreement is a financial assistance instrument under which substantial involvement is anticipated between the sponsor and the recipient during performance of the contemplated project or activity. "Substantial involvement" means that the recipient can expect federal programmatic collaboration or participation in carrying out the effort under the award. Like a grant, a cooperative agreement is an "assistance" mechanism principally designed to accomplish a public purpose.
A subcontract (sometimes referred to as a "subaward") is a formal agreement between a prime institution and one or more other separate organizations (subrecipients) under a sponsored program. The subcontract defines the subrecipient’s involvement in the research project and typically involves a specific time commitment from the subrecipient organization’s Principal Investigator (PI). A subcontract includes a scope of work (representing programmatic effort) and a corresponding budget. In addition, the subcontract incorporates the appropriate terms and conditions from the agreement between the originating sponsor and the prime institution; this is typically referred to as "flow-down".
Amendments are prepared and issued to document changes to the primary award. These changes may include, but are not limited to, a change to the scope of the project, the terms and conditions, the project period dates, the costs (either addition or removal of funds), a change in the payment schedule, or an extension of the project. Agreements may be amended to the extent allowed by the primary award.
A contract is a mechanism for procurement of a product or service with specific obligations for both the sponsor and the recipient. Typically, the research topic and the methods for conducting the research are specified in detail by the sponsor in the request for proposal (RFP) that announces the funding activity. Contract performance is closely monitored by the sponsor and there are greater performance expectations with contracts than with grants, including milestones and detailed deliverables. There are two basic types of funding mechanisms for contracts: cost-reimbursable and fixed price.
In a cost-reimbursable contract, the sponsor agrees to pay for all allowable costs incurred by the University in the process of doing the work or research to the amount prescribed in the contract. If the project costs less to complete than the original amount budgeted, the sponsor is obligated to reimburse the University only up to the allowable incurred costs of the project. If the project costs more, the sponsor may choose to accept only the smaller portion of research that had been completed, or to provide additional funding for the remaining research. The recipient is obligated to inform the sponsor in advance if the funds are anticipated to be insufficient. The deliverables in a cost-reimbursable contract are often theoretical or intangible, such as data and project reports.
A fixed-price contract commits the principal investigator to a defined scope of work for a set sum; that is, the sponsor pays the University a fixed sum to complete a specific job, regardless of actual costs incurred. The principal investigator is obligated to perform the work specified in the contract and to complete that work in accordance with the negotiated time schedule. The sponsor is obligated to pay the specified price, regardless of the actual costs of completing the project. This contract type places upon the contractor maximum risk and full responsibility for all costs and resulting profit or loss. It provides maximum incentive for the contractor to control costs and perform effectively and imposes a minimum administrative burden upon the contracting parties. Accurate cost pricing is critical in preparing the proposal budget for a fixed-price contract. If the cost elements of a fixed-price contract are audited, it occurs at the proposal stage, not after completion of the project. Triple damages may result for any intentional misrepresentation of costs. If the project costs less to complete than the contract price, the funds remaining at project completion are discretionary. The deliverables in a fixed-price contract may be more tangible than in a cost-reimbursable contract, such as a prototype or a component for implementation in a product or system.
Clinical Trials and Research
A clinical trial is a research study designed to test the safety and/or effectiveness of drugs, devices, treatments, or preventive measures in humans. A clinical trial is a legally binding agreement that manages the relationship between the sponsor (typically industry) who may be providing the study drug or device, financial support, and proprietary information and the University, who may be providing data/results, publications or input. Industry sponsored clinical trials are governed by the terms and conditions of the contract between the sponsor and the University. Industry sponsored clinical trials may also involve ancillary agreements such as letters of indemnification (LOIs) or HIPAA-related agreements. Federally sponsored clinical trials have typical NIH terms and conditions.
A master agreement may be used in situations in which a sponsor expects to fund multiple research projects with Northwestern over a period of time. The terms and conditions in a master agreement will influence future projects with the sponsor and should be given thoughtful consideration. Some flexibility may be built into master agreements to accommodate the possibilities regarding future scopes of work, intellectual property, and research personnel. Unlike in an Alliance Agreement, the terms and conditions in a Master Agreement remain unfunded until a funded proposal officially results in a signed project specification.
Researchers often collaborate on research or share research tools with other scientists or institutions without receiving funding. For many unfunded collaborations, a written agreement is beneficial or necessary. Unfunded agreements set out expectations, terms, and requirements that protect the interests of the investigators and the participating organizations. Often these agreements are incorporated within the funded agreements described above. However, unfunded agreements sometimes contain restrictive language that may conflict with basic academic and intellectual property rights, and other terms that must be negotiated by OSR.
Memorandum of Understanding (MOU)
A memorandum of understanding (MOU) is an agreement that specifies mutually agreed-upon expectations between two (or more) entities to collaborate on a project without exchange of funds. The primary objective of an MOU (sometimes also called a "collaboration agreement") is the development or formalization of collaborative efforts between the University and another partner, commonly at the beginning stage of preparing a proposal. MOUs may also be formally required by a sponsor as part of a proposal. MOUs often lack the standard terms and conditions that fully protect both parties during the performance of a funded project. They are not intended to set out contractual terms governing the conduct of a project, but are used to establish a working relationship with a partner organization. MOUs typically discuss subjects including, but not limited to, the scope of the project, confidential information, publication, intellectual property rights, and expenses. More specific legal documents may later be created in response to the specific activities generated by these agreements, or subsequently funded by a sponsor.
A non-disclosure agreement (NDA) -- also called a confidential disclosure agreement (CDA) or proprietary information agreement (PIA) -- is a legal agreement which outlines proprietary information that the parties wish to share with one another for certain evaluation purposes, but wish to restrict from wider use and dissemination to third parties or to the public at large. NDAs are commonly executed when two parties are considering pursing a relationship together and need to understand the other’s processes, methods, or technology solely for the purpose of evaluating the potential for a future relationship. For example, a confidentiality agreement may be required by a company when the company wishes to disclose its proprietary information to an NU investigator who is considering participating in a clinical trial. The parties agree not to disclose the non-public information covered by the agreement for a specific (not indefinite) period of time.
Teaming agreements allow Northwestern to formally partner with potential organizational collaborators, often for the purpose of multi-institutional proposal development responsive to a specific solicitation. Teaming agreements are typically structured with one of the parties assuming the role as the prime organization, with the understanding that a winning submission would result in the prime institution subcontracting to the other members of the team. In a teaming agreement, each party is responsible for their own costs.
Consulting agreements (sometimes called independent contractor agreements) are appropriate when an individual not affiliated with the University provides highly technical, specialized service to a University sponsored project. The consultant is considered to be an independent contractor, and agreement must be in place before any professional service is provided in support of the project. Consulting agreements are generally fee-for service/work-for-hire, and typically a consultant agreement does not contemplate data rights or ownership of intellectual property developed during the project. If a consultant is an employee of a university or company, the consultant should not be using the resources of his/her organization (e.g., the facilities/infrastructure, human resources, etc.) in the performance of the work. If this is the case, a subcontract to the consultant’s organization would be the appropriate agreement for the work engagement.
Material Transfer Agreement (MTA)
A Material Transfer Agreement (MTA) is a written contract used to govern the transfer of research material between organizations. The sharing of research products (such as compounds, software, cell lines, transgenic animals, plasmids and monoclonal antibodies, etc.) is critical to continuing progress in science, and it is the University’s intention to facilitate the exchange of material between researchers at academic institutions, government agencies and corporate entities.
An MTA is established between a provider institution and recipient institution to document the material being transferred and terms and conditions with respect to issues such as ownership, permitted uses of the material, publication of results, development of inventions and liability. Establishing conditions prior to the transfer of material avoids issues and misunderstandings after the research has begun. Because different collaborations require different agreements, MTAs are negotiated on a case-by-case basis.
Data Use Agreement (DUA)
Data sharing is the practice of making data used for scholarly research available to other investigators. Data use agreements are commonly the vehicle for such sharing. Sharing data reinforces open scientific inquiry, encourages diversity of analysis and opinion, promotes new research, makes possible the testing of new or alternative hypotheses and methods of analysis, supports studies on data collection methods and measurement, enables the exploration of topics not envisioned by the initial investigators, and permits the creation of new datasets when data from multiple sources are combined. It is particularly important for unique data that cannot be readily replicated. Many sponsors, including the NIH and NSF, and leading journals promote the sharing of data from sponsored research studies. Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.
Joint Study Agreement / Facility Access Agreement
These types of agreements are used when a researcher needs to enter into an agreement (for example, with a national laboratory or an outside company) to access facilities or non-public information. The relationship between the parties – including potential intellectual property benefits – is described in the final document.
Allocation of Rights Agreement / IP Management Plan
Often a pre-cursor to an STTR/SBIR award and sometimes required at the time of proposal submission, this is an agreement amongst parties as to how rights to any resulting intellectual property will be allocated should IP result from a winning proposal. It is similar to a Teaming Agreement, yet limited to IP concerns. This document is always shared with the federal sponsor.
Militarily Critical Technical Data Agreement
Northwestern University performs only fundamental research and neither produces nor accepts Military Critical Technology Data. Northwestern further accepts no access restrictions limiting the participation of academically qualified researchers based on their citizenship or foreign national status. Northwestern University is therefore unable to sign, certify, or endorse DD form 2345 on behalf of our faculty. However, Northwestern faculty are encouraged to participate in programs outside the University and act as individual consultants. They are therefore free to accept DD form 2345 on behalf of themselves personally for activities which are conducted separate and apart from their activities and obligations at Northwestern University.
NSF GOALI Agreement
NSF provides funding to universities via the Grant Opportunities for Academic Liaison with Industry (GOALI) program to promote university-industry partnerships by making project funds or fellowships/traineeships available to support industry-university linkages. This type of funding requires an agreement between the university and an industrial partner who will collaborate using its own resources, and potentially receive certain benefits as a result, including license benefits in resulting project IP. NSF GOALI agreements target high-risk/high-gain research with a focus on fundamental research, new approaches to solving generic problems, development of innovative collaborative industry-university educational programs, and direct transfer of new knowledge between academe and industry. GOALI seeks to fund transformative research that lies beyond that which industry would normally fund.