Awards and Award Management: Policies

Institutional Review of Research Proposals and Characteristics of Research Support Instruments

Purpose and Scope

1. This policy defines the various types of research support instruments or awards received by the School. It provides the School policy regarding formal review and approval of applications and proposals made by faculty and trainees to outside institutions for research support.
2. This policy is complementary to "Administration of Research and Training Grants or Contracts" (Section VII, pp.14) and to "Guidelines for Academic-Business Relationships" (Section VII, pp.33) in this Handbook.

Background

The traditional form of research support (and the most prevalent at WFUSM) is the federal research grant. The most common form of industry-sponsored research is the controlled clinical trial. Other forms are Government cooperative agreements and research contracts, foundation and association awards, and industry supported basic research. Therefore, it is important for faculty to understand the characteristics of various award mechanisms, and the obligations inherent in each. It is also important to obtain the proper institutional sanction for all extramural research proposals, regardless of the organization to which they are directed.

Definitions

1. Research: Scholarly or scientific systematic investigation or inquiry, designed to contribute to generalizable knowledge.
   1. Basic research: Research that provides fundamental knowledge. It is long-term in nature, unlikely to lead to specific applications, and is undertaken for the sake of increasing knowledge.
   2. Applied research: Scientific activity directed at solving specific practical problems and generally undertaken with hopes for commercialization.
   3. Clinical research: Research involving living humans or human tissues.
   4. Development: The resolution of technical problems associated with transforming research into usable products and processes.
2. Training: Training of students at the pre-doctoral or post-doctoral level in the skills and knowledge necessary to perform research in a specific field of science, or using specific technologies as research tools.

Research training is supported either by institutional grants or by grants or awards to individuals in the form of fellowships.

3. Agreement: Specifically, a research agreement is a two-party agreement that involves the performance of a specific research project or program by faculty, or under the direction of faculty. Research projects or programs sponsored under research agreements usually involve research with specific and clearly defined goals and objectives. Examples are testing a specific hypothesis, or investigating a drug or device according to an established protocol.

Research agreements are written between institutions (the School and a sponsor). They identify the obligations and interests of each party.

Subcontracts are agreements used when the School is sponsoring research at other institutions. This situation occurs when the School is the recipient of support to direct and manage a multi-institutional collaborative study. In other circumstances, an institution must rely on our faculty to provide expertise or services not available internally (see F below).

Research agreements are generally used when the sponsor desires accountability for the scientific results or a degree of control over the conduct of research. Sponsors usually include:

1. Agencies of the Federal government using research contracts. Federal research contracts are also subject to the policies and procedures included in Section VII, pp. . However, they are similar in substance to research agreements sponsored by other organizations;
2. For-profit organizations<, including companies engaged in the production and sale of goods and services, and companies involved in research and development;
3. Agencies of the state government; and
4. Not-for-profit research organizations which require unique expertise or facilities available at the School.
3. Contract: Research contracts are agreements as defined above. Often contracts include a number of restrictions defined by the sponsor:
   1. The award may be subject to formal conditions outlined in the agreement instrument signed by both parties.
   2. The sponsor may place restrictions upon expenditures allowed in the pursuit of the activity (e.g., purchase of equipment, travel, etc.).
   3. Financing may be on a cost-reimbursable basis. Although the School tries to arrange some method of advance funding where possible, some fixed-price contracts may provide for lump sum payments as work progresses.
   4. The sponsor may require periodic progress reports, often including invention reports, royalty reports, financial status reports, equipment inventory reports, etc.
   5. A closing audit is usually required.

Contracts with agencies of the federal government are governed by a complex body of law codified as the "Federal Acquisition Regulations" (Title 48, Code of Federal Regulations). These regulations include detailed restrictions on activity by institutions competing for contract awards and individual employees of these institutions. Institutions and individuals cannot discuss employment with government officials involved in the award of a contract, offer any government official anything of value, or seek "insider" information. The procedures for compliance are complex and often changing. The current information on the Federal Acquisition Regulations is available through the Controller's Office.

5. Cooperative agreement: The cooperative agreement is a research agreement used by the federal agencies when the agency staff wish to participate actively in the direction of the research, helping to set goals, objectives, etc. The cooperative agreement often has the same provisions for financial accountability as a grant (Par. G below), and the scientific constraints and definitions similar to a contract (Par. D. above). Cooperative agreements are used almost exclusively by federal agencies, although many state program "grants" resemble cooperative agreements in their intent and provisions.
6. Consortium agreement: This is an agreement between the School and another organization to support an investigator-initiated research project or program involving staff from both the School and the other organization. Either the School or the other organization may be the principal recipient of support. If the School is the principal recipient, the other organization becomes a "sub-contractor."

Other organizations may include:

1. Educational institutions
2. Not-for-profit research organizations (e.g., Research Triangle Institute)
3. For-profit corporations
4. Federal or Federally-funded laboratories (e.g., NIH or Oak Ridge National Laboratory)
6. Grant: A grant is an assistance award for research or training when the sponsor has determined that the project is meritorious and makes an award relatively free of scientific restrictions and accountability. Grants are awarded in response to a proposal or application developed and initiated by faculty. In general, the following criteria identify a grant:
   1. The award may carry terms on the use of funds such as specified budgetary restrictions; the general objectives to be achieved by the use of the funds; the individuals responsible for the completion of the work; the period of performance; and invention rights.
   2. The sponsor may retain authority to withhold funds pending satisfactory completion of project objectives. The sponsor may require that unused funds be returned.
   3. Financial accounting during the life of the project, at its termination, or both may be required.
   4. Reports related to the substance of the work, during the life of the project or at its termination, may be required by the sponsor. Copies of published materials may also be requested.
   5. Periodic payments are to be made to the School so that the financing of a project is on a continuous basis.

Sponsors of grants include the following organizations:

• Agencies of the Federal Government
• Agencies of the State Government
• Private foundations
• Voluntary organizations
• For-profit corporations
7. Gifts: A gift is a research or training award with only rudimentary or general restrictions as to its use. Gifts are donations made to the School with general restrictions as to use, and often no specific requirements for scientific or financial accountability. In general, the following criteria identify a gift:

1. Contractual requirements are not imposed. Restrictions by donors are normally limited to specifying general areas of use (i.e., within a general field of research or a specific department).
2. The award is irrevocable.
3. A period of performance is not specified.
4. Financial accounting is not required and there is no requirement to return unexpended funds. However, a report to the donor on the utilization and/or impact of the gift may be requested. Even if the donor does not request a report, it is School policy that progress reports and terminal reports be sent to the donor unless the donor specifically requests that no report be made.

Donors may include:

4. Individuals or families
5. Private foundations
6. Voluntary organizations
7. For-profit corporations

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Policies

1. All proposals or applications for research support will be signed by the investigator, and will be reviewed and cleared by the investigator's Department Chair, and by the School administration including the following offices:
   1. The Controller's Office (unless there is no budget)
   2. The Cancer Center (for cancer-related projects)
   3. The General Clinical Research Center for proposals utilizing these facilities.
   4. The Office of Development and Alumni Affairs for proposals to foundations or individuals not in response to a competitive solicitation
   5. The Office of Research

No proposal or application can be considered sanctioned by the School until this clearance is completed.

2. Proposals or applications for research support usually require a detailed budget. It is School policy to request that sponsors support full costs of research including faculty effort and other direct and indirect costs. The School's policy is to request full indirect costs of all sponsors. Full indirect costs are defined as follows:

For all research and demonstration projects except clinical trials of drugs and devices: The current rate approved for Federal awards.

For industry projects, e.g. clinical trials: The current rate approved for industry.

For training projects: The current rate approved for Federal awards.

Faculty are cautioned that unless other arrangements are made at the time the proposal is reviewed or at the time the award is negotiated, indirect costs will be assessed from the award at the appropriate rate. When preparing proposals, currents rates must be used.

3. All research agreements will be executed for the School by officers to whom proper authority has been delegated. Agreements executed by individual investigators cannot bind the School to assure performance or to provide appropriate legal protections for the investigator. The following officers are authorized to execute research agreements for the School:

• The Vice President and Dean or
• The Senior Associate Dean (Science and Technology) or
• The Associate Dean for Research or
• The Director of Sponsored Research
3. All sponsored research programs or projects at the School must be supported by a written instrument. Examples of written instruments include notices of award, letters, contracts or other two-party agreements, all of which include at least the following information:

1. Brief descriptive title of the project
2. The duration of the project (project period)
3. The duration for which funding is provided (if different from the project period)
4. The amount of funding provided

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