Research, development and scholarship activities that include inquiry, experiment, or investigation to discover new knowledge or build upon existing knowledge that increases the scholarly understanding of the involved discipline. It involves systematic study directed toward fuller knowledge or understanding of a subject and includes activities involving the training of individuals in research techniques (research training) where such activities utilize the same facilities as other research and development activities and where such activities are not included in the Instruction function.

Basic research (aka fundamental research) is experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any particular application or use in view. 

Applied research applies the outcomes or theories arising from basic research toward the production of useful materials, devices or systems. It is original investigation undertaken in order to acquire new knowledge. It is directed primarily towards a specific, practical aim or objective.

Clinical Research is research using human subjects to evaluate biomedical, behavioral or health-related outcomes.

1. Patient-oriented research. Research conducted directly with human subjects or on material of human origin such as tissues, specimens and cognitive phenomena. In-vitro studies that use human tissues that cannot be linked to a living individual are excluded from this definition. Patient-oriented research includes: 
   1. mechanisms of human disease; 
   2. therapeutic interventions; 
   3. clinical trials; or 
   4. development of new technologies.
2. Epidemiologic and behavioral studies.
3. Outcomes research and health services research.

NOTE: Externally-funded research training grants are categorized as Research (rather than Instruction or an Other Sponsored Program) if the trainees are primarily performing research activities.

A sponsored project is a research training award/fellowship if:

• The primary purpose of the sponsored agreement is to provide research training for selected UB students or postdoctoral scholars
• The award is made to UB (via The Research Foundation for SUNY as the legal entity), with the provision that UB may name the trainees
• If a trainee leaves UB, the university may reassign the support to another qualified trainee
• The project/research's primary purpose and original intent is to further the individual’s education or training, rather than advance university research or scholarship
• Funding is provided to support the trainee, rather than to accomplish a specified statement of work or research project (i.e., fellowship).

Note: A research training grant may include a description of a specific research project, but the primary purpose of the award must be to support the trainee’s learning experience.

Under a research training award/fellowship, the following characteristics apply:

• The individual is not an employee; he/she is a trainee. There is no employer-employee relationship.
• The individual receives a stipend (not a salary/fringe benefits) and the award may (or may not) include additional funds to cover health insurance and tuition. Stipends are intended to support living expenses of the fellow; they are not wages in exchange for services rendered.
• The individual determines the activities to be performed. Usually a faculty advisor or mentor assists the fellow in his/her course of study, however this faculty member neither controls nor supervises the sequence of the activities performed.

Except for research training, described above, this term includes all teaching and training activities, whether they are offered for credits toward a degree or certificate or on a non-credit basis, and whether they are offered through regular academic departments or separate divisions, such as a summer school division or an extension division.

The following are examples of Instruction projects:

• Curriculum development projects at any level, including those that evaluate curriculum or teaching methods; such evaluation may be considered "research" only when the preponderance of activity is data collection, evaluation and reporting.
• Projects which involve UB students in community service activities for which the UB students are receiving academic credit.
• General support for the writing of textbooks or reference books, video or software to be used as UB instructional materials.
• Any project designed to teach or instruct any student at any location, whether the students are UB students or staff, teachers or students in elementary or secondary schools, or the general public.

Programs and projects that involve the performance of work other than Instruction and Research (as defined above). These programs primarily provide non-instructional services beneficial for individuals and groups external to UB.

Examples include:

• Evaluation/Testing (see below for more detail)
•  Economic development projects
• Public service projects
• Travel grants
• Grants to support conferences or seminars
• Grants to support University public events
• Outreach activities for K-12 students, staff, or teachers or the general public
• Community service projects that engage university students, faculty and staff (excluding credit-bearing activities)
• Library collections, acquisitions, bibliographies or cataloging support
• Exhibitions at the Center for the Arts
• Programs to enhance institutional resources, e.g., data center expansion or computer enhancements.

Clinical trials are research studies designed to answer specific questions about the effects of drugs, vaccines, medical devices, tests, treatments and other therapies for patients. Clinical trials are used to determine safety and effectiveness. For reference, the National Institutes of Health (NIH) categorizes human clinical trials into the following four phases.

1. Phase I uses a small group of human patients (20–80) to evaluate safety and identify side effects.
2. Phase II uses a larger group (100–300) to test effectiveness and further evaluate safety.
3. Phase III uses a large group (1,000–3,000) to confirm effectiveness, monitor side effects, compare to commonly used treatments and collect safety information.
4. Phase IV is a post-market study that collects more information on risks, benefits and optimal use.

All clinical trials must include the prospective enrollment of human subjects and the controlled testing of a drug, device or diagnostic under an approved protocol. Laboratory research, retroactive chart reviews, analyses of existing medical data and records, and animal studies are not considered clinical trials for purposes of applying the clinical trial indirect cost rate.

An IPA allows a UB faculty or staff member to work temporarily with a federal agency while remaining a university employee and continuing to accrue university benefits. These are institutional agreements between RF SUNY and the federal agency. IPA assignments vary in length, but usually last anywhere from six months to three years.

An evaluative or testing award could be defined as either Research or an Other Sponsored Program depending on the unique characteristics of the particular award.

An evaluative/testing agreement for which the Research rate applies is:

• Any agreement with a governmental, non-profit, or private sponsor with a protocol developed by either the Sponsor, UB Principal Investigator, UB Principal Investigator with direction from Sponsor, or Sponsor with direction from UB Principal Investigator;
• Protocol is moderately specific and leaves room for the UB Principal Investigator to experiment or interject his or her own ideas;
• Deliverable is provided to Sponsor in the form of expert data analysis and interpretation from UB; 
• Possibility of faculty and/or staff to make a significant intellectual contribution which could lead to an invention or discovery;
• Peer-reviewed publication or presentation at scientific meeting likely;
• If students are involved, the work will be more than a mere training exercise. For example, their participation may be used in a thesis.

An evaluative/testing agreement for which the Other Sponsored Programs rate applies is defined as:

• any agreement with a private sponsor providing a company-developed protocol that specifies all procedures in detail (or is a routine test that is requested by company) and does not contain any faculty/staff contribution;
• the deliverable must be raw data which cannot include any interpretation;
• the project allows no room for principal investigator to interject his or her own ideas and the deliverable is strictly a report of the data;
• such testing or studies cannot involve contact with human subjects;
• where the University provides a routine service which meets predefined specifications with no novel or creative input by a university member;
• the activity does not add to the body of fundamental knowledge in a given field;
• no intellectual input or value-added is provided by UB and no publishable results are expected. As a result, the sponsor retains all rights to the intellectual property provided and owns the results;
• faculty and/or staff are simply providing a service based on their expertise, e.g., testing, evaluation, fabrication, use of specialized equipment;
• peer-reviewed publication limited to advancements in methodology utilized for test, not the subject of the test;
• presentation at scientific meeting limited to advancements in methodology utilized for test, not the subject of the test;
• if students are involved, the work is a training exercise to familiarize the student with commonly known methodologies and equipment;
• in part, the agreement allows UB to utilize excess capacity in facilities or equipment;
• generally, are for less than $25,000;
• does not involve federal of federal-flow through funding.

UB charges the maximum allowable federally negotiated F&A rate on all sponsored projects regardless of funding source unless a sponsoring agency's written policy will not allow full recovery of F&A costs. UB will abide by the written, published policies of foundation/non-profit and government sponsors who limit payment of F&A, however industrial sponsors are expected to pay full F&A rates when funding sponsored projects. Unlike foundations or non-profits, UB does not accept a letter or other documentation from industrial sponsors indicating a policy of lower F&A rates. Instead, the PI must request a formal waiver (see below for the waiver process). If approved, the waived rate will be applied to a total direct cost base (TDC).

If a sponsor does not have a written policy on the payment of F&A, you must request the full rate in the proposal unless you obtain a waiver. We cannot submit an application with an F&A rate below the applicable full federally approved rate without either a waiver or documentation of a sponsor's published policy.

If a sponsor restricts the F&A rate without specifying the base, we determine the base as follows:

We use the MTDC base when a federal sponsor's published F&A rate is less than the current full DHHS-negotiated rate, but does not specify a base. We use the TDC base when a federal sponsor prescribes use of the TDC base.

We use the TDC base when a non-federal sponsor's published F&A rate is less than the current full DHHS-negotiated rate and when a specific base in not specified. If a base is specified, we use that base.

Please use care determining the appropriate rate for sponsor limitations. Some sponsors limit F&A based not on direct costs, but rather on total project costs, which would include both direct and F&A costs. You should work with your SPS representatives to determine the correct rate and base when there is a sponsor limitation.

An F&A waiver is an institutional agreement that F&A costs will be charged at a lower rate than the sponsor's published rate. Waivers are granted on a case-by-case basis and must be endorsed by the department chair(s) and cognizant dean(s), submitted through Sponsored Projects Services (SPS), and approved by the Vice President for Research and Economic Development.

PI’s seeking a waiver should contact their SPS contacts as early as possible in the proposal process to seek a waiver. Please allow at least one week for us to process the request. Complex requests require additional turn-around time, so plan accordingly. If a waiver is not approved by submission time, you must use the full appropriate F&A rate in your budget.

Some projects require activity performed in multiple locations. When those locations represent both on- and off-campus space (according to the criteria established below), and the proportion of off-campus activity reaches the threshold outlined below, then the applied F&A rate includes on- and off-campus components.

Per UB’s rate agreement and the IDC Policy a project’s F&A rate contains both when:

• Project is performed at an off-campus site for at least 90 consecutive days; and
• During that period at least 20% of the project salary costs are expended in that off-campus site. 

SPS rounds the percentage of the project conducted off-campus to the nearest 25% based on the percentage of salary costs of UB project staff expended at off-campus sites. Please work with your SPS representative to determine the applicable F&A rate.

UB recognizes that if projects transfer between institutions, sponsors rarely increase funds to cover differing F&A rates. NIH awards are the exception because NIH funds F&A at UB’s current rate at the time of transfer.

To minimize the impact, UB will accept a lower F&A rate for an award transferred to UB if the initially awarded F&A rate is lower than UB's established F&A rate. However, once the award is transferred to UB, requests for additional funding would follow UB rates and policies.

We do not assess F&A costs on individual fellowship awards. This is consistent with UB's rate agreement with the federal government which excludes fellowships from the MTDC base upon which F&A costs are assessed.

Department of Health and Human Services (DHHS) agencies include The National Institutes of Health (NIH), Administration for Children and Families (ACF), Administration for Community Living (ACL), Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), and Substance Abuse and Mental Health Services Administration (SAMHSA)