• A-21

    Cost Principles for Educational Institutions, a circular published by the federal Office of Management and Budget (OMB) that establishes the principles for determining the costs applicable to grants, contracts, and other government agreements with educational institutions (also known as sponsored projects).
  • AAALAC

    Association for Assessment and Accreditation of Laboratory Animal Care Intl. - A private nonprofit organization that promotes the humane treatment of animals in science through a voluntary accreditation program
  • Adjuvant Therapy

    Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
  • Adverse Event

    Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
  • Adverse Reaction

    An undesirable and unintended effect, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
  • AFOSR

    Air Force Office of Scientific Research (DOD) - AFOSR Manages all basic research conducted by the U.S. Air Force. They solicit proposals for research through a general Broad Agency Announcement (BAA) and a number of specialized BAAs.
  • AHA

    American Heart Association - The mission of the AHA is to reduce disability and death from cardiovascular diseases and stroke.
  • Allocable Costs

    Those allowable costs that actually benefit the grant or contract to which they are charged.
  • Allowable Costs

    Those categories of costs that are allowable as a charge on a grant or contract as determined by the terms and conditions of the award and/or appropriate cost principles. Certain types of costs, such as the cost of alcoholic beverages are not allowable and may not be charged to a contract or grant.
  • AOR

    Authorized Organizational Representative - Term used by National Science Foundation. The administrative official who on behalf of the proposing organization is empowered to make certifications and assurances and can commit the organization to the conduct of a project that NSF is being asked to support as well as and to adhere to various NSF policies and grant requirements.
  • Applied Research

    Research that attempts to exploit scientific discoveries or improvements in technology, materials, processes, devices or techniques.
  • ARPA

    Advanced Research Projects Agency (DOD) - The Defense Advanced Research Projects Agency (DARPA) is the central research and development organization for the Department of Defense (DoD). It manages and directs selected basic and applied research and development projects for DoD, and pursues research and technology where risk and payoff are both very high and where success may provide dramatic advances for traditional military roles and missions.
  • Assurance

    A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and use of animals and stipulates the procedures through which compliance will be achieved.
  • Audit

    A formal examination of an organization' or individual's accounts or financial situation. An audit may also include examination of compliance with applicable award terms, laws, regulations and policies.
  • Authorized Official

    An individual authorized by the University to act on behalf of The Regents to assume the obligations imposed by the laws, regulations, requirements, sponsor policies and conditions that apply to extramural awards, including signing extramural proposals and the required certifications and/or assurances necessary to fulfill the requirements of the application process.
  • AVMA

    American Veterinary Medical Association - An association dedicated to advancing the science and art of veterinary medicine, including its relationship to public health, biological science, and agriculture.
  • AVMA Report

    Report of the AVMA Panel on Euthanasia (2000) - Veterinary report of humane methods of euthanasia for animals used in research and teaching activities. Humane euthanasia techniques produce a rapid loss of consciousness followed by cardiac or respiratory arrest with an ultimate loss of brain function. The AVMA Report is endorsed by USDA Animal Welfare Regulations and PHS Policy.
  • AWA

    Animal Welfare Act - Federal law regulating the use, sale, and handling of animals. The Animal Welfare Act was signed into law in 1966. While its original intent was to regulate the care and use of animals in the laboratory, it has become the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimum acceptable standard. The Act was amended four times (1970, 1976, 1985, 1990) and can be found in Unites States Code, Title 7, Sections 2131 to 2156.
  • AWS

    This information confirms that the University is approved to use animals in our research and that we have facilities that meet federal standards for the care of animals.
  • Basic Research

    Research directed toward more complete knowledge of a particular subject without regard to application.
  • Beneficence

    An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (l) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
  • Bequest

    A type of donation or gift. Bequests and gifts are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available.
  • Bias

    A partiality that prevents objective consideration of an issue or situation. Bias is controlled by blinding and randomization. See Single-Blind Design, Double-Blind Design, and Randomization.
  • BSL

    Biological Safety Officer - An individual appointed by an institution to oversee management of biosafety risks. The NIH Guidelines require that a BSO be appointed when the institution is engaged in large-scale research or production activities, or in research requiring containment at BL-3 or BL-4. The duties of the BSO are described in section IV-B-3 of the NIH Guidelines.
  • BUA

    Biological Use Authorization - A BUA describes a Principal Investigator's research involving biological agents at UCI. When approved by EH&S, the BUA provides authorization for the PI to conduct research in a "certified laboratory" contingent upon other appropriate UCI regulatory committee approvals.
  • Cage Code

    This number identifies companies doing or wishing to do business with the federal government. This number is assigned by the Defense Logistics Information Service.
  • CAS

    Cost Accounting Standards - Included in OMB Circular A-21, CAS outlines government requirements for education institutions to use consistent cost accounting practices for classifying, estimating, accumulating and reporting costs for sponsored agreements.
  • CDC

    Centers for Disease Control and Prevention - An agency within PHS, the Centers for Disease Control and Prevention (CDC) is recognized as the lead federal agency for protecting the health and safety of people - at home and abroad, providing credible information to enhance health decisions, and promoting health through strong partnerships.
  • certified translation

    A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes. Certified translators attest that the target-language text is an accurate and complete translation of the source-language text. Certified translation of consent documents ensures that the tone, meaning and content of the translated documents remain consistent with the IRB-approved English version. When a translation is certified, both it and the original are accompanied by a signed statement from the translator attesting to the completeness and accuracy of the translation. This is then notarized by a notary public.
  • CFR

    Code of Federal Regulations - The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.
  • Clinical Trials

    A clinical trial is defined as the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments or diagnostics, or comparisons of approved drugs, devices, treatments or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Federally-funded projects, projects funded by interest groups, charities or the State of California, retrospective chart reviews, analysis of existing medical data and records, laboratory research, and animal studies are not categorized as clinical trials for purposes of applying the clinical trial F&A cost rate.
  • COGR

    Council on Governmental Relations - An association of research universities whose primary function is to help develop policies and practices that fairly reflect the mutual interest and separate obligations of federal agencies and universities in federal research and training.
  • COIOC

    The Conflict of Interest Oversight Committee (COIOC) supports research and the pursuit of outside financial interests by reviewing financial disclosures required by Federal, state, and university regulations and policies to address those instances when the outside financial interests may bias or appear to bias the research.
  • Contracting Officer

    A sponsor's designated individual who is officially responsible for the business management aspects of a particular contract. Serving as the counterpart to UCI's Contracts Officer, the contracting officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a contract and interprets the associated administration policies, regulations, and provisions. (For definition of scientific officer, see Program/Project Officer.)
  • Cooperative Agreement

    An award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.
  • Cost Accounting

    Federal government regulations require recipients of federal awards to file a formal disclosure to the federal government of cost accounting practices.
  • Cost Sharing

    A general term, used as a noun or adjective, that can describe virtually any type of arrangement in which more than one party supports research, equipment acquisition, demonstration projects, programs, institutions. Example: A university receives a grant for a project estimated to have a total cost of $100,000. The sponsor agrees to pay 75% ($75,000) and the university agrees to pay 25% ($25,000). The $25,000 is the cost-sharing component.
  • Developmental Research

    The systematic use and practical application of investigative findings and theories of a scientific or technical nature toward the production of, or improvements in, useful products to meet specific performance requirements but exclusive of manufacturing and production engineering. The dominant characteristic is that the effort be pointed toward specific problem areas to develop and evaluate the feasibility and practicability of proposed solutions and determine their parameters. Development includes studies, investigations, initial hardware development and ultimately development of hardware, systems, or other means for experimental or operational test.
  • Deviation

    An incident involving noncompliance with the protocol, but one that does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the data. Deviations may result from the action of the participant, Researcher, or staff. Note: changes or deviations in the protocol due to study participants' non-adherence are not IRB reportable incidents unless it adversely affects the safety and welfare of the participants.
  • DHHS

    Department of Health and Human Services - (formerly known as DHEW - Department of Health, Education and Welfare (DHEW). One of the cabinet-level departments of the US federal government. NIH, FDA, PHS, HIS, ORI and OHRP all are part of DHHS.
  • Direct Cost

    Direct costs are those costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity and are directly assigned to such activities relatively easily with a high degree of accuracy.
  • DOD

    Department of Defense (includes Air Force, Army, ARPA, and Navy) - The mission of the Department of Defense is to provide the military forces needed to deter war and to protect the security of our country. The department's headquarters is at the Pentagon.
  • DOE

    Department of Energy - The Department of Energy's overarching mission is enhancing national security.
  • DoED

    Department of Education - The U.S. Department of Education's mission is to: Strengthen the Federal commitment to assuring access to equal educational opportunity for every individual; Supplement and complement the efforts of states, the local school systems and other instrumentalities of the states, the private sector, public and private nonprofit educational research institutions, community-based organizations, parents, and students to improve the quality of education; Encourage the increased involvement of the public, parents, and students in Federal education programs; Promote improvements in the quality and usefulness of education through Federally supported research, evaluation, and sharing of information; Increase the accountability of Federal education programs to the President, the Congress, and the public.
  • DOT

    Department of Transportation - The mission of DOT is to serve the United States by ensuring a fast, safe, efficient, accessible and convenient transportation system that meets our vital national interests and enhances the quality of life of the American people, today and into the future.
  • Drug

    Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.
  • Drug Research

    The scientifically designed experimental study of the action of drugs or potentially beneficial effect. Initial testing of a drug is usually performed on animals. Before research on a new drug in human beings may be conducted, the sponsor must submit an informative proposal to the FDA. This is the Notice of Claimed Investigational Exemption for a New Drug (IND).
  • DSMB

    Data and Safety Monitoring Board/Committee: An appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design.
  • DSMP

    Data and Safety Monitoring Plan: A plan to oversee the implementation of a study protocol for subjects' safety and compliance monitoring.
  • DUNS

    Data Universal Numbering System, this is the number assigned by Dun and Bradstreet, which provides the University's credit rating to inquirers.
  • EH&S

    Environmental Health and Safety - UCI Office responsible for providing a safe and healthy environment for faculty, staff, students, and visitors. The mission of EH&S is to prevent or to minimize injuries and illnesses through the recognition, evaluation, and control of potential hazards arising from University activities.
  • EIN

    This is a multipurpose tax identification number assigned to all entities which employ people, pay pensions, or open business bank accounts. This number is usually requested from Federal sponsors on their application cover page or their Representation and Certification pages.
  • Ethnographic Research

    Ethnography is the study of people and their culture. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time.
  • European Union PIC

    Assigned by the European Commission, this number indicates that the University has registered its standard legal and financial information.
  • Expedited Review

    Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
  • External Adverse Event

    From the perspective of a UCI Investigator engaged in a multicenter clinical trial, external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial (not under UCI IRB authority).
  • Extramural Sponsor

    An entity external to UCI (including other UC campuses, locations and units) to which UCI submits a proposal, or from which it receives an award.
  • F&A

    Facilities and Administrative Costs - Costs that are incurred for common or joint objectives and, therefore,  cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. F&A costs are synonymous with Indirect Costs. As a recipient of Federal funds,  UCI is required to negotiate a facilities and administrative (F&A) cost rate agreement to establish F&A cost rates for use with UCI's extramural awards
  • Facilities and Administrative Costs

    F&A costs are those incurred for common or joint objectives and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity.
  • FDA

    Food and Drug Administration - Established by Congress in 1912 and presently part of the Department of Health and Human Services, the FDA oversees safety of foods, drugs, devices, biologics and cosmetics for human use.
  • Federalwide Assurance

    The Federal Policy for the Protection of Human Subjects requires that each institution "engaged" in Federally-supported human subject research file in "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. Per Federal Policy, awardees and their collaborating institutions become "engaged" in human subject research whenever their employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain, release, or access individually identifiable private information for research purposes.
  • FICE

    This identifier indicates that we are an educational institution and is requested by some of the federal agencies on their application cover page or their Representation & Certification page.
  • Fieldwork

    Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings).
  • Final Proposal

    The final version of a proposal that includes all documents required to be submitted to the Extramural Sponsor in accordance with the FOA.
  • Financial Disclosure

    Written declaration of non-UC, i.e., external, financial interests of an individual that are related or potentially related to research or other sponsored activities taking place within the university. Disclosures are required under requirements promulgated by federal and state agencies and the Institutional Review Board.
  • FOA

    A published description of an extramural funding program.
  • FOIA

    Freedom of Information Act - Federal law which requires federal agencies to disclose records when requests are made in writing. There are nine exemptions and three exclusions to this statute.
  • Form 730-U

    Also referred to as SEI - Statement of Economic Interests. Form key personnel must complete and submit to the Conflict of Interest Coordinator for review when submitting research proposals to certain non-government agencies.
  • Fringe Benefits

    Employee benefits paid by the employer. (e.g., FICA, Worker's Compensation, Withholding Tax, Insurance, etc.) Must be included in request for funding for UCI employees in proposal budgets.
  • FWA

    Federalwide Assurance - The new agreement used by institutions receiving federal funds to assure compliance with research regulations.
  • Gift

    Gifts and bequests are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available.
  • Grant

    A type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. A grant, as opposed to a cooperative agreement, is used whenever the awarding office anticipates no substantial programmatic involvement with the recipient during the performance of the activities. Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant.
  • Helsinki

    Declaration of Helsinki - A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.
  • Human Subjects

    Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
  • IACUC

    Institutional Animal Care and Use Committee - A faculty committee charged with reviewing and approving the use of animal subjects in research and teaching activities. The IACUC serves as an institutional compliance committee and is responsible for reviewing reported instances of regulatory noncompliance related to the use of animal subjects in research.
  • IBC

    Institutional Biosafety Committee - A faculty committee charged with reviewing and approving the use of recombinant DNA in all research projects. The IBC serves as an institutional compliance committee and is responsible for reviewing reported instances of regulatory noncompliance related to recombinant DNA in research.
  • IDC

    Indirect Costs - Costs related to expenses incurred in conducting or supporting research or other externally-funded activities but not directly attributable to a specific project. General categories of indirect costs include general administration (accounting, payroll, purchasing. etc.), sponsored project administration, plant operation and maintenance, library expenses, department administration expenses, depreciation or use allowance for buildings and equipment, and student administration and services. (See also: Facilities and Administrative Costs)
  • IDE

    Investigational Device Exemptions - Exemptions granted by the FDA from certain regulations that allow use of unapproved devices for testing in clinical investigations. Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations.
  • In Vitro

    Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
  • In Vivo

    Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).
  • In-Kind

    Contributions or assistance in a form other than money. Equipment, materials, or services of recognized value that are offered in lieu of cash.
  • Incremental Funding

    A method of funding grants and contracts that provides specific spending limits below the total estimated costs. Each increment is, in essence, a funding action.
  • Indemnify

    To protect against damage, loss, or injury; to insure.
  • Indirect Cost Rate

    The rate, expressed as a percentage of a base amount (MTDC), established by negotiation with the cognizant federal agency on the basis of the institution's projected costs for the year and distributed as prescribed in OMB Circular A-21. At UCI, indirect costs are applied to a modified total direct costs (MTDC) base. The indirect cost rate is charged on a set of direct costs known as an indirect cost base.
  • Indirect Costs

    Indirect Costs (IDC) - Costs related to expenses incurred in conducting or supporting research or other externally-funded activities but not directly attributable to a specific project. General categories of indirect costs include general administration (accounting, payroll, purchasing. etc.), sponsored project administration, plant operation and maintenance, library expenses, department administration expenses, depreciation or use allowance for buildings and equipment, and student administration and services.
  • Informed Consent

    A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, and the institution or agents thereof from liability for negligence.
  • Instruction

    Instruction means the teaching and training activities of an institution, except for research training as described above. Instruction 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. Instruction also includes sponsored instruction and training which means specific instructional or training activity established by grant, contract, or cooperative agreement.
  • Internal Adverse Event

    From the perspective of a UCI Investigator engaged in a multi-center clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the UCI Investigator(s) (under UCI IRB authority). In the context of a single-site study, all adverse events would be considered internal adverse events.
  • Interpreter

    A qualified interpreter is an individual who is fluent (can speak, read and write) in English and the language of the subject, and (preferably) understands human research informed consent requirements. The interpreter should not be a member of the potential subject's family. Family members may have their own biases regarding research participation.
  • IO

    Institutional Official - The individual who signs and has the authority to sign the institution's Assurances, making a commitment on behalf of the institution that federal regulations and policies with be followed. The Institutional Official at UCI is the Vice Chancellor for Research.
  • IP

    Intellectual Property - Any product of the human intellect that is unique, novel, and unobvious and has some value in the marketplace. Some intellectual property is protectable by statute or legislation, such as patents, copyrights, trademarks, trade secrets, service marks, and plant variety protection certificates. Protection of IP also occurs through agreements that control use of intellectual property.
  • IRB

    Institutional Review Board - A faculty committee charged with reviewing and approving the use of human subjects in all research projects to ensure that the safety and welfare of subjects are protected. The IRB serves as an institutional compliance committee and is responsible for reviewing reported instances of regulatory noncompliance related to the use of human subjects in research. At UCI, there are three IRB committees: two review biomedical research and the third reviews social/behavioral research.
  • Key Personnel

    Personnel considered to be of primary importance to the successful conduct of a research project. The term usually applies to the senior members of the project staff; however, sponsors may have differing definitions of Key Personnel.
  • Lead Researcher

    Lead Researcher (LR) - The person with primary responsibility for meeting all ethical, scientific, and regulatory requirements for conduct of a UCI study protocol, whether or not acting as the Principal Investigator for the award that funds said study.
  • Legally Authorized Representative

    A person authorized either by statute or by court appointment to make legal decisions on behalf of another person. In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
  • Limited Funding Opportunity

    On occasion, award sponsors limit how many applications/nominations UCI may submit for an award. We call these "limiteds" and for these special award opportunities, the Office of Research establishes a pre-proposal screening process. The process may vary slightly depending on the sponsor or award, but in every case the Office of Research forwards a description of the award and the process for screening applicants to the Deans and other relevant unit heads. When the number of applications received by the Vice Chancellor for Research (VCR) exceeds the limit (often only one), a faculty ad hoc committee is convened to conduct the internal review. Once the review is complete and endorsed by the VCR, the selected candidate(s) are notified. Selected candidates are required to follow sponsor and University guidelines when submitting their formal proposal.
  • Matching Grant

    A grant that requires a specified portion of the cost of a supported item of equipment or project be obtained from other sources.
  • Medical Device

    A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body. Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.
  • Minimal Risk

    A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. The definition of minimal risk for research involving prisoners differs somewhat from that given for noninstitutionalized adults.
  • Modification

    An award document that modifies any aspect of an existing award other than those named above. Example: Carryover approvals, adding or deleting special terms and conditions, changes in funding levels (including NSF's Research Experience for Undergraduates, NIH's Minority Supplement, DoD's ASSERT Programs), administrative changes initiated by the agency, extensions that include changes in terms, change of principal investigator, etc.
  • MSI

    In the higher education system of the United States, minority-serving institutions (abbreviated MSI) make up a category of educational establishments (federally recognized Title IV colleges and universities) based on either historical origin or enrollment criteria (typically the percentage of enrolled minorities at a particular school).[1] Such schools are eligible for federal funding under Title III of the Higher Education Act of 1965.[2] Until 2007, no federal legislation existed concerning Asian American and Pacific Islander (AAPI) Serving Institutions. The College Cost Reduction and Access Act of 2007 made history, because it federally recognized the existence of Asian American Pacific Islander (AAPI) serving institutions, making them eligible to be designated as minority serving institutions.[3]
  • MTDC

    The MTDC base is the total direct costs for a project less those budget items that are excluded by agreement with the audit agency. The excluded costs are: equipment, construction, alterations and renovations, hospital or clinic charges for patient care, space rental or lease, tuition and fee remission, scholarships and fellowships, and the amount that exceeds $25,000 of any subaward. See the Calculation section for more information.
  • NAICS

    This number is assigned to any entity (industry, educational, etc.) to classify the type of industry it is.
  • NAS

    National Academy of Sciences - In 1863, the United States Congress created the National Academy of Sciences to advise the government in scientific and technical matters.
  • NASA

    National Aeronautics and Space Administration - NASA is a leading force in scientific research and in stimulating public interest in aerospace exploration, as well as science and technology in general.
  • NCI

    National Cancer Institute (NIH) - An institute in NIH. The National Cancer Institute's goal is to stimulate and support scientific discovery and its application to achieve a future when all cancers are uncommon and easily treated.
  • NCMHD

    National Center on Minority Health and Health Disparities (NIH) - A NIH Center. The mission of the National Center on Minority Health and Health Disparities (NCMHD) is to promote minority health and to lead, coordinate, support, and assess the NIH effort to reduce and ultimately eliminate health disparities.
  • NCURA

    National Council of University Research Administrators - An organization of individuals involved in the administration of sponsored programs at colleges, universities, and teaching hospitals.
  • NDA

    New Drug Application - Request for FDA approval to market a new drug.
  • NEA

    National Endowment for the Arts - The National Endowment for the Arts provides national recognition and support to significant projects of artistic excellence, thus preserving and enhancing our nation's diverse cultural heritage.
  • NEH

    National Endowment for the Humanities - NEH is an independent grant-making agency of the United States government dedicated to supporting research, education, preservation, and public programs in the humanities.
  • NHLBI

    National Heart, Lung, and Blood Institute (NIH) - An institute in NIH. The National Heart, Lung, and Blood Institute (NHLBI) provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative.
  • NIA

    National Institute on Aging (NIH) - An institute in NIH. The National Institute on Aging (NIA) leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life.
  • NIAAA

    National Institute on Alcohol Abuse and Alcoholism (NIH) - An institute in NIH. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports and conducts biomedical and behavioral research on the causes, consequences, treatment, and prevention of alcoholism and alcohol-related problems.
  • NIAID

    National Institute of Allergy and Infectious Diseases (NIH) - An institute in NIH. NIAID conducts and supports research that strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten hundreds of millions of people worldwide. The Institute's mission is driven by a strong commitment to basic research and the understanding that the fields of immunology, microbiology, and infectious disease are related and complementary.
  • NIAMS

    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH) - An institute in NIH. The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on research progress in these diseases.
  • NIBIB

    National Institute of Biomedical Imaging and Bioengineering (NIH) - The newest of the research institutes at the National Institutes of Health (NIH). The mission of the National Institute of Biomedical Imaging and Bioengineering is to improve health by promoting fundamental discoveries, design and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering, enabled by relevant areas of information science, physics, chemistry, mathematics, materials science, and computer sciences.
  • NICHD

    National Institute of Child Health and Human Development (NIH) - An institute in NIH. The National Institute of Child Health and Human Development (NICHD) seeks to assure that every individual is born healthy and wanted, that women suffer no adverse consequence from the reproductive process, and that all children have the opportunity to fulfill their potential for a healthy and productive life unhampered by disease or disability. In pursuit of this mission, the NICHD conducts and supports laboratory, clinical, and epidemiological research on the reproductive, neurobiologic, developmental, and behavioral processes that determine and maintain the health of children, adults, families, and populations.
  • NIDA

    National Institute on Drug Abuse - An institute in NIH. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. This charge has two critical components: The first is the strategic support and conduct of research across a broad range of disciplines. The second is to ensure the rapid and effective dissemination and use of the results of that research to significantly improve drug abuse and addiction prevention, treatment, and policy. NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction.
  • NIDDK

    National Institute of Diabetes and Digestive and Kidney Diseases (NIH) - An institute in NIH. The National Institute of Diabetes and Digestive and Kidney Diseases conducts and supports research on many of the most serious diseases affecting public health. Research encompasses the broad spectrum of metabolic diseases such as diabetes, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, nutrition, pathology, histochemistry, chemistry, physical, chemical, and molecular biology, pharmacology, and toxicology.
  • NIGMS

    National Institute of General Medical Sciences (NIH) - An institute in NIH. The National Institute of General Medical Sciences (NIGMS) primarily supports basic biomedical research that is not targeted to specific diseases or disorders.
  • NIH

    National Institutes of Health - A groups of federal agencies within the Public Health Service, DHHS, comprising 21 institutes and centers. These entities are responsible for carrying out and supporting biomedical and behavioral research.
  • NINDS

    National Institute of Neurological Disorders and Stroke (NIH) - An institute in NIH. The mission of NINDS is to reduce the burden of neurological disease-a burden borne by every age group, by every segment of society, by people all over the world.
  • No Cost Time Extension

    An extension of the period of performance beyond the expiration date to allow the principal investigator to finish a project. Usually, no additional costs are provided.
  • Non-standard Proposal

    A proposal or funding application that involves any of the following uncommon circumstances:
    • The sponsor or prime sponsor is a foreign entity.
    • The proposal is for a U.S. federal government contract – not a grant or cooperative agreement.
    • By virtue of submitting the proposal to the Extramural Sponsor, UCI is accepting award terms and conditions contained in the FOA.
    • As part of the proposal, the sponsor requires the submission of a small business subcontracting plan, an intellectual property management plan, a laboratory safety plan, or any other plan(s) that must be developed by one or more UCI central administration office.
    • The proposal requests funding in excess of $5 million of direct costs per budget year.
    • A purpose of the proposal is to establish a new UCI center or institute.
  • Nontherapeutic Research

    Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
  • NPC

    Nonprofit Program Classification (NPC) This system categorizes the programs of nonprofit organizations.
  • NSF

    National Science Foundation - The National Science Foundation (NSF) is an independent agency of the U.S. Government. Their mission is to promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense.
  • NTEE

    This is a classification system categorizing the activities and purposes of nonprofit organizations.
  • Nuremberg Code

    A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
  • Off-Campus

    Projects that are based at facilities not owned, or leased and maintained by the University. However, if the project is conducted in leased space and the lease costs are directly charged to the project, the off-campus rate must be used. If the project involves both on-campus and off-campus sites, either the on-campus or off-campus rate generally should be applied, consistent with where the majority of the work is to be performed as measured by salary cost. The use of both on- and off-campus rates may be justified if both rates can be clearly identified with a significant portion of project salaries, meaning 25% or more of total salary/wage costs and the project's total salary/wage costs exceed $250,000.
  • Off-Site Research

    Any research that takes place at a site other than UCI/UCIMC.
  • OHRP

    Office for Human Research Protection - An office within the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. The office within the National Institutes of Health, an agency of the Public Health Service, Department of Health and Human Services, responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects.
  • OLAW

    Office of Lab Animal Welfare - An office within NIH which is responsible for developing and monitoring, as well as exercising compliance oversight relative to PHS Policy on Humane Care and Use of Laboratory Animals involved in research conducted or supported by any component of the Public Health Service.
  • OMB

    Office of Management and Budget - Part of the Executive Office of the President. Working cooperatively with the grantmaking agencies and the grantee community, OMB leads development of governmentwide policy to assure that grants are managed properly and that Federal dollars are spent in accordance with applicable laws and regulations (See OMB Circulars). OMB does not award grants.
  • ONR

    Office of Naval Research - The Office of Naval Research (ONR) sponsors science and technology in support of the U.S. Navy and Marine Corps. Founded in 1946, ONR today funds work at more than 450 universities, laboratories, and other organizations.
  • OPE

    Number used to identify UCI in dealings with the U.S. Department of Education, Office of Postsecondary Education.
  • Organized Research

    All research and development activities of an institution including sponsored research. Sponsored research includes all research and development activities that are sponsored by Federal and non-Federal agencies and organizations. This term includes activities involving the training of individuals in research techniques (commonly called 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.
  • Other Sponsored Activities

    This means programs and projects financed by Federal and non-Federal agencies and organizations which involve the performance of work other than instruction and organized research. Examples of such programs and projects are health service projects, and community service programs.
  • Patent

    A patent for an invention is the grant of a property right from a country's patent office to the inventor which excludes others from making, using, offering for sale, selling or importing the invention into the country that granted the patent. US patent grants are effective only within the territories of the United States and are granted by the United States Patent and Trademark Office. To seek patent protection in other countries, a patent application must be made to the individual country's patent office and that office must grant the patent. Public disclosure of inventions eliminates application for foreign patent protection and limits protection to the US and that is assuming a patent application is filed to the USPTO within one year of public disclosure.
  • Peer Review

    Involves the analysis of scientific merit of a proposed research by a group of professionals of comparable knowledge and expertise in a specific scientific or medical field.
  • PHS

    Public Health Service - Part of the U.S. Department of Health and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA.
  • PI

    Principal Investigator - The scientist or scholar responsible for the conduct of research or other activity, described in a proposal for an award. The Principal Investigator is responsible for all programmatic and administrative aspects of a project or program. The scientist or scholar with primary responsibility for the scientific, technical and administrative conduct of a funded research project. (See also: Investigator and Lead Researcher)
  • Post-Award

    In the context of the life cycle of a contract or grant, the post-award period begins after award negotiation and acceptance and ends after closeout of the award. (Compare: Pre-Award)
  • Pre-Award

    In the context of the life cycle of a contract or grant, the pre-award period begins with project development and concludes after the award negotiation and acceptance. (Compare: Post-Award)
  • Pre-Proposal

    A brief description, usually 2-10 pages, of research plans and estimated budget that is sometimes submitted to determine the interest of a particular sponsor prior to submission of a formal proposal. Also termed Preliminary Proposal.
  • Prime Award

    In the context of subawards or subcontracts, the prime award is the award made directly from the sponsor to the recipient institution. When a recipient institution makes a subaward or subcontract under the terms and conditions of the award to a second organization, the sponsor's award is labeled the prime award and the terms and conditions are generally included as part of the agreement to the subaward or subcontract site.
  • Prior Approval

    The requirement for written documentation of permission to use project funds for purposes not in the approved budget, or to change aspects of the program from those originally planned and approved. Prior approval must be obtained before the performance of the act that requires such approval under the terms of the agreement.
  • Program Officer

    A sponsor's designated individual who is officially responsible for the scientific and technical aspects of a particular grant or cooperative agreement. Serves as the counterpart to UCI's Principal Investigator.
  • Project Period

    Project period means the total time for which support of a program has been approved, initially or by a renewal award. As used by the Public Health Service, Project Periods consist of one or more annual budget periods with funding for future years beyond the initial budget period provided on a non-competing basis.
  • Proposal

    An application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested. Formal proposals are officially approved and submitted by an organization in the name of a principal investigator.
  • Prospective Study

    Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
  • Protocol Deviation

    Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject's rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff.
  • Protocol Violation

    Accidental or unintentional changes to, or non-compliance with the IRB approved protocol without prior sponsor and IRB approval. Violations generally increase risk or decrease benefit, affects the subject's rights, safety, or welfare, and/or the integrity of the data.
  • Radioactive Drug

    Any substance defined as a drug the Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Included are any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug and "radioactive biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing compounds or potassium-containing salts containing trace quantities of naturally occurring radionuclides are not considered radioactive drugs.
  • Rebudget

    The act of amending the budget by moving funds from one category or line item to another.
  • Retrospective Studies

    Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
  • RFA

    Request for Applications/Proposals - Announcements that indicate the availability of funds for a topic of specific interest to a sponsor. Proposals submitted in response generally result in the award of a grant. Specific grant announcements may be published in the Federal Register and/or specific sponsor publications.
  • SAE

    Serious Adverse Event - is any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria: 1) results in death; 2) is life-threatening (places the subject at immediate risk of death from the event as it occurs); 3) requires inpatient hospitalization or prolongation of existing hospitalization; 4) results in a persistent or significant disability/incapacity; 5) results in a congenital anomaly/birth defect; or 6)any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
  • SBIR

    Small Business Innovative Research - Agency administered programs supported by ear-marked federal funds, making grants to small business entities.
  • Scope of Work

    The description of the work to be performed and completed on a research project. Also referred to as "Statement of Work".
  • Site Visit

    A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.
  • Sponsor Deadline

    The date and time established by an Extramural Sponsor by which proposals must be received to be considered on time.
  • Standard of Care

    Therapeutic treatment or medical management of a specific disease or condition; a diagnostic and treatment process that a physician should follow for a certain type of illness, disease, or clinical circumstance.
  • Standard Proposal

    A proposal or funding application to a domestic entity that will result in the award of a grant, cooperative agreement or subaward (under a prime grant or prime cooperative agreement) and that does not involve any of the elements of a Non-standard Proposal.
  • Stipend

    A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training. A stipend is not considered compensation for the services expected of an employee.
  • STTR

    Small Business Technology Transfer - Grant applications and/or programs to fund small business "teamed" with research institutions.
  • Subcontract

    A document written under the authority of, and consistent with the terms and conditions of an award (a grant, contract or cooperative agreement), that transfers a portion of the research or substantive effort of the prime award to another institution or organization.
  • Summary Statement

    Used by NIH in relation to the peer review: a combination of the reviewers' written comments and the SRA's summary of the members' discussion during the study section meeting. It includes the recommendations of the study section, a recommended budget, and administrative notes of special considerations.
  • TDC

    Total Direct Costs (TDC) is the total of all direct costs budgeted for a project.
  • therapeutic misconception

    Research participant's belief that enrolling in a research study will provide therapeutic benefit. Participants confuse the goal of clinical therapy which is to provide benefit to the individual patient and where any new knowledge gained is incidental and the goal of research which is to gain knowledge to help future patients (generalizable) and where therapeutic benefit to individual maybe secondary.
  • UCIMC

    UCI Medical Center - The UCI hospital in Orange that is used to teach UCI medical students and to conduct clinical research.
  • UCIMC

    UCI Medical Center - The UCI hospital in Orange.
  • UCInetID

    UCI Network Identification - A UCInetID is a 3 to 8 letter code based on a UCI employee's name that uniquely identifies them at UCI. UCInetIDs are used to authorize UCI affiliates in order to gain access to UCI electronic services.
  • ULAR

    University Laboratory Animal Resources - The office responsible for veterinary care, health surveillance, animal husbandry, animal procurement and facility maintenance for UCI's Animal Care and Use Program.
  • Unanticipated Problems

    Any incident, experience, or outcome that meets all of the following criteria: 1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; 2. related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and 3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
  • Unexpected Adverse Event

    Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either: the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.
  • Unilateral Award

    An award made by a sponsor to an organization without considering competitive proposals. Unilateral awards are most often made when unsolicited proposals receive favorable treatment.
  • Unrestricted Funds

    Monies with no requirements or restrictions as to use or disposition. Grants, contracts, and cooperative agreements are considered to be restricted funds, while gifts are usually considered unrestricted funds.
  • USDA

    United States Department of Agriculture - Federal agency responsible for implementation and enforcement of the Animal Welfare Act.
  • USPTO

    United States Patent and Trademark Office - The US Patent and Trademark Office PTO is a non-commercial federal entity and one of 14 bureaus in the Department of Commerce (DOC). The office's major function is the examination and issuance of patents and the examination and registration of trademarks.
  • VA

    Veterans Affairs - The Department of Veterans Affairs (VA) was established on March 15, 1989. It succeeded the Veterans Administration and has responsibility for providing federal benefits to veterans and their dependents. Headed by the Secretary of Veterans Affairs, VA is the second largest of the 14 Cabinet departments and operates nationwide programs of health care, financial assistance and national cemeteries.
  • VCR

    Vice Chancellor for Research - The Institutional Official (IO) for human, animal and rDNA research at UCI.
  • Whistleblower Policy

    The University Policy and Procedures for Reporting Improper Governmental Activities and Protection Against Retaliation for Reporting Improper Activities that protects employees from retaliation for reporting improper activities and addresses written complaints alleging acts of reprisal or intimidation due to disclosure of improper activities. See also Improper activity.
  • Whistleblower Policy

    The University Policy and Procedures for Reporting Improper Governmental Activities and Protection Against Retaliation for Reporting Improper Activities that protects employees from retaliation for reporting improper activities and addresses written complaints alleging acts of reprisal or intimidation due to disclosure of improper activities
  • Zotmail

    ZotMail is the electronic communication system used to transmit authorized bulk email messages to UCI employees.