Glossary

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    #

    • ©

      Copyright - A copyright is a set of exclusive legal rights authors have for "original works of authorship" including literary, dramatic, musical, artistic, architectural, and certain other intellectual works, both published and unpublished. Under the federal copyright act, copyright protection is secured from the time the work is created in fixed form. Copyright ensures that the owner has the exclusive right to reproduce the work, to prepare derivative works, to distribute by sale or otherwise copies of the work, to perform publicly, and to display. Registration is not a requirement for copyright protection. Copyright does not protect ideas, only the tangible work itself.

  • 32P

    Radioactive Phosphorus - Radioactive isotope of 31P, an element found in DNA molecules.

  • 35S

    Radioactive Sulfur - Radioactive isotope of 32S, an element found in proteins.

  • 510(K) Device

    A medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation 510(k) device.

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    A

    • 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.

  • Abuse-Liable

    Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g., methamphetamines).

  • ADAMHA

    Alcohol, Drug Abuse, and Mental Health Administration - Reorganized in October 1992 as the Substance Abuse and Mental Health Services Administration (SAMHSA). ADAMHA included the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), the Office for Substance Abuse Prevention (OSAP), and the Office for Treatment Intervention (OTI). NIMH, NIAAA, and NIDA are now part of the National Institutes of Health (NIH). (See also: SAMHSA)

  • Adjuvant Therapy

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

  • Adverse Event

    An untoward or undesirable experience or any undesirable experience associated with the use of a medical product/test article in clinical research.

  • Adverse Reaction

    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.

  • 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.

  • AID

    Agency for International Development - An independent federal government agency that receives overall foreign policy guidance from the Secretary of State. The agency works to support long-term and equitable economic growth and advancing U.S. foreign policy objectives.

  • 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.

  • AMA

    American Medical Association - A professional organization of physicians whose core purpose is to promote the science and art of medicine and the betterment of public health.

  • Amendment

    A change in the terms and conditions of a grant or contract mutually agreed upon by the agency and the recipient organization; may also be referred to as a modification.

  • 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.

  • Approved Drugs

    In the U.S. the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy. (See also: IND; Phase I-IV Drug Trials.)

  • 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.

  • ASPR

    Armed Services Procurement Regulations - The 1955 predecessor of the Department of Defense supplement to the FAR.

  • Assent

    Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

  • 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.

  • Attending Veterinarian

    Individual with the authority to implement the veterinary care program and to oversee the adequacy of all other aspects of animal care and use, e.g., animal husbandry, nutrition, sanitation practices, zoonosis control, and hazard containment.

  • Audit

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

  • Authorized Institutional Official

    An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of federal and other regulations.

  • AUTM

    Association of University Technology Managers - AUTM is a nonprofit association with membership of more than 3200 technology managers and business executives who manage intellectual property. AUTM's members represent over 300 universities, research institutions, teaching hospitals, and a similar number of companies and government organizations.

  • Autonomy

    Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

  • 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.

  • Award

    The provision of funds by a sponsor, based on an approved application and budget, to an organizational entity or an individual to carry out an activity or project.

  • Award Synopsis

    The document prepared by the Office of Research Administration to summarize the most important provisions and requirements of the award; it is not a substitute for the award documents issued by a sponsor.

  • AWR

    Animal Welfare Regulations - USDA regulations that implement the Animal Welfare Act.

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    B

    • BAA

      Broad Agency Announcement - An announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made.

  • Basic Research

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

  • Belmont Report

    A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

  • 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.

  • Benefit

    A valued or desired outcome; an advantage.

  • Bequests

    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.

  • Biologic

    Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

  • Biological Safety Officer

    Biological Safety Officer (BSO) - 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.

  • Blind Study Designs

    Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "masked" study designs.

  • BSL

    Biosafety Level - A description of the degree of physical containment being employed to confine organisms containing recombinant DNA molecules and to reduce the potential for exposure of laboratory workers, persons outside of the laboratory, and the environment. NIH Guidelines grades from BSL-1 (the least stringent) to BSL-4 (the most stringent).

  • 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.

  • Budget

    A list of anticipated project costs that represent the Principal Investigator's best estimate of the funds needed to support the work described in a grant or contract proposal.

  • Budget Adjustment

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

  • Budget Description

    A written description of the cost estimation methods used in preparing a budget that also explains or describes the types of individual costs that make up a larger budget category. Also called Budget Justification or Narrative.

  • Budget Justification

    A written description of the cost estimation methods used in preparing a budget that also explains or describes the types of individual costs that make up a larger budget category. Also called Budget Description or Narrative.

  • Budget Narrative

    A written description of the cost estimation methods used in preparing a budget that also explains or describes the types of individual costs that make up a larger budget category. Also called Budget Description or Justification.

  • Budget Period

    The interval of time--usually twelve months--into which the project period is divided for budgetary and funding purposes.

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    C

    • Common Rule

      The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy.

  • Conflict of Interest

    A conflict of interest is a situation where an investigator's outside financial interest(s) or obligation(s) may compromise or have the appearance of compromising the investigator’s professional actions or judgment in the designing, conducting, or reporting of their research projects.

  • Conflict of Interest Oversight Committee

    The Conflict of Interest Oversight Committee (COIOC), a committee comprised of faculty from throughout the campus and the UCI Medical Center, advises the Vice Chancellor for Research (VCR) on issues of conflict of interest in research.

  • Copyright

    Copyright is a form of protection provided by the laws of the United States to the authors of "original works of authorship" that are fixed in a tangible form of expression. This protection provides exclusive legal right to an originator or an assignee to print, publish, perform, film, or record literary, artistic, or musical material, and to authorize others to do the same.

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    D

    • DAR

      Defense Acquisition Regulations - The source regulations for research projects sponsored by the Department of Defense.

  • DCAA

    Defense Contract Audit Agency - The Defense Contract Audit Agency, under the authority, direction, and control of the Under Secretary of Defense (Comptroller), is responsible for performing all contract audits for the Department of Defense, and providing accounting and financial advisory services regarding contracts and subcontracts to all DoD Components responsible for procurement and contract administration. These services are provided in connection with negotiation, administration, and settlement of contracts and subcontracts. DCAA also provides contract audit services to some other Government Agencies.

  • Debriefing

    Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information).

  • Deception

    Withholding information about the real purpose of the research or giving subjects false information about some aspect of the research. To understand what causes humans to act in certain ways one must study behavior in situations regarded as "real."

  • Deficit

    The result of expenditures exceeding the project funds available.

  • Dependent Variables

    The outcomes that are measured in an experiment. Dependent variables are expected to change as a result of an experimental manipulation of the independent variable(s).

  • Descriptive Study

    Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).

  • Design Patent

    Description of a patent that relates to patent protection of new, original, and ornamental designs for articles of manufacture (for example, athletic shoe, a bicycle helmet, and the Star Wars characters).

  • Developmental Research

    Systematic use of scientific and technical knowledge in the design, development, testing or evaluation of a potential new product or service.

  • Development Candidate

    A development candidate is a small molecule, biologic or stem cell-derived cell therapy for which there are compelling data demonstrating reproducible disease-modifying activity in animal models of disease, as well as other supporting data sufficient to consider initiation of IND-enabling activities.

  • DFARS

    Defense Federal Acquisition Regulation Supplement - Department of Defense supplement to the FAR.

  • 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 Costs

    Clearly identifiable costs related to a specific project. General categories of direct costs include but are not limited to salaries and wages, fringe benefits, supplies, contractual services, travel and communication, equipment, and computer use.

  • Divisional Patent Application

    If two or more independent and distinct inventions are claimed in one patent application, the USPTO Commissioner may request that the application be divided into two or more patent applications. If the inventor decides to maintain only one of the distinct inventions, the other invention will become abandoned.

  • 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.

  • DOI

    Department of Interior - The Department of the Interior (DOI) is the nation's principal conservation agency. Their mission is to protect America's treasures for future generations, provide access to our nation's natural and cultural heritage, offer recreation opportunities, honor our trust responsibilities to American Indians and Alaska Natives and our responsibilities to island communities, conduct scientific research, provide wise stewardship of energy and mineral resources, foster sound use of land and water resources, and conserve and protect fish and wildlife.

  • Donation

    Transfer of equipment, money, goods, services, or property with or without specifications as to its use. Sometimes donation is used to designate contributions that are made with more specific intent than is usually the case with a gift, but the two terms are often used interchangeably.

  • 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.

  • Double-blind

    A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes referred to as "double-masked."

  • Double-masked

    A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Often referred to as "double-blind."

  • DRG

    Division of Research Grants (National Institutes of Health) - See: Center for Scientific Review

  • Drug

    Any chemical compound that may be used on or administered to a subject 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.

  • DSMB

    Data and Safety Monitoring Board/Committee (DSMB or DSMC): 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.

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    E

    • 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.

  • Emancipated Minor

    A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.

  • Embryo

    Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy.

  • Encumbrance

    Funds that have been set aside or "claimed" for projected expenses pending actual expenditure of the funds.

  • Endowment

    A fund usually in the form of an income-generating investment, established to provide long-term support for faculty/research positions (e.g., endowed chair).

  • Entity

    For conflict of interest matters, this term refers to the company or organization in which an investigator is disclosing their financial interests. An "entity" may be, but is not necessarily, a "sponsor" of a project.

  • EPA

    Environmental Protection Agency - EPA's mission is to protect human health and to safeguard the natural environment - air, water, and land - upon which life depends.

  • EPO

    European Patent Office - The European Patent Office (EPO) grants European patents for the contracting states to the European Patent Convention (EPC). With its centralized grant procedure, the EPO offers applicants a cost-effective and time-saving way of applying for patent protection in up to 20 European countries by a single patent grant procedure.

  • Equitable

    Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.

  • ERA

    Electronic Research Administration - Conducting research administration by utilizing electronic resources such as the internet, the world wide web, form templates, databases, and other electronic tools.

  • Ethics Advisory Board

    An interdisciplinary group that advises the Secretary, HHS, on general policy matters and on research proposals (or classes of proposals) that pose ethical problems.

  • 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. (See also: Fieldwork)

  • Exclusion Criteria

    The medical or social standards determining whether a person may or may not be allowed to enter a research study (often used in clinical research). These criteria may include such factors as age, gender, the type and stage of a disease or disorder, previous treatment history, and other medical conditions.

  • Exempt Registration

    Registration of human subjects research that involves virtually no risk to human subjects. There are six (6) federally-defined exempt categories. UCI requires review by the IRB Chair or a designated voting member. Registration of exempt research is granted for three years.

  • Expanded Availability

    Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them. Examples of expanded availability mechanisms include Treatment INDs, Parallel Track, and open study protocols.

  • 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.

  • Experimental Study

    A true experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation.

  • Expiration Date

    The date signifying the end of the performance period, as indicated on the Notice of Grant Award or award letter.

  • Extension

    An additional period of time authorized by the sponsor (or awardee institution, as appropriate) to an organization for the completion of work on an approved grant or contract. An extension allows previously allocated funds to be spent after the original expiration date.

  • 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's purview).

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    F

    • 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.

  • FAA

    Federal Aviation Administration - The Federal Aviation Administration (FAA) is the element of the U.S. government with primary responsibility for the safety of civil aviation.

  • False Negative

    When a test wrongly shows an effect or condition to be absent (e.g., that a woman is not pregnant when, in fact, she is).

  • False Positive

    When a test wrongly shows an effect or condition to be present (e.g. that a woman is pregnant when, in fact, she is not).

  • FAR

    Federal Acquisition Regulation - The FAR was established to codify uniform policies for acquisition of supplies and services by executive agencies.

  • 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.

  • FDP

    Federal Demonstration Partnership - The Federal Demonstration Partnership (FDP) is a cooperative initiative among federal agencies and institutional recipients of federal funds. It was established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds.

  • 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.

  • Fetal Material

    The placenta, amniotic fluid, fetal membranes, and umbilical cord

  • Fetus

    The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development.

  • FIC

    Fogarty International Center (NIH) - The Fogarty International Center promotes and supports scientific research and training internationally to reduce disparities in global health.

  • 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 Report

    The final technical or financial report required by the sponsor to complete a research project.

  • 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.

  • Firm Commitment

    An oral or written representation by the appropriate sponsor official that a formally executed award is forthcoming.

  • Fiscal Year

    Any twelve-month period for which annual accounts are kept (at UCI, July 1 through June 30).

  • Fixed-Price

    Fixed-Price refers to a contract/grant for which one party pays the other party a predetermined price, regardless of actual costs, for services rendered or the delivery of a final product/report.

  • 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.

  • For-Profit Organization

    An organization, institution, corporation, or other legal entity that is organized and/or operated for the profit or financial benefit of its shareholders or other owners. Such organizations are also referred to as "commercial organizations."

  • 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.

  • Funding Cycle

    Range of time during which proposals are accepted, reviewed, and funds are awarded. If a sponsor has standing proposal review committees (or boards) that meet at specified times during the year, application deadlines are set to correspond with those meetings. For some sponsors, if proposals are received too late to be considered in the current funding cycle, they may be held over for the next review meeting(i.e., National Science Foundation's Target Dates).

  • FWA

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

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    G

    • GAC

      General Clinical Research (GCRC) Center Advisory Committee - Investigators who wish to utilize the resources of the GCRC need to obtain review by the GCRC Advisory Committee (GAC). The protocol may be reviewed simultaneously by the GCRC Advisory Committee (GAC) and the Institutional Review Board (IRB).

  • GCRC

    General Clinical Research Center - A unit at UCIMC that is funded by NIH to provide free research services to investigators in lieu of grant funds. Investigators wishing to receive GCRC services must submit their protocols for GAC review.

  • General Controls

    Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act.

  • General Purpose Equipment

    Tangible, nonexpendable equipment which is usable for other than research, medical, scientific, or technical activities. Examples are office equipment, furnishings, reproduction and printing equipment, and motor vehicles.

  • Genetic Screening

    Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.

  • 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.

  • GSA

    General Services Administration - The GSA helps federal agencies better serve the public by offering, at best value, superior workplaces, expert solutions, acquisition services and management policies.

  • Guardian

    An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.

  • Guide for the Care and Use of Laboratory Animals

    A Manual of standards for animal care and use developed under the auspices of the Institute for Laboratory Animal Research.

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    H

    • 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.

  • Historical Controls

    Control subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently. The study is considered historically controlled when the present condition of subjects is compared with their own condition on a prior regimen or treatment

  • HREA

    Health Research Extension Act of 1985 - Federal law that mandates the PHS Policy.

  • 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.

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    I

    • 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.

  • ICTS

    The Institute for Clinical and Translational Science (ICTS) Scientific Review Committee (SRC) is charged with ensuring that all College of Health Sciences clinical research protocols to be submitted to the IRB are written in a manner that will render a scientifically valid interpretation of the results as defined by the study plan and objectives.

  • 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.

  • Improper Activity

    Any activity by a University department or employee that is undertaken in the performance of the employee's official duties, whether or not such action is within the scope of the individual's employment, and that (1) is in violation of any State or Federal law or regulation, including but not limited to corruption, malfeasance, bribery, theft of University property, fraudulent claims, fraud, coercion, conversion, malicious prosecution, misuse of University property and facilities, or willful omission to perform duty, or (2) is economically wasteful, or involves gross misconduct, incompetence, or inefficiency.

  • Inclusion criteria

    The medical or social standards determining whether a person may or may not be allowed to enter a research study (often used in clinical research). These criteria may include such factors as age, gender, the type and stage of a disease or disorder, previous treatment history, and other medical conditions.

  • Incompetence

    Technically, a legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity.

  • 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.

  • IND

    Investigational New Drug or Device - Exemptions granted by the FDA from certain regulations that allow use of unapproved for testing in clinical investigations. A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.

  • Indemnify

    To protect against damage, loss, or injury; to insure.

  • Independent Variables

    The conditions of an experiment that are systematically manipulated by the investigator.

  • 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.

  • 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.

  • Institutionalized

    Confined, either voluntarily or involuntarily (e.g., a hospital, prison or nursing home).

  • Institutionalized Cognitively Impaired

    Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).

  • Institutional Official

    Institutional Official (IO) - 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.

  • Interim Funding

    Authorization to expend funds on a project to a specified limit before the award document has been received from the sponsor.

  • 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 authority). In the context of a single-site study, all adverse events would be considered internal adverse events.

  • Invention

    A product of the human intellect that is a new, useful, and non-obvious process, machine, or product.

  • Investigator

    An individual who actually conducts an investigation. Any interventions (e.g., drugs) involved in the study are administered to subjects under the immediate direction of the investigator.

  • Investigator-Initiated Proposal

    A proposal submitted to a sponsor that is not in response to an RFP, RFA, or a specific program announcement.

  • 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).

  • 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.

  • IUCRP

    Industry-University Cooperative Research Program - A UC-managed, State-funded, grants program that partners UC scientists and California businesses in research projects through matching grants.

  •  

    K

    • 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.

  •  

    L

    • LAR

      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.

  • 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.

  • limiteds

    On occasion, award sponsors limit how many applications/nominations UCI may submit for an award. We call these "limiteds" or “limited submissions” 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.

  • LOC

    Limitation of Cost - A mandatory clause for cost-reimbursement type contracts. Under the clause, the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. The contractor, however, is not obligated to continue performance once expenses reach the stated amount.

  • Longitudinal Study

    A study designed to follow subjects forward through time.

  •  

    M

    • Maintenance Fees

      All utility patents that issue from patent applications are subject to the payment of maintenance fees which must be paid to each country's patent office to maintain the patent in force in that particular country. The due date for these fees differ depending on the country. Failure to pay the current maintenance fee on time may result in expiration of the patent.

  • Masked Study

    Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs.

  • 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.

  • Mature Minor

    Someone who has not reached adulthood (as deemed by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor.

  • MDA

    Medical Device Amendments - Amendments to the Federal Food, Drug and Cosmetic Act passed in 1976 to regulate the distribution of medical devices and diagnostic products.

  • 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.

  • Medical Experimentation

    Medical Experimentation is defined by the State of California as: the severance or penetration or damaging of tissues of a human subject or the use of a drug or device, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject; the use of an investigational drug or device; or 2) The withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.

  • 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.

  • Monitoring

    The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.

  • MPA

    Multiple Project Assurance - The old agreement used by institutions receiving federal funds to assure compliance with research regulations.

  • MTDC

    Modified Total Direct Costs - At UCI, the basic indirect costs are calculated on a subset of direct costs, normally excluding among other costs, equipment, patient care, space rental, alterations and renovations, and subcontract costs in excess of the first $25,000.

  •  

    N

    • NACUBO

      National Association of College and University Business Officers - NACUBO is a nonprofit professional organization representing chief administrative and financial officers at more than 2,100 colleges and universities across the country.

  • 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.

  • NASA Principles

    NASA Principles for the Ethical Care and Use of Animals; aka the NASA Sundowner Report. Ethical standards for the use of animals in research (respect for life, societal benefit, and non-maleficence.)

  • National Commission

    National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. An interdisciplinary advisory body, established by Congressional legislation in 1974, which was in existence until 1978, and which issued a series of reports and recommendations on ethical issues in research and medicine, many of which are now embodied in federal regulations.

  • 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.

  • NCRR

    National Center for Research Resources (NIH) - An institute in NIH. NCRR supports primary research to create and develop critical resources, models, and technologies. NCRR funding also provides biomedical researchers with access to diverse instrumentation, technologies, basic and clinical research facilities, animal models, genetic stocks, biomaterials, and more.

  • NCURA

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

  • 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.

  • NEI

    National Eye Institute (NIH) - An institute in NIH. The National Eye Institute (NEI) conducts and supports research that helps prevent and treat eye diseases and other disorders of vision. This research leads to sight-saving treatments, reduces visual impairment and blindness, and improves the quality of life for people of all ages.

  • New Award

    An award not previously awarded or a renewal or continuation award treated as a new award by the sponsor and given a new agency number.

  • NHGRI

    National Human Genome Research Center (NIH) - An institute in NIH. The National Human Genome Research Institute supports genetic and genomic research, investigation into the ethical, legal and social implications surrounding genetics research, and educational outreach activities.

  • 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 (NIH) - 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.

  • NIDCD

    National Institute on Deafness and other Communication Disorders (NIH) - An institute in NIH. NIDCD is mandated to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, smell, taste, voice, speech, and language.

  • NIDCR

    National Institute of Dental and Craniofacial Research (NIH) - Formerly referred to as NIDR. An institute in NIH. The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to promote the general health of the American people by improving their oral, dental and craniofacial health.

  • 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.

  • NIEHS

    National Institute of Environmental Health Sciences (NIH) - An institute in NIH. The mission of the National Institute of Environmental Health Sciences (NIEHS) is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate.

  • 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.

  • NIMH

    National Institute of Mental Health (NIH) - An institute in NIH. The mission of the National Institute of Mental Health (NIMH) is to diminish the burden of mental illness through 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.

  • NINR

    National Institute for Nursing Research (NIH) - An institute in NIH. The National Institute of Nursing Research supports clinical and basic research to establish a scientific basis for the care of individuals across the life span-from management of patients during illness and recovery to the reduction of risks for disease and disability, the promotion of healthy lifestyles, promoting quality of life in those with chronic illness, and care for individuals at the end of life.

  • NLM

    National Library of Medicine - The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland, is the world's largest medical library. The Library collects materials in all areas of biomedicine and health care, as well as works on biomedical aspects of technology, the humanities, and the physical, life, and social sciences.

  • 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.

  • NOGA

    Notice of Grant Award - The legally binding document that serves as a notification to the recipient and others that a grant or cooperative agreement has been made; contains or references all terms of the award; and documents the obligation of funds.

  • Nonaffiliated Member

    Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).

  • Nonsignificant Risk Device

    An investigational medical device that does not present significant risk to the patient. (See also: Significant Risk Device)

  • 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.

  • Nonviable Fetus

    An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance.

  • Normal Volunteers

    Volunteer subjects used to study normal physiology and behavior or who do not have the condition under study in a particular protocol, used as comparisons with subjects who do have the condition. "Normal" may not mean normal in all respects. For example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, patients with heart disease but without diabetes may be the "normals" in a study of diabetes complicated by heart disease.

  • NPR

    National Performance Review - The National Performance Review, led by Vice President Gore, provided Federal agencies with guidelines for their procurement systems in an effort to streamline and reform the acquisition regulations in place.

  • 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.

  • Null Hypothesis

    The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.

  • 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.

  •  

    O

    • OBA

      Office of Biotechnology Activities - An office within NIH which monitors scientific progress in human genetics research in order to anticipate future developments, including ethical, legal, and social concerns, in basic and clinical research involving Recombinant DNA, Genetic Testing, and Xenotransplantation; develops and implements NIH policies and procedures for the safe conduct of Recombinant DNA Activities, and Human Gene Transfer; Reviews and evaluates the composition of Institutional Biosafety Committees; and develops registries of activities related to Recombinant DNA Research and Human Gene Transfer.

  • Objectivity in Research

    Used in conflict of interest policies to indicate concern for the potential impact of an individual's financial interests upon the design, conduct, or reporting of research or educational activities. See 42 CFR Part 50 and NSF Grants Policy Manual, Chapter 500, effective 10/1/95.

  • Off-Label use

    When physicians use a drugs, biologics and devices for a condition not approved by FDA labeling. Physicians using good medical practice and the best interests of the patient may use legally available products using their best knowledge and judgment.

  • Off-Site Research

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

  • OFPP

    Office of Federal Procurement Policy - OMB's procurement policies are handled by our Office of Federal Procurement Policy (OFPP).

  • OHP

    Occupational Health Program - The Occupational Health Program consists of medical care for occupational disease and injury and preventive health measures and surveillance programs for prevention of occupational diseases.

  • OHRP

    Office for Human Research Protection (formerly known as OPRR - Office for Protection from Research Risks) - An office within the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. (formerly Office for Protection from Research Risks [OPRR]) 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.

  • OMA

    Office of Management Assessment - An office within the Office of the Director of NIH. The OMA is responsible for reviewing allegations related to NIH programs and activities. The OMA also provides broad management oversight and advice to the Associate Director for Administration and the Institutes and Centers (ICs) on management reviews, corrective actions, and the NIH-wide management of activities related to regulations, delegations of authority, Privacy Act requirements, records and forms management, organizational and functional analysis, and manual issuances.

  • 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.

  • OMB Circular

    Regulatory circulars issued by the Office of Management & Budget (OMB). Definitions included in OMB Circulars A-21, 110, 122, 128 and 133.

  • 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.

  • OPAS

    Organizational Prior Approval System - Funding agencies have delegated to grantee organizations increasingly expanded authority to approve certain administrative actions. Agencies require that grantees assure that there are adequate institutional reviews and approvals of decisions affecting the management of federally supported projects and all approvals must be documented. At UCI, submission of the FDP Action form is required for institutional approval of expanded authority actions.

  • OPHS

    Office of Public Health and Science - The Office of Public Health and Science (OPHS) is under the direction of the Assistant Secretary for Health, who serves as the Senior Advisor on public health and science issues to the Secretary of Health and Human Services (HHS). The Office serves as the focal point for leadership and coordination across the Department in public health and science; provides direction to program offices within OPHS; and provides advice and counsel on public health and science issues to the Secretary.

  • OPRR

    Office for Protection from Research Risks (DHHS) - See Office for Human Research Protections (OHRP)

  • 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.

  • ORI

    Office of Research Integrity - The Office of Research Integrity promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities. Organizationally, ORI is located in the Office of Public Health and Science (OPHS) within the Office of the Secretary of Health and Human Services (OS).

  • ORU

    Organized Research Unit - An Organized Research Unit (ORU) is an academic agency within the University. ORUs consist of an interdepartmental group of faculty members and students engaged in research, interdisciplinary in focus, involving two or more academic departments or schools. An ORU may not be established if research objectives are essentially the same as any existing department, nor may the offer formal courses or support faculty positions. The purpose of an ORU must be complementary to the academic goals of the University.

  •  

    P

    • 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 patents are effective only within the territories of the United States.

  • Patent Pending

    Term used to inform the public that an application for a patent on that article or process is on file in the Patent Office.

  • Paternalism

    Making decisions for others against or apart from their wishes with the intent of doing them good.

  • PCT

    Patent Cooperation Treaty - The Patent Cooperation Treaty (PCT) created a patent application that is standardized across 115 member countries of which the United States is a designated member. The PCT allows patent applicants to simultaneously seek patent protection for an invention in all 115 countries with the filing of one international patent application.

  • 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.

  • Phase 1 Drug Trial

    Phase 1 trials include the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers; sometimes, where the drug is intended for use in patients with a particular disease, however, such patients may participate as subjects. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. The total number of subjects involved in Phase 1 investigations is generally in the range of 20-80.

  • Phase 2 Drug Trial

    Phase 2 trials include controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well-controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.

  • Phase 3 Drug Trial

    Phase 3 trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug. Phase 3 trials usually involve several hundred to several thousand patient-subjects.

  • Phase 4 Drug Trial

    Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time [21 CFR §312.85].

  • PHS

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

  • PHS 2590

    Application for Continuation of a PHS Grant (National Institutes of Health ).

  • PHS 398

    Application Form for a PHS Grant (National Institutes of Health).

  • PHS Policy

    PHS Policy on Humane Care and Use of Laboratory Animals. Document that implements the Health Research Extension Act of 1985, and governs activities involving animals conducted or supported by PHS agencies.

  • Placebo-controlled study

    A study in which treatment with a placebo is compared with treatment with the test drug. A placebo-controlled trial can be single blind, double blind, or open label. The results of the groups are then compared to see if the test drug in more effective in treating the condition or disorder.

  • Plant Variety Protection Act

    The Plant Variety Protection Act provides legal intellectual property rights protection, to developers of new varieties of plants that are sexually reproduced (by seed) or are tuber-propagated. Bacteria and fungi are excluded. The PVP act is administered by the United States Department of Agriculture. A Certificate of Protection is awarded to an owner of a variety after an examination shows that it is new, distinct from other varieties, and genetically uniform and stable through successive generations. The term of protection is 20 years for most crops and 25 years for trees, shrubs, and vines. The owner of a U.S. protected variety has exclusive rights to multiply and market the seed of that variety.

  • Postamendments Devices

    Medical devices marketed after enactment of the 1976 Medical Device Amendments.

  • 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)

  • Post-Differential Allowance

    Expenses authorized for employees based abroad to provide additional compensation for services as a recruitment and retention tool. When the allowance is authorized, the employee's base salary is increased accordingly.

  • PRDA

    Program Research and Development Announcement - Similar to a BAA, PRDAs are solicitations for proposal and are intended to be used when the area of interest is more specialized but still has general application and is associated with the needs of a program or programs. It may be appropriate for exploratory research that has general application and is not system specific.

  • Preamendments Devices

    Medical devices marketed before enactment of the 1976 Medical Device Amendments.

  • 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)

  • Preclinical Investigations

    Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans.

  • Predicate Devices

    Currently legally marketed devices to which new devices may be found substantially equivalent under the 510(k) process.

  • Premarket Approval

    Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices.

  • 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.

  • Principal Investigator

    Principal Investigator (PI) - The scientist or scholar responsible for the conduct of research or other activity, described in a proposal for an award. The PI is responsible for all programmatic and administrative aspects of a project or program.

  • 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.

  • Prior Art

    Any publically available subject matter (for example, patents, publications, abstracts, etc.) bearing on the novelty and nonobviousness of a claimed invention.

  • Priority Score

    A numerical rating that reflects the scientific merit of the proposed research relative to the "stae of the science". The score is derived from the rating given a research proposal by each member on a review committee. It is used to help determine which approved proposals will be granted awards, based on funds available.

  • Privacy

    Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

  • Proband

    The person whose case serves as the stimulus for the study of other members of the family to identify the possible genetic factors involved in a given disease, condition, or characteristic.

  • Program Announcement

    Program Announcement - Describes existence of a research opportunity. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program.

  • Program Income

    Gross income earned by a grantee that is directly generated by the grant-supported project or activity or earned as a result of the award.

  • 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.

  • Progress Report

    Periodic, scheduled reports required by the sponsor summarizing research progress to date. Technical, fiscal, and invention reports may be required.

  • Project Period

    Project Period - The total time for which support of a project has been programmatically approved. A project period may consist of one or more budget periods. (See also: Budget Period.)

  • Prophylactic

    Preventive or protective; a drug, vaccine, regimen, or device designed to prevent, or provide protection against, a given disease or disorder.

  • 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 Studies

    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.

  • Protocal 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.

  •  

    Q

    • Quasi-experimental

      A study that is similar to a true experimental study except that it lacks random assignments of subjects to treatment groups. (See also: Experimental Study)

  •  

    R

    • RAC

      Recombinant DNA Advisory Committee - The Recombinant DNA Advisory Committee is the public advisory committee that advises the Department of Healthy and Human Services (DHHS) Secretary, the DHHS Assistant Secretary for Health, and the NIH Director concerning recombinant DNA research.

  • 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.

  • Radiopaque Contrast Agents

    Materials that stop or attenuate radiation that is passed through the body, creating an outline on film of the organ(s) being examined. Contrast agents, sometimes called "dyes," do not contain radioisotopes. When such agents are used, exposure to radiation results only from the X-ray equipment used in the examination. The chemical structure of radiopaque contrast agents can produce a variety of adverse reactions, some of which may be severe, and possibly life-threatening, in certain individuals.

  • Radiopharmaceuticals

    Drugs (compounds or materials) that may be labeled or tagged with a radioisotope. These materials are largely physiological or subpharmacological in action, and, in many cases, function much like materials found in the body. The principal risk associated with these materials is the consequent radiation exposure to the body or to specific organ systems when they are injected into the body.

  • RAS

    Request for Approval to Spend Funds - UCI form used when it is necessary to obtain an account/fund number for an extramurally funded project prior to receipt of the actual award from the sponsor. When appropriate, a RAS form is also completed to request authorization for pre-award spending for a period of no more than 90 days before the actual start date of the award.

  • RDRC

    Radioactive Drug Research Committee - An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. Research involving human subjects that proposes to use radioactive drugs must meet various FDA requirements, including limitations on the pharmacological dose and the radiation dose. Furthermore, the exposure to radiation must be justified by the quality of the study and the importance of the information it seeks to obtain. The committee is also responsible for continuing review of the drug use to ensure that the research continues to comply with FDA requirements, including reporting obligations. The committee must include experts in nuclear medicine and the use of radioactive drugs, as well as other medical and scientific members [21 CFR 36.1].

  • Rebudget

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

  • Recombinant DNA Technologies

    Procedures used to join together DNA segments in a cell-free system (an environment outside a cell or organism). Under appropriate conditions, a recombinant DNA molecule can enter a cell and replicate there, either autonomously or after it has become integrated into a cellular chromosome.

  • Regs

    Short for "regulations."

  • Regulatory Noncompliance

    Failure to adhere to regulations, policies, procedures or special conditions related to the conduct of research. Examples of such noncompliance include, but are not limited to, failure to obtain/maintain approval for research; coercion of human subjects; performing unapproved procedures; and conducting research at unapproved sites.

  • Relatedness

    1) Concept under OMB A-21 that allows a recipient to declare two or more projects to be "related" based upon interrelated theoretical approaches, studies of the same phenomena by same or different techniques, or studies of different phenomena by the same technique. Relatedness then allows a cost allocable to the related projects to be charged to any one or more of the projects/awards, in any proportion. 2) Related to conflict of interest matters, a broadly defined field of interest wherein the work to be performed under a sponsored project or human protocol, and the results therefrom, would reasonable appear to have the potential to affect the financial interests of the investigator or the Entity in which the investigator has a financial interest.

  • REM

    Roentgen Equivalent in Man - The unit of measurement for a dose of an ionizing radiation that produces the same biological effect as a unit of absorbed does (1 rad) of ordinary X-rays. One millirem is equal to 1/1000 of a rem.

  • Remission

    A period in which the signs and symptoms of a disease are diminished or in abeyance. The term "remission" is used when one cannot say with confidence that the disease has been cured.

  • Renewal Proposal

    Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.

  • Respect for Persons

    An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

  • 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.

  • Revision

    A modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.

  • RFA

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

  • RFP

    Request for Proposal - Announcements that specify a topic of research, methods to be used, product to be delivered, and appropriate applicants sought. Proposals submitted in response to RFPs generally result in the award of a contract. Notices of federal RFPs are published in the Commerce Business Daily (CBD).

  • RFQ

    Request for Quotations - A formal request to vendors for a price quotation on equipment or supplies to be purchased.

  • RNA

    Ribonucleic Acid - A chemical found in the nucleus and cytoplasm of cells; it plays an important role in protein synthesis and other chemical activities of the cell. The structure of RNA is similar to that of DNA. There are several classes of RNA molecules, including messenger RNA, transfer RNA, ribosomal RNA, and other small RNAs, each serving a different purpose.

  • RSC

    Radiation Safety Committee - Each of the RSCs ( hospital and campus) is charged with review and approval of procedures that expose humans to radiation.

  •  

    S

    • 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

  • SAMHSA

    Substance Abuse and Mental Health Services Administration - An agency of the Department of Health and Human Services (DHHS) charged with improving the quality and availability of prevention, treatment, and rehabilitative services in order to reduce illness, death, disability, and cost to society resulting from substance abuse and mental illnesses. Includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services. Previously the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). (See also: ADAMHA)

  • SBA

    Small Business Administration - The U.S. Small Business Administration, established in 1953, provides financial, technical and management assistance to help Americans start, run, and grow their businesses.

  • SBIR

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

  • Scientific Misconduct

    Fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the academic community for proposing, conducting or reporting research.

  • Scope of Work

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

  • Senior Personnel

    Professional personnel who are responsible for the scientific or technical direction of project.

  • Servicemark

    The same as a trademark, except that it identifies and distinguishes the source of a service rather than a product.

  • Significant Risk Device

    An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.

  • Single-Masked

    Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."

  • 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.

  • Somatic Cell

    Any cell in the body except gametes and their precursors.

  • Special Purpose Equipment

    Permanent equipment which is usable only for research, medical, scientific, or technical activities. Examples include microscopes, x-ray machines, surgical instruments and spectrometers.

  • SRA

    Society of Research Administrators - Founded in 1967, the Society of Research Administrators International is a nonprofit association dedicated to advancing the profession and improving the efficiency and effectiveness of research administration.

  • SRG

    Scientific Review Group - A group of highly regarded experts in a given field, convened by NIH to advise NIH on the scientific merit of applications for research grants and contracts. Scientific review groups are also required to review the ethical aspects of proposed involvement of human subjects. Various kinds of scientific review groups exist, and are known by different names in different institutes of the NIH (e.g., Study Sections, Initial Review Groups, Contract Review Committees, or Technical Evaluation Committees).

  • SSA

    Social Security Administration - Social Security Administration is a federal agency whose mission is to promote the economic security of the nation's people through compassionate and vigilant leadership in shaping and managing America's social security programs. Virtually all of SSA's administrative resources are committed to the management of three major programs: the Old Age and Survivors Insurance (OASI) program, the Disability Insurance (DI) program, and the Supplemental Security Income (SSI) program.

  • 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 Treatment

    A treatment currently in wide use and/or approved by the FDA, considered to be effective in the treatment of a specific disease or condition.

  • 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.

  • 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.

  • Sundowner Report

    NASA Principles for the Ethical Care and Use of Animals issued in October 1996.

  • Surveys

    Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.

  •  

    T

    • Teaming Agreement

      An agreement between two or more parties to participate in a research project or teaching activity.

  • Technology Transfer

    Technology Transfer is a process involving assessing an invention disclosure (technology), patenting the technology, marketing and finally licensing the technology or forming start-up companies based on the invention.

  • Therapeutic Intent

    The research physician's intent to provide some benefit to improving a subject's condition (e.g., prolongation of life, shrinkage of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected.) This term is sometimes associated with Phase 1 drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient's condition as well as assessing the safety and pharmacology of a drug.

  • 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.

  • TOA

    Task Order Agreement - A legally binding document authorizing work and appropriating funds as a supplement to a basic contract or master agreement.

  • Toxicity

    An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the disease or condition that the drug is used to treat.

  • Trademark

    Trademark is a symbol, design, picture, word, phrase, or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of others. The owner of a trademark has exclusive right to use it on the product it was intended to identify and often on related products and may use the symbol TM to let the public know that the mark is a trademark. The symbol ® can only be used in the United States if the trademark is federally registered with the USPTO.

  • Trade Secret

    Information that companies keep secret to give them an advantage over their competitors. The formula for Coca-Cola is the most famous Trade Secret. No registration is required and the Trade Secret is valid as long as it is kept a secret from the public.

  •  

    U

    • 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.

  • Uniform Anatomical Gift Act

    Legislation adopted by all 50 States and the District of Columbia that indicates procedures for donation of all or part of a decedent's body for such activities as medical education, scientific research, and organ transplantation.

  • 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.

  • United States Provisional Application for a Patent

    A U.S. provisional application for patent (U.S. provisional) is a U. S. national application for patent filed in the USPTO. Contrary to foreign countries, a US provisional can be filed within one year of publically disclosing an invention. However, if the public disclosure occurs before filing the US Provisional, the applicant cannot apply for foreign patent protection therefore, potentially losing the monopoly of selling that technology in those foreign countries. An U.S. provisional has a pendency lasting 12 months from the date the provisional application is filed. The 12-month pendency period cannot be extended. Therefore, an applicant who files a provisional application must file a corresponding non-provisional application (such as a US Utility and/or PCT international patent application) for patent during the 12-month pendency period of the provisional application in order to benefit from the earlier filing of the provisional application.

  • 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.

  • Unsolicited Proposal

    Proposals submitted to a sponsor that are not in response to an RFP, RFA, or program announcement. (See also: Investigator-Initiated Proposal.)

  • UPOV

    International Union for the Protection of New Varieties of Plants - An intergovernmental organization (headquarters located in Geneva (Switzerland)) based on the International Convention for the Protection of New Varieties of Plants. The objective of the Convention is the protection of new varieties of plants by an intellectual property right.

  • USC

    United States Code - The Code is a consolidation and codification by subject matter of the general and permanent laws of the United States. For example, the United States Code includes all of the patent statues (Title 35, beginning at section 1), all of the copyright statues (Title 17, beginning at section 1) and all the trademark statues (Title 15, beginning at section 1051).

  • USDA

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

  • USIA

    United States Information Agency - U.S. Government foreign affairs agency.

  • 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.

  • Utility Patent

    Description of a patent that relates to patent protection of compositions of matter (compounds), useful processes, and machines.

  •  

    V

    • VA

      The U.S. Department of Veterans Affair.

  • VAH

    Veterans Administration Hospital - Health care facility operated by the Department of Veterans Affairs.

  • VCR

    Vice Chancellor for Research - The Institutional Official for human, animal and rDNA research at UCI.

  • Viable Infant

    When referring to a delivered or expelled fetus, the term "viable infant" means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy [45 CFR 46.203(d)]. This judgment is made by a physician. In accordance with DHHS regulations, the Secretary, HHS, may publish guidelines to assist in the determination of viability. Such guidelines were published in 1975, and specify an estimated gestational age of 20 weeks or more and a body weight of 500 grams or more as indices of fetal viability [Federal Register 40 (August 8, 1975): 33552]. These indices depend on the state of present technology and may be revised periodically.

  • Violation

    Accidental or unintentional changes to or noncompliance with the IRB approved protocol that affects the subject's rights, safety, welfare, and/or the integrity of the data.

  • Voluntary

    Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.

  •  

    W

    • Washout Period

      Period of time without active treatment, usually scheduled before the beginning of the placebo and active treatment arms. This can refer to a required period of withdrawal from treatment before active treatment starts.

  • 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.

  • WIPO

    World Intellectual Property Organization - An international organization dedicated to promoting the use and protection of works of intellectual property. With headquarters in Geneva, Switzerland, WIPO is one of the 16 specialized agencies of the United Nations system of organizations. It administers 23 international treaties dealing with different aspects of intellectual property protection. As of the year 2002, the Organization counts 179 nations as member states.

  •  

    Z

    • Zotmail

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

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