Useful Links

On-Line Tools

Glossary of Terms

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z |
© 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literary, dramatic, musical, artistic, architectural, and certain other intellectual works, both published and unpublished.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."
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).
AA Form Administrative Approval Form - An internal routing form used for securing institutional approvals prior to submitting a proposal to a sponsor for funding consideration.
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)
Adenine A nitrogenous base. Pairs with thymine in DNA molecules.
Adjuvant Therapy Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
Adverse Event Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Adverse Reaction (Effect) An undesirable and unintended effect, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
AE Adverse Event - An untoward or undesirable experience or any undesirable experience associated with the use of a medical product/test article in clinical research (See also: Serious Adverse Event and Unexpected Adverse Event).
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.
Agency In relation to sponsored projects, the sponsoring organization that provides funds to support research, training, or public service activities.
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.
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 the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.
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.
Autopsy Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts.
AV 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.
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.
| back to top |
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.
Base Pair Two nitrogenous bases held together by weak bonds. In a DNA molecule adenine always pairs with thymine while cytosine always pairs with guanine. Thus, one DNA strand directs the synthesis of the other strand. This specificity of DNA base pairing is what enables accurate replication of a DNA molecule.
Baseline
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. Bias is controlled by blinding and randomization. See Single-Blind Design, Double-Blind Design, and Randomization.
Biologic Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.
Blind Study Designs See: Masked Study Designs; Double-Masked Design; and Single-Masked Design.
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).
BSO Biological Safety Officer - An individual appointed by an institution to oversee management of biosafety risks. The NIH Guidelines require that a BSO be appointed when the institution is engaged in large-scale research or production activities, or in research requiring containment at BL-3 or BL-4. The duties of the BSO are described in section IV-B-3 of the NIH Guidelines.
BUA Biological Use Authorization - A BUA describes a Principal Investigator's research involving biological agents at UCI. When approved by EH&S, the BUA provides authorization for the PI to conduct research in a "certified laboratory" contingent upon other appropriate UCI regulatory committee approvals.
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. (See also: Rebudget)
Budget Description (or Justification or 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.
Budget Period The interval of time--usually twelve months--into which the project period is divided for budgetary and funding purposes.
| back to top |
C
Cadaver The body of a deceased person.
CAS Cost Accounting Standards - Included in OMB Circular A-21, CAS outlines government requirements for education institutions to use consistent cost accounting practices for classifying, estimating, accumulating and reporting costs for sponsored agreements.
Case-control Study A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors. (See also: Retrospective Studies.)
CAT Scan Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer.
CBD Commerce Business Daily - A daily list of U.S. Government procurement invitations, contract awards, subcontracting leads, sales of surplus property and foreign business opportunities.
CDC Centers for Disease Control and Prevention - An agency within PHS, the Centers for Disease Control and Prevention (CDC) is recognized as the lead federal agency for protecting the health and safety of people - at home and abroad, providing credible information to enhance health decisions, and promoting health through strong partnerships.
Cell The individual units from which tissues of the body are formed. All living organisms are composed of one or more cells.
Certified Translation A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes. Certified translators attest that the target-language text is an accurate and complete translation of the source-language text. Certified translation of consent documents ensures that the tone, meaning and content of the translated documents remain consistent with the IRB-approved English version.
CFDA Catalog of Federal Domestic Assistance - A searchable database of Federal assistance programs.
CFR Code of Federal Regulations - The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.
Challenge Grant A grant that provides monies in response to monies from other sources, usually according to a formula. A challenge grant may, for example, offer two dollars for every one that is obtained from a fund drive. The grant usually has a fixed upper limit, and may have a challenge minimum below which no grant will made. This form of grant is fairly common in the arts, humanities, and some other fields, but is less common in the sciences. A challenge grant differs from a matching grant in at least one important respect: The amount of money that the recipient organization realizes from a challenge grant may vary widely, depending upon how successful that organization is in meeting the challenge. Matching grants usually award a clearly defined amount and require that a specified sum be obtained before any award is made.
Change Order A written order signed by the contracting officer, outlining specific changes to a contract. The change order directs the contractor to make changes as ordered. The changes clause of the contract authorizes the contracting officer to issue change orders without the consent of the contractor.
Children Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.
Chromosome A self-replicating genetic structure, composed primarily of proteins and DNA, which carry nucleotide sequences known as genes.
CIP Continuation-In-Part - When improvements are made to an invention, an applicant can file a new patent application citing the improvement to the original patent application, and that patent application is called a Continuation-In-Part.
CIT Center for Information Technology (NIH) - A NIH Center whose mission is to provide, coordinate, and manage information technology, and to advance computational science.
Claim In the context of intellectual property, a claim or claims must be included in a formal patent application such as an international application for patent (PCT) or non-provisional US application for patent. The claim must clearly and distinctly describe the invention and define the scope of the protection of the patent.
Class I, II, III Devices Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.
Clinic Class of medical instruction; facility for diagnosis and treatment of outpatients.
Clinical Of, or relating to, or conducting in, or as if in, a clinic; involving direct observation of the patient; diagnosable by, or based upon, clinical observation.
clinical investigation Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
Clinical Trial A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.
Clinician One qualified in the clinical practice of medicine, psuchiatry or psychology.
Cloning "The process of asexually producing a group of cells (clones), all genetically identical, from a single ancestor. In recombinant DNA technology, the use of DNA manipulation procedures to produce multiple copies of a single gene or segment of DNA is referred to as cloning DNA."
Cloning vector "DNA molecule originating from a virus, a plasmid, or the cell of a higher organism into which another DNA fragment of appropriate size can be integrated without loss of the vectors capacity for self-replication; vectors introduce foreign DNA into host cells, where it can be reproduced in large quantities. Examples are plasmids, cosmids, and yeast artificial chromosomes; vectors are often recombinant molecules containing DNA sequences from several sources."
Close Out The act of completing all internal procedures and sponsor requirements to terminate or complete a research project.
Cognitively Impaired Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
COGR Council on Governmental Relations - An association of research universities whose primary function is to help develop policies and practices that fairly reflect the mutual interest and separate obligations of federal agencies and universities in federal research and training.
Cohort A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
COI Conflict of Interest - A conflict of interest is a situation in which an employee has the opportunity to influence a University decision that could lead to financial or other personal advantage, or that involves other conflicting official obligations. A conflict of interest can also occur when the conduct of research or other sponsored activities is or has the potential to be influenced by the outside financial interests of an investigator.
COIOC Conflict of Interest Oversight Committee - A faculty committee serving as an advisory to the Vice Chancellor for Research and charged with reviewing conflict of interest matters when a faculty member submits a "Statement of Economic Interests" Form 730-U or a Disclosure of Financial Interests Form with a positive disclosure. A positive disclosure means that the faculty member has a financial or other interest in the sponsor, or in an entity that may impact the conduct of the research proposed.
COLA Cost of Living Allowance - Granted to employees based in a foreign city, where cost of living is higher than in Washington, D.C.
Competence Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. (See also: Incompetence, Incapacity)
Competing Proposals Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired.
Complementary Base Pair A pair of bases in which the identity of one base defines the identity of its partner base. E.g., In a DNA molecule there are two complementary base pairs--Adenine and thymine, and guanine and cytosine.
Confidentiality Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.
Conflict of Commitment An outside activity, whether professional or non-professional, compensated or uncompensated, that interferes with successful performance of the faculty member's or other employee's duties. This is often related to the time and effort of the individual.
Consent See: Informed Consent.
Consortium Agreement Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.
Consultant Individuals hired to give professional advice or services for a fee but not as an employee of the University. Consultants do not perform a portion of the programmatic work. University personnel may not serve as paid consultants on grants or contracts awarded to UCI.
Continuation Project (Non-Competing) Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects do not compete with new project proposals and are not subjected to peer review beyond the initial project approval.
Contract A mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Typically, a research topic and the methods for conducting the research are specified in detail by the sponsor, although some sponsors award contracts in response to unsolicited proposals. An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant. (Compare: Grant)
Contract and Grant Accounting Under the Vice Chancellor for Administrative and Business Services, Contract and Grant Accounting is the campus office responsible for financial oversight of extramural funds, for receiving actual contract and grant monies, preparing monthly ledgers, submitting invoices, and for submitting official financial reports related to extramural awards.
Contracting Officer A sponsor's designated individual who is officially responsible for the business management aspects of a particular contract. Serving as the counterpart to UCI's Contracts Officer, the contracting officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a contract and interprets the associated administration policies, regulations, and provisions. (For definition of scientific officer, see Program/Project Officer.)
Contracts Officer UCI's designated institutional official responsible for the institutional administrative aspects of a particular contract or subcontract. Serving as the counterpart to the sponsor's contracting officer, the Contracts Officer is responsible for all institutional administrative matters associated with the review and approval of contract proposals, negotiation, acceptance and execution of contract awards, administration of institutional oversight and compliance with contract terms and conditions, and interpretation of associated institutional and sponsor policies, regulations, and provisions.
Contraindicated Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).
Control (Subjects) or Controls Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
Cooperative Agreement An award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.
Correlation Coefficient A statistical index of the degree of relationship between two variables. Values of correlation coefficients range from -1.00 through zero to +1.00. A correlation coefficient of 0.00 indicates no relationship between the variables. Correlations approaching -1.00 or +1.00 indicate strong relationships between the variables. However, casual inferences about the relationship between two variables can never be made on the basis of correlation coefficients, no matter how strong a relationship is indicated.
COS Community of Science - A web server containing information about scientific expertise, funded scientific research, and funding opportunities for research.
Cost-Reimbursement Type Contract/Grant A contract/grant for which the sponsor pays for the full costs incurred in the conduct of the work up to an agreed-upon amount.
Cost-Sharing A general term, used as a noun or adjective, that can describe virtually any type of arrangement in which more than one party supports research, equipment acquisition, demonstration projects, programs, institutions. Example: A university receives a grant for a project estimated to have a total cost of $100,000. The sponsor agrees to pay 75% ($75,000) and the university agrees to pay 25% ($25,000). The $25,000 is the cost-sharing component.
CPRA California Public Records Act - State of California's legislative code that gives the public the right to request, in writing, public records. Similar to the federal Freedom of Information Act.
CRADA or CRDA Cooperative Research and Development Agreement - A written agreement between a private company and a government agency to work together on a project. By entering into a CRADA, the Federal government and non-Federal partners can optimize their resources and cost-effectively perform research by sharing the costs of this research. The collaborating partner agrees to provide funds, personnel, services, facilities, equipment, or other resources needed to conduct a specific research or development effort while the Federal government agrees to provide similar resources but not funds directly to the partner.
CRFA Clinical Research Finance Assessment - An administrative office at UCIMC that reviews proposed study budgets to ensure full costing of clinical trials. If a study involves biomedical interventions and may use UCIMC facilities or resources (including the Plaza and satellite clinics), financial review by the CRFA is required prior to initiation of research procedures.
Cross-over Design A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.
CSR Center for Scientific Review (NIH) - CSR is the focal point at NIH for the conduct of initial peer review, the foundation of the NIH grant and award process. The Center carries out peer review of the majority of research and research training applications submitted to the NIH. Formerly know as the Division of Research Grants (DRG).
CTPRMC Comprehensive Cancer Center (CCC) Clinical Trials Protocol and Review Committee - Due to NIH funding requirements for our comprehensive cancer center designation, investigators wishing to conduct research about cancer, precancerous conditions, or cancer prevention must submit their human research protocols for CTPRMC review prior to applying for IRB review.
Cytoplasm It consists of a continuous aqueous solution (cytosol) and the organelles and inclusions suspended in it (phaneroplasm) and is the site of most of the chemical activities of the cell. The cytoplasm creates proteins.
Cytosine A nitrogenous base. Pairs with guanine in DNA molecules.
| back to top |
D
DAR Defense Acquisition Regulations - The source regulations for research projects sponsored by the Department of Defense.
DC 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.
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.
Dead Fetus An expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached). Generally, some organs, tissues, and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead.
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."
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.
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).
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.
More complete information can be found here: http://www.cirm.ca.gov/RFA/rfa_08-05/default.asp
Developmental Research Systematic use of scientific and technical knowledge in the design, development, testing or evaluation of a potential new product or service.
Deviation An incident involving noncompliance with the protocol, but one that does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the data. Deviations may result from the action of the participant, Researcher, or staff. Note: changes or deviations in the protocol due to study participants' non-adherence are not IRB reportable incidents unless it adversely affects the safety and welfare of the participants.
Device (Medical) See: Medical Device.
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.
Diagnostic (procedure) Tests used to identify a disorder or disease in a living person.
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.
DNA Deoxyribonucleic Acid - The molecule that encodes genetic information. DNA is a double-stranded molecule held together by weak bonds between base pairs of nucleotides. The four nucleotides in DNA contain the bases: adenine (A), guanine (G), cytosine (C), and thymine (T). In nature, base pairs form only between A and T and between G and C; thus the base sequence of each single strand can be deduced from that of its partner.
DNA Helix The helical structure assumed by two strands of deoxyribonucleic acid, held together throughout their length by hydrogen bonds between bases on opposite strands, referred to as Watson-Crick base pairing; The shape that two linear strands of DNA assume when bonded together.
DNA Sequence The relative order of base pairs, whether in a fragment of DNA, a gene, a chromosome, or an entire genome.
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. (Also see: Gift)
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-masked Design A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes 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 humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.
Drug Research The scientifically designed experimental study of the action of drugs or potentially beneficial effect. Initial testing of a drug is usually performed on animals. Before research on a new drug in human beings may be conducted, the sponsor must submit an informative proposal to the FDA. This is the Notice of Claimed Investigational Exemption for a New Drug (IND).
DSMB Data and Safety Monitoring Board/Committee (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.
DSRC Dean's Scientific Review Committee - SOM committee that provides scientific peer review prior to IRB review for all clinical studies that do not otherwise undergo peer review.
| back to top |
E
EDISON EDISON - NIH Extramural Invention Information Management System - Interagency Edison supports a "Common Face" for Invention Reporting to the Government. The system has been designed to facilitate grantee/contractor institutions with the compliance of laws and regulations mandated by the Bayh-Dole Act whose purpose is to ensure transfer of technology from the research laboratory to the commercial/public sector.
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.
Eligibility criteria Summary criteria for study participation. Includes inclusion and exclusion criteria. (See also: Inclusion and exclusion criteria.)
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. (See also: Mature Minor)
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 (i.e., from conception to the eighth week of pregnancy). (See also: Fetus)
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.
Epidemiology A scientific discipline that studies the factors determining the causes, frequency, and distribution of diseases in a community or given population.
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.
Equipment Defined by UCI as an article of nonexpendable, tangible personal property having a useful life of more than one year and an acquisition cost of $5000 or more per unit. (See also: General Purpose Equipment and Special Purpose Equipment)
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. (For more information, link to NCURA or ERA Task Force)
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)
Eukaryote Cell or organism with membrane-bound, structurally discrete nucleus and other well-developed subcellular compartments. Eukaryotes include all organisms except viruses, bacteria, and blue-green algae. Compare prokaryote. See chromosome.
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 Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness. (See also: 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. (See also: Quasi-Experimental Study)
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 IRB authority).
| back to top |
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 is 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.
FDA Advisory Councils Groups of experts which provide advice and recommendations to the FDA.
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.
Federal Policy (The) 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. (Also known as the "Common Rule.")
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.
FEDIX On-line federal database serving most federal agencies for on-line searches.
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. (See also: Embryo)
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). (See also: Ethnographic Research)
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. Disclosures are required under requirements promulgated by federal and state agencies and the Institutional Review Board.
Firm Commitment An oral or written representation by the appropriate sponsor official that a formally executed award is forthcoming.
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."
Form 730-U Also referred to as SEI - Statement of Economic Interests. Form key personnel must complete and submit to the Conflict of Interest Coordinator for review when submitting research proposals to certain non-government agencies.
FP Fixed-Price Contract/Grant - 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. Quite often this is a fee-for-service agreement.
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.
Full Board/Committee Review Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
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.
FY Fiscal Year - Any twelve-month period for which annual accounts are kept (at UCI, July 1 through June 30).
| back to top |
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.
Gene The fundamental physical and functional unit of heredity. A gene is an ordered sequence of nucleotides located in a particular position on a particular chromosome that encodes a specific functional product (i.e., a protein or RNA molecule).
Gene Expression The process by which a gene's coded information is converted into the structures present and operating in the cell. Expressed genes include those that are transcribed into mRNA and then translated into protein and those that are transcribed into RNA but not translated into protein (e.g., ribosomal RNAs).
Gene Therapy The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells.
General Assurance Obsolete term, previously used to denote an institutional assurance covering multiple research projects. (See also: Assurance)
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.
GENIUS Global Expertise Network for Industry, Universities and Scholars - GENIUS is a WWW network of profiles entered and maintained by scholars and researchers at leading universities and research institutions throughout the world.
Genome All the genetic material in the chromosomes of a particular organism; its size is generally given as its total number of base pairs.
Genotype The genetic constitution of an individual.
Germ-line Cell A type of cell specifically involved in reproduction.
Germ-line Gene Therapy Gene therapy in which the therapeutic DNA that is introduced is inherited by subsequent generations, i.e. the sperm or egg DNA is irrevocably modified by the therapy.
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. (Also see: Donation)
GPG Grant Proposal Guide for the National Science Foundation. - The Grant Proposal Guide (GPG) provides guidance for the preparation and submission of proposals to NSF.
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. (Compare: Contract)
Grant Management Specialist (or Officer) A sponsor's designated individual who is officially responsible for the business management aspects of a particular grant or cooperative agreement. Serving as the counterpart to UCI's Grants Officer, the grant management specialist is responsible for all business management matters associated with the review, negotiation, award, and administration of a grant or contract and interprets the associated administration policies, regulations, and provisions. (For definition of scientific officer; see Program/Project Officer)
Grants Officer UCI's designated institutional official responsible for the institutional administrative aspects of a particular grant or cooperative agreement. Serving as the counterpart to the sponsor's grants management specialist, the Grants Officer is responsible for all institutional administrative matters associated with the review and approval of grant and cooperative agreement proposals, negotiation, acceptance and execution of these awards, administration of institutional oversight and compliance with award terms and conditions, and interpretation of associated institutional and sponsor policies, regulations, and provisions.
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.
Guanine A nitrogenous base. Pairs with cytosine in DNA molecules.
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 Guide for the Care and Use of Laboratory Animals - Manual of standards for animal care and use developed under the auspices of the Institute for Laboratory Animal Research.
| back to top |
H
Helsinki Declaration See: Declaration of Helsinki.
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 in Vitro Fertilization Any fertilization involving human sperm and ova that occurs outside the human body.
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.
Hypothesis A tentative assumption that is made for the purpose of empirical scientific testing. A hypothesis becomes a theory when repeated testing and evidence suggests the hypothesis has a strong chance of being correct.
| back to top |
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.
iCOI Institutional Conflict of Interest - Definition is under discussion at the national level at the present time. A common understanding is that an institutional conflict of interest (iCOI) occurs when the university, members of senior administration (chairs, deans, vice chancellors, directors), or affiliated organizations have a financial interest in a company that is associated with university research that may financially benefit the institution. Examples include, but are not limited to, grant and contract dollars, license fees and royalty payments, gifts to the institution, investments in start-up companies associated with faculty inventions, research relationships with companies that make significant contributions for facilities or endowed chairs, or stock ownership in companies that conduct research at the university. The COIOC does not routinely review iCOI.
IDC Indirect Costs - Costs related to expenses incurred in conducting or supporting research or other externally-funded activities but not directly attributable to a specific project. General categories of indirect costs include general administration (accounting, payroll, purchasing. etc.), sponsored project administration, plant operation and maintenance, library expenses, department administration expenses, depreciation or use allowance for buildings and equipment, and student administration and services. (See also: Facilities and Administrative Costs)
IDE Investigational Device Exemptions - Exemptions granted by the FDA from certain regulations that allow use of unapproved devices for testing in clinical investigations. Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations.
IFB Invitation for Bid - A solicitation issued to prospective bidders. An IFB describes what is required and how the bidders will be evaluated. Award is based on the lowest bid. Negotiations are not conducted.
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.
In Vitro Literally, "in glass" or "test tube;" used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
In Vivo Literally, "in the living body;" processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).
In-Kind Contributions or assistance in a form other than money. Equipment, materials, or services of recognized value that are offered in lieu of cash.
Incapacity Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. (See also: Incompetence)
Inclusion and 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.
Incompetence Technically, a legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity. (See also: 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.
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.
Institution (1) Any public or private entity or agency (including federal, state, and local agencies).
Institution (2) A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.
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).
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 IRB authority). In the context of a single-site study, all adverse events would be considered internal adverse events.
Interpreter A qualified interpreter is an individual who is fluent (can speak, read and write) in English and the language of the subject, and (preferably) understands human research informed consent requirements.
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. (See also: Lead Researcher and Principal Investigator)
Investigator-Initiated Proposal A proposal submitted to a sponsor that is not in response to an RFP, RFA, or a specific program announcement.
IO Institutional Official - The individual who signs and has the authority to sign the institution's Assurances, making a commitment on behalf of the institution that federal regulations and policies with be followed. The Institutional Official at UCI is the Vice Chancellor for Research.
IP Intellectual Property - Any product of the human intellect that is unique, novel, and unobvious and has some value in the marketplace. Some intellectual property is protectable by statute or legislation, such as patents, copyrights, trademarks, trade secrets, service marks, and plant variety protection certificates. Protection of IP also occurs through agreements that control use of intellectual property.
IRB Institutional Review Board - A faculty committee charged with reviewing and approving the use of human subjects in all research projects to ensure that the safety and welfare of subjects are protected. The IRB serves as an institutional compliance committee and is responsible for reviewing reported instances of regulatory noncompliance related to the use of human subjects in research. At UCI, there are three IRB committees: two review biomedical research and the third reviews social/behavioral research.
IRG Integrated Review Group - Term used by NIH in relation to peer review. A cluster of study sections responsible for the review of grant applications in scientifically related areas. These study sections share common intellectual and human resources.
IRIS Illinois Researcher Information Service - An on-line search system available by subscription for research opportunities developed by the University of Illinois.
IRU Irvine Research Unit - An Irvine Research Unit (IRU) is established by the Irvine campus of the University of California for the purpose of initiating and sustaining collective research endeavors. The rationale for establishing an IRU may include: attracting greater recognition for a research program at UCI and/or providing a formal infrastructure for research development that promotes synergistic interactions between a group of researchers within a school or across schools. The research purposes of the IRU must be complementary to the academic goals of the University. An IRU may not have jurisdiction over courses or curricula and cannot offer formal courses for credit. However, an IRU may perform other academic functions ordinarily carried on by Departments; e.g., organize research conferences and meetings, advise on graduate curricula, help professors provide guidance for graduate students, and manage training programs in conjunction with a department of instruction. It may employ graduate students and conduct other administrative activities in the pursuit of its goals.
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. IUCRP includes Biotechnology STAR (BioSTAR), Digital Media Innovation (DiMI), Communications Research Program (CoRe), Life Sciences Informatics (LSI), and UC Semiconductor Manufacturing Alliance for Research and Training (UC-SMART).
| back to top |
J
Justice An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
| back to top |
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.
| back to top |
L
Lactation The period of time during which a woman is providing her breast milk to an infant or child.
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.
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.
LOD Score An expression of the probability that a gene and a marker are linked.
Longitudinal Study A study designed to follow subjects forward through time.
LR Lead Researcher - 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.
| back to top |
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 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 "blind" study designs. (See also: Double-Masked Design and Single-Masked Design)
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. The required match may be more or less than the amount of the grant. Some matching grants require that the additional funds be obtained from sources outside the recipient organization. Many matching grants are paid in installments, the payments coinciding with the attainment of pre-specified levels of additional funding. Matching grants are very common in the sciences, especially for equipment. They are standard practice in some government agencies. (Also see: Challenge Grant)
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. (See also: 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
  • The withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
Meiosis The process of cell division in which a single cell produces four daughter cells each of which contains half of the number of chromosomes of the parent cell. For example, a single diploid spermatogonium (primordial germ cell) will divide meiotically to produce 4 haploid sperm cells.
Mentally Disabled See: Cognitively Impaired.
Metabolism (of a drug) The manner in which a drug is acted upon (taken up, converted to other substances, and excreted) by various organs of the body.
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.
Misconduct in Science Fabrication, plagiarism, falsification or destruction of data, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
Mission A sponsor's stated purpose, which is designed to address a specified set of problems. Almost all federal research agencies are designated as mission agencies.
Mitosis The process of nuclear division in cells that produces daughter cells that are genetically identical to each other and to the parent cell.
Modification An award document that modifies any aspect of an existing award other than those named above. Example: Carryover approvals, adding or deleting special terms and conditions, changes in funding levels (including NSF's Research Experience for Undergraduates, NIH's Minority Supplement, DoD's ASSERT Programs), administrative changes initiated by the agency, extensions that include changes in terms, change of principal investigator, etc.
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.
mRNA Messenger RNA - RNA that serves as a template for protein synthesis.
MRU Multi-campus Research Unit - Organized Research Units that exist on two or more campuses.
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.
| back to top |
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.
Naked DNA Pure, isolated DNA devoid of any proteins that may bind to it.
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 of 1996 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