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literary, dramatic, musical, artistic, architectural, and certain other intellectual works, both published and unpublished.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 pre-market 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 (NIP)Form - An internal routing form used for securing institutional approvals prior to submitting a proposal to a sponsor for funding consideration.
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 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).
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.
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 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.
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 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.)
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.
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.
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 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.
Animal Welfare Regulations - USDA regulations that implement the Animal Welfare Act.
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 PVAMU. When approved by EH&S, the BUA provides authorization for the PI to conduct research in a "certified laboratory" contingent upon other appropriate PVAMU 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.
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.
Commerce Business Daily - A daily list of U.S. Government procurement invitations, contract awards, subcontracting leads, sales of surplus property and foreign business opportunities.
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.
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 be tendered. 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. Additionally, time limits for achieving the challenge goal may affect the award and distribution
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.
Center for Information Technology (NIH) - A NIHCenter 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 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, psychiatry 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.
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.
Conflict of Interest Oversight Committee - A faculty committee serving as an advisory to the Vice President for Research and charged with reviewing conflict of interest matters when a faculty member submits a "Statement of Economic Interests" Form 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 an international 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 PVAMU.
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 President for Research and Development, the Office of Sponsored Projects and the Prairie View Research Foundation 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 PVAMU'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
PVAMU'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.
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.
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.
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.
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).
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.
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.
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).
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.
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 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.
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.
Department of Energy - The Department of Energy's overarching mission is enhancing national security. This is a federal agency that provides technical support and entertains requests for solicited and unsolicited funding.
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.
Department of Interior - The Department of the Interior (DOI) is the nation’s principal conservation agency. Their mission is to protect American national treasures for future generations, provide access to our nations 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)
Department of Transportation - The mission of DOT is to serve the 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.
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 - PVAMU 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)
