Glossary

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©

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literary, dramatic, musical, artistic, architectural, and certain other intellectual works, both published and unpublished.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

32P

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

35S

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

510(K) Device

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

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 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 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.

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 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.

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.

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.

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 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.

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 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.

COIOC

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.

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.

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.

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.

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.

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. 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.

DOI

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)

DOT

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.

E

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)

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 PVAMU as an article of nonexpendable, tangible personal property having a useful life of more than one year and an acquisition cost of $1,500 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 or minimal risk to human subjects. There are six (6) federally-defined exempt categories. PVAMU 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.

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 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-PVAMU, 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.”

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 PVAMU employees in proposal budgets.

Full Board/Committee Review

Review of proposed research at a convened meeting at which a majority or quorum 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 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 PVAMU, August 31 through July 31).

G

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 (non-reproductive) or germline (reproductive) cells.

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.

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 Administrator)

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 PVAMU’s Sponsored Projects Administrator, 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

PVAMU’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 implement 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 federal Institute for Laboratory Animal Research (ILAR).

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.

I

IACUC

Institutional Animal Care and Use Committee – A faculty and staff membership committee charged with reviewing and approving the use of animal subjects in research and teaching activities. The IACUC serves as a federal mandated 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 federally mandated faculty and staff membership 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 presidents, 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 PVAMU, 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.

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 PVAMU is the Vice President for Research and Development.

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 federally mandated committee charged with reviewing and approving the involvement of human subjects/participants 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 involvement of human subjects/participants in research. At PVAMU, there is one IRB committee to review biomedical research and 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.

Illinois Researcher Information Service – An on-line search system available by subscription for research opportunities developed by the University of Illinois.

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.

K

Key Personnel

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

L

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 PVAMU study protocol, whether or not acting as the Principal Investigator for the award that funds said study.

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/participants, 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 Texas 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 PVAMU, the basic indirect costs are calculated on a subset of direct costs, normally excluding among other costs, equipment, patient care, space rental, alterations and renovations, and subcontract costs in excess of the first $25,000.

N

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.

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 are now embodied in federal regulations.

NCI

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

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

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

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

NDA

New Drug Application – Request for FDA approval to market a new drug.

NEA

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

Necrosis

Death of cells or tissues through injury or disease, especially in a localized area of the body.

NEH

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

NEI

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

New and Competing Proposals

Proposals that are submitted for the first time or ongoing projects that must recompete for funding prior to expiration of the original award.

New Award

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

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

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

NIA

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

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

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

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

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

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

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

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

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

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

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

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

NIH

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

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

National Institute of Neurological Disorders and Stroke (NIH) – An institute in NIH. The mission of NINDS is to reduce the burden of neurological disease-a burden borne by every age group, by every segment of society, by people all over the world.

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

Nitrogenous Base

A molecule with the properties of a base, which also contains the element nitrogen.

NLM

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

No Cost Time Extension

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

NOGA or NGA

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

Nonaffiliated Member

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

Nonsignificant Risk Device

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

Nontherapeutic Research

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

Nonviable Fetus

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

Normal Volunteers

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

NPR

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

NSF

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

Nucleic Acid

A large molecule composed of repeating nucleotides.

Nucleotide

A subunit of DNA or RNA consisting of a nitrogenous base (adenine, guanine, thymine, or cytosine in DNA; adenine, guanine, uracil, or cytosine in RNA), a phosphate molecule, and a sugar molecule (deoxyribose in DNA and ribose in RNA). Thousands of nucleotides are linked to form a DNA or RNA molecule. See DNA, base pair, RNA.

Nucleus

The cellular organelle in eukaryotes that contains the genetic material.

Null Hypothesis

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

Nuremberg Code

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

O

OBA

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

Objectivity in Research

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

Off-Label use

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

Off-Site Research

Any research that takes place at a site other than PVAMU main campus or College of Nursing, Houston facility.

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

OHP

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

Office for Human Research Protections (formerly known as OPRR – Office for Protection from Research Risks) – An office within the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. (formerly Office for Protection from Research Risks [OPRR]) The office within the National Institutes of Health, an agency of the Public Health Service, Department of Health and Human Services, responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects.

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

OMA

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

OMB

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

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

ONR

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

OPAS

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

Open Design

An experimental design in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned.

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

OPRR

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

ORA

Office of Research Administration – Part of Research and Graduate Studies, ORA consists of two divisions: Sponsored Projects and Research Protections. ORA reports to the Vice Chancellor for Research, who is also the Dean of Graduate Studies.

Waller County Census

According to the U.S. Census Bureau, the 2000 census of Population and Housing breaks down Waller County’s population as: 15% Asian/Pacific; 2% Black; 32% Latino ; 51% White. To achieve a balance of subjects, recruitment efforts in various media and in languages other than English should be used.

Organelles

Subcellular particles of membrane-bound organized living substances present in practically all eukaryotic cells, including mitochondria, the golgi complex, endoplasmic reticulum, lysosomes, centrioles and the cell center, as well as the plastids of plant cells. Includes also the minute organs of protozoa concerned with such functions as locomotion and metabolism.

ORI

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

ORU

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

P

PA

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

Patent

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

Patent Pending

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

Paternalism

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

PCT

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

Peer Review

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

Pentose Sugar

A sugar molecule containing five carbon atoms. E.g.: deoxyribose.

Percentile

As used by NIH in relation to peer review: represents the relative position or rank of each priority score (along a 100.0 percentile band) among the scores assigned by a particular study section.

Permission

The agreement of parent(s) or guardian to the participation of their child or ward in research.

Phage

A virus which infects a bacterial cell. Also called a Bacteriophage.

Pharmacokinetics

The action of drugs or vaccines in the body including the processes of absorption, distribution to the tissues, duration of action, and elimination.

Pharmacology

The scientific discipline that studies the action of drugs on living systems (animals or human beings).

Phase 1 Drug Trial

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

Phase 1, 2, 3, 4 Drug Trials

Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phase 3), to post-marketing studies (Phase 4).

Phase 2 Drug Trial

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

Phase 3 Drug Trial

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

Phase 4 Drug Trial

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

Phenotype

(1) the observable physical or biochemical characteristics of an organism, as determined by both genetic makeup and environmental influences; (2) the expression of a specific trait, such as stature or blood type, based on genetic and environmental influences.

PHS

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

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

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

PHS Policy

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

PI

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

Placebo-controlled study

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

Plasmid

A small, independently replicating, piece of extrachromosomal cytoplasmic DNA that can be transferred from one organism to another. Linear or circular DNA molecules found in both pro and eukaryotes capable of autonomous replication.

Post-Award

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

Post-Differential Allowance

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

Postamendments Devices

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

PP

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

PRDA

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

Pre-Award

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

Pre-Proposal

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

Preamendments Devices

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

Preclinical Investigations

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

Predicate Devices

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

Pregnancy

The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i. e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test. This “confirmation” may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.

Premarket Approval

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

President’s Commission

President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. An interdisciplinary advisory group, established by congressional legislation in 1978, which was in existence until 1983, and which issued reports on ethical problems in health care and in research involving human subjects.

Prime Award

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

Principles

Government Principles – Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. Nine principles that provide a foundation for humane care and use of animals in the .

Prior Approval

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

Prior Art

Any publicly available subject matter (for example, patents, publications, abstracts, etc.) bearing on the novelty and non-obviousness of a claimed invention.

Priority Score

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

Prisoner

An individual involuntarily confined in a penal institution, including persons: (l) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.

Privacy

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

Proband

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

Program Income

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

Program/Project Officer

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

Progress Report

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

Prokaryote

Cell or organism lacking a membrane-bound, structurally discrete nucleus and other subcellular compartments. Bacteria are prokaryotes. Compare eukaryote. See chromosome.

Prophylactic

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

Proposal

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

Prospective Studies

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

Protein

A large molecule composed of one or more chains of amino acids in a specific order; the order is determined by the base sequence of nucleotides in the gene coding for the protein. Proteins are required for the structure, function, and regulation of the body cells, tissues, and organs, and each protein has unique functions. Examples are hormones, enzymes, and antibodies.

Protocol

The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.

Purine

A nitrogen- containing, single ring compound that occurs in nucleic acids. In DNA molecules, the purines are adenine and guanine.

Purity

The relative absence of extraneous matter in a drug or vaccine that may or may not be harmful to the recipient or deleterious to the product.

PVPA or PVP

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

Pyrimidine

A nitrogen containing, double ring compound that occurs in nucleic acids. In DNA molecules, the pyrimidines are cytosine and thymine.

Q

Quasi-experimental Study

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

R

RAC

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

Radioactive Drug

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

Radiopaque Contrast Agents

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

Radiopharmaceuticals

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

Random, Random Assignment, Randomization, Randomized

Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.

RAS

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

rDNA

Recombinant DNA Molecules – Molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from their replication; A combination of DNA molecules of different origin that are joined using recombinant DNA technologies.

RDRC

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

Rebudget

The act of amending the budget by moving funds from one category or line item to another. (See also: Budget Adjustment) Some funding agencies require prior approval before rebudgeting can occur.

Recombinant DNA Technologies

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

Regs

Short for “regulations.”

Regulations

The contractual rules and procedures governing sponsored research projects.

Regulatory Noncompliance

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

Related

An event is “related” if it is more likely than not to have been caused by the research procedures.

Relatedness (1)

Concept under OMB A-21 that allows a recipient to declare two or more projects to be “related” based upon interrelated theoretical approaches, studies of the same phenomena by same or different techniques, or studies of different phenomena by the same technique. Relatedness then allows a cost allocable to the related projects to be charged to any one or more of the projects/awards, in any proportion.

Relatedness (2)

2) Related to conflict of interest matters, a broadly defined field of interest wherein the work to be performed under a sponsored project or human protocol, and the results there from, would reasonable appear to have the potential to affect the financial interests of the investigator or the Entity in which the investigator has a financial interest.

REM

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

Remission

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

Renewal

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

Research

A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.

Respect for Persons

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

Retrospective Studies

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

Review (of research)

The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis [Federal Policy ß .108(e)].

Revision

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

RFA

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

RFP

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

RFQ

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

RGS

Research and Graduate Studies – The Mission of the Office of Research and Graduate Studies is to support, facilitate and promote world-class graduate education, research and technology transfer with integrity.

Risk

The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both magnitude of possible harm may vary from minimal to significant. define only “minimal risk.” (See also: Minimal Risk)

Risk/Benefit ratio

The risk to a participant versus the potential benefits; the risk/benefit ratio differs depending on the nature of the research. The principle of beneficence requires a systematic assessment of all possible harms, including physical, psychological, social, and economic. The principle of beneficence requires both protecting participants against risk of harm and consideration of not only the benefits for the participant, but also the societal benefits that might be gained from the research.

RNA

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

RCP

Research Compliance Protections – A division of the Office of the Vice President for Research and Development. RCP staff liaise with federal officials, serve in an advisory role to university executive management and manage the University’s programs for human subjects, animal subjects, rDNA, and conflict of interest. This includes supporting PVAMU’s Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), and the Conflict of Interest Oversight Committee (COIOC). The staff provide training/education and advice in writing applications and consent forms, process protocols to be reviewed by the Committees, and maintain documentation of the protocol review and approval as required by Federal regulatory agencies. The Compliance Unit provides broad scale and individual consultation and to researchers related to these compliance activities.

RSC

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

S

S & W

Salaries and Wages – Payments made to employees of the institution for work performed.

SR

Safety Report – Alert issued to inform researchers using same the pharmacological compound about unanticipated, serious, negative experience in patients/participants who are not necessarily enrolled as subjects on a given PVAMU study. These reports usually are issued by the U.S. Food and Drug Administration (FDA) or by a drug/device manufacturer.

SAE

Serious Adverse Event – Any adverse event that results in any of the following outcomes:

·Death;

·Life-threatening adverse event;

·Inpatient hospitalization or prolongation of existing hospitalization;

·A persistent or significant disability/incapacity;

·A congenital anomaly/birth defect; or

·Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

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

SBA

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

SBIR

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

Scientific Misconduct

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

Secretary

A U.S. Cabinet Officer. In the context of DHHS-conducted or -supported research, usually refers to the Secretary of Health and Human Services.

Serious

An event is “serious” if it adversely alters the risk-benefit relationship of the research.

Senior Personnel

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

Significant Risk Device

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

Single-Masked Design

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

Site Visit

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

SM

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

Small Grant

A special type of award, often limited to a beginning researcher. Typically, such an award may be obtained for one year only.

SPIN Matching and Researcher Transmittal System – An electronic matching and funding opportunity notification which provides investigators with a direct and targeted electronic link to funding information via e-mail.

Social Experimentation

Systematic manipulation of, or experimentation in, social or economic systems; used in planning public policy.

Somatic Cell

Any cell in the body except gametes and their precursors.

SOW

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

SP and Research Foundation

Sponsored Projects and PVAMRF- A division of the Office of Research and Sponsored Projects. SP staff are the sole point of contact for research and sponsored project activity either pre- award or post award for PVAMU responsible for reviewing and submitting contract and grant proposals, accepting grants, and negotiating contracts for extramurally-funded research, training, and public service projects on behalf of the University. SP staff act as PVAMU’s institutional official in matters involving the sponsor’s awarding office. SP and RF are also responsible for post-award activities, such as approving certain actions delegated to the campus by sponsors, obtaining sponsor approvals as required, resolving issues that arise during the project period, reviewing consultant agreements, and assuring compliance with University and sponsor policies and regulations. SP staff review for legal sufficiency and execute subcontracts with other institutions for performance of a portion of the scope of work under contracts and grants awarded to the University. Working with University Development, SP and RF coordinate proposal and award activity involving private entities and is responsible for the review and classification of income to the University.

Special Purpose Equipment

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

Sponsored Programs Information Network – An on-line search system available by subscription for research opportunities developed by the InfoEd.

Sponsor (1)

The organization or entity that funds a research project.

Sponsor (2) (of a drug trial)

A person or entity that initiates a clinical investigation of a drug, usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials. The drug is administered to subjects under the immediate direction of an investigator who is not also a sponsor. A clinical investigator may, however, serve as a sponsor-investigator. The sponsor assumes responsibility for investigating the new drug, including responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.

Sponsor Investigator

An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies, or other institutions do not qualify as sponsor-investigators.

SRA

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

SRG

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

SSA

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

Standard of Care

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

Standard Treatment

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

Statistical Significance

A determination of the probability of obtaining the particular distribution of the data on the assumption that the null hypothesis is true. Or, more simply put, the probability of coming to a false positive conclusion. [See McLarty (1987), p. 2.] If the probability is less than or equal to a predetermined value (e.g., 0.05 or 0.01), then the null hypothesis is rejected at that significance level (0.05 or 0.01).

Sterility (1)

The absence of viable contaminating microorganisms; aseptic state.

Sterility (2)

The inability to procreate; the inability to conceive or induce conception.

Stipend

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

STTR

Small Business Technology Transfer – Grant applications and/or programs to fund small business “teamed” with research institutions.

Study Section

See: Scientific Review Group

Subcontract, Subaward, Subgrant, or Subagreement

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

Subjects (Human)

See: Human Subjects.

Subs

Short for subcontractors.

Summary Statement

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

Sundowner Report

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

Supplemental (Rebudgeting or Modification) Proposal

A request to the sponsor for additional funds for an ongoing project during the previously approved performance period. A supplemental proposal may result from increased costs, modifications in design, or a desire to add a closely related component to the ongoing project.

Surveys

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

T

T Phages

A phage which infects Escherichia coli. Viral parasites of this type are labeled T1 through T7. T2 was the first phage observed under the electron microscope.

TDC

Total Direct Costs – The total of all allowable direct costs of a project.

Teaming Agreement

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

Technical Data

Recorded information, regardless of form or characteristic, of a scientific or technical nature. Often referred to as the “science” of a proposal.

Technology Transfer

Technology Transfer is a process involving assessing an invention disclosure (technology), patenting the technology, marketing and finally licensing the technology or forming start-up companies based on the PVAMU technology. At PVAMU, technology transfer is the mission of the Office of Technology Alliances (OTA).

Templates

Facsimiles of agency forms created with common software (MS Word, Excel, WordPerfect, etc.) that enable the user to complete agency forms with their computer.

Terms of Award

All legal requirements imposed on an agreement by the sponsor, whether by statute, regulation(s), or terms in the award document. The terms of an agreement may include both standard and special provisions that are considered necessary to protect the sponsor’s interests.

Therapeutic Intent

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

Therapeutic Misconception

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

Therapy

Treatment intended and expected to alleviate a disease or disorder.

Thymine

A nitrogenous base. Pairs with adenine in DNA molecules.

TM/®

Trademark – Trademark is a symbol, design, picture, word, phrase, or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of others. The owner of a trademark has exclusive right to use it on the product it was intended to identify and often on related products and may use the symbol TM to let the public know that the mark is a trademark. The symbol ® can only be used in the if the trademark is federally registered with the USPTO. Rights in a federally-registered trademark can last indefinitely if the owner continues to use the mark on or in connection with the goods and/or services in the registration and files all necessary documentation in the USPTO at the appropriate times.

TOA

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

Total Project Costs

The total allowable direct and indirect costs incurred by the institution to carry out an approved project or activity.

Toxicity

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

Trade secret

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

TPRA

Texas Public Records Act – State of Texas’ legislative code that gives the public the right to request, in writing, public records. Similar to the federal Freedom of Information Act.

TRAM

A service initially developed by the Texas Research Administrators Group providing funding opportunity searches, agency form templates, links to research administration home pages, and other resources.

U

University NetID

University Network Identification – A UIN ID is a 9 digit randomized number code assigned to students and employees that uniquely identifies them through the PVAMU/TAMS. NetIDs are used to authorize PVAMU affiliates to gain access to PVAMU electronic services.

ULAR

University Laboratory Animal Resources – The office responsible for veterinary care, health surveillance, animal husbandry, animal procurement and facility maintenance for PVAMU’s Animal Care and Use Program.

Unanticipated

An event is “unanticipated” when it was unforeseeable at the time of its occurrence. The term unanticipated, is not synonymous with “unexpected”. A research protocol can monitor for an unexpected event, but one cannot monitor for an unforeseen event. All unanticipated events are unexpected, but not vice versa.

Unanticipated Problems Involving Risk to Participants or Others

Any event that was unanticipated, serious, and related; that is, more likely than not to have been caused by the research procedures.

Unexpected Adverse Event

Any adverse event, the frequency and/or severity of which is not consistent with the Sponsor’s Brochure and/or the protocol narrative and consent form (See also Adverse Event).

Uniform Anatomical Gift Act

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

Unilateral Award

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

Provisional Application for a Patent

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

Unrestricted Funds

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

Unsolicited Proposal(s)

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

IUPOV

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

USC

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

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

USDA, APHIS, AC

USDA Animal and Plant Health Inspection Service-Animal Care – APHIS is the component of the USDA that administers the Animal Welfare Act. Within APHIS, Animal Care (AC) is the agency that is responsible for ensuring compliance with the Animal Welfare Regulations.

USIA

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

USPTO

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

Utility Patent

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

V

VA

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

Vaccine

A biologic product generally made from an infectious agent or its components – a virus, bacterium, or other microorganism – that is killed (inactive) or live-attenuated (active, although weakened). Vaccines may also be biochemically synthesized or made through recombinant DNA techniques.

VAH

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

Variable

(noun): An element or factor that the research is designed to study, either as an experimental intervention or a possible outcome (or factor affecting the outcome) of that intervention.

Vector

“A vehicle that transfers material (typically genetic) into a host cell or organism. Typically, vectors are of two types viral or non-viral. Non-viral vectors are self replicating, circular elements that can be easily manipulated to carry genetic cargo and are easily purified in bulk; they are transferred into cells by standard laboratory techniques. These vectors can have different features (such as the size of DNA-insert they can accommodate) and include plasmids, cosmids, and yeast artificial chromosomes (YACs). Recombinant viruses that have been bioengineered to be harmless can also carry genetic cargo for transfer into cells in the laboratory, or into an entire host organism, the latter is an example of gene therapy.”

Viable Infant

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

Violation

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

Virus

A noncellular biological entity that can reproduce only within a host cell. Viruses consist of nucleic acid covered by protein; some animal viruses are also surrounded by membrane. Inside the infected cell, the virus uses the synthetic capability of the host to produce progeny virus.

Voluntary

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

VPRD

Vice President for Research and Development- The Institutional Official (IO) for human, animal and rDNA research at PVAMU.

W

Washout Period

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

Whistleblower Policy

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

WIPO

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

Z

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