Research Administration Glossary

DRAFT VERSION 06/27/2016

Also see 2 CFR 200, Subpart A—Acronyms and Definitions

2 CFR 200:Uniform Guidance

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 (also known as Sponsored Projects) with educational institutions. Superseded by Uniform Guidance.

A-110:Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations - a circular published by the federal Office of Management and Budget (OMB) that establishes the administrative requirements for federal grants and cooperative agreements. Superseded by Uniform Guidance.

A-133:Audits of States, Local Governments, and Non-Profit Organizations - a circular published by the federal Office of Management and Budget (OMB) that establishes the requirements that ensure consistency and uniformity in audits of federal funds, by concentrating on systems for financial control and regulatory compliance. Superseded by Uniform Guidance.

AAALAC:American Association for the Accreditation of Lab Animal Care

AAHRPP:The Association for the Accreditation of Human Research Protection Programs

ACF:Animal Care Facility

ADEM:Alabama Department of Environmental Management

Advanced Spending Authorization (ASA):A form/process to authorize expenditure of funds on a project, up to a specified limit, before the award document has been received from the sponsor.

Adverse Events:Anyadverse change in health or "side-effect" that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a pre-specified period after their treatment has been completed.

Advertising/Advertisement: In relation to human subject research, any outreach effort designed to encourage potential participants to contact the investigator for more information about a study.

Affiliate: Any entity that controls, is controlled by, or is under common control with, SPONSOR. In this context, “control” shall mean (1) ownership by one entity, directly or indirectly, of at least forty percent (40%) of the voting stock of another entity; (2) power of one entity to direct the management or policies of another entity, by contract or otherwise; or (3) any other relationship between SPONSOR and an entity which SPONSOR and Institution have agreed in writing may be considered an “Affiliate” of SPONSOR.

Agreement: Generic name for agrant, contract or other agreement which is enforceable at law, and which must be executed by an authorized official.

AIME:The University of Alabama’sAlabama Innovation and Mentoring of Entrepreneurs Center.

Allegation: Any written or oral statement or other indication of possible misconduct in research or scholarship.

Allegation of Noncompliance: An unproven assertion of noncompliance made by an informant, IRB chair or member, or Research Compliance staff member against an investigator which will be investigated by the IRB.

Alleging party: The author of an assertion of noncompliance.

Allocable Costs:A cost is allocable to a particular Federal award or other cost objective if the goods or services involved are chargeable or assignable to that Federal award or cost objective in accordance with relative benefits received.

Allowable Costs:An allowable cost must be reasonable, allocable, consistently treated, and conform to any limitations or exclusions of the Cost Principles included in federal Uniform Guidance, the sponsor and the agreement.

Animal Care and Use Program (ACUP): A program that comprises all activities conducted by and at an institution that have a direct impact on the well-being of animals, including animal and veterinary care, policies and procedures, personnel and program management and oversight, occupational health and safety, institutional animal care and use committee (IACUC) functions, and animal facility design and management.

Animal Welfare Act:The Animal Welfare Act was signed into law in 1966. It is the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers.

Apparent (or Perceived) Conflict of Interest: Appearance of Conflict of Interest: a situation in which an investigator’s or the University’s conflicts of interests might adversely affect the credibility of the Human Research Protection Program if publicly disclosed, even if the conflict does not affect the protection of research participants.

Assent: A child’s affirmative agreement to participate in research, obtained in child-appropriate language. Mere failure to object should not be construed as assent. Investigators should include actual scripts and forms that describe and document the assent process and outcome and describe what will happen should an adult give consent but the child refuses to assent.

Assistance:Under federal law, the process that leads to a grant or cooperative agreement, as opposed to procurement. The purpose is to "assist" the grantee with what it would do anyway, if it had the resources.

Assurance: A contract or agreement between an institution and a federal agency in which the institution promises to comply with applicable regulations governing research with human subjects as approved by the Office for Human Research Protections (OHRP) and stipulates the procedures through which compliance will be achieved.

Attending Veterinarian (AV): A veterinarian who has direct or delegated authority for animals at a facility subject to the jurisdiction of the Secretary of Agriculture.

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 terms, laws, and regulations.

Authorized Official:An individual formally authorized to bind the institution to the terms of a grant, contract or other agreement.The Board of Trustees of The University of Alabama directs that only certain designated persons on each campus of the System are authorized to sign contracts and other documents on the System’s behalf.

AUTM:Association of UniversityTechnology Managers

Autonomy: Individuals’ personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. Both a status of human beings and an ethical principle underling the conduct of research.

Award:Funds that have been obligated by a funding sponsor for a particular project

Banner: Accounting system for The University of Alabama

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. The principles identified in this report have been adopted by the University of Alabama.

Beneficence: An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. It is expressed in two general rules: (1) do not harm, and (2) protect from harm by maximizing possible benefits and minimizing possible risks from harm.

Benefit: A valued or desired outcome; an advantage or gain.

Biohazardous Materials: Hazardous biological materials and organisms, including: a) infectious organisms (bacteria, fungi, parasites, prions, rickettsias, viruses, etc), which can cause disease in healthy humans and/or significant environmental or agricultural impact; b) human or primate tissues, fluids, cells, or cell culture; c) recombinant DNA; and d) animals known to be vectors of zoonotic diseases.

Biological Safety Program (BSP): The University of Alabama has an institutional biological safety program established to ensure that all research, testing and teaching activities involving the use of biohazardous materials and the facilities used to conduct such work are in compliance with all external regulations (e.g., National Institutes of Health Guidelines for Recombinant DNA Research and applicable University policies. The University of Alabama reserves the right and the obligation to impose additional terms and conditions on investigators who conduct research or testing or engage in teaching activities that involve microorganisms harmful to humans, animals, or the environment.

Biologic:Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Biosafety Cabinet(Biological Safety Cabinet): A devise enclosed (except for necessary exhaust purposes) on three sides and top and bottom, designed to draw air inward by mean of mechanical ventilation, operated with insertion of only the hands and arms of the user, and in which virulent pathogens are used. Biosafety Cabinets are classified as: Class I - Provides personnel and environmental protection but no product protection, the exhaust is HEPA filtered; Class II - Provides personnel, product and environmental protection; Class III - Totally enclosed (glove box) ventilated cabinet with gas-tight construction.

Biosafety Level: Combinations of laboratory practices and techniques, safety equipment, and laboratory facilities appropriate for the operations performed and are based on the potential hazards imposed by the agents used and for the laboratory function and activity. Biosafety Level I provides the least stringent containment conditions and Biosafety Level 4 the most stringent.

Blood-borne Pathogen (BBP): Microorganisms that are present in human/primate blood, tissues or fluids and can cause disease in humans. These pathogens include (but are not limited to) hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

Broad Agency Announcement (BAA): 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. A Broad Agency Announcement is not considered a formal solicitation under theFAR.

Budget:The detailed financial plan for the project or program that the sponsor approves during the award process or in subsequent amendments to the agreement.

Budget Modification:An amendment to the budgetthat moves funds from one expense category to another.

Budget Period: The interval of time--usually twelve months--into which the projectperiod is divided for budgetary, funding purposes and reporting purposes.

CAF:The University of Alabama’sCentral Analytical Facility

CDC: Centers for Disease Control and Prevention.

Certification: A statement signed by an authorized representative of the university indicating that the university will adhere to certain conditions and will or will not undertake certain actions. Certifications related to specific costs or activities may also be required of individuals engaged in research and other sponsored activities.

CGA:The University of Alabama’sContract and Grant AccountingOffice.

Child: A person considered a minor under the laws of the state where the research procedures involving the minor will be performed, regardless of whether the minor may consent to components of the research, except where such a person has been emancipated as evidenced by a valid court order or by operation of law. For purposes of this policy, the words “child” and “minor” are interchangeable. Likewise, “children” is the plural of either word.

Clinical Investigation: In FDA regulations, any experiment that involves a test article and one or more human participants and is one of the following: (1) Subject to requirements for prior submission to the FDA; (2) Is not subject to requirements for prior submission to the FDA but the results are intended to be submitted later or held for inspection by the FDA as part of an application for a research or marketing permit; (3) Does not include experiments subject to 21 CFR §58, regarding non-clinical laboratory studies.

Clinical Trial: A clinical trial is a study designed to assess in humans the safety, efficacy, benefits, adverse reactions, and/or other outcomes of drugs, devices, behavioral interventions diagnostics, treatments, procedures, medical evaluations, monitoring, or preventive measures. Preclinical laboratory studies or studies in animals are not included under the term clinical trial.

Code of Federal Regulations (CFR):The codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States.

Coercion: Either negative or unduly appealing measures that work to deprive a person of his or her free choice to participate in a research study. Negative measures include the use of express or implied threats of violence, reprisal, or other intimidating behavior to compel a person to act against his or her will. Unduly appealing measures include the use of such attractive incentives that a prospective research participant will minimize risks and feel unable to refuse to participate.

Cognitively Impaired: Having a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia) or a development 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.

Cognizant Agency for Audit:The Federal agency designated with responsibility for performing audit-related activities on behalf of the federal government for federally-funded activity at the University. The cognizant audit agency for The University of Alabama is the Department of Education.

COI:Conflict of Interest

Co-Investigator: In some cases, several individuals conduct the scientific portion of the project. One of theseinvestigators is given fiscal and administrative responsibility over the project and designated as thePrincipal Investigator. The other investigators are considered as Co-Investigators, provided thesponsor accepts the role of Co-Investigator. (Also see Co-Principal Investigator)

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.)

Complainant: The person who, in good faith, makes an allegation of scholarly or scientific misconduct in research. Concealment Research: Research in which participants are not told all the details of the research purpose or design. This differs from deception research in that no untruthful information is provided. The IRB must approve a waiver or alteration of consent and may require a debriefing process with a participant option to withdraw their data from the study.

Confidentiality: Safeguarding research data by explaining to prospects what measures will be taken in handling research data, such as access only to the research team, storage in locked files, use of encryption, password-protected files, and timing of data destruction. See also “privacy.”

Confidentiality Agreement: See Non-Disclosure Agreement

Conflict of Interest:

Conflicting Interest of an Investigator: Any interest of the investigator that competes with the investigator’s obligation to protect the rights and welfare of research participants. Not all conflicts of interest may interfere with this obligation.

Conflicting Interest of an IRB Member or Chair: Any interest of an IRB member or chair that competes with their ability to provide an objective review of a proposal. Includes but is not limited to significant personal conflicts with the investigator, a educational or employment-related supervisory relationship with the investigator, a financial interest in the research, or a spouse or family member with a financial interest in the research. IRB members should notify the Chair as soon as they are aware of a conflict or consult with the Chair if they are concerned about the appearance of a conflict of interest; the proposal should be assigned to another reviewer, and the member should absent himself from the room during its discussion. IRB Chairs should request the Vice Chair to assign and conduct the review of a proposal with which they have an actual or apparent conflict of interest.

Consent documentation: Refers to securing participants’ or LARs’ signatures on a consent form before start of the study or, if appropriate, at intervals throughout a study, unless the IRB has given permission to waive or alter written documentation of consent.

Consent process: Refers to explaining the study purpose, procedures, costs, risks, and benefits before prospects agree to participate; responding to prospects’ or participants’ questions; verification of prospects’ comprehension of study procedures, risks, and benefits; providing contact information for the investigator and the Director of Research Compliance in case of later questions or complaints; sharing scientific news that may affect participants’ willingness to continue in a study, and, if appropriate, providing repeated opportunities for participants to reaffirm or refuse study participation throughout the study.

Consistently Treated:Charges/expenditures accounted for in the same way, as either direct costs or as indirect costs.

Consultant: An individual or organization that provides services of an advisory nature. The University may enter into a Professional Service Agreement for this type of service when the necessary expertise is not available within the University.

Containment: Safe methods for managing infectious agents in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure to laboratory workers, other persons and the environment to potentially hazardous agents.

Continuation Project (Non-Competing): A project can be 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, a Continuation award is made for the next budgetperiod, subject to the availability of funds.

Continuing Noncompliance: Multiple or repeated instances of noncompliance, particularly after written notice from the IRB that the investigator must take or must not take a certain action, thus suggesting a pattern of behavior or an unwillingness to follow IRB direction. The multiple or repeated instances of noncompliance may occur on one protocol or on more than one protocol and may occur simultaneously over a period. Instances of continuing noncompliance may also be judged as serious. Although continuing noncompliance may consist in principle of minor administrative forms of noncompliance, the IRB may regard multiples of such events as indicative of lax conduct by the investigator and may term them serious.

Continuing Review (CR): Investigators with approved protocols (including exempt protocols) must submit them for continuing review at least annually or more often if required by IRB based on the degree of risk. See GUIDANCE: General Responsibilities of Investigators. Continuing review is allowed to stop only when the research is permanently closed to the enrollment of new participants, all participants have completed all research-related interventions, collection and analysis of private identifiable information has been completed, and the data have been de-identified.