Glossary

A B C D E F G H I J L M N O P Q R S T U V

A

AAALAC International – Accrediting organization for the animal care and use program.

Adverse Event – An unexpected, unfavorable event occurring during the conduct of or as a result of a research study.

Arms Export Control Act - Act giving the US President the authority to control imports and exports of defense services.

Animal Facility - Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation.

Animal Plant Health Inspection Service (APHIS) – A division of the USDA; APHIS is responsible for protecting and promoting U.S. agricultural health, administering the Animal Welfare Act, and carrying out wildlife damage management activities.

Animal Welfare Act (AWA) - Public Law 89-544, 1966, as amended (P.L. 91-579, P.L. 94-279, and P.L. 99-198), 7 U.S.C. 2131 et seq. Implementing regulations are published in the Code of Federal Regulations (CFR), Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3, and are administered by the U.S. Department of Agriculture.

Animal Welfare Assurance - Documentation from an institution assuring institutional compliance with the PHS Policy and Guide, as well as the Animal Welfare Act.

Animal Users Advisory Committee (AUAC) - A committee charged with enhancing communication between stakeholder groups of the Animal Care and Use Program and participates in ongoing development of an Animal Use Program that effectively and efficiently provides client services to animal users and thus maximizes research potential.

Anonymous – Without identifying information. Data that is anonymous has no way of linking a given data point with identifying information, even for the researcher. Not to be confused with confidential.

Appeal – To make a request for the rehearing or review of a decision.

Arizona Department of Health Services – covers species where there is a concern of zoonotic disease.

Arizona Game and Fish Department – oversees the capture and holding of native wildlife as well as the holding of restricted non-native wildlife.

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. Parental or guardian consent is typically also required.

Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) - A private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

Attending Veterinarian (AV) – Veterinarian who has received training or experience in the care of the species being attended and who has direct or delegated institutional authority for activities involving animals, including ensuring the provision of adequate veterinary care.

AUAC – Animal Users Advisory Committee

AV – Attending Veterinarian

AWA – Animal Welfare Act

B

Belmont Report -- A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects (respect for persons, beneficence and autonomy).

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: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Benefit – a psychological, physical, social, educational, or functional advantage that can reasonably be attributed to the research. Not to be confused with compensation.

Biological Waste – Hazardous or nonhazardous waste generated during laboratory experiments which use material of a biological origin. Federal regulations and institutional policies require proper handling and disposal of specific biological waste depending on the origin.

Biosafety – The application of knowledge, techniques and engineering controls to reduce the potential exposure of the laboratory worker, persons outside of the laboratory, and the environment to potentially infectious agents.

Biosafety Officer – The position responsible for advising research and the Institutional Biosafety Committee concerning the most appropriate safety practices that will assure the safe conduct of research with biohazards.

Biosafey Level (BSL) – A set of biocontainment precautions designed to mitigate risk when working with biohazardous materials. Precautions range from the lowest level, BSL-1, to the highest level, BSL-4.

BSL – Biosafety Level

C

Center for Disease Control and Prevention (CDC) – One of the major operating components of the Department of Health and Human Services. CDC serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities designed to improve the health of the people of the United States.

CITI - Collaborative Institutional Training Initiative

Collaborative Institutional Training Initiative (CITI) - a program that provides research ethics and compliance education to meet institutional and/or sponsor training requirements for researchers.

Clinical Research - investigation or experiment that involves research with one or more human subject (or on material of human origin such as tissues or specimens) that is patient oriented. No all research meeting this definition meets the criterial for a clinical trial.

Clinical Trial -- a prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, biologics, treatments, devices, or new ways of using known drugs, biologics, treatments, or devices). Behavioral interventions are intended to prevent or treat an acute or chronic disease or condition. Clinical trial research involves the evaluating effects of an intervention on biomedical or behavioral human health related to outcomes. This definition is not intended to be inclusive of all clinical research activity.

Commerce Control List (CCL) - part of the Export Administration Regulations (EAR) that is made up of 10 categories that cover items that can be used for either civilian or military applications (dual use).

Commercial Entity - any corporation, partnership, sole proprietorship, limited liability company, or other legal entity organized for profit. The term does not include the University or any other entity controlled by the University. For faculty members in the professional schools, a commercial entity does not include a client to whom you provide individual professional services (e.g., an individual for whom a trusts and estates professor in the Law School prepares a will or provides estate planning advice; an individual or corporation for whom a faculty member in The Design School designs a residence or building). The term does include a law firm, architectural firm or other professional firm or business enterprise with which a faculty member is affiliated (e.g., in an "of counsel" relationship or as a partner or member in such a firm).

Common Rule – federal policy for the protection of human subjects.

Compensation – payment in the form of money, gifts, services, or course credit given. Not to be confused with a benefit.

Complainant - a person or persons who in good faith make(s) an allegation of research misconduct.

Conflict of Interest - a competing personal financial interest that could affect, or could appear to affect, an individual's judgment or could cause the individual's impartiality to be questioned.

Confidential – Private. Data that are confidential may contain personally identifying information or ways of linking data points with individuals (e.g. master list), but the researcher agrees to keep any personally identifying details private. Not to be confused with anonymous.

Cognitively Impaired - Having a psychiatric disorder (e.g., psychosis, 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.

Consent – See: Informed consent

Competence - 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.

Covered Entities - under the HIPAA Privacy Regulations include the following entities: 1) health plans; 2) healthcare clearinghouses; and 3) healthcare providers who conduct certain electronic transactions, including billing and claims. Therefore, "covered entities" will include hospitals, skilled nursing facilities, pharmacies, most physician practices and most other healthcare providers. Entities such as ASU may also be covered entities, even if the entity's primary purpose is not the provision of healthcare services, if the entity has a unit that is a health plan, healthcare clearinghouse or healthcare provider. Such entities are referred to as "hybrid entities" under the regulation.

D

DACT - Department of Animal Care Technologies

Data Safety Monitoring Board (DSMB) - an independent body that reviews the integrity, safety and progress of a study with the purpose of protecting participants during the course of the study and periodically recommends continuance, modification or termination of the study for reasons of efficacy or safety.

Debriefing - providing human research subjects previously undisclosed information following completion of their participation in research.

Deciding Official (DO) - the institutional official who makes final determinations on allegations of research misconduct and any institutional administrative actions. At ASU, the DO is the Senior Vice-President for OKED or designee.

Defense Article –any item designated in the United States Munitions List (USML).

Defense Service – Refers to: (1) the furnishing of assistance (including training) anywhere (inside the United States or abroad) to foreign nationals in connection with the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, processing, or use of defense articles; or (2) the furnishing of any controlled “technical data” (see definition below) to foreign nationals anywhere.

Department of Animal Care and Technologies (DACT) – department responsible for providing care to all research animals housed on campus and provides technical support to all investigators who use animals in research.

DHHS – United States Department of Health and Human Services.

Drug - any chemical compound that may be used as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.

DSMB – Data Safety Monitoring Board

Dual use – to have more than one application

Dual Use Research of Concern (DURC) – life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

DURC – Dual Use Research of Concern

E

EAR – Export Administration Regulations

EH&S – Environmental Health and Safety

EHSA – Environmental Health and Safety Assistant

End use – detailed description of how the ultimate consignee intends to use the commodities being exported

End user – person abroad who receives and ultimately uses the exported or re-exported items. The end-user is not a forwarding agent or intermediary, but may be the purchaser or ultimate consignee.

Enrollment – number of participants to be consented for a research study.

Enterprise Research Administration (ERA) – an integrated system that ASU uses to develop proposals, ensure research integrity and assurance, as well as the negotiation and management of awards. IRB submissions and COI disclosures are managed through ERA.

Environmental Health and Safety (EH&S) – university office that provides safety training and risk assessments to ensure a safe work environment.

Environmental Health and Safety Assistant (EHSA) – EH&S database which serves as a repository for safety training documentation.

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 – Enterprise Research Administration

Ethical – conforming to accepted standards of conduct. Aims or goals of research that describe methods, procedures, or perspectives for deciding how to act and analyze complex problems and issues.

Exempt – for human subjects research, one of the three levels of IRB review. This is the lowest risk type of study. For IBC, disclosure that does not require adherence to the NIH Guidelines.

Expedited – one of the three levels of IRB review. An expedited study is determined to present no greater than minimal risk to participants but may involve procedures, devices, protected populations, or other details that warrant additional oversight per the federal regulations.

Export – An actual shipment or transmission of items, services, or technical data subject to either the EAR or the ITAR out of the United States, or the release of technology, software, or technical data subject to either EAR or ITAR to a foreign national in the United States. Technology, software, or technical data is “released” for export through: (1) Visual inspection by a foreign national of U.S. origin equipment and facilities, (2) Oral exchanges of information in the United States or abroad, (3) Transfer or shipment via any means (physical or electronic) to a foreign entity, or (4) Providing a service or technical know-how acquired in the United States to a foreign individual or entity.

Export Administration Regulations (EAR) – Regulations administered by the Department of Commerce that regulate the export of goods and related technology identified on the Commodity Control List. They cover dual use (civilian and military) technology.

F

Fabrication - making up data or results and recording or reporting them.

Falsification - manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record or publications.

Family or Relative - spouse or domestic partner, children, grandchildren, parents, grandparents, brothers, and sisters (including half- brothers and half-sisters) and the spouses of children, grandchildren, parents, grandparents, brothers and sisters (including half-brothers and half-sisters. Also included are the spouse's parents, brother, sisters and children.

Family Educational Rights and Privacy Act (FERPA) - Federal law that protects the privacy of student education records (20 U.S.C. § 1232g; 34 CFR Part 99).

Federalwide Assurance (FWA) - agreement that fulfills the requirements of 45CFR part 46 approved by the Secretary of Health and Human Services. Arizona State University has an approved FWA on file with DHHS – Assurance Number FWA 00009102. A copy of the assurance is available upon request from the Office of Research Integrity and Assurance.

FERPA - Family Educational Rights and Privacy Act

Financial Conflict of Interest (FCOI) - means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of funded research.

Financial Interest - the receipt or expectation of anything of monetary value, including, among others, salary or other payments for services (e.g., consulting fees, honoraria or paid authorship), equity, stock or stock option or other ownership interests, and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The terms do not include:

salary, royalties or other remuneration paid by the University directly to an employee of the University;
income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
income from service on review panels or advisory committees for a Federal, state or local government agency, an institution of higher education, an academic teaching hospital, medical center or research institute affiliated with an Institution of higher education;
income from writing or editing professional journals or textbooks;
or a financial interest in a commercial entity if the value of such financial interest, when aggregated with the interests of your family does not exceed reporting thresholds ($5,000 for investigators supported by a PHS agency or $10,000 for other investigators) and does not represent more than a 5% ownership interest in the commercial entity.

Foreign National – a person residing in the U.S. who is not a lawful permanent resident. This term also includes any foreign corporation, business association, partnership, trust, society or any other group not incorporated or organized to do business in the United States, and any international organization, foreign government or diplomatic entity. Under ITAR, the term “foreign person” is often used.

Full Board – one of the three levels of IRB review. A “full board” study is reviewed by the convened IRB and typically involves greater than minimal risk to participants.

Fundamental Research – refers to basic or applied research in science and engineering performed or conducted at an accredited institution of higher learning in the United States where the resulting information is ordinarily published and shared broadly in the scientific community. The products of fundamental research are not subject to export license requirements or other government approval. Fundamental research is distinguished from research that results in information that is restricted for proprietary reasons or national security reasons (EAR) or pursuant to specific U.S. government access and dissemination controls (ITAR).

Funded Research – research that receives external or internal funding from sources such as the federal government, foundations or private industry.

FWA – Federal-wide Assurance

G

Good Faith - as applied to a complainant or witness, means having a belief in the truth of one’s allegation or testimony that a reasonable person could have based on the information known to the complainant or witness at the time. Good faith as applied to a committee member means cooperating with the purpose of helping an institution meet its responsibilities under these procedures. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.

Grant - financial assistance mechanism providing funds to carry out a sponsored project.

Guardian – an individual who is authorized under applicable State or local law to provide consent on behalf of a child.

Guide for the Care and Use of Laboratory Animals – published by the National Research Council and widely accepted as the standard for animal care and use programs.

H

Hazardous Materials - Any item or agent (biological, chemical, radiological, and/or physical), which has the potential to cause harm to humans, animals, or the environment, either by itself or through interaction with other factors.

Health Insurance Portability and Accountability Act of 1996 (HIPAA) – legislation governing the provision of health benefits, the delivery and payment of healthcare services, and the security and confidentiality of individually identifiable, protected health information in written, electronic or oral formats.

HIPAA - Health Insurance Portability and Accountability Act of 1996

Human Subject - a living individual about whom an investigator (whether professional or student) conducting research 1) obtains data through intervention or interaction with the individual or 2) obtains identifiable private information. Also referred to as participant. An individual becomes a human subject upon granting consent to participate in a study (or upon having consent granted on their behalf by someone legally authorized to do so).

Husbandry – care and housing provided to animals.

Hybrid Entity - a covered entity whose business activities include both covered and non-covered functions, and that designates those healthcare components that must comply with the HIPAA Privacy Regulations.

I

IAA – Institutional Review Board Authorization Agreement

IBC – Institutional Biosafety Committee

IDE – Investigational Device Exemption

IIA – Interinstitutional Assurance

IND – Investigation New Drug

Informed Consent – A person’s voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects 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, the institution or agents thereof from liability for negligence.

Institution - public or private organization, business, or agency (including components of federal, state, and local governments).

Institutional Animal Care & Use Committee (IACUC) - federally mandated committee that oversees the institution's animal care and use program and animal research activities.

Institutional Biosafety Committee (IBC) – administrative body federally mandated to oversee institutional research utilizing recombinant or synthetic nucleic acid molecules.

Institutional Official (IO) -- An officer of an institution with the authority to speak for and legally commit the institution to adherence to federal compliance regulations.

Institutional Responsibility - an Investigator's professional responsibilities performed on behalf of Arizona State University including but not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Institutional Review Board (IRB) - An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated. The Institutional Review Board has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.

Institutional Review Board Authorization Agreement (IAA) – an agreement between IRBs to allow one IRB to cede review of studies to the other.

Intellectual Property and Institutional Review Committee (IPIRC) – committee that advises the Senior Vice President for Knowledge Enterprise Development on issues related to intellectual property management and reviewing conflict of interest disclosures related to research in which an investigator has disclosed significant financial interests that could affect the design, conduct, or reporting of his/her research and to recommend and implement management strategies designed to reduce, manage or eliminate perceived conflicts.

Interinstitutional Assurance (IIA) – agreement for an institution with an Animal Welfare Assurance to provide oversight for animal research activities to an institution without an Animal Welfare Assurance.

International Traffic in Arms Regulations (ITAR) – defense article export control regulations administered by the Us Department of State.

Intervention - a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

Inquiry - the purpose of an inquiry is for preliminary information-gathering and preliminary fact-finding to determine whether an allegation or apparent instance of research misconduct has substance and if an investigation is warranted.

Investigation - means the formal development of a factual record and the examination of that record leading to a decision of whether research misconduct has been committed, by whom, and to what extent. The investigation may include a recommendation for other appropriate actions, including administrative actions.

Investigational Device Exemption (IDE) - exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations.

Investigation New Drug (IND) – a drug or device permitted by FDA to be used 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.

Investigator - any person regardless of title, position or employment status who is responsible for the design, conduct, or reporting of research at, on behalf of, or in collaboration with the University. This will normally not be a student, postdoc, consultant, technician, or staff member.

IO – Institutional Official

IPIRC – Intellectual Property and Institutional Review Committee

IRB – Institutional Review Board

ITAR - International Traffic in Arms Regulations

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.

L

Legally Authorized Representative – an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective human subject to the subject’s participation in the procedure(s) involved in the research.

M

Materials Transfer Agreement (MTA) - an agreement between two parties which describes the transfer of materials (i.e. biological and research), how they will be used and responsibilities of each party. There are two types of MTAs: Incoming and Outgoing. Incoming MTAs are agreements for materials transferring from an outside entity to ASU. Outgoing MTAs are agreements for materials transferring out of ASU.

Medical Device -- 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.

Minimal Risk – as defined in 45 CFR 46, subpart A, exists when "the risks of harm anticipated in the proposed research are not greater considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

Minor – persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. In the US, this refers to children under the age of 18.

MTA – Material Transfer Agreement

N

National Institutes of Health (NIH) – federal agency whose mission is to improve the health of the people of the United States. NIH is a part of the Public Health Service, which is part of the U.S. Department of Health and Human Services.

National Institute of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) – guidelines that detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules.

NIH – National Institutes of Health

NIH Guidelines - National Institute of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Nuremberg Code - 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.

Non-compliance – failure to adhere to federal regulations or the requirements and determinations of the compliance unit.

Not Human Subjects Research – a determination by the IRB that a study does not meet the DHHS definition of Human Subject Research. See Human Subject and Research definitions.

O

OBA – Office of Biotechnology Activities

Object Code - machine readable instructions or output (a compiled file) which is produced when the source code is compiled

Occupational Health and Safety Program (OHSP) – promotes and protects the health and safety of employees, visitors, and students who work with animals in teaching and/or research.

Occupational Safety and Health Administration (OHSA) – a federal agency under the United States Department of Labor responsible for safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education and assistance.

OFAC – Office of Foreign Assets Control

Office of Biotechnology Activities (OBA) – an office of the NIH. OBA promotes science, safety and ethics in the development of public policies in three areas: Biomedical Technology Assessment, Biosafety, and Biosecurity.

Office for Human Research Protections (OHRP) – Health and Human Services office overseeing human subject protections.

Office of Foreign Assets Control (OFAC) – part of the U.S. Department of Treasury that administers and enforces economic embargoes and trade sanctions based on U.S. foreign policy and national security goals against targeted foreign countries, terrorists, international narcotics traffickers, and those engaged in activities related to the proliferation of weapons of mass destruction.

Office of Laboratory Animal Welfare (OLAW) – National Institutes of Health office overseeing compliance with the Public Health Services Policy on Humane Care and Use of Laboratory Animals.

Office of Research Integrity (ORI) - HHS office promoting integrity in biomedical and behavioral research supported by the Public Health Service by monitoring institutional investigations of scientific misconduct and facilitating the responsible conduct of research.

Office of Science Policy – The NIH office that is responsible for reviewing and coordinating all activities relating to the NIH guidelines.

OHRP – Office for Human Research Protections

OHSP – Occupational Health and Safety Program

OLAW – Office of Laboratory Animal Welfare

ORI – Office of Research Integrity

OSP – Office of Science Policy

P

Participant - See: human subject.

Patient Care Costs - costs of routine and ancillary services provided by hospitals to participants in research protocols.

Pecuniary interest - money. Anytime an ASU employee or a relative of an ASU employee might benefit monetarily by an ASU contract, purchase, sale, or decision, the employee or relative has a substantial interest. The monetary benefit to the ASU employee or relative may be direct or indirect.

Personal Representative - The person who is legally entitled to act on behalf of the individual and may include the following: a parent of an unemancipated minor, a court appointed guardian, or the individual named to act on behalf of another through a power of attorney or health care representative.

Personally Identifiable Information (PII) - information that can be used to distinguish or trace an individual's identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual.

PHI – Protected Health Information

PHS – Public Health Service

PI – Principal Investigator

PII – Personally Identifiable Information

Plagiarism - the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.

Principal Investigator (PI) – a full-time faculty or staff member with authority and responsibility for oversight of a research project or teaching activity. It is the responsibility of the PI to make certain that all applicable regulations, policies, and procedures are adhered to in the performance of the activities.

Proprietary interest - ownership. Anytime an ASU employee or a relative of an ASU employee holds an ownership interest in a corporation partnership other legal entity that is about to enter into a transaction with ASU, the ASU employee or relative has a proprietary interest.

Prospectively Assigned - a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

Protected Health Information (PHI) - health information, in any form, collected or created as a consequence of the provision of healthcare if the information includes any information (including demographic information) that identifies or could be used to identify an individual. PHI includes information that is used for research purposes if that information identifies or could be used to identify a human research subject, including name, address, social security number, account numbers, treatment records, pharmacy records, lab reports, etc.

Protected Personally Identifiable Information (Protected PII) - An individual's first name or first initial and last name in combination with any one or more of types of information, including, but not limited to, social security number, passport number, credit card numbers, clearances, bank numbers, biometrics, date and place of birth, mother's maiden name, criminal, medical and financial records, educational transcripts. This does not include PII that is required by law to be disclosed.

Protected PII – Protected Personally Identifiable Information

Public Domain – information that is already published and that is generally accessible or available to the public: (1) through sales at newsstands and bookstores; (2) through subscriptions that are available without restriction to any individual who desires to obtain or purchase the published information; (3) through second-class mailing privileges granted by the U.S. government; (4) at libraries open to the public or from which the public may obtain documents, including most university libraries; (5) through published patents; (6) through unlimited distribution at a conference, meeting, seminar, trade show, or exhibition, generally accessible to the public, in the United States (ITAR) or anywhere (EAR); (7) through public release (i.e., unlimited distribution) in any form (e.g., not necessarily in published form) after approval by the cognizant U.S. government department or agency, including websites accessible to the public for free and without the host’s knowledge of or control of who visits or downloads the software and/or information (clearly acceptable under EAR and likely acceptable under ITAR); and (8) through fundamental research in science and engineering at accredited institutions of higher learning in the United States where the resulting information is ordinarily published and shared broadly in the scientific community.

Public Health Service (PHS) – A unit of the Department Health and Human Services (DHHS). The mission of PHS is to protect, promote, and advance the health and safety of the United States.

Public Health Service Policy (PHS Policy) – requires institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities conducted or supported by the PHS.

Q

Quorum - the minimum number of committee members that must be present at a meeting to make the proceedings of that meeting valid.

R

RCR – Responsible Conduct of Research

rDNA – Recombinant Deoxyribonucleic Acid

Request for changes (RFC) – modification; A form required to be submitted to the IACUC when changes to an approved protocol are required. Such changes include: personnel; increase in number of animals; addition/change in species; addition/change in locations used outside the vivarium; addition/change in procedures.

Responsible Conduct of Research (RCR) – research ethics training for undergraduates, graduate students and postdoctoral researchers.

Recombinant DNA – molecules of DNA formed by laboratory methods of gene recombination by combining genetic material from multiple sources to form genetic sequences not normally found in a genome. Recombinant DNA can replicate in living cells.

Recruitment – the process of advertising a study and making contact with potential participants. Recruitment is a distinct process from informed consent. IRB approval must be obtained before recruitment begins.

Re-export – refers to an actual shipment or the transmission of items subject to export regulations from one foreign country to another foreign country. For the purposes of the U.S. EAR, the export or re-export of items subject to the EAR that will transit through a country or countries to a new country, or that are intended for re-export to the new country, are deemed to be exports to the new country.

Remote Interest

Nonprofit Corporation - an ASU employee or a relative of an ASU employee who is a non-salaried officer of a nonprofit corporation has a remote interest in any ASU transaction with or decision affecting that corporation.
Landlord/Tenant of a Contracting Party - an ASU employee or relative of an ASU employee who is a landlord or tenant of another party has a remote interest in any ASU transaction with or decision affecting the other party.
Attorney of a Contracting Party - an ASU employee or relative of an ASU employee who is an attorney for a client has a remote interest in any ASU transaction with or decision affecting the client.
Nonprofit Cooperative Marketing Association - an ASU employee or relative of an ASU employee who is a member of a nonprofit cooperative marketing association has a remote interest in any ASU transaction with or decision affecting that association.
Insignificant Stock Ownership - an ASU employee or relative of an ASU employee who owns shares of a for-profit corporation has a remote interest in any ASU transaction or decision affecting the corporation, if all three conditions are satisfied:
1. ownership is less than three percent of the shares of the corporation
2. the dividends including the value of stock dividends from the corporation do not exceed five percent of the person's total annual income
3. any other payments made to the person by the corporation do not exceed five percent of the persons total annual income.
Reimbursement of Expenses - an ASU employee or relative of an ASU employee being reimbursed for actual and necessary expenses incurred in the performance of official duty has a remote interest in any decision affecting the reimbursement.
Recipient of Public Services Generally Available - an ASU employee or relative of an ASU employee who receives public services provided to the general public by a government or governmental agency by which he or she is employed has a remote interest in any contract with or decision affecting services to the employee or relative. The services must be provided on the same terms and conditions as are provided to nonemployees.
Public School Board Member - the interest of a public school board member is a remote interest when the decision involves a relative who is not a dependent or a spouse of the school board member.
Public Agency Employee - the interest of an ASU employee or relative of an ASU employee is a remote interest when the transaction with ASU or the ASU decision indirectly affects that person as a public officer or employee of another public agency or political subdivision and does not confer a direct economic benefit or detriment upon the ASU employee or relative.
Class Interests - an ASU employee or relative of an ASU employee who is a member of a trade business, profession, or other class of persons of at least ten members with an interest no greater than the interest of the other members of the class has a remote interest in a decision by ASU affecting the class.

Remuneration - salary or any payment for services not otherwise identified as salary (e.g., consulting fees honoraria, paid authorship.

Research - scientific inquiry; usually a systematic experiment, study or evaluation designed to contribute to general knowledge in all fields of science, engineering, mathematics and education.

Research – (DHHS definition): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Research Integrity Officer (RIO) - the institutional official responsible for assessing allegations of research misconduct and for determining when such allegations warrant inquiries and for overseeing inquiries and investigations.

Research Misconduct - fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results. Research misconduct does not include honest error or honest differences of opinion.

Research Patient Care Costs - costs of routine and ancillary services provided by hospitals to participants in research protocols

Respect for Persons -- an ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

Respondent - in the context of research misconduct: the person or persons against whom an allegation of research misconduct is directed; or the person whose actions are the subject of the inquiry or investigation. In the context of human subjects research, a respondent is a synonym for a research participant.

Retaliation - means an adverse action taken against a complainant, witness, or committee member by ASU or a person associated with ASU in response to (1) a good faith allegation of research misconduct; or (2) good faith cooperation with a research misconduct proceeding.

RFC – Request for Changes

RIO - Research Integrity Officer

Risk – the probability of incurring harm. Risks may be physical, psychological, social, legal, or economic in nature.

S

Sanctioned Countries – countries designated by OFAC as having limited or comprehensive trade sanctions imposed by the United States for reasons of anti-terrorism, non-proliferation, narcotics trafficking, or other reasons.

Satellite Facility – a location outside of a centrally designated or managed area in which animals are housed for more than 24 hours.

Select Agent - biological agent or toxin listed in 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121, or the HHS and USDA Select Agents and Toxins List.

SIG – Standard Institutional Guideline

sNA – Synthetic Nucleic Acid

SOP – Standard Operating Procedure

Source code - programming statements that are created by a programmer with a text editor or a visual programming tool and then saved in a file.

Sponsor - any agency of the U.S. federal government, state government, private foundation, corporation, or other entity external to ASU that provides funds to support a research project, research program, or other research activity.

Standard Institutional Guidelines (SIG) – guidelines approved by the IACUC for common procedures used in regards to animal research.

Standard Operating Procedures (SOP) – written step-by-step instructions on implementing specific, routine procedures to ensure personnel produce proper, consistent results safely.

Study Team Member – any person who is responsible for the design, conduct, analysis, or reporting of research; has contact with participants or is involved in the consent process; or who has access to identifiable data. Study team members may be ASU or non-ASU personnel.

Substantial Interest - any pecuniary or proprietary interest, direct or indirect.

Synthetic Nucleic Acid (sNA) – Molecules of DNA formed by laboratory methods by chemically synthesizing new sequences of base pairs sequentially rather than combining genes from multiple genetic sources normally found in a genome. Synthetic nucleic acids can base pair with naturally occurring nucleic acid molecules.

T

Technical assistance – technical assistance may take forms such as instruction, skills training, working knowledge, and consulting services, and also may involve the transfer of technical data.

Technical data - information, other than software, which is required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of defense articles. This includes classified information relating to defense articles and defense services, information covered by an invention secrecy order, and software directly related to defense articles.

Technology – any specific information and know-how (whether in tangible form, such as models, prototypes, drawings, sketches, diagrams, blueprints, manuals, or software—or in intangible form, such as training or technical services) that is required for the development, production, or use of a good, but not the good itself.

U

USDA - United States Department of Agriculture

U.S. Department of Agriculture (USDA) – A federal executive department of the U.S. government whose responsibilities include developing and executing federal laws related to farming, agriculture, forestry, and food.

U.S. Fish and Wildlife Services – a bureau within the U.S. Department of Interior charged wit conservation, development, and protection of the nation's fish and wildlife.

USML - United States Munitions List

U.S. Munitions List (USML) – (22 CFR § 121.1) The USML includes articles, services, and related technical data designated as defense articles and defense services pursuant to the Arms Export Control Act (AECA).

U.S. National or U.S. Person - either 1) a U.S. citizen, lawful permanent resident alien ("Green Card Holder"), refugee, protected political asylee or someone granted temporary residency under amnesty or Special Agricultural Worker provisions; or, 2) Any juridical person (i.e. organizations under the laws of the United States or any jurisdiction within the U.S., including foreign branches).

V

Vertebrate Animal – animals that have an internal skeleton.

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.