Research Compliance Definitions

Terms

Full Definitions

.118 Determination

.118 Determination is a letter provided by the IRB that states that a study will involve research with human subjects but the protocol cannot be fully developed yet and it lacks immediate plans for the involvement of human subjects. This letter is often provided to a funder at the proposal stage or right before award.

Adverse Event

Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. (OHRP Guidance for Adverse Events)

Animal Resource Unit

An animal resource unit is an administrative unit that, for the purposes of this policy, acknowledges and accepts responsibility for tracking IACUC approval and approved animal numbers. That unit could be an animal facility (e.g., Biological Resources Facility); a collegewide service unit (e.g., CVM Laboratory Animal Resources); a University Field Lab or Field Station; or an academic department.

Application for Vertebrate Animal Use (AVAU)

Form that allows the investigator to communicate to the Institutional Animal Care and Use Committee (IACUC) their reasons for and methods of animal use. Once approved, this form is often referred to as an IACUC protocol.

Appointments, Academic

Appointments defined in an institutional policy and conveyed in a formal manner (e.g., via appointment letter, executed offer letter, or employment contract) by an entity other than NC State that relates to research, teaching, or associated scholarly activities.

Appointments, Institutional

appointments that include institutional administrative responsibilities (e.g., dean, department head, center director, chief executive officer, chief technical officer) and are conveyed in a formal manner (e.g., via appointment letter, executed offer letter, employment contract) by an entity other than NC State.

Appointments, Professional

Appointments conveyed in a formal manner (e.g., via appointment letter, executed offer letter, or employment contract) by an entity other than NC State, which are undertaken owing to the Covered Individual’s professional expertise (e.g., as a consultant, physician, structural engineer, or mathematician).

Clinical Trial

Research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (45 CFR 46.102b) 

Commerce Control List (CCL)

The list of controlled items subject to the Export Administration Regulations (EAR). Technology or other controlled items subject to the EAR but not specifically enumerated on the CCL are considered EAR99 and are restricted, in most cases, from Export to Countries/regions subject to U.S. Comprehensive Sanctions.

Complainant

See “Whistleblowers“

Conflict of Interest (COI)

Conflict of interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities. (REG 10.25.01 Section 4.2)

Conflicts of Commitment (COC)

Conflict of commitment relates to an individual’s distribution of effort between obligations to his or her University employment and participation in activities outside of University employment. The latter may include such generally encouraged extensions of professional expertise as professional consulting. A conflict of commitment occurs when the pursuit of such outside activities involves an investment of time that interferes with the employee’s duties and responsibilities. (REG 10.25.01 Section 4.1)

Contextualized Controlled Research Data

Information generated, processed, stored, and transmitted by a controlled research project subject to export control regulation. The information has been correlated with additional input form a person, application or second data source in scope of the controlled research project. Such data is fully subject to the federal regulations and contractual obligations and effective security controls must be maintained over such data as defined by the applicable Technology Control Plan.

Controlled Research

Research either subject to publication restrictions or dissemination controls or which involves proprietary or controlled inputs that make it subject to export control regulations. Controlled Research is often protected with a Technology Control Plan.

Controlled Unclassified Information (CUI)

Controlled Unclassified information was defined in the Executive Order 13556 as information held by or generated for the federal government that requires safeguarding or dissemination controls pursuant to and consistent with applicable law, regulations and government-wide policies that isn’t classified under Executive Order 13526 or the Atomic Energy Act, as amended. Federal CUI is divided into several categories and subcategories and is listed in the CUI registry, managed by National Archives and Records Administration (NARA). CUI, by definition is federal information. (from Executive Order 13556) For more about NC State’s CUI program visit the CUI Program page https://research.ncsu.edu/administration/compliance/research-compliance/export-controls/cui/

Cooperative Research

Projects covered by the IRB regulations (45 CFR 46.114) that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

Countries of Concern

With the CHIPS and Science Act (PL No. 117-167), Congress identified countries that are strategic competitors to the United States or have demonstrated behavior that is counter to the national security of the United States. State-owned enterprises within these countries are deemed to also be foreign entities of concern. Researchers working with government entities and state-owned enterprises within these countries will likely experience additional federal scrutiny when being considered for federal-sponsored research projects. 

The following countries are currently identified as countries of concern:

• China (Including Hong Kong and Macau, excluding Taiwan)
• Iran
• North Korea 
• Russia

Countries/regions subject to U.S. Comprehensive Sanctions

These countries/regions and their governments are sanctioned by the U.S. government. Most activities with or for entities or persons within these countries are subject to a license or authorization requirement. Note: Other countries are subject to list-based sanctions, which impact certain entities or persons within those countries. In most cases, these countries are also considered by the U.S. government to be state sponsors of terrorism.

The list of comprehensively sanctioned countries is currently (subject to change):

• Cuba
• Iran
• North Korea
• Syria and
• the Crimean, Donetsk and Luhansk regions of Ukraine.

Covered Defense Information (CDI)

Is a term defined in the DFAR clause 252.204-7012 Safeguarding Covered Defense Information as unclassified controlled technical information or other information, as described in the Controlled Unclassified Information (CUI) registry that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations and government-wide policies and is (1) Marked or otherwise identified in a contract, task order or delivery order and provided to Purdue by or on behalf of the DoD in support of the performance of a contract or (2) collected, developed, received, transmitted, used or stored by or on behalf of the contractor in support of the performance of the contract.

Covered Individuals

Refer to Covered Individuals and Senior Personnel.

Deemed Export

Releasing or otherwise transferring Technology (EAR) technical data (ITAR) or source code to a foreign person in the United States.

Defense Article

Any item or technical data designated on the U.S. Munitions List (USML) (22 CFR § 121.1). All items on the USML are subject to the ITAR.

ECCN

ECCNs are five-character alpha-numeric designations used on the Commerce Control List (CCL) to identify dual-use items for export control purposes. An ECCN categorizes items based on the nature of the product (i.e., type of commodity, software, or technology and its respective technical parameters).

Effective Control

The condition of certain temporary exports and reexports, you maintain effective control over an item when you either retain physical possession of the item, or secure the item in such an environment as a hotel safe, a bonded warehouse, or a locked or guarded exhibition facility. (15 CFR §772.1)

End User

The person abroad that receives and ultimately uses the exported or reexported items. The end user is not a forwarding agent or intermediary, but may be the purchaser or ultimate consignee.

Entity of Concern

Entity of Concern is any entity that the US Government has identified in accordance with Section 10114 of the CHIPS Act of 2022 (Public Law 117-167) as posing an unmanageable threat to the national security of the United States or of theft or loss of United States intellectual property. See the Export Control Office Restricted Party Screening page for more information.

Exemption Determination

Exemption Determination means that a study involving research with human subjects is determined to be minimal risk and it fits into the categories of exemption outlined in 45 CFR 46.104. Research studies determined Exempt from the regulations are considered research with human subjects. An Exemption determination means that not all of the regulations in 45 CFR 46 must be applied to the individual study and the NC State IRB office may instead choose to apply or not apply some standards. Studies reviewed at this level may be required to undergo a limited IRB review. Limited IRB review considers data protection and, where appropriate, broad consent. 

Expedited Approval

Expedited Approval means that a study involving research with human subjects is both minimal risk and fit into one of the “Expedited Review Categories.” Every Expedited level study is subject to the regulations outlined in 45 CFR 46.110. Studies reviewed at the Expedited level must have all informed consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.

Experimentally Naive

The IACUC defines experimentally naïve as USDA Category B procedures, non-invasive procedures as USDA Category C procedures, and invasive procedures as USDA Category D or E procedures. Link to Classification of Animal Use by Pain and Distress Categories – https://research.ncsu.edu/administration/compliance/research-compliance/iacuc/iacuc-procedures-and-guidance/classification-of-animal-use-by-pain-and-distress-categories/

Export

Includes the actual shipment or transmission out of the United States, even temporarily; releasing or otherwise transferring controlled technical data to a foreign person in the United States (“deemed export”)(See 15 CFR § 734.13 and 22 CFR § 120.17 for exact definitions)

Export Administration Regulations (EAR)

Export Administration Regulations (15 CFR § 730 – 774) are the set of regulations administered by the U.S. Department of Commerce, Bureau of Industry and Security (BIS). The EAR regulates dual-use items (items which have both civil and military applications) and related technology. Items subject to the EAR are categorized in the Commerce Control List (CCL) (15 CFR § 774). The EAR contains a number of defined terms (See 15 CFR §772.1)

Export Control Regulations

Federal regulations that control the export of information and physical items from the U.S. or to a Foreign Person within the United States. Regulations most commonly affecting university activity are the Export Administration Regulations (EAR), the International Traffic In Arms Regulations (ITAR) and the Sanction and Embargo programs overseen by the U.S. Treasury Department’s Office of Foreign Asset Controls (OFAC). There are other federal agencies and regulations that govern the export of specific items like nuclear material and medicine.

External Professional Activity for Pay (EPAP)

Any activity that 1) is not included within one’s University employment responsibilities; 2) is performed for any entity, public or private, other than the University employer; 3) is undertaken for compensation, including an equity interest in an external entity; and 4) is based upon the professional knowledge, experience and abilities of the EHRA employee for which that employee is employed by the University. Activities for pay not involving such professional knowledge, experience and abilities are not subject to the advance disclosure and approval requirements of this Policy, although they are subject to the basic requirement that outside activities of any type not result in neglect of primary University duties, conflicts of commitment or interest, inappropriate uses of the University name or resources, or claims of University responsibility for the activity. (REG 10.25.01 Section 4.3)

Fabrication

Making up data or results and recording or reporting them. (REG 10.00.02 Section 2.3)

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. (REG 10.00.02 Section 2.4)

Financial Conflict of Interest (FCOI)

Financial conflict of interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research.

Financial Interest (FI)

A financial interest is anything of monetary value (whether a dollar value can be easily determined or not) that could reasonably appear to be related to the covered individual’s University employment responsibilities. Financial interests also include those of their spouse/dependent children when the financial interest could appear to relate to the covered individual’s university employment responsibilities. Click here to review examples of FI that the covered individual must report on their COI Disclosure.

Foreign Talent Recruitment Program (FTRP)

Refer to Foreign Talent Recruitment Programs (FTRPs)

Foreign Person

Any person who is not a U.S. citizen or lawful permanent resident (Green Card holder), and entities that are not incorporated or organized to do business in the United States. This includes students, visiting scholars and employees on non-immigrant visas as well as foreign subsidiaries of foreign parent companies of U.S. entities.

Full Board Approval

Full Board Approval means that a study involving research with human subjects is reviewed and approved by the convened Full IRB Board. These studies are considered either “more than minimal risk” to participants or they are “minimal risk” to participants but do not fit into any of the Expedited Categories. Studies reviewed at the Full Board level must have all informed consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.

Fundamental Research

Fundamental research means research in science, engineering, or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have not accepted restrictions for proprietary or national security reasons. (15 CFR § 734.8(c)) (EAR Definition)

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR 46.102(e)(1)) 

Institutional Animal Care and Use Committee (IACUC)

The committee, appointed by the chancellor, that has general concern and oversight for the welfare of animals used in research, teaching and testing.

IACUC Protocol

See “Application for Vertibrate Animal Use (AVAU)“

Identifiable Biospecimen

A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. (45 CFR 46.102b(e)(1)(i)(6))

Identifiable Private Information

Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. (45 CFR 46.102b(e)(1)(i)(5))

Institutional Review Board (IRB)

The IRB is a review board that reviews research protocols involving human subjects. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence). The IRB should be diverse in its membership including diversity of race, gender, sex, age, religion, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. Each IRB shall include at least one member whose primary concerns are in scientific areas, at least one member whose primary concerns are in nonscientific areas, and at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. This is also called the IRB Full Board. (45 CFR 46.102(g) and 45 CFR 46.107(a))

Interaction

Interaction includes communication or interpersonal contact between investigator and subject. (45 CFR 46.102b(e)(1)(i)(3))

International Traffic in Arms Regulations (ITAR)

International Traffic in Arms Regulations (ITAR) (22 CFR § 120-130) are the set of regulations administered by the U.S. Department of State, Directorate of Defense Trade Controls (DDTC). The ITAR controls the export and import of defense articles and defense services. The ITAR contains a number of defined terms (See 22 CFR §120)

Intervention

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (45 CFR 46.102b(e)(1)(i)(2))

Investigator

Any university personnel, regardless of title or position, who is responsible for the design, conduct, or reporting of research.

This can include, but is not limited to, the Principal Investigator(PI), Project Director (PD), or Co-principal investigator (CO-PI), and may also include senior/key personnel, a postdoctoral fellow, graduate student, trainee, staff member, collaborator, or consultant, depending on the person’s role in the research.
NOTE: For specific research projects funded by the U.S.  Department of Energy (DOE), the relevant DOE program office may expand the definition of an investigator for Conflict of Interest disclosure purposes to include any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE.  This expansion will be noted in the applicable Funding Opportunity Announcement (FOA) and/or the terms and conditions of the awarding contract. The primary factor to be used in determining who is an investigator is based on the significance of the tasks assigned to the individual with regard to the design, conduct, and reporting of the Research and the degree of independence that individual may have in performing such Research-related tasks.

IRB Amendment

A study involving research with human subjects has an intended change to an IRB-approved study. These intended changes must be submitted to the IRB for review and approval before those changes are implemented. Changes to a study may range from editorial to procedural. Amendment requests are reviewed at the same level the initial study was approved under. If the amendment changes the risk profile to participants or procedures that require additional levels of review, then a new review level will be implemented for the protocol. 

IRB Approval

IRB Approval means that an individual research study involving human subjects has been reviewed and approved by the IRB Full Board or IRB Office staff in accordance with the criteria for approval detailed in 45 CFR 46.111. A study that is reviewed and approved by the NC State University IRB is approved at its initial review as either Exempt, Expedited, or requiring Full Board Approval. Once a study is approved by the IRB, it is expected that the approved protocol is adhered to. Any changes must be reviewed by the IRB before implementation through the Amendment process. Some studies require annual approval renewal. 

IRB Approval Renewal (aka Continuing Review)

The review process for Full Board studies and, rarely, a few Expedited studies where the researcher renews their IRB approval once every 12 months (or more frequently as determined by the convened Full Board). 45 CFR 46.109(e) and 45 CFR 46.109(f)(1)

Malign Foreign Talent Recruitment Program (MFTRP)

Below is the statutory definition included in Section 10638(4) of the CHIPS and Science Act (PL No. 117-167) .  For more information concerning MFTRPs, refer to Foreign Talent Recruitment Programs (FTRPs).

(A) any program, position, or activity that includes compensation in the form of cash, in kind compensation, including research funding, promised future compensation, complimentary foreign travel, things of non  de minimis value honorific titles, career advancement opportunities, or other types of remuneration or consideration directly provided by a foreign country at any level (national, provincial, or local) or their designee, or an entity based in, funded by, or affiliated with a foreign country, whether or not directly sponsored by the foreign country, to the targeted individual, whether directly or indirectly stated in the arrangement, contract, or other documentation at issue, in exchange for the individual—

• (i) engaging in the unauthorized transfer of intellectual property, materials, data products, or other nonpublic information owned by a United States entity or developed with a Federal research and development award to the government of foreign country or an entity based in, funded by, or affiliated with a foreign country regardless of whether that government or entity provided support for the development of the intellectual property, materials, or data products;
• (ii) being required to recruit trainees or researchers to enroll in such program, position, or activity;
• (iii) establishing a laboratory or company, accepting a faculty position, or undertaking any other employment or appointment in a foreign country or with an entity based in, funded by, or affiliated with a foreign country if such activities are in violation of the standard terms and conditions of a Federal research and development award;
• (iv) being unable to terminate the foreign talent recruitment program contract or agreement except in extraordinary circumstances;
• (v) through funding or effort related to the foreign talent recruitment program, being limited in the capacity to carry out a research and development award or required to engage in work that would result in substantial overlap or duplication with a Federal research and development award;
• (vi) being required to apply for and successfully receive funding from the sponsoring foreign government’s funding agencies with the sponsoring foreign organization as the recipient;
• (vii) being required to omit acknowledgment of the recipient institution with which the individual is affiliated, or the Federal research agency sponsoring the research and development award, contrary to the institutional policies or standard terms and conditions of the Federal research and development award;
• (viii) being required to not disclose to the Federal research agency or employing institution the participation of such individual in such program, position, or activity; or 
• (ix) having a conflict of interest or conflict of commitment contrary to the standard terms and conditions of the Federal research and development award; and

(B) a program that is sponsored by—

• (i) a foreign country of concern or an entity based in a foreign country of concern, whether or not directly sponsored by the foreign country of concern;
• (ii) an academic institution on the list developed under section 1286(c)(8) of the John S. McCain
• National Defense Authorization Act for Fiscal Year 2019 (10 U.S.C. 2358 note; Public Law 115-232); or
• (iii) a foreign talent recruitment program on the list developed under section 1286(c)(9) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (10 U.S.C. 2358 note; Public Law 115-232).

Material Transfer Agreement (MTA)

A contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. MTAs are also invaluable tools to ensure the recipient has clearance guidance on the regulatory requirements, including Export Control compliance, that might apply to the material. Contact the Office of Research Commercialization (ORC) if you believe your activity warrants an MTA.

Minimal Risk

The probability and magnitude of harm or discomfort anticipated in the 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. (45 CFR 46.102j)

Non-Contextualized Controlled Research Data

Information that is raw output with no identifying marks generated, processed, stored, and/or transmitted under a controlled project subject to dissemination controls, export control regulations and federal cybersecurity rules. The information is raw output with no identifying marks for the controlled project. The information must be correlated with additional input from a person, application or second data source in scope of the controlled research project to become Contextualized Controlled Research Data thus in scope of the export control regulations and federal cybersecurity rules.

Noncompliance

The failure (regardless of intentionality) to comply with any federal, state, or local regulation governing human research including university policies on human research. It includes any deviation from the protocol approved by the IRB, or deviations from stipulations imposed by the IRB, as a condition of approval. Noncompliance may be serious, non-serious (minor), and may be continuing. NC State University IRB Policy for Noncompliance 

Not Human Subject Research

Not Human Subjects Research (NHSR) means that the research activity is not regulated by the IRB in any way because the activity is not considered human subjects research. A study would not be considered human subjects research if the answer to the questions “is it research as defined by the federal regulations?” or “is it human subjects research as defined by the federal regulations?” is no. Answering “no” to either of those questions means the IRB does not have jurisdiction to review the project and no IRB approval is necessary. Note, this determination is different from a study reviewed and determined to be Exempt.

Notice of Intent

Prior approval process required before engaging in External Activities for Pay (EPAP).

OFAC

Office of Foreign Asset Controls is the office within the U.S. Department of Treasury that oversees the embargo and sanction programs.

Personally Identifiable Information (PII)

Personally Identifiable Information (PII) means 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. Some information that is considered to be PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials. The definition of PII whenever additional information is made publicly available, in any medium and from any source, that, when combined with other available information, could be used to identify an individual. (2 CFR 200.79)

PHS-Like Agencies

Those agencies that follow the PHS Conflict of Interest Rules.

Plagiarism

The appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. (REG 10.00.02 Section 2.5)

Private Information

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record) (45 CFR 46.102b(e)(1)(i)(4))

Public Domain

Public domain means information which is published and which is generally accessible or available to the public (22 CFR 120.34)

Reexport

The shipment or transmission of an item subject to the EAR from one foreign country (i.e., a country other than the United States) to another foreign country. A reexport also occurs when there is “release” of technology or software (source code) subject to the EAR in one foreign country to a national of another foreign country.

“Related” to University Employment Responsibilities

“Related” to University employment responsibilities means the responsibilities that the covered individual is hired to perform at the University and the professional expertise necessary to perform those responsibilities. This may include activities such as conducting research (including research administration), teaching, clinical practice, and other activities that rely significantly on the expertise for which the individual was hired. 

Ask yourself, “Am I being asked to participate in this outside activity because I am a professional in my field at NC State University?” If the answer is “Yes,” then it may reasonably appear that the requested activity is “related to your university employment responsibilities.” By this measure, any consultation in your area of professional expertise should be disclosed. On the other hand, if, for example, you are an orthopedist with a family business that imports rugs, that would not need to be disclosed. Keep in mind that “relatedness” is not always a bright-line determination. You should use your judgment when deciding what needs to be disclosed, but when in doubt, err on the side of transparency.

Reliance Agreement

Reliance Agreement (also called institutional authorization agreement): is a contract that allows one IRB office to rely on another IRB office for protocol review and oversight. The IRB that reviews and approves the research is called the “IRB of Record.” The IRB that does not review the research and relies on another IRB for review and approval of the project is called the “Relying IRB.” Reliance agreements are typically implemented for research with human subjects that is reviewed at the expedited or Full Board level. In rare cases, these may be completed for exemptions. NC State University does not require a reliance agreement for exemptions but will enact one if a partnering IRB requires it.

Research

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (45 CFR 46.102(l)) 

Research Misconduct

Defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion. (REG 10.00.02 Section 2.1)

Respondent

A person against whom an allegation of Research Misconduct is made. The respondent is required to cooperate with the conduct of an Inquiry and Investigation.

Scientific Integrity

The adherence to professional practices, ethical behavior and the principles of honesty and objectivity when conducting, managing, using the results of and communicating about science and scientific activities. Inclusivity, transparency and protection from inappropriate influence are hallmarks of scientific integrity.

Reference: National Science and Technology Council’s Framework for Federal Scientific Integrity Policy and Practice

Senior Personnel (NSF)

Refer to Covered Individuals and Senior Personnel.

Senior/Key Personnel (NIH)

Refer to Covered Individuals and Senior Personnel.

Significant Financial Interest (SFI)

Salary or other payments for services such as consulting fees or honoraria; equity, interests, such as stock and stock options; and intellectual property rights, such as patents, copyrights, and royalties from such rights, that

a. In the case of salary, royalties (including those distributed to the individual through the University), or other payments, including consulting fees or honoraria, when aggregated from a single entity for the employee and his or her family, are expected to exceed $5,000 over the next twelve months; or

b. In the case of equity interest in publicly-traded entities, when aggregated for the employee and his or her family, meets either of the following tests: exceeds $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value or represents more than a (5%) ownership interest in any single entity; or

c. In the case of entities that are not publicly traded, consists of any equity interest held by the employee or his or her family.

d. When the project or proposed project requires the use of human subjects and approval from the Institutional Review Board, these minimum remuneration and equity thresholds do not apply. In such cases, the disclosure threshold is any amount of payment and any equity holding by the employee or his or her family. (REG 01.25.01)

Technical Data

(ITAR term) Information which is required for the design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of defense articles. This includes information in the form of blueprints, drawings, photographs, plans, instructions or documentation (22 CFR 120.9).

Technology

(EAR term) Information necessary for the “development,” “production,” “use,” operation, installation, maintenance, repair, overhaul, or refurbishing (or other terms specified in ECCNs on the CCL that control “technology”) of an item (15 CFR part 772).

Technology Control Plan (TCP)

Project-specific document used to provide clear guidelines and controls deemed necessary to safeguard controlled technical data, information or equipment that is subject to export control regulations. May also be used for federally funded research information that is subject to specific cybersecurity requirements

U.S. Government Restricted Party List

The U.S. government restricts certain exports, reexports and transfers of items to certain persons, entities and destinations. These restrictions are maintained by several federal agencies, including but not limited to the State, Treasury and Commerce Departments, on various lists. When a person or entity is on such a list, U.S. entities are expected to do additional due diligence to ensure that any proposed interaction doesn’t involve an activity that is prohibited by U.S. law. If a proposed sponsor, subcontractor or international visitor is believed to be on one of these lists, the Export Controls Team must review the situation to determine if a license is required or if the activity can be approved. The federal government maintains a free website that searches against all such lists. The University reserves the right to restrict additional parties based on emerging U.S. government legislative or administrative guidance, or when it is otherwise in the University’s best interest.

U.S. Person

Any person who is a U.S. citizen, lawful permanent resident (Green Card holder), or a protected individual as defined by 8 U.S.C. 1324b(a)(3); and entities that are incorporated or organized to do business in the U.S. This includes U.S. subsidiaries of foreign entities.

Unanticipated Problem

Unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria: 1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; 2) related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and 3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized (OHRP Guidance for Unanticipated Problems)

University Employment Responsibilities

The responsibilities that a Covered Individual is hired to perform at NC State and the professional expertise necessary to perform those responsibilities. This may include but is not limited to teaching, conducting scholarly research (including research administration) and publication, providing professional services such as membership in and service to professional associations and learned societies, membership on professional review or advisory panels, presentation of lecturers, papers, concerts, or exhibits, participation in seminars and conferences, reviewing or editing scholarly publications and books, service to accreditation bodies and any other activities that rely significantly on the expertise for which the Covered Individual was hired.

USDA Covered Animals

All live or dead warm-blooded animals used in research except birds, rats of the genus Rattus, and mice of the genus Mus bred for research. This also excludes “cold-blooded” animals such as fish, reptiles, and amphibians. For the purposes of the Animal Welfare Regulations, teaching is equivalent to research. Using farm animals for teaching related to food or fiber, or breeding, management or production efficiency is not regulated. Using farm animals for teaching related to basic science or biomedical research is regulated.

Whistleblowers

A person who makes an allegation of scientific misconduct. (REG 10.00.02 Section 2.9)