Help – eTRACS Definitions

General

Pre-Proposal  Submission of a project summary/concept paper/white paper required by the Proposal Sponsor which is intended to result in an invitation to submit a full proposal.  May or may not require an estimated cost or budget.  Does not include a pre-submission “Letter of Intent” intended to assist the Proposal Sponsor in determining the number of proposals expected for a particular call or the number of reviewers that will be needed.

New Proposal for Sponsored Project Sponsored Project:  A project and/or activity which is conducted by the faculty and/or staff that is supported wholly or in part by external restricted funds awarded to the University under a formal written agreement (i.e., a grant, contract, or cooperative agreement, or other funding instrument).  A sponsored project may be thought of as a transaction in which there is a specified statement of work with a related, reciprocal transfer of something of value.

Supplemental Funding Request Request for additional funds for the current approved project period

Clinical Professional Services Contract A contract between ECU and a health/dental care facility/clinic in ECU’s service region to provide ECU physician services through the ECU Physicians practice plan and dental medicine services through the School of Dental Medicine. Clinical professional services contracts are not negotiated, executed, or managed by the Office of Research Administration (ORA) and, although a type of external funding, are not considered sponsored programs. 

Individual Award  The sponsor awards the funds to an individual but, at the recipient’s request and with sponsor approval, ECU receives and manages the award as a courtesy to the individual.  Examples include ACLS fellowships and NEH summer stipends. All university policies and procedures are applicable to expenditure of the funds when managed by ECU. Individual awards, however, are not institutional awards and are not be counted in reports of institutional sponsored activity. 

Fiscal Agent Service:  ECU manages funds for an external organization. The organization is not considered a sponsor, as ECU has no programmatic or administrative responsibility or oversight.  These funds are not counted in reports of institutional sponsored activity.

Proposal/Change Request Approval Types

Approved  An approval of the proposal or change request record that acknowledges a department, college, center or other reviewer’s approval of the desired request.

Conditionally Approved  An approval of the proposal or change request record that acknowledges a department, college, center or other reviewer’s approval of the desired request under a certain condition.  Conditions should be explained and entered as comments within the route.  Conditional Approvals are considered an official APPROVAL by the institution and will not be returned to the reviewer to confirm that the condition was met.  Conditional approvals are not an appropriate selection for PI certifications of a proposal.

Disapproved  A denial of the proposal or change request by a department, college, center or other reviewer.  A disapproval will stop the route and require that route start over and obtain approvals by all parties in order to be completed.

Request Type

Solicited – Competitive A competitive Request for Proposal (RFP) or Request for Application (RFA) issued for a specific purpose by the funding agency or organization.

Solicited – Non-Competitive A non-competitive request made by an external entity solely to ECU for a proposal or quote for a specific purpose. 

Unsolicited A request for funding from an external entity initiated by ECU on behalf of the PI/PD.

Sponsor Hierarchy

Proposal Sponsor The entity that directly funds ECU to conduct a sponsored project, clinical trial, or non-interventional or registry study.  Funds may originate with the Proposal Sponsor itself or may have been provided to the Proposal Sponsor by an Originating Sponsor or a higher-tier recipient of an Originating Sponsor’s funds. 

Originating Sponsor The agency/organization from which funds are initially made available for a sponsored project. 

Higher-Tier Subrecipient The entity that receives and passes through funds from the Originating Sponsor to ECU. 

Sponsor Type

US Federal Government Any department, independent establishment, commission, administration, authority, board, bureau, or office of the United States or any corporation in which the United States has a proprietary interest, unless the context shows that such term was intended to be used in a more limited sense.  Excluded are specific non-profit entities (e.g., State Justice Institute, PCORI) that are created and funded by Congress but intended to function as non-profit, non-governmental entities.  Examples of federal sponsors include:

  •   US Department of Health and Human Services (executive department)
  •   National Science Foundation (independent agency)
  •   Equal Employment Opportunity Commission (independent agency)
  •   Congressional Budget Office (legislative branch office)

NC State Government Any department, institution, commission, committee, board, division, bureau, office, officer, or official of the State of North Carolina.  For purposes of reporting on ECU sponsored programs, the University of North Carolina system (UNC) and its constituent institutions are excluded from this sponsor category.  Any community/technical college in the North Carolina Community College System is considered a NC state government entity.  Examples of state government sponsors include:

  •  NC Department of Public Instruction (agency)
  •  Atlantic States Marine Fisheries Commission (commission)
  •  NC Department of Health and Human Services (agency)
  •  NC Community College System
  •  Sandhills Community College
  •  Wake Technical Community College

NC Local Government Any department, institution, commission, committee, board, division, bureau, office, officer, or official of any county or municipality in the State of North Carolina.  Examples include:

  •  City of Greenville
  •  Pitt County

Non-NC State Government  Any department, institution, commission, committee, board, division, bureau, office, officer, or official of any U.S. state or territory (including Washington, DC) except the State of North Carolina.  For purposes of reporting on ECU sponsored programs, public Institutions of Higher Education in other states and territories are excluded from this sponsor category.  Examples include:

  •  South Carolina Department of Natural Resources
  •  Virginia Department of Education

Non-NC Local Government Any department, institution, commission, committee, board, division, bureau, office, officer, or official of any county or municipality in any U.S. state or territory (including Washington, DC) except the State of North Carolina.  Examples include:

  •  Henrico County (VA) Public Schools
  •  Horry County SC
  •  City of Columbia SC

Foreign Government Any non-U.S. federal, state/province, or local level governmental agency.  Examples include:

  •  Kingdom of Saudi Arabia
  •  Province of Ontario (Canada) – Ministry of the Environment, Conservation and Parks
  •  City of Toronto (Canada)

UNC Institution of Higher Education The system office and any constituent institution of the University of North Carolina system.  Examples include:

  •  University of North Carolina System Office
  •  University of North Carolina Chapel Hill
  •  Appalachian State University
  •  UNC School of the Arts
  •  NC School of Science and Mathematics

Non-UNC Domestic Institution of Higher Education Any North Carolina private non-profit college or university or any non-North Carolina domestic public or private non-profit university system or constituent institution of such system.  Also includes non-profit research foundations/institutes established by such institutions of higher education for the specific purpose of applying for and receiving sponsored project funds on behalf of the institution.  Examples include:

  •  Duke University
  •  University of Michigan
  •  Old Dominion University/Old Dominion University Research Foundation
  •  Augusta University Research Institute
  •   University of Puerto Rico

Foreign Institution of Higher Education Any non-U.S. university system or domestic public or private Institution of Higher Education.  Examples include:

  •  King Saud University
  •  University College London
  •  University of Guelph

Non-Profit Research Organization Any domestic or U.S. based international public or private non-profit institute, center, foundation, specialty hospital, or other organization that has a primary purpose of supporting research and development (R&D). Excludes organizations that have a broader mission (e.g., providing public education or health or human services). Also excludes private, non-profit Institutions of Higher Education and Cooperative Groups. Examples include:

  • Research Triangle Institute
  • Oak Ridge Associated Universities (an association but with a singular research focus)
  • Burroughs Wellcome Fund (non-profit research arm of the company)
  • Morris Animal Foundation (research focus)
  • National Geographic Society
  • Barth Syndrome Foundation (primary focus on research; secondary focus on public education and resource identification)
  • St. Jude Children’s Research Hospital (focused on research and innovative patient treatment)

Cooperative Group A non-profit entity consisting of a coordinated group of organizations and investigators that collaborate on clinical research initiatives under the National Institutes of Health.  Some of the funding for these Groups is federal, but industry and/or non-profit organizations are also typical sources of Cooperative Group funding.  Funding received by the University from a Cooperative Group under a specific work order will be classified as identified in the award document.  If no originating source is noted, they are classified and managed as non-profit funds.  Examples of Cooperative Groups are:

  •  NRG Oncology
  •  ECOG-ACRIN Cancer Research Group
  •  Alliance for Clinical Trials in Oncology Foundation
  •  Children’s Oncology Group (COG)

Professional/Trade Organization Any domestic or U.S. based international organization or association (including organizations or associations of IHEs) intended primarily to serve the professional needs of its members (e.g., professional education/development, program accreditation, individual credentialing, public advocacy).  Activities and programs intended to advance the field through basic and applied research are not a major priority for these entities.  Examples include:

  •  American Medical Association
  •  American Mosquito Control Association
  •  American Chemical Society
  •  American Speech-Language-Hearing Foundation
  •  American Council on Social Work Education
  •  Society of Actuaries

Foundation/Corporate Giving Program Any public or private foundation with IRS 501(c)(3) (i.e., tax exempt) status or any general corporate giving program with tax exempt status that is not specifically focused on research.  Examples include:

  • American Honda Foundation
  • Golden LEAF Foundation
  • National Fish and Wildlife Foundation
  • K. Kellogg Foundation
  • Duke Endowment

Domestic Non-Profit Organization All other domestic non-profit organizations that cannot be described by other non-profit Sponsor Types (10, 11 and 12).  Examples include:

  • Hemophilia of Georgia (priority is service provision and education)
  • Restore America’s Estuaries (focus on advocacy and community involvement)
  • American Cancer Society (funds research but also focused heavily on services and education)
  • Nature Conservancy (limited research program)

Foreign Non-Governmental Organization Any foreign not-for-profit, non-governmental organization. Examples include:

  • Alzheimer Society of Canada
  • Comité international pour la protection des droits de l’homme (France)
  • Children’s Leukaemia & Cancer Research Foundation Inc (Australia)

Pharmaceutical/Medical Device Company Any domestic for-profit business that is engaged in the development, manufacture, testing, and/or distribution of pharmaceuticals or medical devices intended for human use. A Contract Research Organizations (CRO) that manages clinical trials on behalf of pharmaceutical or medical device manufacturers is not considered a pharmaceutical/device company and should be coded as either domestic or foreign business/industry (Sponsor Type 16 or Type 17). Examples of Pharmaceutical/Medical Device Companies include:

  •  Janssen Pharmaceuticals Inc
  •  Novo Nordisk
  •  GlaxoSmithKline Inc
  •  AkaskaOmega (produces dietary supplements)

Foreign Pharmaceutical/Medical Device Company Any foreign for-profit business that is engaged in the development, manufacture, testing, and/or distribution of pharmaceuticals or medical devices intended for human use.

Domestic Business/Industry  Any domestic for-profit business, except a business that is engaged in the development, manufacture, testing, and/or distribution of pharmaceuticals or medical devices intended for human use. Includes for-profit Contract Research Organizations (CROs).  Examples include:

  •  CVS Health
  •  Walt Disney Company
  •  Major League Baseball
  •  Parexel (a CRO)
  •  IQVIA (formerly Quintiles) (a CRO)

Foreign For-Profit Entity (Non-Pharma/Med Device) Any non-US for-profit business, except a business that is engaged in the development, manufacture, testing, and/or distribution of pharmaceuticals or medical devices intended for human use.

  • Huawei Technologies Co, Ltd (China)
  • Credit Suisse (Switzerland)
  • George Weston Limited (Canada)

 

Program Type

Research & Development – All research activities, both basic and applied, and all development activities.  Also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function.  Excludes all types of clinical research.

Clinical Trial – Industry Sponsored – A research study, funded by a for-profit company that is engaged in the development, manufacture, testing, and/or distribution of pharmaceuticals or medical devices intended for human use, 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 those interventions on health-related biomedical or behavioral outcomes.

  • Prospectively assigned refers to 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 the clinical trial.
  • An intervention is a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related 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.
  • A health-related biomedical or behavioral outcome is the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life.

Clinical Trial – Non-Industry Sponsored – A research study, funded by any other entity except a for-profit company that is engaged in the development, manufacture, testing, and/or distribution of pharmaceuticals or medical devices intended for human use, 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 those interventions on health-related biomedical or behavioral outcomes.

  • Prospectively assigned refers to 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 the clinical trial.
  • An intervention is a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related 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.
  • A health-related biomedical or behavioral outcome is the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life.

Non-Interventional, Patient Registry, or Point of Care Device Validation Study – A non-interventional study is a study conducted to assess safety, tolerability, and effectiveness of marketed medicines in clinical practice, i.e. in a naturalistic setting where the choice of therapy is consistent with approved marketing authorization and in line with the current standard of practice.  Patient selection and the diagnostic or monitoring procedures are those applied per the usual treatment paradigm of the treating physician and not per protocol.  A patient registry study uses observational (not interventional) study methods to collect uniform data (clinical and other) in an organized system and to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).  A point of care device validation study tests the clinical analytical performance of a new device against the relevant standard of care diagnostic test.

Clinical Research (Excludes Clinical Trials and Non-Interventional, Patient Registry and Point of Care Device Validation Studies) – Clinical Research is patient-oriented research conducted with human subjects that is not a clinical trial, registry, or non-interventional study.  Examples of clinical research include, but are not limited to:

  • Studies that use cognitive phenomena to elucidate mechanisms of human disease and therapeutic interventions or to develop new technologies;
  • Epidemiological and behavioral studies
  • Outcomes research and health services research

Instruction – All teaching and training activities, whether offered for credit toward a degree or certificate or on a non-credit basis, and whether offered through regular academic departments or separate divisions, such as a summer school division or an extension division.  Includes training of professionals, including those who provide public services.  Excludes research training that meets the definition of Research & Development.

Public Service – Activities related to the delivery of health service projects and other community service programs intended for public benefit.  Does not include activities preformed for the benefit of non-public entities, including professional organizations.

Student Support – Financial assistance provided to students in the form of scholarships, fellowships, grants in aid, trainee stipends, tuition and fee waivers and remissions, gifts, and prizes awarded and/or administered by the institution that are not contingent upon the student rendering services to the institution.  Excludes assistance for research training that meets the definition of Research & Development.

Other – Includes:  (1) activities that support research, instruction and public service programs, such as library services and museums, media services, academic computing, academic program administration, and professional development of academic personnel; (2) activities that contribute to the emotional and physical well-being of students, as well as to their intellectual, cultural, and social development outside the context of the institution’s formal instruction program; (3) institutional administration activities that contribute to the day-to-day function and the long-range viability of the institution, including planning and executive direction, administrative and logistical services, student recruitment and admission, constituency building, and employee services and professional development; (4) physical plant operations, including facilities and grounds maintenance, utility service provision, and planning/designing plant modifications and expansions; (5) independent operations that are independent of or unrelated to the primary mission of the institution; and (6) any other activities not described by any other Program Type.

 

Affiliations

Associated Center A university center/institute that plays an integral role in the conduct and/or administration of the project and is eligible to receive a share of recovered F&A per ECU F&A policy if it administers the project. 

Associated Program A university center/institute that plays an integral role in the conduct of the project but is not eligible to receive recovered F&A per ECU F&A policy. 

Associated Department A department, office, or other unit (except an Affiliated Center or Affiliated Program) that plays an integral role in the conduct and/or administration of the project.  Such units may share in F&A recovery in accordance with ECU’s F&A policy. 

Primary Associated Department A department, office, or other unit (except an Affiliated Center or Affiliated Program) that administers the project.  The Primary Associated Department is eligible to receive a share of recovered F&A per ECU F&A policy.

Cost-Sharing

Cost Share Cost sharing is the use of institutional or third party funds to supplement the sponsor’s support of a project.

Mandatory Cost Share Cost share that is required by the Proposal Sponsor as a condition of award.  Such cost share must be quantified and tracked and is auditable.  If the cost share in not provided, the amount of the award may be reduced.

Voluntary Committed Cost Share Quantifiable cost share that is not required by the Proposal Sponsor.  Because such cost share must be quantified and tracked and is auditable, it is strongly discouraged and will only be allowed with compelling justification.

Mandatory and Voluntary Cost Share A combination of required cost share plus additional non-required cost share.  Both types are quantified, tracked and are auditable.  Because of added administrative burden and audit risk, addition of voluntary cost share to that which is mandatory is strongly discouraged and will only be allowed with compelling justification.

Third Party Cost Share Quantifiable cost share committed by an external party which may be used to meet a mandatory cost share requirement.  Because of its high-risk nature, voluntary third party cost sharing is not allowed.

Facilities & Administrative Costs

F&A (Facilities & Administration) Cost F&A, or “indirect costs,” are those costs incurred for a common or joint purpose benefitting more than one objective, and not readily assignable to the cost objectives specifically benefitted without effort disproportionate to the results achieved (2 CFR 200.56).  F&A costs include the costs of general departmental and research-specific administration; facilities and equipment operation and maintenance; and other general overhead costs

Full Recovery The project budget includes F&A at the appropriate federally negotiated rate

Pre-Approved Rate The project budget includes a sponsor-specific pre-negotiated approved F&A rate (e.g., NCDHHS, NCDEQ, NCDPI, CESU funding mechanism, etc.)

Sponsor Cap The Proposal Sponsor limits recovery of F&A to less than ECU’s negotiated rate in accordance with a published policy or as presented in proposal development guidelines

Partial Waiver The institution voluntarily under-recovers F&A at some rate greater than 0% but less than the applicable federally negotiated rate, a sponsor-specific pre-approved rate, or a sponsor cap

Full Waiver The institution voluntarily waives recovery of any F&A that the Proposal Sponsor allows.

Off-Campus F&A Rate An off-campus F&A rate must be used, and can only be used, when all three of the following criteria are met:

  • Project activities will occur in a facility/space that is not owned or leased for general purposes by ECU
  • The facility/space will be used for ECU sponsored project activities under a Lease Agreement with an outside party, with the proportion of lease payments allocable to the sponsored project budgeted as a direct cost to be reimbursed by the sponsor or the facility/space is made available for project use by an outside party under a no-cost real estate Lease Agreement or other legal instrument that emulates a real estate lease
  • More than 50% of project activities will take place in the leased or donated facility over the life of the sponsored project award

Off-Campus Off-Campus means a location in which project activities take place that meet the criteria for application of the off-campus F&A rate. The University’s federally negotiated F&A agreement requires the application of an off-campus F&A rate (either an “adjacent” rate or a “remote” rate, as applicable) “for all activities performed in facilities not owned by the institution and to which rent is directly allocated to the project(s).”  Based on a recent ruling in a federal false claims suit, space donated by a third party for project activities may also dictate application of an off-campus rate in certain circumstances.

Adjacent Adjacent means the off-campus facility is within commuting distance of the ECU East Campus (within 50 miles and/or within Pitt County)

Remote Remote means the off-campus facility is outside of commuting distance of the ECU East Campus (beyond 50 miles and outside of Pitt County)

Other Sponsored Activity Programs and projects sponsored by federal and non-federal agencies which involve the performance of work other than instruction and organized research. Examples include travel grants; health service projects; non-credit community education; seminars and conferences; art exhibits and performances; support for students, staff, or teachers in elementary or secondary schools, or the general public, through outreach-related activities; community service activities  where the students are not receiving academic credit for their involvement; support for library collections, acquisitions, bibliographies, or cataloging; and enhancement of institutional resources, including but not limited to data center expansion and computing capabilities.

Rent Rent means payments made monthly under a real property lease agreement (“lease payment”) for 24/7 occupation and control, to the exclusion of any other party, of a facility/space for a sponsored project for an extended period of time in exchange for compensation made to the owner/controller of the facility/space.  It does not mean payments made under a space use agreement (a “use fee”) for temporary, short-term, or episodic use of a space for the conduct of sponsored project activities.  Real property leases usually describe the premises; penalties for late payments, termination for default of payment, or breach of any significant conditions; increases in periodic payments based on some type of standard; inclusion or exclusion of property taxes and insurance in payments; limitations on use of the property; charges for staying on beyond the term (holding over); any right to renew the lease for another period; and/or a requirement for payment of attorneys’ fees and costs in case of the need to enforce the lease (including eviction).  Leasing of space for an ECU sponsored project is considered a real property transaction and is negotiated and managed by the Associate Vice Chancellor for Business Services.

Personnel Type

Key  Key Personnel include the Principal Investigator/Program Director (PI/PD) and other ECU personnel who contribute to the development or execution of the project in a substantive, measurable way, whether or not they are compensated from the project budget.  A consultant should be identified as “Key” only if he/she will contribute substantively to the scientific development or execution of the project (as opposed to providing expertise in one aspect of the project) and commits measurable effort.  (Note that, regardless of role, external consultants are contracted and paid through ECU’s procurement process.)  PD/PIs are always Key.

Non-Key Individuals who do not contribute to the scientific/technical development or execution of a project in a substantive, measurable way.

Sponsor Matrix – When to use specific personnel types and when they are “key”.

Role

PD/PI Program Director/Principal Investigator (or PI/PD:  Principal Investigator/Project Director):   The individual who has primary responsibility for the scientific/ technical direction and financial management of the project.  PD/PI is the equivalent NIH term meaning Program Director/Principal Investigator.  If a student is applying for external funding, the faculty mentor will serve as the PI/PD in eTRACS and Banner, although the student may be identified as PI/PD on the proposal document.  NIH allows multiple PD/PIs who have equal responsibility for project management, including reporting; one must be designated as “Contact PD/PI.”   PD/PIs are always Key Personnel.

Co-PD/PI:  Co-Program Director/Principal Investigator A Co-PD/PI shares the authority and responsibility for leading and directing the project, intellectually and logistically, and commits measurable effort to the project.  Each Co-PD/PI is accountable for the proper conduct of the project or program, including the submission of all required reports.  A Co-PD/PI is always Key Personnel.  Note that NIH does not recognize the Co-PD/PI role.

Faculty An ECU faculty member who participates in the development and execution of the project.  Although he/she commits measurable effort to the project, he/she is not responsible for scientific or technical direction or financial management of the project.  The “Faculty” role is used for NSF and may be used for other sponsors, but it is not used by NIH.

Postdoctoral Scholar An individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his/her chosen career path.  A Postdoctoral Scholar may be recognized as Key or Non-Key depending on whether his/her contribution to the development and execution of the project is substantial and measurable.

Other Professional An individual who may or may not hold a doctoral degree or its equivalent, who is considered a professional, and who is not identified as a PD/PI, Co-PD/PI, Co-I, postdoc, or student.  Includes, but is not limited to, doctoral associates not identified as postdocs, technicians, physicians, veterinarians, system experts, computer programmers, design engineers, etc.  May be used by NSF and other sponsors for all professional and technical personnel, including lab technicians, and desigated as Non-Key, but this role should not be used for NIH proposals.

Graduate Student A part-time or full-time student working on the project in a research capacity who holds at least a bachelor’s degree and is enrolled in a degree program leading to an advanced degree.  Graduate students are Non-Key personnel.

Undergraduate Student A student who is enrolled in a degree program (part-time or full-time) leading to a bachelor’s or associate’s degree.  Undergraduate students are Non-Key personnel.

Technician An employee who provides technical services to the project, such as a laboratory analyses, data input and analysis, equipment fabrication, etc.  These individuals do not have significant responsibility for the design, conduct, and reporting on the project.  This role is used for NIH and may be used for other sponsors, but it should not be used for NSF (use “Other Professional” for NSF).  This role is Non-Key.

Consultant An individual (or firm) not employed by ECU  who provides specialized services or expertise to fill a project gap.  (Note:  If the proposed consultant is employed by another institution of higher education, that institution should determine if a independent consulting agreement is appropriate or if the individual’s services should be provided under a consortium/subaward arrangement.)  External consultants may be identified as such in NIH proposals; they may be Key or Non-Key depending on whether their contributions are substantial and measurable.  This Role should not be assigned for NSF; consultant services are included in NSF proposals as a type of contractual service.

Other Significant Contributor Individuals who contribute to the development or execution of the project but do not commit any specified measurable effort to the project.  These individuals are typically presented at effort of “zero person months” or “as needed.”  Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs).  Consultants are included if their focus is on a single aspect of the project.  This Role is used for NIH, including the faculty mentor on career development awards; the personnel type is “Other Significant Contributor.”  This role may be used for NSF and other sponsors, but not for unfunded collaborators.  Other Significant Contributors for non-NIH projects may be Key or Non-Key depending on whether the contribution is substantial and measurable.

Co-I:  Co-Investigator   An individual involved with the PD/PI in the scientific development or execution of a project. The Co-Investigator (collaborator) may be employed by, or be affiliated with, the applicant/recipient organization or another organization participating in the project under a consortium/subaward agreement. The Co-I devotes a specified percentage of time to the project, does not have responsibility for the technical or financial management or reporting, and may or may not be compensated by the project. Co-Investigator may be used for the “Other Senior Associate” role for NSF. A Co-I may be Key or Non-Key depending on whether his/her contribution is substantial and measurable. (Note:  If the Co-I is acting as PD/PI on a consortium/subaward agreement, he/she does have scientific/technical and financial management responsibility for his/her organization’s portion of the work.)

Other (Specify) Other individuals working on the project in a non-research capacity

Sponsor Matrix – When to use specific personnel types – by sponsor.

Other Definitions

Classified Research Classified research is research that has a security classification established by an authorized agency of the federal government.  An entire sponsored research project or a specific section of a research project may be categorized as classified.  Identification of and requirements for managing classified research activities are typically detailed in the contract document but, in infrequent cases, research results that are of extreme importance to national security may be classified after-the-fact.

Classified Information and Materials The government may classify information that is deemed to be important to national security interests. Classification is the means by which information is restricted. The standard classification categories include confidential, secret, and top secret.  Several more levels have been added to the classification scheme but are used only under very special conditions.  Successive levels of classification imply increasingly stringent requirements on access to and use of information that is increasingly important to national security interests.  The process by which individuals are granted access to the various categories of classified information is via security clearance granted by the Defense Security Office. Classified materials can be any resources, equipment, or supplies utilized in a project that contains classified research or information.  These materials may include, but are not limited to, computer disks used to compiled information about the project, as well as hardcopy documents, forms, drawings, notebooks, cameras, tapes, chemicals, substances or any other resources related to a classified project.

Controlled Unclassified Information Controlled Unclassified Information (CUI) is information that requires safeguarding or dissemination controls pursuant to and consistent with applicable law, regulations, and government-wide policies but is not classified under Executive Order 13526 or the Atomic Energy Act, as amended.  The National Archives provides a listing of CUI categories (https://www.archives.gov/cui/registry/category-list).

Foreign National Any person other than a U.S. citizen or a U.S. permanent or temporary legal resident alien.

Community Engagement Community Engagement describes the collaboration between institutions of higher education and their larger communities (local, regional/state, national, global) for the mutually beneficial exchange of knowledge and resources in a context of partnership and reciprocity. The purpose of community engagement is the partnership of college and university knowledge and resources with those of the public and private sectors to enrich scholarship, research, and creative activity; enhance curriculum, teaching and learning; prepare educated, engaged citizens; strengthen democratic values and civic responsibility; address critical societal issues; and contribute to the public good (Carnegie Foundation for the Advancement of Teaching).

ENC-29 The twenty-nine northeastern counties in Eastern North Carolina, served by ECU, that face greater economic, education, and health disparities that other North Carolina counties.

Community Partner A university partner is an external entity that engages in mutually beneficial collaborations with ECU faculty, staff or students to benefit both stakeholders but is not providing funding to ECU for this project.

Immediate Family Immediate family means the investigator’s spouse and dependent children.

Related Person Related persons include:  spouse, significant other, parent, child, brother, sister, grandparent, grandchild, aunt, uncle, niece, nephew, first cousin, stepparent, stepchild, stepsibling, parent-in-law, child-in-law, siblings-in-law, guardian, ward, and person engaged in an amorous relationship.

Biological Agent A biological agent is any microorganism, including those which have been genetically modified, genetic elements, or materials containing or derived from microorganisms or biological materials (e.g. toxins, allergens, prions, cell cultures and parasites), which may cause an infection, create or provoke an immune reaction or exhibit toxicity in humans, animals, or plants or have an adverse effect on the environment.  This includes any recombinant DNA molecule, DNA or RNA derived from recombinant DNA, or organisms or viruses containing recombinant DNA including plants and animals.

Hazardous Chemical  A hazardous chemical is any item or agent which is a health or physical hazard and has the potential to cause harm to humans or the environment, either by itself or through interaction with other factors.

Project Description  A short synopsis that can include keywords, target populations and regions, techniques and other details to explain the nature of the project. The description should not be a copy of the scope of work as that often exceeds the character limit and provides more detail than is necessary.  “See scope of work” or “Not applicable” are not sufficient answers to the Project Description section.  The project description becomes part of the proposal data set in ECU’s data storehouse and can be analyzed to respond to requests from UNC System Office and other campus initiatives regarding specific research topics and other service project subjects

Funding Instrument Type

Grant/Grant Agreement A grant is an award of funds to a recipient organization to carry out a public purpose.  A grant from a federal agency is termed “financial assistance,” with funds intended to support domestic public purpose programs authorized by U.S. law.  Federal grants are subject to the provisions of 2 CFR 200 (the “Uniform Guidance”) and additional agency-specific regulations.  Grants may also be issued by state and local agencies, non-profit organizations such as foundations, not-for-profit corporations, and charitable trusts, and foreign entities.  Generally, the sponsor is not involved in the development and execution of the grant-funded project.  A grant may be made unilaterally or may require signatures of both parties on a grant agreement.

Cooperative Agreement A cooperative agreement is a special type of federal financial assistance grant.  The funds are intended for a public purpose but, unlike a traditional grant, the sponsor plays a collaborative role in the development and execution of the project.  A cooperative agreement clearly spells out the responsibilities of each party.

Contract A contract is a legal agreement between two parties in which one party, for consideration, agrees to provide goods or services to benefit the other party.  A federal contract is a “procurement” action by a federal agency and is governed by the Federal Acquisition Regulations (FAR).  Contracts are legally enforceable, generally have more stringent terms and conditions than grant agreements, and may include penalties for non-delivery.

Subaward A subaward is an award of a portion of grant funds received by the proposal sponsor from another entity (the originating sponsor or a higher tier subrecipient).  The originating sponsor is usually a federal agency, although non-profit organizations may be originating sponsors.  The subawardee uses the grant funds to make a substantive contribution to the planning, development, and/or execution of the proposal sponsor’s project.

Subcontract A subcontract is a legal deliverables-based agreement in which the university conducts a portion of a contractor’s work, usually for a fee, to satisfy the contractor’s performance obligations to the funding organization.   If federal procurement funds are subawarded, the Federal Acquisition Regulations (FAR) will apply to the subcontractor.  A subcontract is consider a procurement action.

Purchase Order/Agreement For-profit funders may issue a purchase order/agreement for work to be done by the university.  Purchase orders are typically subject to provisions of the Uniform Commercial Code (UCC) and  may include terms and conditions that are not acceptable to public universities.  Purchase orders typically require negotiation before the university can accept the order and commit to providing the goods and/or services.

Letter/Check Some funders, typically small non-governmental organizations, make grant awards via a simple letter that contains no specific terms and conditions other than a requirement to use the funds for the proposed process and possibly to provide a final report to the sponsor.  Occasionally, a funder provides only a check, in which case, the check is the official award document.

Payment Basis

Cost-Reimbursement The award recipient incurs the costs of conducting the project and then requests reimbursement of actual costs from the Proposal Sponsor on a periodic basis.  Typically used for awards of federal funds and awards from many other governmental and some not-for-profit organizations.

Fixed Price Typically a contract for a set price for which the Proposal Sponsor makes payments based on milestones or deliverables.  Payments may also be made in schedule increments and may include a first payment upon contract execution.

Fixed Fee (or Fee for Service) Services are separately costed (i.e., cost per analysis, cost per treatment, per-capita cost) and may allow for tiered pricing/volume discount.  Invoicing usually occurs after services are delivered.

Firm Fixed Price with FAR Clauses A type of contract/agreement under which the Federal awarding agency or pass-through entity provides a specific level of support without regard to actual costs incurred under the Federal award.  Payments are typically based on milestones or deliverables and may be made in scheduled increments and may include an initial payment upon contract execution.  There should be no CFDA # associated with the funding since the funding is not Federal Domestic Assistance. This would be excluded from SEFA reporting.

Hybrid Payment A single award includes a fixed price (i.e., fixed cost) component and a cost-reimbursement (i.e., variable cost) component.  Most common is a fixed price amount for specified deliverables plus reimbursement for actual travel costs.

Agreement Types (for Agreement Tracking)

Master Sponsored Project Agreement Non-CT) An overarching agreement between the Proposal Sponsor and ECU that establishes terms and conditions that will apply to multiple separately issued task or work orders.  (Do not use for industry clinical trials or non-interventional or registry studies.)

Master Sponsored Project Agreement Modification/Amendment (Non-CT) An agreement between the Proposal Sponsor and ECU that modifies an existing Master Sponsored Project Agreement.   (Do not use for industry clinical trials or non-interventional or registry studies.)

New Award/Contract/Work Order (Non-CT) An agreement between the Proposal Sponsor and ECU that initiates a project that is funded by the Proposal Sponsor with its own funds.  (Do not use for industry clinical trials or non-interventional or registry studies.)

Award/Contract/Work Order Modification/Amendment (Non-CT) An agreement between the Proposal Sponsor and ECU that modifies an existing award/contract/work order.  (Do not use for industry clinical trials or non-interventional or registry studies.)

An agreement between ECU, acting as a pass-through entity, and another party that initiates an activity by the other party that is funded by an agreement between the ECU and the Proposal Sponsor.

Outgoing Subaward/Subcontract Modification/Amendment An agreement between ECU, acting as a pass-through entity, and another party that modifies an existing subaward/subcontract.

Master Industry Clinical Trial Agreement An overarching agreement between the Proposal Sponsor and ECU that establishes terms and conditions for industry clinical trial activity that will apply to multiple separately funded trials.

Master Industry Clinical Trial Agreement Modification An agreement between the Proposal Sponsor and ECU that modifies an existing Master Industry Clinical Trial Agreement.

Industry Clinical Trial Contract/Work Order  An agreement between the Proposal Sponsor and ECU that initiates a separately-funded clinical trial, either as a stand-alone project or under a Master Industry Clinical Trial Agreement.  (Also applies to non-interventional and registry studies.)

Industry Clinical Trial Contract/Work Order Modification/Amendment  An agreement between the Proposal Sponsor and ECU that modifies an existing industry clinical trial contract/work order.

Study Start-Up Agreement An agreement between the Proposal Sponsor and ECU that provides Proposal Sponsor funds for preliminary clinical study activities, including investigator selection, regulatory and ethics submission, site training, and site initiation visits.

In-Kind Grant Agreement (with ascertainable value) An agreement between parties in which one party provides a tangible good with an objective known value rather than providing the money to purchase that tangible good.

Cost-Sharing Agreement An agreement in which a party provides personnel time or other quantifiable resources to another party for a sponsored project without receiving any project funding.

Award Transfer Agreement An agreement related to the transferring of a sponsored project to permit the PI/PD to retain the award and/or project resources when he/she changes institutions.

MOU – Memorandum of Understanding (non-financial) A document describing the general intent of the parties with respect to the subject matter of the MOU. It expresses a convergence of will between the parties, indicating an intended common line of action.

MOA – Memorandum of Agreement (non-financial) A document written between parties to cooperatively work together on an agreed upon project or meet an agreed upon objective. The purpose of an MOA is to have a written understanding of the agreement between parties.

CDA/NDA – Confidential Disclosure/Non-Disclosure Agreement  A contract between at least two parties that outlines the obligations of the parties with respect to confidential material, knowledge, or information that the parties wish to share with one another for certain purposes. Such agreements are commonly signed to prevent disclosure of confidential information to third parties when two entities are considering doing business and need to understand the processes used in each other’s business for the purpose of evaluating the potential business relationship.

DUA/DTUA – Data Use/Data Transfer and Use Agreement A formal contract that clearly documents what data is being shared between the parties and how the data can be used. The agreement protects the entity providing the data, ensuring that the data will not be misused, and it prevents miscommunication between the provider and recipient regarding the use of the data.

MTA – Materials Transfer Agreement A contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use the materials for its own research purposes. The MTA defines the rights of the provider and the recipient with respect to the use and ownership of the materials and any derivatives, progeny, or modifications.

Teaming Agreement A contract between two or more parties (team members) that is used to combine the parties’ applicable resources so that one of the parties may pursue a bid or contract with a third party (prime contract).  The teaming agreement sets forth the rights and obligations of the parties with respect to the combining of resources.

Visiting Scientist Agreement An agreement to allow an ECU faculty member to conduct research at an external organization or to allow a non-ECU employee to conduct research in an ECU facility, to provide the opportunity to learn research methods and best practices and to collaborate on one or more projects.

Facility Use/User Agreement A specific type of license agreement in which the sole purpose is to permit ECU to use research facilities or resources of another party or for another party to use ECU facilities for research purposes without exchange of money.

Equipment Use Agreement Agreement for ECU to borrow research equipment owned by another party or for the other party to borrow research equipment owned by ECU

License Agreement A contract between the parties in which one party (the licensor/grantor) grants the other party (the licensee/grantee) the right (a license) to use software, equipment, materials, access property or resources, etc. to perform a specific task.  Licenses granted may be revocable or irrevocable and are usually very specific as to use and duration of the license.

Research Collab/Cooperative R & D Agreement (CRADA) An agreement between one (or more) federal lab/agency and one (or more) non-federal party under which the government provides personnel, services, equipment, IP, other resources, etc. with (or without, depending on the CRADA) reimbursement and the non-federal party(ies) provide the funds, personnel services, equipment, IP, and/or other resources towards the specified research and development efforts which are consistent with the mission of the federal lab/agency. (Note: This differs from a cooperative agreement because the federal agency is not providing any funding or transferring anything of value to the non-federal party.)

Educational Partnership Agreement An agreement between a defense laboratory/agency (for example, Naval Medical Center Camp Lejeune) and an educational institution (ECU) in which the defense lab/agency provides assistance to the educational institution by loaning equipment, transferring computer or scientific equipment, making personnel available to teach science courses, involving faculty and students in defense lab/agency projects and research, providing internship opportunities, etc.