Administrators and the Responsible Conduct of Research
Glossary

Glossary

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A-21, OMB Circular

Cost Principles for Educational Institutions (05/10/2004) issued by the U.S. Office of Management and Budget. Document Link

A-110, OMB Circular

Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations (11/19/1993) (further amended 09/30/1999) – issued by the U.S. Office of Management and Budget. Document Link

A-133, OMB Circular

A-133, OMB Circular
 Audits of States, Local Governments, and Non-Profit Organizations (06/24/1997) (includes revisions published in Federal Register 06/27/2003) – issued by the U.S. Office of Management and Budget. Document Link

Allocable Costs

Allocable Costs
 A cost is allocable to a particular cost objective (i.e., a specific function, project, sponsored agreement, department, or the like) if the goods or services involved are chargeable or assignable to such cost objective in accordance with relative benefits received or other equitable relationship. (Ref. A-21, C.4.a)

Allowable Costs

Allowable Costs
 The tests of allowability of costs are: (a) they must be reasonable; (b) they must be allocable to sponsored agreements under sponsor-defined principles and methods ; (c) they must be given consistent treatment through application of those generally accepted accounting principles appropriate to the circumstances; and (d) they must conform to any limitations or exclusions set forth in sponsor policies or in the sponsored agreement as to types or amounts of cost items. (Ref. modified from A-21, C.2)

Bayh-Dole Act

Bayh-Dole Act
 Public Law 96-517, the law that governs the rights to inventions discovered at educational institutions or small businesses under projects funded in whole or in part with federal funds. The Bayh-Dole Act is codified in the federal regulations in 37 CFR 401.

Clinical Trial

Clinical Trials
 A scientifically designed and executed investigation of the effects of a drug (or vaccine) administered to human volunteers. The goal is to define the safety, clinical efficacy, and pharmacological effects (including toxicity, side effects, incompatibilities, or interactions) of the drug. The US government, through the FDA, requires strict testing of all new drugs and vaccines prior to their approval for use as therapeutic agents. (Source: amFAR, the Foundation for AIDS Research) Reference Link

Co-investigator

Co-Investigators
 An individual collaborating with the Principal Investigator in the conduct of a sponsored project. A co-investigator usually works under the supervision and direction of the Principal Investigator.

Co-Principal Investigator

An individual designated along with one or more other Co-Principal Investigators by the institution to direct a project or activity being supported by external funding. He or she is responsible and accountable to the institution and sponsor for the proper conduct of the project or activity. Co-Principal Investigators have equal authority and responsibility for the conduct of the sponsored project.

Collaboration Agreement

Collaboration Agreement
 An agreement between two or more researchers that sets forth the nature of their working relationship in a research project. The agreement may include provisions concerning the intent of the parties to share data, research materials and facilities, and to publish research findings. Since collaboration agreements are usually executed between researchers, they are not documents that legally bind the researchers' institutions to a commitment of any resources.

Confidential Disclosure Agreement

Confidential Disclosure Agreement
 A document executed between institutions permitting the exchange of information that is confidential to one or both parties. The scope of the confidential information will be defined as well as the period during which information will be considered confidential.

Conflict of Commitment

A situation in which an individual has outside activities and business interests so significant that they may interfere with the primacy of the individual's commitments to the institution as his/her primary employer.

Conflict of Interest

Conflicts of Interest
A situation in which an individual has one or more significant financial interest that have the potential for tainting or have the potential to taint the conduct or reporting of the work conducted under a sponsored project.

Conflict of Interest Committee

Conflict of Interest Committee
 The body designated by the institution to review and manage or eliminate conflicts of interest.

Conflict of Interest Disclosure

Conflict of Interest Disclosure
 The document completed by those having decision-making authority in proposing, performing, and reporting the work under sponsored projects.

Consulting Agreement

Consulting Agreement
 An agreement between two or more researchers that sets forth the nature of their working relationship in a research project. The agreement may include provisions concerning the intent of the parties to share data, research materials and facilities, and to publish research findings. Since collaboration agreements are usually executed between researchers, they are not documents that legally bind the researchers' institutions to a commitment of any resources. Reference Link

Copyright

Copyright is a form of protection provided by the laws of the United States (title 17, U.S. Code) to the authors of "original works of authorship," including literary, dramatic, musical, artistic, and certain other intellectual works. This protection is available to both published and unpublished works. The owner of copyright has the exclusive right to do and to authorize others to do the following:

  1. To reproduce the work in copies or phonorecords;
  2. To prepare derivative works based upon the work;
  3. To distribute copies or phonorecords of the work to the public by sale or other transfer of ownership, or by rental, lease, or lending;
  4. To perform the work publicly;
  5. To display the copyrighted work publicly; and
  6. In the case of sound recordings, to perform the work publicly by means of a digital audio transmission.

Link to U.S.Copyright Office

Cost-Sharing

A portion of the total project or program expenses related to a sponsored agreement that is contributed by parties other than the primary sponsor and not charged to the sponsor.

Cost Transfer

The movement of costs from one project to another to correct an assignment of costs that may not have been allocable or allowable.

Data

Data
 In the context of sponsored projects, data includes all information or tangible materials collected or generated in the course of the project. Data is subdivided into research data, financial data, and administrative data.

Data Sharing Plan

Data Sharing Plan
 A brief description of how research data resulting from the work conducted under large NIH grants will be disseminated and shared with others having a valid purpose for access to the data.

Effort Reporting

Effort reporting is a method for documenting activity provided in support of sponsored projects. Ref: UPenn Discussion PP

Equity

Whole or partial ownership of a commercial entity.

Facility Use Agreement

Facility Use Agreement
 A document containing the provisions under which access to an institution's facilities (e.g. laboratories and research equipment) is governed. The agreement may be executed between the institution and either an entity or an individual researcher. The individual executing the agreement on behalf of the institution must be authorized by the institution to permit access to institutional facilities.

FERPA

FERPA
 Family Educational Rights and Privacy Act of 1974, also known as the "Buckley Amendment."More information

Institutional Animal Care and Use Committee (IACUC)

Institutional Animal Care and Use Committee (IACUC)
 The body that is charged with ensuring the proper care and welfare of animals involved in research. The IACUC reviews research to ensure that research methods are appropriate and comply with ethical and regulatory standards. The IACUC also has the responsibility to review periodically the condition of the animal facility(ies) as well as policies, procedures and operational functions of the facility and program.

Institutional Biosafety Committee (IBC)

Institutional Biosafety Committee (IBC)
 An institutional committee created under the NIH Guidelines for Research Involving Recombinant DNA Molecules to review research involving recombinant DNA. The role of IBCs has evolved over time, and many committees also review other forms of research that entail biohazardous risks as part of their institutionally assigned responsibilities. (Source: NIH, Office of Biotechnology)

Institutional Review Board (IRB)

Institutional Review Board (IRB)
 The committee established by the institution to review and approve research protocols involving the use of human participants.

Intellectual Property

Intellectual Property
 Creations of the mind - creative works or ideas embodied in a form that can be shared or can enable others to recreate, emulate, or manufacture them. There are four ways to protect intellectual property - patents, trademarks, copyrights or trade secrets. Ref. USPTO Glossary

Intellectual Property Agreement

Intellectual Property Agreement
 A document executed between or among collaborating institutions that sets forth the rights and responsibilities of each institution pertaining to the intellectual property that may be created during the term of the collaboration. An Intellectual Property Agreement will likely address the rights associated with intellectual property that is created jointly by the collaborating researchers as well as intellectual property created independently by each.

Liability

Liability
 In the context of sponsored projects, liability is an obligation incurred by an institution due to its negligence or wrong-doing in the performance of the research project. Sponsors may attempt to expand the obligations to cover liability resulting from any acts or omissions of the institution. Institutions needs to decide the extent of the liability they are willing to accept and ensure that award negotiations address the relevant provisions.

License

License
 An agreement by which the owner of intellectual property permits the use, performance, and/or sale of the intellectual property by another party. Such use is generally made available for some form of financial compensation.

Management Plan

Management Plan
 The document describing the methods by which conflicts of interest will be mitigated or eliminated.

Mandatory Cost Sharing Plan

The sharing of projects costs that is required by the terms of a sponsored agreement or sponsor policy.

Material Transfer Agreement

Material Transfer Agreement
 An agreement outlining conditions under which material is provided from the owner to another entity for a specific use. Material may be any chemical compounds or any form of biological materials, such as cultures, cell lines, plasmids, nucleotides, proteins, transgenic animals or plants, or pharmaceuticals. MTAs address such issues as: a) ownership of the transferred material and any of the modifications and derivatives, b) limits on the use of the material, c) confidentiality of information relating to the material, and publication restrictions, d) rights to inventions and use of research results, e) legal liability as a result of the use of the Material or any results obtained. (Source: NCURA Online Subaward Tutorial, 2006)

Mentor

Mentor
 Someone who is more experienced and takes a special interest in the development of another, particularly a student. "A mentoring relationship is a close, individualized relationship that develops over time between a graduate student and a faculty member (or others) that includes both caring and guidance." Ref. Univ. of Michigan Student Information. Document Link

Mentoring relationship

An advising relationship between a more-experienced person and a more-junior person that is professional in nature but also includes a more personalized nurturing aspect.

Patent

The exclusive property rights to an invention which permit the owner the right to exclude others from making, using, offering for sale, or selling the invention. Ref. U.S. Patent and Trademark Office

Prime Agreement

Prime Agreement
 The sponsored project award document received by the Prime Awardee directly from the sponsor.

Prime Awardee

Prime Awardee
 The institution that executes the prime agreement with the sponsor.

Principal Investigator

Principal Investigator
 An individual designated by the institution to direct the project or activity being supported by external funding. He or she is responsible and accountable to the institution and sponsor for the proper conduct of the project or activity. Ref: Modified from the NIH Grants Policy Statement, 12/03

Proprietary

Proprietary
 Rights to intellectual property that are owned, possessed, or held exclusively by an entity or individual. Proprietary rights include the right to permit or prohibit others from using the intellectual property.

Protocol

Protocols
 The written plan describing the methodology and research design of projects involving animals or human participants.

Reasonable Costs

A cost may be considered reasonable if the nature of the goods or services acquired or applied, and the amount involved therefore, reflect the action that a prudent person would have taken under the circumstances prevailing at the time the decision to incur the cost was made. (ref. A-21, C.3)

Shelby Amendment

Shelby Agreement
 Public Law 105-277, which was enacted to permit members of the public to gain access through the Freedom of Information Act to research data generated through the use of federal funds. The Office of Management and Budget, in promulgating the implementing regulations, limited public access to data used by federal agencies in the formulation of federal policy.

Significant Financial Interest

A situation in which any one of the following exists:

(1) an Employee and/or immediate family members or associated entity have an aggregated equity interest in a Business representing ownership of 5 percent or more or a value of $10,000 or more, as determined through reference to public prices or other reasonable measures of fair market value;

(2) an Employee and/or immediate family members or associated entity are expected to receive an aggregated annual income or other consideration from a Business equal to or exceeding $10,000 over the next 12 months (income includes all types of compensation);

(3) an Employee and/or immediate family members or associated entity have a commitment for future royalties from a business the next 12 months and beyond that are expected to equal or exceed $10,000 in aggregated annual income; or

(4) an Employee or immediate family member has a Business Interest in a Business whose purpose or activities are similar or related to the work to be conducted under the Sponsored Project. (Ref: BC COI Policy)

Sponsor

Sponsor
 The organization providing funds for the project

Sponsored Project

Sponsored projects are research, training, or instructional projects involving funds, materials, other forms of compensation, or exchanges of in-kind efforts from sources external to the institution under awards or agreements which contain any one of the following criteria:

Stewardship

Stewardship
 The conducting, supervising, or managing of something; especially: the careful and responsible management of something entrusted to one's care. (Source: Merriam-Webster's 11th Collegiate Dictionary)

Subaward

Subaward
 A contract or legal agreement between the prime recipient of a grant, cooperative agreement or contract and another organization (the subrecipient) that will engage in a portion of the research or perform other programmatic activities that constitute substantive work under the prime award. The agreement is written under the authority of the prime award and specifies the terms and conditions under which the subrecipient will engage in the work. A subaward includes the administrative requirements of the funding agency to which the subrecipient must adhere. The performance of substantive work is the key feature which distinguishes subawards from purchase orders and other third party agreements. A subaward is not an agreement for the procurement or purchase of goods or services. Subaward are referred to by a variety of terms – leading in part to the confusions surrounding these agreements and their administration. Subaward, subgrant, subcontract, consortium agreement and subrecipient agreement are all terms that are used. Some of these terms come from specific regulation and have more precise definitions. (Source: NCURA Online Subaward Tutorial, 2006)

Subawardee/Subrecipient

Subrecipient
 The legal entity to which a subaward is made and which is accountable to the recipient for the use of the funds provided. Subrecipients must adhere to the administrative regulations of the prime award. Other terms used include subawardee or subgrantee. (Source: NCURA Online Subaward Tutorial, 2006)

Teaming Agreement

Teaming Agreement
 A document typically executed by parties intending to collaborate on a sponsored project. The teaming agreement will cover general issues related to intellectual property rights and other aspects defining the reporting and working relationship of the parties.

Trade Secret

Trade Secret
 Something (as a formula) which has economic value to a business because it is not generally known or easily discoverable by observation and for which efforts have been made to maintain secrecy (Source: Merriam Webster's 11th Collegiate Dictionary).

Trainee

Trainee
 A more-junior member of a research team who is being advised by someone. In academic research, trainees may be graduate students or post-doctoral fellows.

Voluntary Committed Cost Sharing

The sharing of project costs on that if offered by an institution over and above a sponsor's cost-sharing requirements. Once accepted by the sponsor, voluntary committed cost-sharing becomes mandatory cost-sharing.

Voluntary Uncommitted Cost Sharing

The sharing of project costs over and above sponsor cost-sharing requirements, but not offered as a part of a funding application. It does not become a part of the award requirements and is, therefore, not considered mandatory.

Work-for-Hire

Work-for-hire
 Works created within the scope of one's employment, or works commissioned or contracted by which the creator retains no rights to the works.