Glossary of Terms


A

AAALAC

Private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

A-2

"Cost Principles for Educational Institutions," a circular published by the federal Office of Management and Budget (OMB) that establishes the principles for determining the costs applicable to grants , contracts , and other government agreements with educational institutions (also known as Sponsored Projects).

Accounts Payable (AP)

Amounts a company owes because it purchased goods or services on credit from a supplier or vendor.

Accounts Receivable (AR)

Amounts a company has a right to collect because it sold goods or services on credit to a customer. 

Adverse Effest

An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention. Also referred to as an adverse event.

Agent

Institution's employees or agents refer to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities.  This can include staff, students, contractors and volunteers, among others, regardless of whether the individual is receiving compensation.  A student's affiliation with an academic institution makes him/her an agent of that institution; and thus the academic institution is engaged in the research regardless of where the research takes place.

Allegation of Non-Compliance

Unproved assertion of non-compliance.

Allocable Costs

Those allowable costs that actually benefit the grant or contract to which they are being charged.

Allowable Costs

Categories of costs that can be charged to a grant, such as salaries and equipment.

Alternate Member

Alternate Institutional Review Board (IRB) committee members may be designated, as needed, for regular voting members. The appointment of alternate members should be based on expertise similar to that of the regular voting member. An alternate member may vote only when the regular voting member is absent.

Amendment

Any change to an IRB-approved study protocol regardless of the level of review it receives initially. Also referred to as a modification.

Automated Clearning House (ACH)

Electronic funds-transfer system run by the National Automated Clearing House Association (NACHA). This payment system deals with payrolldirect deposittax refunds, consumer bills, tax payments and many more payment services.

Award

Funds that have been obligated by a funding agency for a particular project.

B

Belmont Report

Statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

Beneficence

Ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm.  The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Benefit

Valued or desired outcome; an advantage.

Bequests

Type or donation or gift. Bequests and gifts are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. The unique flexibility, or lack of restrictions, makes gifts attractive sources of support.

Beta Test Agreement

In terms of Intellectual Property law, beta-test agreement is a software license agreement between a software developer and a customer. The agreement allows the customer to use the software program in a “live” environment before its release to the general public. Beta-test agreements differ from more conventional software licenses. They typically have more significant limitations on liability; contain few warranties, if any; and require user evaluation and feedback. This is also known as software beta-test agreement.

Billing Grid

Line item list of study activities and visit schedule which displays the billing designation(s) for each event and/or item.

Broad of Regents for the University System of Georgia (BOR)

Created in 1931 as a part of a reorganization of Georgia's state government, public higher education in Georgia was unified for the first time under a single governing and management authority.

Broad Agency Announcement (BAA)

Announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made.

Budget

Detailed statement outlining estimated project costs to support work under a grant or contract.

Budget Adjustment (BA)

Act of amending the budget by moving funds from one category or line item to another.

Budget Period

Interval of time--usually twelve months--into which the project period is divided for budgetary and funding purposes.

C

Catalog of Federal Domestic Assistance and EPA Programs (CFDA)

Comprehensive and centralized foundation for the annual publication of federal domestic assistance programs, which is a government-wide compendium of federal programs, projects, services, and activities that provide assistance or benefits to the public. 

Challenge Grant

Grant that provides monies in response to monies from other sources, usually according to a formula. A challenge grant may, for example, offer two dollars for every one that is obtained from a fund drive. The grant usually has a fixed upper limit, and may have a challenge minimum below which no grant will be made. This form of grant is fairly common in the arts, humanities, and some other fields, but is less common in the sciences. A challenge grant differs from a matching grant in at least one important respect: The amount of money that the recipient organization realizes from a challenge grant may vary widely, depending upon how successful that organization is in meeting the challenge. Matching grants usually award a clearly defined amount and require that a specified sum be obtained before any award is made.

Change Order

Written order signed by the contracting officer, directing the contractor to make changes that the changes clause of the contract authorizes the contracting officer to order without the consent of the contractor.

Chart Field Combination (CFC)

Also known as the “account string”, the CFC is a set of numerical characters that indicate important financial data.  A CFC is assigned when a project is initiated.


Chart Field Combination image

Children

Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)] .

Clinical Trial

Biomedical or behavioral research study of human subjects designed to answer specific questions about diagnostic procedures or therapeutic interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new diagnostic procedures or therapeutic interventions are safe, efficacious, and effective.

Clinical Trial Agreement (CTA)

Legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication, input into further intellectual property.

Closure

Continuing review and re-approval of a study is required so long as the project continues to involve human subjects. When research activities no longer involves subjects or their identifiable data, the study may be closed with the IRB.  If the all of the following are true, a study may be closed:

  • The protocol is permanently closed to enrollment.
  • All subjects enrolled have completed all protocol related interventions and interactions, including interventions and interactions related to collection of long-term follow-up data.
  • No additional identifiable private information about the subjects is being obtained by this organization’s investigator(s).

Analysis of private identifiable information at this organization is completed.

Close Out

Act of completing all internal procedures and sponsor requirements to terminate or complete a research project.

Code of Federal Regulations (CFR)

Rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

Cognitively Impaired

Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

Collaborative Research Agreement (CRA)

Collaborative Research Agreements (CRAs) are contracts between the institution and one or more organizations that are cooperating in the conduct of a research program. In these agreements, there is generally no transfer of funds between organizations (referred to as a “No Cost Collaboration”). Instead, the agreement describes the actions that each organization has agreed to undertake, and defines the obligations each party has to the others participating in the collaborative research effort.

Collaborative Research Agreements may include terms governing the following:

  • Scope of work to be conducted
  • Management and staffing of the research project
  • Schedules and deliverables
  • Publication of the research results
  • Options to license the intellectual property arising from the research collaboration
  • Care of data and confidential information exchanged during the research
  • Transfer of materials among the collaborating organizations
  • Compliance with export control and other laws and regulations
  • Use of institution’s name and the collaborator’s name
  • Rights and procedures to terminate the project
  • Taxes, insurance, warranties, liability, governing law, and other items necessary for contracts
Compensation

Means to offset inconvenience, travel expenses and/or lost revenue due to participation in a research project, however, it may be structured to serve as a recruitment incentive as well.  Alternate terms are payment, reimbursement, or remuneration.  Compensation also refers to payments or treatments provided for research-related injury.

Competence

Technically, a legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. See also incapacity and cognitively impaired.

Competing Proposals

Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired.

Confidentiality

Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission. Compare to anonymity and privacy.

Confidentiality Agreement (CDA)/Non-Disclosure Agreement (NDA)

Designed to protect the confidential information that may be released between an industry sponsor or other entity and the AU faculty and staff so that they can determine whether or not to enter into a subsequent agreement for either a clinical trial (CTA) or basic research (SRA).  CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other information which the sponsor considers proprietary.  Not all sponsors require a CDA prior to disclosure of confidential information.

Conflict of Interest

An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s spouse, domestic partner, children, and dependents have any of the following interests in the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual’s immediate family:

  • Involvement in the design, conduct, or reporting of the research.
  • Ownership interest, stock options, or other ownership interest of any value exclusive of interests in publicly-traded, diversified mutual funds.
  • Compensation of any amount in the past year or of any amount expected in the next year, excluding compensation for costs directly related to conducting research.
  • Proprietary interest including, but not limited to, a patent, trademark, copyright or licensing agreement.
  • Board or executive relationship, regardless of compensation.
  • Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or medical center.

Any other reason for which the individual believes that he or she cannot be independent.

Consent

See informed consent.

Consortium Agreement

Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.

Continuation Project (Non-Competing)

Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects typically do not compete with new project proposals and are not subjected to peer review beyond the initial project approval.

Continued Non-Compliance

Persistent failure to adhere to the laws, regulations, or policies governing human research.

Continuing Review

Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year.  The criteria for approval are defined by federal regulations. 

Contract

Mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Typically, a research topic and the methods for conducting the research are specified in detail by the sponsor, although some sponsors award contracts in response to unsolicited proposals.

Contract/Grant Officer

Sponsor's designated individual who is officially responsible for the business management aspects of a particular grantcooperative agreement, or contract. Serving as the counterpart to the business officer of the grantee/contractor organization, the grant/contract officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a grant or contract and interprets the associated administration policies, regulations, and provisions. (For definition of scientific officer, see Program Project Officer.)

Cooperative Agreement

Award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.

Corporate Person Index (CPI#)

Unique number assigned to a study that uses billable hospital services.

Cost Accounting Standards (CAS)

Federally mandated accounting standards intended to ensure uniformity in budgeting and spending funds.

Cost-Reimbursement Type Contract/Grant

Contract / grant for which the sponsor pays for the full costs incurred in the conduct of the work up to an agreed-upon amount.

Cost-Sharin

General term, used as a noun or adjective, that can describe virtually any type of arrangement in which more than one party supports research, equipment acquisition, demonstration projects, programs, institutions.

Cost Transfer (CT or COT)

After-the-fact transfer of costs (labor or non-labor) from a sponsored or non- sponsored award to a federally funded award.

D

Data Collection Instruments

Examples of data collection instruments include, but are not limited to:

  • Questionnaires, surveys;
  • Videotapes, audiotapes, and photographs;
  • Interview and focus group questions, guides, and notes;
  • Field notes, observation guides and notes;
  • Data collection forms and spreadsheets;
  • Verbal or written instructions given to participants for research activities; and/or
  • May also include visual images, objects, tools, or devices used in the data collection.
  • Copies and/or detailed descriptions of all data collection instruments are required in the initial review, and submitted materials (and versions) are noted in the IRB approval.  Proposed changes to approved study instruments must be submitted via a modification and must be reviewed and approved by the IRB before any changes are implemented.
Data Universal Numbering System (DUNS)

Proprietary system developed and regulated by Dun & Bradstreet (D&B) that assigns a unique numeric identifier, referred to as a "DUNS number" to a single business entity.

Data Use Agreement (DUA)

Used for the transfer of data that has been developed by nonprofit, government, or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use.

Debriefing

Giving subjects previously undisclosed information about the research following completion of their participation in research activities.  Debriefing is often used as an extension of the informed consent process when incomplete disclosure or deception is used.  Debriefing may also be used as an educational tool.  (Note that this usage, which occurs within the behavioral sciences, departs from Standard English where debriefing is obtaining rather than imparting information.)

Declaration of Helsinki

Code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.

Defense Acquisition Regulations (DAR)

Source regulations for research projects sponsored by the Department of Defense. 

Defense Acquisition Regulations (DAR)

The source regulations for research projects sponsored by the Department of Defense.

Deficit

Expenditures exceed funds available.

De-Identified Data

Data that has been stripped of all identifiers so that the information cannot be traced back to an individual.  De-identified data may also pertain to information that has been assigned and retains a code provided that:

  • The code is not derived from or related to the information about the individual;
  • The code could not be translated to identify the individual; and
  • No link to identifiers exists, or the holder of the link record does not use or disclose the code for other purposes or disclose the mechanism for re-identification.
Deliverables

Deliverables may include, but are not limited to records, detailed research results, study data, research publications, completion of milestones, or the completion of project actions, etc.

Department of Health and Human Services (DHHS)

Cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services.  The DHHS regulations on the Protection of Human Subjects, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

Department of Defense (DOD)

Department of the U.S. federal government charged with ensuringthat the military capacity of the U.S. is adequate to safeguard thenational security.

Department of Energy (DOE)

Department of the U.S. federal government that sets forth and maintains the national energy policy, including energy conservation, environmental protection, etc.

Designated Reviewe

IRB Chair or an experienced IRB member designated to conduct non-committee reviews (e.g., expedited review).

Direct Costs

Clearly identifiable costs related to a specific project. General categories of direct costs include but are not limited to salaries and wages, fringe benefits, supplies, contractual services, travel and communication, equipment, and computer use.

Documentation

Act or an instance of furnishing or authenticating with documents.  Documentation of informed consent includes use of a written consent form (approved by the IRB) and signed and dated by the subject or the subject's legally authorized representative and, typically, by the person obtaining consent.

Donation

Any item of value give to the University by a donor who expects nothing significant of value in return, other than recognition and disposition of the gift in accordance with the donor’s wishes.

In general, the following characteristics describe a gift:

  • The agreement does not impose and there are no "deliverables" to the donor.
  • Gifts may be accompanied by an agreement that restricts the use of the funds to a particular purpose.
  • A gift is typically irrevocable. Gifts may be intended for a specific use within a certain timeframe, but there is no specified "period of performance" or "start"/ "end" dates as associated with sponsored projects.
  • There is no formalfiscal accountability to the donor beyond periodic progress reports and summary reports of expenditures. These reports may be thought of as requirements of good stewardship, and, as such, may be required by the terms of a gift. They are not characterized as contractual obligations or "deliverables."

The institution agrees to use restricted gifts as the donor specifies, and does not accept gifts that it cannot use as the donor intends. University approval for changes in the purpose of a gift fund may be required.

E

Eligibility Criteria

Requirements that must be met, or characteristics that he or she must have, for an individual to be included in a study. These include inclusion criteria and exclusion criteria.  For example, a study might only accept participants who are above or below certain ages.

Electronic Medical Record (EMR)

Online system used to manage patient care. Also referred to as the electronic health record (EHR).

Electronic Personnel Action Request (ePAR)

Allows departments to submit online requests to update employee job records. These requests are moved through a predefined approval queue and then posted to the employee's record.

Electronic Research Administration (ERA)

Industry term for doing what used to be done on paper, except electronically – using software to manage the data and to automate many of the processes that facilitate the administrative work involved in research.

Emancipated Minor

Legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.

Encumbrance

Funds that have been set aside or "claimed" for projected expenses pending actual expenditure of the funds.

Endowment

Fund usually in the form of an income-generating investment, established to provide long-term support for faculty/research positions (e.g., endowed chair).

Enrollment

Occurs when an eligible, prospective subject undergoes the initial informed consent process and voluntarily agrees to participate in a research project.  The number of enrolled subjects includes withdrawals.

Entity Identification Number (EIN)

Unique identification number that is assigned to a business entity so that they can easily be identified by the Internal Revenue Service.

ePRMS

OnCore’s electronic protocol review and monitoring system is a paperless committee management system.  It is designed to assist the workflow of a Protocol Review and Monitoring Committee (PRMC).

Equitable

Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.

eSirius

Web-based product comprising a fully integrated group of applications to manage IACUC and Animal Resource Facility (ARF) functions.

Exclusion Criteria

Factors (or reasons) that prevent a person from participating in a research study.

Exempt

Certain categories of human research may be exempt from federal regulation but require IRB review.  It is the responsibility of the institution, not the investigator, to determine whether human research is exempt from IRB review. 

Expaned Authorities (EA

Limited number of actions that normally require awarding agency prior approval but for which HHS has waived its authority and given this authority to the grantee.

Expedited Review

Review of proposed research by the IRB Chair, a designated voting member, or group of voting members rather than by the convened IRB.  Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. 

Expiration Date

Date signifying the end of the performance period, as indicated on the Notice of Grant Award.

Expired

When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically.  The study expires on the date specified on the approval letter and the consent document.  No activities can occur after the expiration date.  Also referred to as a lapsed study or protocol.

Extension

Additional period of time given by the sponsor to an organization for the completion of work on an approved grant or contract. An extension allows previously allocated funds to be spent after the original expiration date.

F

Facilities and Administrative (F&A) Costs

Costs that are incurred for common or joint objectives and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. F&A costs are synonymous with Indirect Costs.

Family Educational Rights and Privacy Act of 1974 (FERPA)

Federal legislation in the United States that protects the privacy of students' personally identifiable information (PII).  The act applies to all educational institutions that receive federal funds. 

Federal Cash Transaction Report (FCTR)

Internal Revenue Code (IRC) provides that any person who, in the course of its trade or business, receives in excess of $10,000 in cash in a single transaction (or in two or more related transactions) must report the transaction to the IRS and furnish a statement to the payer.

Federal Demonstration Partnership or Federal Demonstration Project (FDP)

Association of federal agencies, academic research institutions with administrative, faculty and technical representation, and research policy organizations that work to streamline the administration of federally sponsored research. 

Federalwide Assurance for Protection of Human Subjects (FWA)

All institution’s human subjects research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution.  This is accomplished via contract with the federal government allowing research involving human subjects to take place.

Finding of Non-Compliance

Non-Compliance in fact.

Final Report

Final technical or financial report required by the sponsor to complete a research project.

Financial Status Report (FSR)

Accounting of expenditures and obligations incurred during the period of performance and/or at the conclusion of the sponsored project. The financial report reflects the institution's official accounting records.

Fiscal Year (FY)

Any twelve-month period for which annual accounts are kept (at AU, July 1 through June 30).

Fixed-Price (FP) Contract/Grant

Contract/grant for which one party pays the other party a predetermined price, regardless of actual costs, for services rendered. Quite often this is a fee-for-service agreement.

Food and Drug Administration (FDA)

Agency within the US Public Health Service that provides a number of health-related services. Abbreviated FDA. The FDA's services include inspecting food and food-processing facilities to ensure wholesomeness and safety; scrutinizing food and drugs for pets and farm animals; ensuring that cosmetics will not cause harm; monitoring the health of the nation's blood supply; ensuring that medicines, medical devices, and biologicals (such as insulin and vaccines) are safe and effective; and testing radiation-emitting products such as microwave ovens to protect the public.

Fringe Benefits

Employee benefits paid by the employer. (e.g., FICA, Worker's Compensation, Withholding Tax, Insurance, etc.)

Full Board Review

Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

Full Time Equivalent (FTE)

Hours worked by one employee on a full-time basis. The concept is used to convert the hours worked by several part-time employees into the hours worked by full-time employees. On an annual basis, an FTE is considered to be 2,080 hours, which is calculated as 8 hours per day.

Funding Cycle

Range of time during which proposals are accepted, reviewed, and funds are awarded. If a sponsor has standing proposal review committees (or boards) that meet at specified times during the year, application deadlines are set to correspond with those meetings. For some sponsors, if proposals are received too late to be considered in the current funding cycle, they may be held over for the next review meeting (i.e., National Science Foundation's Target Dates).

Funding Opportunity Announcement (FOA)

Publically available document that a Federal agency uses to announce its intention to award grants or cooperative agreements that are usually the result of a competition of funds.  Synonyms:  Program Announcements, Requests for Application, Notices of Funding, etc. 

G

General Ledger (GL)

Main accounting record of a company or organization.

Generally Accepted Accounting Principles (GAAP)

Collection of commonly-followed accounting rules and standards for financial reporting. The acronym is pronounced "gap." GAAP specifications include definitions of concepts and principles, as well as industry-specific rules.

Gift

Gifts and bequests are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. The unique flexibility, or lack of restrictions, makes gifts attractive sources of support. (Also see Donation.)

Graduate Research Assistant (GRA)

Researcher employed, often on a temporary contract, by a university or research institute, for the purpose of assisting in academic research.

Grant

Type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. A grant, as opposed to a cooperative agreement, is used whenever the awarding office anticipates no substantial programmatic involvement with the recipient during the performance of the activities. 

Grant/Contract Management Officer (GMO)

Sponsor's designated individual who is officially responsible for the business management aspects of a particular grantcooperative agreement, or contract. Serving as the counterpart to the business officer of the grantee/contractor organization, the grant/contract officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a grant or contract and interprets the associated administration policies regulations, and provisions. (For definition of scientific officer, see Program/Project Officer.) 

Greater than Minimal Risk

When research involves more than minimal risk to subjects. See minimal risk.

Guardian

Individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)]. 

H

Health Resources and Services Administration (HRSA)

Agency of the U.S. Department of Health and Human Services, which is the primary federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable.

Health Insurance Portability and Accountability Act (HIPAA)

Sets standards and regulations to protect patients from inappropriate disclosures of their protected health information (PHI) that could cause harm to their insurability, employability and their privacy.  Also known as “The Privacy Rule.” 

HIPAA Authorization

Customized document or form that gives permission to use specified protected health information (PHI) for a specific purpose, or to disclose PHI to a third party specified by the investigator other than for treatment, payment or health care operations.

Human Subject (as defined by DHHS)

Living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. 

Human Subject Research

Any activity that is research as defined by DHHS and involves human subjects as defined by DHHS 

I

Identifiable Information

Linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.  Identifiable information can include, but are not limited to:

Protected Health Information (PHI)


The Privacy Rule (HIPAA) protects all individually identifiable health information held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral.

PHI is information, including demographic data, that relates to:

  • the individual’s past, present or future physical or mental health or condition,
  • the provision of health care to the individual, or
  • the past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.  PHI identifiers include:
  1. Names
  2. All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:
    • The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and
    • The initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
  3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date,, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
  4. Telephone numbers
  5. Fax numbers
  6. Electronic mail addresses
  7. Social security numbers
  8. Medical record numbers
  9. Health plan beneficiary numbers
  10. Account numbers
  11. Certificate/license numbers
  12. Vehicle identifiers and serial numbers, including license plate numbers
  13. Device identifiers and serial numbers
  14. Web Universal Resource Locators (URLs)
  15. Internet Protocol (IP) address numbers
  16. Biometric identifiers, including finger and voice prints
  17. Full face photographic images and any comparable images, and
  18. Any other unique identifying number, characteristic, or code, (excluding a random identifier code for the subject that is not related to or derived from an existing identifier)

Source:  HIPAA

Personally Identifiable Information (PII)


  • Name, such as full name, maiden name, mother‘s maiden name, or alias
  • Personal identification number, such as social security number (SSN), passport number, driver‘s license number, taxpayer identification number, patient identification number, and financial account or credit card number
  • Address information, such as street address or email address
  • Asset information, such as Internet Protocol (IP) or Media Access Control (MAC) address or other host specific persistent static identifier that consistently links to a particular person or small, well defined group of people
  • Telephone numbers, including mobile, business, and personal numbers
  • Personal characteristics, including photographic image (especially of face or other distinguishing characteristic), x-rays, fingerprints, or other biometric image or template data (e.g., retina scan, voice signature, facial geometry)
  • Information identifying personally owned property, such as vehicle registration number or title number and related information
  • Information about an individual that is linked or linkable to one of the above (e.g., date of birth, place of birth, race, religion, weight, activities, geographical indicators, employment information, medical information, education information, financial information

The Family Educational Rights and Privacy Act (FERPA) specifically defines PII as including, but not limited to:

(a) The student's name;

(b) The name of the student's parent or other family members;

(c) The address of the student or student's family;

(d) A personal identifier, such as the student's social security number, student number, or biometric record;

(e) Other indirect identifiers, such as the student's date of birth, place of birth, and mother's maiden name;

(f) Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty; or

(g) Information requested by a person who the educational agency or institution reasonably believes knows the identity of the student to whom the education record relates.


Sources: US GSAFERPANIST 

Many demographics (e.g. age, sex, ethnicity, etc.) on their own are not considered identifiable to individual subjects.  However, researchers should be aware that a combination of demographic information may be sufficient to identify an individual within a group or a limited population. 

Descriptions of personal and highly specific events may be sufficient to identify an individual in a known community even when typical identifiers, like names, are removed.

In-Kind

Contributions or assistance in a form other than money. Equipment, materials, or services of recognized value that are offered in lieu of cash.

Incapacity

Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.  Often used as a synonym for incompetence. See also competence and cognitively impaired.

Inclusion Criteria

Factors (or reasons) that allow a person to participate in a research study.

Incremental Funding

Method of funding contracts that provides specific spending limits below the total estimated costs. These limits may be exceeded only at the contractor's own risk. Each increment is, in essence, a funding action.

Indirect Costs (ICR)

See Facilities and Administrative Costs.

Indirect Cost Rate (ICR)

Rate, expressed as a percentage of a base amount established by negotiation with the cognizant federal agency on the basis of the institution's projected costs for the year and distributed as prescribed in OMB Circular A-21. At AU, indirect costs are applied to a modified total direct cost (MTDC) base. The indirect cost rate is charged on a set of direct costs known as an indirect cost base.

Informed Consent

Voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [45 CFR 46.116; 21 CFR 50.20 and 50.25].  In the review and conduct of human research, informed consent refers as much to the process as to any particular form or document.  The goal of the informed consent process is to protect participants.  It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends.  Because giving consent to participate in research is not a contract, participants can leave a study at any time.

Institution

1) Any public or private entity or agency (including federal, state, and local agencies. 
Or,
2) a residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care. Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.

Institutional Animal Care and Use Committee (IACUC)

Federally mandated committee responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and the Guide for the Care and Use of Laboratory Animals.

Institutional Engagement

Institution becomes "engaged" in human research when its employees or agents 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes.  An institution is also considered engaged in human research when it receives a direct Federal award to support the research.  See also agent.

Institutional Official

Person at an institution who is designated as the Institutional Official and is the Signatory Authority on the University’s federalwide assurance (FWA) with OHRP.  Also referred to as the Organizational Official.

Institutional Review Board (IRB)

Administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Institutionalized

Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).

Intellectual Property

Work or invention that is the result of creativity, such as a manuscript or a design, to which one has rights and for which one may apply for a patent, copyright, trademark, etc.

Interaction

Communication or interpersonal contact between investigator and subject.

Inter Departmental Request (IDR)

Request for service from one department to another department within an institution/organization.

Inter Departmental Request (IDR)

Request for service from one department to another department within an institution/organization.

Interim Funding

Authorization to expend funds on a project to a specified limit before the award document has been received from the sponsor.

Intervention

Physical procedures by which data are gathered (for example, venipuncture) or manipulations of the subject or the subject’s environment that are performed for research purposes.

Intramural Grants Program (IGP)

Comprehensive and coordinated competitive grant program that is committed to the advancement of knowledge through basic and applied research, to the enrichment of society through creative initiatives, to promoting faculty research in all disciplines, and recognizing that scholarly activity can take different forms across disciplines.  It is designed to support faculty in becoming competitive in securing external funding and sponsorship.

Invention Disclosure Form (IDF)

Invention disclosure form is useful for easily documenting your invention, providing evidence of your earliest invention date and submitting your invention to your patent attorney. 

Investigator-Initiated Proposal

Proposal submitted to a sponsor that is not in response to an RFPRFA, or a specific program announcement.

Invitation for Bid (IFB)

Solicitation issued to prospective bidders. An IFB describes what is required and how the bidders will be evaluated. Award is based on the lowest bid. Negotiations are not conducted.

Investigator

Individual (researcher, member of the research team, etc.) who interacts or intervenes with subjects for the purposes of the research or who has access to identifiable private information for research purposes.  In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3].  See also Principal Investigator.

IRB Approval

Determination of the IRB that the research study has been reviewed and meets the criteria set forth by the IRB, the institution, and other federal, state, and local requirements.

IRB Authorization Agreement

Formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution, including an academic institution.  Agreements are generally used to cover a single research study, categories of research studies, or research studies within a research program.

J

Justice

Ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.

Justi-In-Time

Selected information that is requested at the time a decision is made to fund a project.  Examples included, compliance approvals/training, Other Support, etc.  

K

Key Personnel

Personnel considered to be of primary importance to the successful conduct of a research project. The term usually applies to the senior members of the project staff.

L

Legally Authorized Representative (LAR)

Person authorized either by statute or by court appointment to make decisions on behalf of another person.  In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Life Science Business Development Center (LSBDC)

Business incubator on the AU campus with approximately 16,000 gross square feet of space that accommodate the incubator and the technology transfer offices.

Limitation of Cost (LOC)

Mandatory clause for cost-reimbursement type contracts. Under the clause, the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. The contractor, however, is not obligated to continue performance once expenses reach the stated amount.

Limited Data Set

Limited data set allows retention of specific elements of identifying private information: geographic subdivisions, town, city, state, ZIP code, dates, age.  Limited data sets are not considered to be de-identified information.

M

Master Agreement

Comprehensive contract that governs all research activities supported by a particular sponsor. Individual project specific addendums (or task orders) are issued each time a new project is engaged. Each addendum details such aspects as the personnel, funding amount, performance period, and scope of work for the individual project, along with any deviations from the terms of the Master Agreement that may be necessary for performance of the specific project. Also called “umbrella” agreements, this mechanism often takes much longer to establish than a traditional agreement, however it virtually eliminates any need to negotiate the individual project addendums.

Masting Grant

Grant that requires a specified portion of the cost of a supported item of equipment or project be obtained from other sources. The required match may be more or less than the amount of the grant. Some matching grants require that the additional funds be obtained from sources outside the recipient organization. Many matching grants are paid in installments, the payments coinciding with the attainment of pre-specified levels of additional funding. (Also see Challenge Grant.) Matching grants are very common in the sciences, especially for equipment. They are standard practice in some government agencies.

Material Transfer Agreement (MTA)

Permit the exchange of real property with non-profit institutions or with for-profit companies. 

Medical Record Number (MRN)

Unique 9 -digit number assigned to an Augusta University Health patient.

Mentally Disabled

See cognitively impaired.

Minimal Risk

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 46.102(i)]

Misconduct in Science

Fabrication, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

Mission

Sponsor's stated purpose, which is designed to address a specified set of problems. Almost all federal research agencies are designated as mission agencies.

Modification

Award document that modifies any aspect of an existing award. Example: Carryover approvals, adding or deleting special terms and conditions, changes in funding levels (including NSF's Research Experience for Undergraduates ; NIH's Minority Supplement, DOD's ASSERT Programs), administrative changes initiated by the agency, extensions that include changes in terms, change of principal investigator , etc. OR any change to an IRB-approved study protocol regardless of the level of review it receives initially.  Also referred to as an amendment.

Modified Total Direct Costs (MTDC)

Basic indirect costs are calculated on a subset of direct costs, normally excluding, among other costs, equipment, patient care, space rental, alterations and renovations, and subcontract costs in excess of the first $25,000.

Monitoring

Collection and analysis of information or data as the project progresses to assure the appropriateness of the research, its design, and subject protections.

Multicenter Research

Research conducted at more than one location and under the jurisdiction of more than one IRB.

Multi-site Research

Research conducted at more than one location and under the jurisdiction of only one IRB.

N

National Reserach Service Award (NRSA)

Family of grants provided by the United States National Institutes of Health for training researchers in the behavioral sciences and health sciences.

National Science Foundation (NSF)

United States government agency that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the National Institutes of Health.

Campus Network ID (NetID)

Assigned to staff, faculty, students for accessing Outlook, Desire2Learn, Citrix, axiUm, and other university applications; sometimes referred to as JagID.

New Award

Award not previously awarded or a renewal or continuation award treated as a new award by the sponsor and given a new agency number.

New and Competing Proposals

Proposals that are submitted for the first time or ongoing projects that must re-compete for funding prior to expiration of the original award.

No Cost Time Extension

Extension of the period of performance beyond the expiration data to allow the principal investigator to finish a project. Usually, no additional costs are provided.

Nonaffiliated Member

Member of an Institutional Review Board who has no ties (and whose immediate family has no ties) to the parent institution, its staff, or faculty.  This individual is usually from the local community (e.g., minister, business person, attorney, teacher, and homemaker).

Non-Competing (Continuation Project)

Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects typically do not compete with new project proposals and are not subjected to peer review beyond the initial project approval.

Non-Compliance

Failure to follow the regulations, the requirements, and/or determinations of the IRB.

Non-Disclosure Agreement (NDA)/Confidentiality Agreement (CDA)

Confidentiality Agreement, also sometimes referred to as a non-disclosure agreement (CDA or NDA), is designed to protect the confidential information that may be released between an industry sponsor or other entity and the AU faculty and staff so that they can determine whether or not to enter into a subsequent agreement for either a clinical trial (CTA) or basic research (SRA).  CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other information which the sponsor considers proprietary.  Not all sponsors require a CDA prior to disclosure of confidential information.

Notice of Grant Award

Legally binding document that serves as a notification to the recipient and others that a grant or cooperative agreement has been made; contains or references all terms of the award; and documents the obligation of funds.

Nuremberg Code

Code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.

O

Office of Human Research Protection (OHRP)

Provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

Office of Innovation and Commercialization (OIC)

Supports the collaboration between AU and our industry partners, AU faculty and staff inventions, and intellectual property commercialization-related activities with companies from the Fortune 100 to the newest startup firm.  The OIC hosts the Life Sciences Business Development Center (LSBDC).

Office of Inspector General (OIG)

Develops and distributes resources to assist the health care industry in its efforts to comply with the Nation’s fraud and abuse laws and to educate the public about fraudulent schemes to they can protect themselves and report suspicious activities.

Office of Laboratory Animal Welfare (OLAW)

Provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.

Office of Management and Budget (OMB)

Business division of the Executive Office of the President of the United States that administers the United States federal budget and oversees the performance of federal agencies.

Office of Technology Transfer and Economic Development (OTTED)

Process of transferring scientific findings from one organization to another for the purpose of further development and commercialization.

OMB Circulars

Regulatory circulars issued by the Office of Management & Budget (OMB). 

Online Collaborative Research Environment (OnCore)

Clinical Research Management System for Augusta University

Oral Consent

Spoken presentation of the elements of informed consent to the prospective subject or their legally authorized representative and received agreement (or refusal).  The presentation may be based on information contained within an oral consent script or the written consent document.  Oral consent is often associated with waiving the documentation of consent.  Oral consent is usually documented in the research project files or, in some cases, may be audio or video recorded.  Also referred to as verbal consent.

Organizational Official

See Institutional Official

P

Parent Announcements

Broad funding opportunity announcements that enable investigator-initiated applications to be submitted.

Payment

See Compensation.

Payment Management System (PMS)

Centralized grants payment system operated by the Division of Payment Management, Program Support Center. 

Peer Review

System using reviewers who are the professional equals of the principal investigator or program director who is to be responsible for directing or conducting the proposed project. It is a form of objective review. Peer review is legislatively mandated in some programs and in other programs is administratively required.

Performance Site

Site where research is performed.

Period of Performance

Entire amount of time needed to programmatically complete a project.

Permission

Agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].  Permission may also be used more generally to refer to the consent of an adult participant or to the assent of a child participant.

Person Months (PM)

Method of expressing the amount of time (or effort) devoted to a project.  PM takes into account the individual’s type of appointment (i.e. calendar year CY, academic year AY, or summer month SM) and the percentage of effort.

Personally Identifiable Information (PII)

Information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual.  The definition of PII is not anchored to any single category of information or technology.  Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified.  In performing this assessment, it is important to recognize that non-PII can become PII whenever additional information is made publicly available that, when combined with other available information, could be used to identify an individual.  See also identifiable information and FERPA.

PHS 2590

Application for Continuation of a PHS Grant ( National Institutes of Health).

PHS 398

Application Form for a PHS Grant ( National Institutes of Health).

Physician Practice Group (PPG) / Augusta University Medical Associates (AUMA)

Defining characteristic of single-specialty practice is the presence of two or more physicians providing patients with one specific type of care (i.e., primary care or a specific subspecialty practice), while multispecialty group practices are defined as offering various types of medical specialty care within one organization.

PowerChart

Name of the electronic medical record used by Augusta University Health system.

Point of Contact (POC)

Person or a department serving as the coordinator or focal point of an activity or program.

Pre-Contract Agreement

Agreement between an institution and a study sponsor that is executed prior to enrollment of subjects into a clinical trial.  This agreement ensures all payments for services done to prepare for the study are paid for by the sponsor should the study not initiate.

Pre-Proposal

Brief description, usually 2-10 pages, of research plans and estimated budget that is sometimes submitted to determine the interest of a particular sponsor prior to submission of a formal proposal. Also termed Preliminary Proposal.

Pregnancy

Period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e. has been delivered).  Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)].

Principal Investigator/Project Director (PI/PD)

Individual responsible for the conduct of research or other activity described in a proposal for an award.  For DSPA internal purposes, a PI/PD must be a faculty member.  For the IRB, the Principal Investigator is the individual who assumes overall responsibility for the ethical conduct of the study.  AU's IRB requires that the Principal Investigator be a member of the University's faculty or staff.  Multiple PIs are not allowed on an IRB submission.  Students may serve as the Principal Investigator on a research study as long as they have a Faculty Advisor (Faculty Sponsor) who is a Faculty Member of AU.  Submissions to the IRB must be made by the PI and IRB correspondence will be directed to the PI.

Prior Approval

Requirement for written documentation of permission to use project funds for purposes not in the approved budget, or to change aspects of the program from those originally planned and approved. Prior approval must be obtained before the performance of the act that requires such approval under the terms of the agreement.

Priority Score

Score derived from the rating given a proposal by each member on a review committee. It is used to help determine which approved proposals will be granted awards, based on funds available.

Prisoner

Individual involuntarily confined or detained in a penal institution.  The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. [45 CFR 46.303(c)].  For Department of Defense (DOD) research the term includes military personnel in either civilian or military custody. 

Privacy

Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.  Compare to confidentiality.

Private Information

1) Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. 
Or,
2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]

Program Announcement

Describes existence of a research opportunity. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program.

Progress Report

Periodic, scheduled reports required by the sponsor summarizing research progress to date. Technical, fiscal, and invention reports may be required.  For the IRB, details of the study activity during the last approval period.  Often requested when submitting for continuation or closure of your active IRB research study.

Program Official (PO)

NIH official responsible for the programmatic, scientific, and/or technical aspects of a grant.

Project Period (PP)

Total time for which support of a project has been programmatically approved. A project period may consist of one or more budget periods. (Also see Budget Period.)

Proposal

Application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested. Formal proposals are officially approved and submitted by an organization in the name of a principal investigator.

Protected Health Information (PHI)

Individually identifiable health information transmitted or maintained by a covered entity or its business associate [45 CFR 160.103].  PHI and its potential uses in research are described in more detail in the Health Insurance Portability and Accountability Act (HIPAA).  See also identifiable information.

Protocol

Written description of a research study.  It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.  For IRB review, a protocol should include detailed information about the study population and components of human subjects’ protections (risks, benefits, recruitment, consent, etc.).

Protocol Deviation

Divergence (unintentional or intentional) from the IRB-approved protocol without significant consequences.  A deviation generally (a) does not increase risk or decrease benefit, (b) does not have a significant effect on the subject's rights, safety, or welfare, and (c) does not impact the integrity of the data.  Deviations may result from the action of the subject or the researcher.  May also be non-compliance.  See protocol violation.

Protocol Violation

Divergence (unintentional or intentional) from the IRB-approved protocol that (a) increases risk or decreases benefit, (b) affects the subject's rights, safety, or welfare, or (c) impacts the integrity of the data.  May also be non-compliance.  See protocol deviation.  (Note: Deviation and violation may be used synonymously, but violation tends to be more serious.)

Public Health Service (PHS)

Operating division of the Health and Human Services Department (HHS) responsible for promoting the protection and advancement of the American population's physical and mental well-being.

Purchase Order (PO)

Commercial document and first official offer issued by a buyer to a seller, indicating types, quantities, and agreed prices for products or services. It is used to control the purchasing of products and services from external suppliers

Q

Quorum

Majority of voting members are present.

R

Rebudget

Act of amending the budget buy moving funds from one category or line item to another. (See also Budget Adjustment.)

Re-Consenting

Process of notifying research subjects of changes (or new risks, problems, events, etc.) in the research, including documentation of the subject's continued informed consent through signature on a revised written consent form.

Recruitment

Recruitment, a component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.

Regs

Short for "regulations."

Regulations

Contractual rules and procedures governing sponsored research projects.

Related

Event or issue (e.g., unanticipated problem, side effect, etc.) is "related" if in the opinion of the investigator it is likely to have resulted from participation in the research study.

Renewal

Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.

Reportable New Information

Categories of information that require immediate or timely reporting to the IRB for review and determination.  Includes, but is not limited to, information that indicates a new or increased risk to subjects or others, non-compliance, audits, unresolved complaints, and other unanticipated problems, events, acts, or omissions.  See also unanticipated problem involving risks to subjects or others.

Request for Applications (RFA)

Announcements that indicate the availability of funds for a topic of specific interest to a sponsorProposals submitted in response to RFAs generally result in the award of a grant. Specific grant announcements may be published in the Federal Register and/or specific sponsor publications. (Also see Broad Agency Announcements.)

Request for Proposal (RFP)

Announcements that specify a topic of research, methods to be used, product to be delivered, and appropriate applicants sought. Proposals submitted in response to RFPs generally result in the award of a contract. Notices of federal RFPs are published in the Commerce Business Daily.

Request for Quotations (RFQ)

Formal request from to vendors for a price quotation on equipment or supplies to be purchased.

Research (as defined by DHHS)

Systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]

Research (as defined by FDA)

Experiment that involves a test article and one or more human subjects, and that meets any one of the following:

  • Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
  • Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
  • Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Note: FDA-regulation of research is not dependent on funding or funding sources.

Research Development Services (RRSS)

Conducting research administration by utilizing electronic resources such as the internet, the World Wide Web, form templates, databases, and other electronic tools.

Respect for Persons

Ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

Restrieve Process Execution (RPE)

Interface used to facilitate the sharing of clinical research data with Electronic Medical Record (EMR) systems (PowerTrials/PowerChart) and OnCore.  The RPE Interface allows users to send basic protocol and subject status information from OnCore to an EMR, increasing patient safety and reducing the need for duplicate data entry.

Revision

Modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.

Risk

Probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.  Both the probability and magnitude of possible harm may vary from minimal to significant.  Federal regulations define only "minimal risk."  See also minimal risk.

S

Scope of Work

Description of the work to be performed and completed on a research project.

Senior/Key Personnel

Individual who contributes to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation.  Note that Principal Investigator/Project Directors are always considered key personnel.

Serious Non-Compliance

Failure to adhere to laws, regulations, or policies governing research involving human participants that might reasonably be regarded as:

  • Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research participants, research staff, or others
  • If studies conducted at the Charlie Norwood VA Medical Center, it includes substantively compromising the effectiveness of a VA facility’s human research protection program.
Short-Form Consent Process

Used with IRB approval when a subject or the subject’s legally authorized representative cannot read the standard written consent form.  The short form consent document states the elements of consent that are presented orally and is translated into the appropriate language.  The short form consent process requires a witness (and in some cases an interpreter or translator) and has specific requirements for documentation of consent.

Signing Official aka Authorized Official or Authorized Organizational Representative

Individual who has been delegated the authority to bind Augusta University/Augusta University Research Institute, Inc. in grant and contract administrative activities.

Small Business Innovative Research (SBIR)

Agency administered programs supported by ear-marked federal funds, making grants to small business entities.

Small Business Technology Transfer (STTR)

Grant applications and/or programs to fund small business "teamed" with research institutions.

Small Grant

Special type of grant, often limited to a beginning researcher. Typically, such an award may be obtained for one year only.

Society of Research Administrators (SRA)

Research management society providing education, professional development and the latest comprehensive information about research management.

Sponsor

Organization that funds a research project.

Sponsored Program Administration (SPA)

Serves as the principal interface between Augusta University and external agencies providing sponsored program support, including the Augusta University Research Institute (AURI).

Sponsored Programs

Externally funded activities in which a written agreement (e.g. grant, contract or cooperative agreement) is entered into or issued on behalf of Augusta University Research Institute, Inc. or Augusta University.

Sponsored Projects Information Network (SPIN)

Computer database with detailed and up-to-the minute information about thousands of government and private funding opportunities.

Stewardship Report

Stewardship Report (including a general financial report, a brief summary of how the funding was used, and/or the impact of the gift) states how funds were used. A stewardship report may not be a detailed technical report. However, if publications result, copies of such publications may be shared with the donor. In addition, confirmation of proper utilization of funds is allowed.

Stipend

Payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training.

Streamlined No-Competing Award Process (SNAP)

Program to simplify the requirements of the non-competing application and financial reporting processes for the National Institutes of Health.

Study Billing Grid

Schematic that shows study procedures, codes, prices, location and billing designation (study, patient, insurance).

Subcontract, Subgrant, or Subagreement

Document written under the authority of, and consistent with the terms and conditions of an award (a grantcooperative agreement, or contract) that transfers a portion of the research or substantive effort of the prime award to another institution or organization.

Subjects

May also be referred to as participants. See human subjects.

Supplemental (Rebudgeting or Modification) Proposal

Request to the sponsor for additional funds for an ongoing project during the previously approved performance period. A supplemental proposal may result from increased costs, modifications in design, or a desire to add a closely related component to the ongoing project.

T

Task Order Agreement (TOA)

Legally binding document authorizing work and appropriating funds as a supplement to a basic contract.

Tax Identification Number

Identifying number used for tax purposes in the United States. It is also known as a Tax Identification Number or Federal Taxpayer Identification Number. A TIN may be assigned by the Social Security Administration or by the Internal Revenue Service (IRS).

Teaming Agreement

Agreement between two or more parties to participate in a research project or teaching activity.

Technical Data

Recorded information, regardless of form or characteristic, of a scientific or technical nature. Often referred to as the "science" of a proposal.

Termination of IRB Approval

Action of the IRB, IRB designee, Organizational Official, or designee of the Organizational Official to permanently withdraw IRB approval of all research procedures.  Terminated studies are permanently closed and no longer require continuing review.

Terms of Award

Legal requirements imposed on an agreement by the sponsor, whether by statute, regulation(s), or terms in the award document. The terms of an agreement may include both standard and special provisions that are considered necessary to protect the sponsor's interests.

Third Party in-kind Contributions

Property or services which benefit a federally assisted project or program and which are contributed by non-federal third parties without charge to the grantee, or sub grantee, under the grant agreement.

Total Direct Costs (TDC)

Cost that can be specifically identified with a particular project, program, or activity or that can be directly assigned to such activities relatively easily and with a high degree of accuracy. Direct costs include, but are not limited to, salaries, travel, equipment, and supplies directly benefiting the grant-supported project or activity.

Total Project Costs

Total allowable direct and indirect costs incurred by the institution to carry out an approved project or activity.

U

Unanticipated Problem

Any incident, experience, or outcome in any study involving human subjects that meets ALL of the following criteria:

  • Is new or greater than previously known in terms of nature, severity, or frequency given the research procedures that are described in the protocol‐ related documents, such as the IRB‐approved research protocol, informed consent document, and the PI brochure;  and the characteristics of the subject population being studies using the terms “unanticipated” and “unexpected”; AND
  • Is related or possibly related to participation in the research (“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
  • 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.
Uncommitted Voluntary Cost Share

University expenses, such as faculty salaries, that is over and above that which is committed and budgeted for in a sponsored agreement.

Uniform Grant Management Guide (UGMA)

Provides awarding agencies and grantees a standardized set of financial management procedures and definitions. State agencies are required to adhere to these standards when administering grants and other financial assistance agreements with cities, counties and other political subdivisions of the state.

Uniform Guidance

Regulations published by the Federal Office of Management and Budget (OMB) that establish principles for determining administrative requirements, cost principles, and audit requirements applicable to grants, contracts, and other government agreements.  The Regulation is codified in 2 CFR Part 200.

Unilateral Award

Award made by a sponsor to an organization without considering competitive proposals. Unilateral awards are most often made when unsolicited proposals receive favorable treatment.

United States Department of Agriculture (USDA)

Provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management.

USDA Pain Classification

Vertebrate animals used for research or teaching must be assigned to a USDA pain and distress category on the protocol under which they are used.

United States Patent and Trademark Office (USPTO)

Federal agency for granting U.S. patents and registering trademarks.

Unrestricted Funds

Monies with no requirements or restrictions as to use or disposition. Grantscontracts, and cooperative agreements are considered to be restricted funds, while gifts are usually considered unrestricted funds.

Unsolicited Proposals

Proposals submitted to a sponsor that are not in response to an RFPRFA, or program announcement. (See also Investigator-Initiated Proposal.)

V

Venture Capital or Venture Capitalist (VC)

Venture capital (VC) is a type of private equity, a form of financing that is provided by firms or funds to small, early-stage, emerging firms that are deemed to have high growth potential, or which have demonstrated high growth (in terms of number of employees, annual revenue, or both). A venture capitalist is an investor who either provides capital to startup ventures or supports small companies that wish to expand but do not have access to equities markets. 

Verbal Consent

See oral consent.

Voluntary

Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.

W

Ward

Child who is placed in the legal custody of the state or other agency, institution or entity, consistent with applicable federal, state or local law.

Withdrawal

Subject who enrolled (i.e., consented to participate) but later withdrew from (i.e., discontinued his or her participation in) a study, either before, during, or after completing research procedures.  For a variety of reasons, a subject enrolled in a research study may decide to withdraw from the research, or an investigator may decide to terminate a subject’s participation in research regardless of whether the subject wishes to continue participating (e.g., for non-compliance with research procedures).