Glossary

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Data and Safety Monitoring Board (DSMB)

A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.

Data and Safety Monitoring Plan

Prior to award, this plan must be approved by the applicant’s IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

Data Universal Numbering System (DUNS)

A nine-digit number established and assigned by Dun and Bradstreet to uniquely identify a business entity.

Debarment and Suspension

The actions taken by a debarring official in accordance with OMB guidance at 2 CFR 180, "Non-procurement Debarment and Suspension," as implemented by HHS in 2 CFR 376, to exclude a person or organization from participating in grants and other non-procurement awards government-wide. If debarred or suspended, the person or organization may not receive financial assistance (under a grant, cooperative agreement, or subaward, or contract under a grant) for a specified period of time. Debarments and suspensions carried out pursuant to 2 CFR 376 are distinct from post-award suspension action by an awarding agency. (See NIH Grants Policy Statement: 4 Public Policy Requirements, Objectives and Other Appropriation Mandates 4.1.6 Debarment and Suspension).

Debt Collection

The process of collecting funds owed by recipients to the Federal government, which, under grants, generally are owed as a result of formal cost disallowances.

Debt Instrument

A document used to record a legal obligation of one party to pay a financial obligation to another in accordance with predetermined terms and conditions.

Deductive Alternative

An alternative for the use of program income earned during the period of grant support under which allowable costs of the project or program to be paid by the Federal government are offset by the amount of the program income. (See also definitions for additive alternative and cost sharing or matching alternative and NIH Grants Policy Statement: 8 Administrative Requirements 8.3 Management Systems and Procedures 8.3.2 Program Income.)

degenerative diseases

A disease in which the function or structure of the affected tissues or organs changes for the worse over time. Osteoarthritis, osteoporosis, and Alzheimer disease are examples.

Delayed Onset Study

Research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.

Delayed Start

Research plans can be described at time of application, but research will not immediately begin (will occur later in the funding period)

dementia

A condition in which a person loses the ability to think, remember, learn, make decisions, and solve problems. Symptoms may also include personality changes and emotional problems. There are many causes of dementia, including Alzheimer disease, brain cancer, and brain injury. Dementia usually gets worse over time.

Department of Health and Human Services (HHS)

Federal Executive Department of which the U.S. Public Health Service (PHS) is a component and the NIH is an agency of the PHS. Go to HHS.Previously DHHS.

Departmental Grants Appeals Board

The independent office established in the Office of the Secretary with delegated authority from the Secretary to review and decide certain disputes between recipients of HHS funds and HHS awarding agencies under 45 CFR Part 16 and to perform other review, adjudication and mediation services as assigned.

depression

A mental condition marked by ongoing feelings of sadness, despair, loss of energy, and difficulty dealing with normal daily life. Other symptoms of depression include feelings of worthlessness and hopelessness, loss of pleasure in activities, changes in eating or sleeping habits, and thoughts of death or suicide. Depression can affect anyone, and can be successfully treated

developmental disorders

A group of conditions marked by delayed development or an impairment in learning, language, communication, cognition, behavior, socialization, or mobility. These conditions may impact day-to-day functioning and can last through a person's lifetime.

diagnostic tool

A type of method or test used to help diagnose a disease or condition. Imaging tests and tests to measure blood pressure, pulse, and temperature are examples of diagnostic techniques.

Direct Costs

Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)

Disaggregated Application

An application with a portion (or subproject) funded as a separate grant.

Disallowed Costs

Those charges to a Federal award that the Federal awarding agency or pass-through entity determines to be unallowable, in accordance with the applicable Federal statutes, regulations, or the terms and conditions of the Federal award.

Domestic Organization

A public (including a State or other Governmental Agency) or private non-profit or for-profit organization located in the United States or its territories which is subject to U.S. laws and assumes legal and financial accountability for awarded funds and for the performance of the grant-supported activities.

Dual Assignments

Applications simultaneously assigned to two Institutes, Centers, or Divisions. The primary Institute has complete responsibility for administering and funding the application; the secondary assumes this responsibility only if the primary is unable or unwilling to support it.

Dual Review System

Peer review process used by NIH. The first level of review provides a judgment of scientific merit. The second level of review (usually conducted by an ICD's advisory Council) assesses the quality of the first review, sets program priorities, and makes funding recommendations.

dysfunctional

Not working normally.
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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021