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Definition of Terms


Below are some of the terms used in the research database along with a explanation.
CFR (Code of Federal Regulations):
The official U.S. Government published regulations that codify and specify standard practices in executing Federal programs.

Clinical Research:
Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Patient-oriented research includes: (a) mechanisms of human disease (diagnostic evaluations), (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

CRADA (Cooperative Research and Development Agreement):
A particular type of project funding arrangement between a Federal agency and an entity in the private sector to conduct research and development activities.

Funding Types:
  • DOE Funding: Funding provided by the Department of Energy (DOE) in whole or in part to sustain a project
  • Other Federal Funding: Funding provided by any other organization within the U.S. Government in whole or in part to sustain a project
  • Non-Federal Funding: Amount of project funding from non-Federal sources not reported after FY2004

FWP Site:
A research organization performing work for the DOE Former Worker Medical Screening Program

Human Subjects:
Human subject means a 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.

International Project Site:
A foreign entity or research organization involved in human subjects research activities but affiliated in some manner with a U.S. counterpart or collaborative research organization through the DOE (International affiliations were first reported in FY2006).

LDRD (Laboratory Directed Research and Development):
Denotes funding provided for a project from sources internal to a DOE national laboratory.

Research:
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Types of Research:
The specific attribute of the research being conducted involving human subjects that reflects its applicability or utility.

Type of Site (Research Organization):
  • DOE Site: A research organization conducting research involving human subjects that is part of the U.S. Department of Energy system of facilities.
  • Non-DOE Site: A research organization conducting human subjects research activities involving the DOE (for example through funding or personnel) that is in another Federal agency or that is not affiliated with the U.S. Government (includes research institutes, hospitals, research foundations, universities, private companies, and other corporate entities).

Unanticipated Problems/Adverse Events:

The phrase unanticipated problems involving risks to subjects or others, in general, includes any incident, experience, or outcome that meets all of the following criteria:
  • Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document and (b) the characteristics of the subject population being studied.
  • 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).
  • 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.
The term adverse event in general is used very broadly and includes any event meeting the following definition:
  • Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
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