Glossary

Adverse Event

An adverse event (AE) in research can be any unfavorable or unintended event, including abnormal laboratory findings, symptom or disease, or death associated with the research or the use of a medical investigational test article. An AE in research may occur even in the absence of any error or protocol deviation and does not necessarily have to be caused by any identifiable aspect of the research.

A significant adverse event is an adverse event that is unexpected and substantively impacts the human subjects, and must be reported to DOE as required by DOE O 443.1C.

A serious adverse event is any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria: a) results in death; b) is life-threatening; c) requires inpatient hospitalization or prolongation of existing hospitalization; d) results in a persistent or significant disability/incapacity; e) results in a congenital anomaly/birth defect, or f) based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. A serious adverse event must be reported immediately to DOE as required by DOE O 443.1C.

Assurance

The legally binding written documentation, satisfactory to the Secretary of Energy, required from the prospective performing institution, that ensures institutional compliance with and implementation of DOE and Department of Health and Human Services (DHHS) regulations for the protection of human research subjects. The only documentation currently meeting this requirement is a Federalwide Assurance (FWA). See: http://ohrp.cit.nih.gov/efile/FwaStart.aspx.

De-identified Data

Records that have had enough personally identifiable data removed or obscured such that the remaining information does not identify an individual and there is no reasonable basis to believe that the information can be used to identify an individual.

DOE HSR Database (HSRD)

An unclassified compilation of summary information, which is available on the DOE HSP website and updated annually, on HSR projects funded by DOE, conducted at DOE institutions or facilities, or performed with DOE or contractor personnel.

DOE Human Subjects Protection Program Manager (DOE HSP Program Manager)

The program manager responsible for overseeing the non-NNSA components of DOE’s Human Subjects Protection Program.

DOE Institutional Official

The Senior DOE Official responsible for overseeing and monitoring Departmental implementation of the requirements of 45 CFR Part 46, 10 CFR 745, and DOE Order 443.1C, in consultation with NNSA as appropriate.

Generalizable

Information/research findings that can be applied to populations or situations beyond that studied/will have meaning and impacted outside of the single immediate activity itself.

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research:

Obtains information or biospecimens though intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens;
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and 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).

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Human Subjects Research (HSR)

Any activity meeting the definitions of both: 1) research, and 2) human subject, as defined in this section

Human Terrain Mapping (HTM)

Research and data gathering activities primarily conducted for military or intelligence purposes to understand the “human terrain,”—the social, ethnographic, cultural, and political elements of the people among whom the U.S. Armed Forces are operating and/or in countries prone to political instability. This work includes observations, questionnaires, and interviews of groups of individuals, as well as modeling and analysis of collected data, and may become the basis for U.S. military actions in such locations. In addition to HTM, such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that HTM activities will be managed as HSR.

HTM Data

Data collected or used as part of HTM efforts, as described above, as well as any auxiliary data on the same group(s) of individuals.

Institution

Any public or private entity or agency (including Federal, State, and other agencies). This term refers to laboratories and other facilities managed by DOE, DOE contractors, or DOE financial assistance recipients.

Institutional Review Board (IRB)

A committee or board established by an institution that performs initial and continuing reviews of research involving human subjects, and is registered with the Office for Human Research Protections (OHRP) and designated on an FWA. DOE has multiple IRBs. Most universities that do research involving human subjects do as well.

NNSA Human Subjects Protection Designee (NNSA HSP Program Manager)

The program manager responsible for overseeing the Human Subjects Protection Program for DOE’s NNSA elements.

Personally Identifiable Information (PII)

Any information collected or maintained about an individual, including but not limited to, education, financial transactions, medical history and criminal or employment history, and information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security number, date and place of birth, mother’s maiden name, biometric data, and any other personal information that is linked or linkable to a specific individual (From DOE O 206.1, DOE Privacy Program).

Research

A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, 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.

For purposes of this part, the following activities are deemed not to be research:

Scholarly or journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitory, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Strategic Intelligence Partnership Program (SIPP)

SIPP, formerly the Intelligence Work for Others (IWFO) program, is the mechanism by which DOE provides highly-specialized scientific and technical services and products to non-DOE Intelligence Community (IC) and other agencies for intelligence and intelligence-related activities carried out under unique IC authorities held by DOE’s Office of Intelligence and Counterintelligence and sponsoring IC agencies. All human subjects research funded through the SIPP program, regardless of which DOE site conducts it, must be reviewed by the CDOEIRB-C.

Strategic Partnership Projects (SPPs)

SPP, formerly the Work for Others (WFO) program, is the mechanism by which non-DOE entities fund DOE/NNSA and/or their contractors or use of DOE/NNSA facilities for work that is not directly funded by DOE/NNSA appropriations.

Unanticipated Problem

In general, to be classified as an unanticipated problem, any incident, experience, or outcome should meet all three 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)
Likely to place subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.