Any 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 subjects' participation in the research, whether or not considered related to the subject’s participation in the research. A significant adverse event is an adverse event that is unexpected and substantively impacts the human subjects.
The 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).
A data set that has no, or limited personal, identifiers such that the IRB and/or a person with current knowledge of generally accepted scientific principles determines that the risk that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient, to identify an individual who is a subject of the information, has been reduced to the extent practicable.
DOE HSR Database (HSRD)
An unclassified compilation of summary information, updated annually, on every HSR project 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 individual designated by the Under Secretary for Science and Energy to oversee 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 (40KB), DOE Order 443.1B Chg 1, DOE Notice 443.1, as well as Executive Orders, Presidential Memoranda, and other Presidential directives, as applicable.
Information/research findings that can be applied to populations or situations beyond that studied.
A living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information.
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).
Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Human Subjects Research (HSR)
Any research activity that involves a human subject.
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.
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.
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 individual appointed by the NNSA Administrator to oversee the Human Subjects Protection Program for 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).
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.
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.
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.