Glossary

For a full list of acronyms and definitions, see HRP-001-SOP-Definitions in the IRB library within the electronic IRB system.

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 AE is an AE that is unexpected and substantively impacts the human subjects.

All adverse events must be reported to the Oak Ridge Sitewide Institutional Review Board (ORSIRB) immediately.

Assurance of Compliance (Human Subjects) or Federalwide Assurance

A 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: Federalwide Assurance (FWA) for the Protection of Human Subjects.

The FWA is the only type of assurance of compliance accepted and approved by Office for Human Research Protections (OHRP) for institutions engaged in non-exempt HSR conducted or supported by DHHS. Under an FWA, an institution commits to DHHS that it will comply with the requirements set forth in 45 CFR part 46.

Authorization Agreement

Also called a Reliance Agreement, is the agreement that documents respective authorities, roles, responsibilities, and communication between an institution/organization providing the ethical review and a participating institution relying on the ethical review.

Collaborative Study

A study in which two or more institutions coordinate, with each institution completing a portion of the research activities outlined in a specific protocol.

Continuing Non-Compliance

A pattern of non-compliance that suggests the likelihood that, without intervention, instances of non-compliance will recur, a repeated unwillingness to comply, or a persistent lack of knowledge of how to comply.

De-identified Data

A data set that has no, or limited, identifiers and for which 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. A graded approach must be used in balancing de identification of the datasets and the usability of the dataset to accomplish the needed research.

DOE HSR Database (HSRD)

A compilation of summary information, which is available on the Human Subjects Research Database (HSRD), updated annually, on every unclassified human subjects research project funded by DOE, conducted at DOE institutions or facilities, or performed with DOE or contractor personnel.

Finding of Non-Compliance

Information found during an investigation or review that indicates a failure to follow the regulations, requirements or determinations of the IRB.

Generalizable

Information/research findings that are intended to be applied to populations or situations beyond that which was studied/will have meaning and impact outside of the single immediate activity itself.

Institutional Review Board

An ethics committee or board established by an institution that performs initial and continuing reviews of research involving human subjects, is registered with the Office of Human Research Protections (OHRP) and designated on an FWA.

IRB Library

A library of standard operating procedures, general documents, worksheets, checklists, templates, and other documents relevant to the submission and IRB review of research that resides within the IRB system.

IRB System

The electronic system used by the IRB.

Multi-Site Study

A study in which two or more institutions coordinate, with each institution completing all research activities outlined in a specific protocol.

Non-Compliance

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

In the case of research funded or conducted by the U.S. Department of Defense (DOD), non-compliance includes failure of a person, group, or institution to act in accordance with DOD instruction 3216.02, its references, or applicable requirements.
In the case of research funded or conducted by the DOE, non-compliance includes failure of a person, group, or institution to act in accordance with DOE Order 443.1C, their references, or applicable requirements.

Participating Site

An institution that participates in a single IRB study.

Personally Identifiable Information

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.

Protected Health Information

Identifying information about an individual in oral or recorded form, if the information:

Relates to the physical or mental health of the individual, including information that consists of the medical history of the individual’s family;
Relates to providing health care to the individual, including the identification of a person as a provider of health care to the individual; is a plan of service within the meaning of the Long-Term Care Act, 1994 for the individual;
Relates to payments or eligibility for health care with respect to the individual;
Relates to the donation of any body part or bodily substance of the individual or is derived from the testing or examination of any such body part or bodily substance;
Is the individual’s health number; or
Identifies an individual’s substitute decision-maker.

Reportable New Information

Information that must be reported immediately to the IRB including any incident, audit, or external study review. These should also include any increase in level of risk, harm, non-compliance, research error, breach of confidentiality, unreviewed change, incarceration of subject, complaint, suspension, unanticipated problem or adverse event.

Research

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that 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 and 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, monitor, 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.

Serious Adverse Event

A serious adverse event is any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:

results in death;
is life-threatening;
requires inpatient hospitalization or prolongation of existing hospitalization;
results in a persistent or significant disability/incapacity;
results in a congenital anomaly/birth defect, or
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 ORSIRB and DOE as required by DOE Order 443.1C.

Serious Non-Compliance

Non-Compliance such the failure to comply could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.

For DOE research, serious non-compliance includes failure of a person, group, or institution to act in accordance with DOE Order 443.1C and their references such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.

Significant Adverse Event

An adverse event that is unexpected and substantively impacts the human subjects, and must be reported immediately to ORSIRB and DOE as required by DOE Order 443.1C.

Unanticipated Problem

Any information that is (1) unanticipated, (2) related to the research, and (3) indicates that subjects or others are at increased risk of harm.

For DOE research "Unanticipated Problem Involving Risks to Subjects or Others" includes any incident, experience, or outcome that meets ALL three of the following conditions:

Unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB approved research protocol and informed consent document) and the characteristics of the human 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 a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.