Definitions

Definitions

The terms in this section apply to all human research activities at UAB. Additional terms that apply to specific aspects of those activities are defined in the applicable sections (e.g., Compliance & Monitoring).

Agent—
Person authorized to act on behalf of UAB. This includes an individual performing UAB designated activities or exercising UAB-delegated authority or responsibility.
Clinical Investigation—
See definition for "Research (as defined by FDA regulations)."
Code of Federal Regulations (CFR)—
A codification of federal agency regulations which has the force and effect of law.
Coded private information or biological specimens—
For related definitions, please see http://www.hhs.gov/ohrp/policy/reposit.html
Federal Guidance—
Information published by federal agencies on the topic that represents the agency’s current thinking or view but does not have the effect or force of law.
Federalwide Assurance (FWA)—
A document filed with the Office for Human Research Protections (OHRP) of the Department of Health and Human Services expressing an institution‘s commitment to comply with the department’s regulations for the protection of human subjects.
Human Subject (as defined by DHHS regulations)—
A living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) 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 Subject (as defined by FDA regulations)—
An individual who becomes a participant in research regulated by the Food and Drug Administration (FDA), either as a recipient of a test article or as a control. A subject may be either a healthy human or a patient. In the case of research involving medical devices, a human subject includes an individual on whose specimen a medical device is used.
Human Subjects Research—
Any activity that is either (a) “research” as defined by DHHS regulations that involves “human subjects” as defined by DHHS regulations or (b) "research” as defined by FDA regulations that involves “human subjects” as defined by FDA regulations.
IRB—
Institutional Review Board established in accord with and for the purposes expressed in federal regulations to protect the rights and welfare of human research subjects.
Research (as defined by DHHS regulations)—
A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.
Research (as defined by FDA regulations) (synonymous with the term Clinical Investigation)—
Any experiment that involves a test article and one or more human subjects that is subject to the IND or IDE regulations or that is not subject to the IND or IDE regulations but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
  • An experiment subject to the IND regulations is defined as any use of a drug other than the use of a marketed drug in the course of medical practice.
  • An experiment subject to the IDE regulations is defined as any evaluation of the safety or efficacy of a medical device.
UAB Facilities—
Facilities owned and operated by UAB; does not include facilities leased by the Board of Trustees of the University of Alabama to private entities.
UAB Institutional Official—
Individual authorized to act for UAB and, on its behalf, obligates UAB to the Terms of its Federalwide Assurance with the Department of Health and Human Services and OHRP.
UAB-Affiliated Entities—
UAB Health System, University of Alabama Health Services Foundation, UAB Highlands, and Callahan Eye Foundation Hospital and Ophthalmology Services Foundation and their wholly or majority owned subsidiaries.

Page updated: May 8, 2013