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Office of Research and Sponsored Programs
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  • Certification
    The official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
  • Clinical trial

    A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

  • Department or Agency Head

    The head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated.

  • Federal department or Agency

    A federal department or agency (the department or agency itself rather than its bureaus, offices, or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates (e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency).

  • Generalizable Knowledge

    Activities that are intended to develop or contribute to generalizable knowledge are those specifically designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or a specific program.

    NOTE: The intent to develop or contribute to generalizable knowledge makes an activity research. Results do not have to be published or presented to qualify the activity as research.

  • Human subject

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

    1. Obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or
    2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
  • Identifiable biospecimen
    A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
  • Identifiable private information

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

  • Institution

    Any public or private entity, or department, or agency (including federal, state, and other agencies).

  • Intervention

    Includes both physical procedures by which information or biospecimens are gathered (e.g., 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.

  • IRB
    An institutional review board established in accordance with and for the purposes expressed in this policy.
  • IRB approval

    The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Legally authorized representative
    An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, a legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.
  • Minimal risk
    The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
  • Not 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.

  • 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Public health authority

    An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • 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.

  • Systematic Investigation
    A deliberate approach to obtaining quantitative or qualitative information from or about one or more individuals, and the planned analysis of data to address a question, describe a phenomenon, or test a hypothesis. Characteristics of a systematic investigation include the articulation of research questions, and an articulated plan for data collection, analysis of the data, and conclusions to be drawn from the data analysis.
  • Written, or in writing
    For purposes of this part, refers to writing on a tangible medium (e.g., paper) or in an electronic format.