Department or agency head means the head of any federal department or agency and any other officer or employee
of any department or agency to whom authority has been delegated.
Institution means any public or private entity or agency (including federal, state, and other
Legally authorized representative means 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.
Research means a systematic investigation, including research development, testing and evaluation,
designed to develop or 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 examples, some demonstration and service programs may include research
Research subject to regulation, and similar terms are intended to encompass those research activities for which
a federal department or agency has specific responsibility for regulating as a research
activity, (for example, Investigational New Drug requirements administered by the
Food and Drug Administration). It does not include research activities which are
not incidentally regulated by a federal department or agency solely as part of the
department’s or agency’s broader responsibility to regulate certain types of activities
whether research or non-research in nature (for examples, Wage and Hour requirements
administered by the Department of Labor).
Human subject means 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 associate with the information) in order for obtaining the information
to constitute research involving human subjects.
IRB means an institutional review board established in accord with and for the purposes
expressed in this policy.
IRB approval means 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.
Minimal risk means that 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
Certification means the official notification by the institution to the supporting department or
agency, 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.