Title 40:
Protection of Environment
PART 26—PROTECTION OF HUMAN SUBJECTS
Subpart A—Basic EPA Policy for Protection of Subjects
in Human Research Conducted or Supported by EPA
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§ 26.102 Definitions.
(a) 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.
(b) Institution means any public or private entity or agency
(including Federal, State, and other agencies).
(c) 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.
(d) 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 example, some demonstration and service
programs may include research activities.
(e) 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 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 example, Wage and Hour
requirements administered by the Department of Labor).
(f) Human subject means a living individual about whom an
investigator (whether professional or student) 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.
(g) IRB means an institutional review board established in
accord with and for the purposes expressed in this policy.
(h) 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.
(i) 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 or
tests.
(j) 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.
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