PART 745—PROTECTION OF HUMAN SUBJECTS

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(b) of this section, this policy applies
to all research involving human subjects
conducted, supported or otherwise
subject to regulation by any federal department
or agency which takes appropriate
administrative action to make
the policy applicable to such research.
This includes research conducted by
federal civilian employees or military
personnel, except that each department
or agency head may adopt such procedural
modifications as may be appropriate
from an administrative standpoint.
It also includes research conducted,
supported, or otherwise subject
to regulation by the federal government
outside the United States.

(1) Research that is conducted or supported
by a federal department or
agency, whether or not it is regulated
as defined in § 745.102(e), must comply
with all sections of this policy.

(2) Research that is neither conducted
nor supported by a federal department
or agency but is subject to
regulation as defined in § 745.102(e)
must be reviewed and approved, in
compliance with § 745.101, § 745.102 and
§ 745.107 through § 745.101 of this policy,
by an institutional review board (IRB)
that operates in accordance with the
pertinent requirements of this policy.

(b) Unless otherwise required by department
or agency heads, research activities
in which the only involvement
of human subjects will be in one or
more of the following categories are
exempt from this policy:

(1) Research conducted in established
or commonly accepted educational settings,
involving normal educational
practices, such as

(i) research on regular
and special education instructional
strategies, or

(ii) research on the
effectiveness of or the comparison
among instructional techniques, curricula,
or classroom management
methods.

(2) Research involving the use of educational
tests (cognitive, diagnostic,
aptitude, achievement), survey procedures,
interview procedures or observation
of public behavior, unless:

(i) Information obtained is recorded
in such a manner that human subjects
can be identified, directly or through
identifiers linked to the subjects; and

(ii) any disclosure of the human subjects’
responses outside the research
could reasonably place the subjects at
risk of criminal or civil liability or be
damaging to the subjects’ financial
standing, employability, or reputation.

(3) Research involving the use of educational
tests (cognitive, diagnostic,
aptitude, achievement), survey procedures,
interview procedures, or observation
of public behavior that is not
exempt under paragraph (b)(2) of this
section, if:

(i) The human subjects are elected or
appointed public officials or candidates
for public office; or (ii) federal statute(
s) require(s) without exception that
the confidentiality of the personally
identifiable information will be maintained
throughout the research and
thereafter.

(4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified,
directly or through identifiers linked to the subjects.

(5) Research and demonstration
projects which are conducted by or subject
to the approval of department or
agency heads, and which are designed
to study, evaluate, or otherwise examine:

(i) Public benefit or service programs;

(ii) Procedures for obtaining benefits
or services under those programs;

(iii) Possible changes in or alternatives
to those programs or procedures;

or

(iv) Possible changes in methods or
levels of payment for benefits or services
under those programs.

(6) Taste and food quality evaluation
and consumer acceptance studies,

(i) if
wholesome foods without additives are
consumed or

(ii) if a food is consumed
that contains a food ingredient at or
below the level and for a use found to
be safe, or agricultural chemical or environmental
contaminant at or below
the level found to be safe, by the Food
and Drug Administration or approved
by the Environmental Protection
Agency or the Food Safety and Inspection
Service of the U.S. Department of
Agriculture.

(c) Department or agency heads retain
final judgment as to whether a
particular activity is covered by this
policy.

(d) Department or agency heads may
require that specific research activities
or classes of research activities conducted,
supported, or otherwise subject
to regulation by the department or
agency but not otherwise covered by
this policy, comply with some or all of
the requirements of this policy.

(e) Compliance with this policy requires
compliance with pertinent federal
laws or regulations which provide
additional protections for human subjects.

(f) This policy does not affect any
state or local laws or regulations which
may otherwise be applicable and which
provide additional protections for
human subjects.

(g) This policy does not affect any
foreign laws or regulations which may
otherwise be applicable and which provide
additional protections to human
subjects of research.

(h) When research covered by this
policy takes place in foreign countries,
procedures normally followed in the
foreign countries to protect human
subjects may differ from those set
forth in this policy. [An example is a
foreign institution which complies
with guidelines consistent with the
World Medical Assembly Declaration
(Declaration of Helsinki amended 1989)
issued either by sovereign states or by
an organization whose function for the
protection of human research subjects
is internationally recognized.] In these
circumstances, if a department or
agency head determines that the procedures
prescribed by the institution afford
protections that are at least
equivalent to those provided in this
policy, the department or agency head
may approve the substitution of the
foreign procedures in lieu of the procedural
requirements provided in this
policy. Except when otherwise required
by statute, Executive Order, or the department
or agency head, notices of
these actions as they occur will be published
in the FEDERAL REGISTER or will
be otherwise published as provided in
department or agency procedures.

(i) Unless otherwise required by law,
department or agency heads may waive
the applicability of some or all of the
provisions the provisions of this policy to specific research
activities or classes of research
activities otherwise covered by this
policy. Except when otherwise required
by statute or Executive Order, the department
or agency head shall forward
advance notices of these actions to the
Office for Protection from Research
Risks, Department of Health and
Human Services (HHS), and shall also
publish them in the FEDERAL REGISTER
or in such other manner as provided in
department or agency procedures.¹

[56 FR 28012, 28018, June 18, 1991; 56 FR 29756, June 28, 1991]

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