I
103D CONGRESS
2D SESSION
H. R. 3878
To amend the Public Health Service Act to establish a requirement of in-
formed consent regarding the use of human subjects in research con-
ducted or supported by the Federal Government, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 23, 1994
Mr. COOPER (for himself, Mr. CLEMENT, Mr. TANNER, Mr. GORDON, Mr.
DUNCAN, Mr. QUILLEN, Mr. FORD of Tennessee, Mrs. LLOYD, and Mr.
SUNDQUIST) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce
A BILL
To amend the Public Health Service Act to establish a re-
quirement of informed consent regarding the use of
human subjects in research conducted or supported by
the Federal Government, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Federal Research In-
formed Consent Act’’.
SEC. 2. REQUIREMENT OF INFORMED CONSENT REGARD-
ING USE OF HUMAN SUBJECTS IN FEDER-
ALLY QUALIFIED RESEARCH.
(a) IN GENERAL.—Section 491 of the Public Health
Service Act (42 U.S.C. 289) is amended by adding at the
end the following subsection:
‘‘(c) REQUIREMENT
OF INFORMED CONSENT RE-
GARDING HUMAN SUBJECTS.—
‘‘(1) IN GENERAL.—Subject to paragraph (2),
the Secretary shall by regulation establish the re-
quirement that, in federally qualified research in
which any human subject is to be used, an individual
may not be used as a subject unless the principal re-
searcher obtains the informed consent of the individ-
ual to serve as a subject.
‘‘(2) EXEMPTED CATEGORIES OF RESEARCH.—
‘‘(A) With respect to the requirement of
paragraph (1) that informed consent be ob-
tained, the Secretary may, in issuing regula-
tions under such paragraph, establish such ex-
empted categories of research as the Secretary
determines to be appropriate. The regulations
may not authorize any waiver of the applicabil-
ity of the requirement to a research activity
that is not within such a category.
‘‘(B) In the case of a particular research
activity, the Secretary is responsible for approv-
ing or disapproving the activity as qualifying
for an exemption under subparagraph (A).
‘‘(C) If under subparagraph (B) the Sec-
retary approves an exemption, the Secretary
shall submit to the congressional committees of
jurisdiction a notification that the exemption
has been approved (together with a description
of the circumstances). In the case of classified
materials, the notification shall be submitted to
the committees, and reviewed by the commit-
tees, in accordance with any applicable require-
ments for such materials.
‘‘(D) An exemption approved by the Sec-
retary under subparagraph (B) takes effect
upon the expiration of the 60-day period begin-
ning on the date on which the notification re-
garding the exemption is submitted under sub-
paragraph (C).
‘‘(3) CRITERIA REGARDING PROVISION OF CON-
SENT.—In issuing regulations under paragraph (1),
the Secretary shall establish requirements for ob-
taining informed consent, including requirements re-
garding the information to be provided to the pro-
spective research subject and requirements regarding
documentation of the informed consent of such sub-
ject.
‘‘(4) NONCOMPLIANCE.—
‘‘(A) An individual aggrieved as a result of
a violation of the requirement under paragraph
(1) may obtain appropriate relief through a civil
action, including damages, equitable relief, and
a reasonable attorney’s fees and costs. Damages
in such an action may include damages other
than actual damages.
‘‘(B) With respect to a civil action under
subparagraph (A), if the research involved al-
legedly was conducted by the United States, the
defendant shall be the United States. The Unit-
ed States district courts have exclusive original
jurisdiction of actions described in the preced-
ing sentence, and such actions may be com-
menced in a judicial district only in accordance
with applicable law on the venue of civil actions.
‘‘(C) With respect to a civil action under
subparagraph (A), if the research involved al-
legedly was conducted by a State, the defendant
shall be the head of the State agency involved.
Actions described in the preceding sentence
may be commenced in any court of competent
jurisdiction. For purposes of this subparagraph,
a State is not immune under the Eleventh
Amendment of the Constitution of the United
States from a civil action under subparagraph
(A) in Federal court.
‘‘(D) With respect to a civil action under
subparagraph (A), if the research involved al-
legedly was not conducted by the United States
or by a State, the entity that allegedly did con-
duct the research shall be the defendant. Ac-
tions described in the preceding sentence may
be commenced in any court of competent juris-
diction.
‘‘(E) With respect to the death of an indi-
vidual who is aggrieved for purposes of sub-
paragraph (A), the cause of action survives the
individual and the civil action under such sub-
paragraph may be commenced only by a per-
sonal representative of the individual.
‘‘(F) With respect to limitations on com-
mencing a civil action under subparagraph
(A)—
‘‘(i) the civil action may not be com-
menced after the expiration of the 5-year
period beginning on the date on which the
individual (or the personal representative,
as the case may be) receives notice of the
alleged facts with respect to which the in-
dividual is aggrieved; and
‘‘(ii) notwithstanding clause (i), the
civil action may not be commenced after
the expiration of the 50-year period begin-
ning on the date on which the individual
dies.
‘‘(5) PREEMPTION.—This subsection supersedes
any private cause of action under the laws of a State
arising as a result of the use of an individual as a
subject in federally qualified research without the
consent of the individual.
‘‘(6) DEFINITIONS.—For purposes of this sub-
section:
‘‘(A) The term ‘federally qualified re-
search’ means—
‘‘(i) any research conducted or sup-
ported by the Federal Government; and
‘‘(ii) any research regulated by the
Federal Government, other than research
which is only incidentally regulated.
‘‘(B) The term ‘principal researcher’, with
respect to federally qualified research, means
the individual with the principal responsibility
for conducting the research.’’.
(b) STYLISTIC CONFORMING AMENDMENTS.—Sec-
tion 491 of the Public Health Service Act (42 U.S.C. 289)
is amended—
(1) in subsection (a), by striking ‘‘(a) The Sec-
retary’’ and inserting ‘‘(a) INSTITUTIONAL REVIEW
BOARDS.—The Secretary’’; and
(2) in subsection (b)—
(A) by striking ‘‘(b)(1) The Secretary’’ and
inserting the following:
‘‘(b) ETHICS GUIDANCE PROGRAM.—
‘‘(1) IN GENERAL.—The Secretary’’; and
(B) in paragraph (2), by striking ‘‘(2) The
Secretary’’ and inserting the following:
‘‘(2) RESPONSE
RESPECTING
VIOLATIONS.—
The Secretary’’.
SEC. 3. EFFECT ON EXISTING REGULATIONS; EFFECTIVE
DATE REGARDING CAUSES OF ACTION.
(a) EFFECT ON EXISTING REGULATIONS.—With re-
spect to the provisions of part 46 of title 45, Code of Fed-
eral Regulations (relating to the protection of human sub-
jects), as in effect on the date of the enactment of this
Act, the legal status of such provisions is affected by the
amendment made by section 2(a) only to the extent that
any such provision is inconsistent with the amendment.
(b) EFFECTIVE DATE REGARDING CAUSES OF AC-
TION; APPLICABLE PROVISIONS.—The requirement estab-
lished under section 491(c)(1) of the Public Health Serv-
ice Act (as added by the amendment made by section 2(a)
of this Act) is effective in the case of any violation of the
requirement occurring on or after the date of the enact-
ment of this Act, without regard to the date on which final
regulations under such section take effect. For purposes
of the preceding sentence, in the case of a cause of action
accruing before such regulations take effect—
(1) a defendant is liable, subject to paragraphs
(2) and (3), if the principal researcher involved (as
defined under such amendment) failed to obtain in-
formed consent in accordance with the provisions of
part 46 of title 45, Code of Federal Regulations (re-
lating to the protection of human subjects), as in ef-
fect on the date of the enactment of this Act;
(2) it is a defense that the Secretary of Health
and Human Services—
(A) determined that the research activity
involved was within one of the categories of re-
search described in section 46.101(b) of such
part;
(B) determined that the research activity
otherwise was not covered by the policy; or
(C) with respect to informed consent,
waived the applicability of the requirements in-
volved; and
(3) it is not a defense (except as provided in
paragraph (2)) that—
(A) for purposes of section 46.101(a) of
such part, the Federal department or agency in-
volved did not take action to make the policy
applicable;
(B) for purposes of section 46.101(c) of
such part, the department or agency head de-
termined that the research activity was not cov-
ered by the policy; or
(C) for purposes of section 46.101(i) of
such part, the department or agency head
waived the applicability of some or all of the
provisions of the policy.
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