Q: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Federal Research Informed Consent
Act''.

SEC. 2. REQUIREMENT OF INFORMED CONSENT REGARDING USE OF HUMAN SUBJECTS
IN FEDERALLY 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 Regarding Human Subjects.--
''(1) In general.--Subject to paragraph (2), the Secretary
shall by regulation establish the requirement 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 researcher obtains the informed consent of the
individual to serve as a subject.
''(2) Exempted categories of research.--
''(A) With respect to the requirement of paragraph
(1) that informed consent be obtained, the Secretary
may, in issuing regulations under such paragraph,
establish such exempted categories of research as the
Secretary determines to be appropriate. The regulations
may not authorize any waiver of the applicability 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 approving or
disapproving the activity as qualifying for an
exemption under subparagraph (A).
''(C) If under subparagraph (B) the Secretary
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 committees, in accordance with any applicable
requirements for such materials.
''(D) An exemption approved by the Secretary under
subparagraph (B) takes effect upon the expiration of
the 60-day period beginning on the date on which the
notification regarding the exemption is submitted under
subparagraph (C).
''(3) Criteria regarding provision of consent.--In issuing
regulations under paragraph (1), the Secretary shall establish
requirements for obtaining informed consent, including
requirements regarding the information to be provided to the
prospective research subject and requirements regarding
documentation of the informed consent of such subject.
''(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 allegedly
was conducted by the United States, the defendant shall
be the United States. The United States district courts
have exclusive original jurisdiction of actions
described in the preceding sentence, and such actions
may be commenced 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 allegedly
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 allegedly
was not conducted by the United States or by a State,
the entity that allegedly did conduct the research
shall be the defendant. Actions described in the
preceding sentence may be commenced in any court of
competent jurisdiction.
''(E) With respect to the death of an individual
who is aggrieved for purposes of subparagraph (A), the
cause of action survives the individual and the civil
action under such subparagraph may be commenced only by
a personal representative of the individual.
''(F) With respect to limitations on commencing a
civil action under subparagraph (A)--
''(i) the civil action may not be commenced
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 individual is
aggrieved; and
''(ii) notwithstanding clause (i), the
civil action may not be commenced after the
expiration of the 50-year period beginning 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 subsection:
''(A) The term 'federally qualified research'
means--
''(i) any research conducted or supported
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.--Section 491 of the Public
Health Service Act (42 U.S.C. 289) is amended--
(1) in subsection (a), by striking ''(a) The Secretary''
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 respect to the provisions
of part 46 of title 45, Code of Federal Regulations (relating to the
protection of human subjects), 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 Action; Applicable
Provisions.--The requirement established under section 491(c)(1) of the
Public Health Service 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 enactment 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 informed consent in accordance
with the provisions of part 46 of title 45, Code of Federal
Regulations (relating to the protection of human subjects), as
in effect 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 research 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 involved; 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 involved 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 determined that the
research activity was not covered 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.
A:
Federal Research Informed Consent Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to establish the requirement that, in federally qualified research in which any human subject is to be used, the principal researcher obtain the informed consent of the subject. Allows the Secretary to exempt categories of research from such consent requirement. Requires congressional notification of such exemptions and a 60-day waiting period before the exemption is effective.
Directs the Secretary to establish requirements for obtaining informed consent. Provides for civil actions by those from whom no such consent was obtained, allowing damages, equitable relief, and attorney's fees and costs. Preempts any State law concerning the obtaining of such consent.