[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3878 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 3878

 To amend the Public Health Service Act to establish a requirement of 
   informed consent regarding the use of human subjects in research 
    conducted 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 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to establish a requirement 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 Representatives of the 
United States of America in Congress assembled,

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.

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