[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 193 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                 S. 193

  To provide protections to individuals who are the human subject of 
                               research.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 22, 1997

   Mr. Glenn introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
  To provide protections to individuals who are the human subject of 
                               research.

    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 ``Human Research Subject Protections 
Act of 1997''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress makes the following findings:
            (1) The Constitution guarantees the right of the people to 
        be secure in their persons, and the Declaration of Independence 
        asserts as self-evident that all men have certain unalienable 
        rights among these are life, liberty and the pursuit of 
        happiness.
            (2) The first principle of the Nuremberg code states that 
        with respect to human research, the voluntary consent of the 
        human subject is absolutely essential. The Nuremberg code 
        further asserts that such consent must be competent, informed 
        and comprehending.
            (3) In 1974, the Department of Health, Education and 
        Welfare published regulations (45 CFR 46) governing the 
        protection of human subjects in research. These regulations 
        applied only to research sponsored by the Department. In 1991 
        these regulations were adopted by 16 additional Federal 
        agencies to apply to any research which these agencies may 
        sponsor.
            (4) Between 1974 and 1983, Congress enacted 2 Public Laws 
        that established ethical advisory bodies. Public Law 91-348 
        established the National Commission for the Protection of Human 
        Subjects of Biomedical Research and Public Law 95-622 
        established the President's Commission for the Study of Ethical 
        Problems in Medicine and Biomedical and Behavioral Research. 
        Each of these advisory bodies made recommendations to the 
        President and Congress to expand protections for human research 
        subjects. Some of these recommendations have been incorporated 
        into the Federal regulation (45 CFR 46).
            (5) In 1995, the President's Advisory Committee on Human 
        Radiation Experiments found that there are significant 
        deficiencies in some aspects of the current system for the 
        protection of human subjects. In particular, the Committee 
        found that some consent forms currently in use are flawed in 
        morally significant aspects.
            (6) The President's Advisory Committee on Human Radiation 
        Experiments recommended the adoption of a Federal policy 
        requiring the informed consent of all human subjects of 
        classified research and that this requirement not be subject to 
        exemption or waiver. The Committee further recommended that in 
        all cases, potential subjects should be informed of the 
        identity of the sponsoring Federal agency and that the project 
        involves classified information.
            (7) Some agencies of the Federal government sponsor 
        research involving human subjects, but these agencies have not 
        adopted the Common Rule as provided for in part 46 of title 45, 
        Code of Federal Regulations.
            (8) Private individuals or institutions that do not receive 
        any Federal funding or that are not seeking the approval of the 
        Food and Drug Administration for a drug or device, and that 
        sponsor research involving human subjects, do not need to abide 
        by the requirements of part 46 of title 45, Code of Federal 
        Regulations.
            (9) Many, but not all, research institutions that receive 
        Federal sponsorship for research involving human subjects may 
        voluntarily apply the protections of the Common Rule to all 
        research conducted at the research institution.
            (10) Notwithstanding paragraphs (1) through (9), no 
        provision of United States law explicitly requires that 
        informed consent and independent review of research involving 
        human subject be obtained.
            (11) The human research subject activities described in 
        this section are either in interstate (or foreign) commerce or 
        substantially affect such commerce or the free flow thereof, 
        and the regulation of those activities as provided for in this 
        Act is necessary to prevent and eliminate burdens upon such 
        commerce and to effectively regulate such commerce, in order to 
insure that the rights and welfare of human research subjects are 
protected.
    (b) Purpose.--The purposes of this Act are--
            (1) to apply common rule protections to all human subject 
        research and provide for criminal sanctions for violations of 
        this Act;
            (2) to prohibit the provision of Federal support for 
        classified research that is not reviewed by an institutional 
        review board and require disclosure to human research subjects 
        of certain information regarding classified research; and
            (3) to address any potential regulatory conflict of 
        interest within the Department of Health and Human Services and 
        the National Institutes of Health, and establish an Office for 
        Protection of Research Subjects within the Office of the 
        Secretary of Health and Human Services.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Assurance.--The term ``assurance'' means a written 
        agreement between the Secretary and a research facility, or an 
        institution supporting the research facility, that such 
        research facility will comply with all Federal ethical 
        standards regarding human subject research, including the 
        common rule protections. Such term includes a ``single project 
        assurance'', ``multiple project assurance'', and ``cooperative 
        project assurance''.
            (2) Board.--The term ``board'' means an institutional 
        review board established in accordance with and for the 
        purposes expressed in this Act.
            (3) Classified research.--The term ``classified research'' 
        means research involving human subjects that is specifically 
        authorized under criteria established by an Executive Order to 
        be kept secret in the interest of national defense of foreign 
        policy.
            (4) Common rule protections.--The term ``common rule 
        protections'' means the requirements and protections provided 
        under part 46 of title 45, Code of Federal Regulations, as in 
        effect on the date of enactment of this Act.
            (5) Human subject.--The term ``human subject'' means a 
        living individual about whom an investigator (whether 
        professional or student) conducting research obtains--
                    (A) data through intervention or interaction with 
                the individual; or
                    (B) individually identifiable private information.
            (6) Interstate commerce.--The term ``interstate commerce'' 
        has the meaning given the term in section 201(b) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
            (7) Office.--The term ``Office'' means the Office for 
        Protection of Research Subjects established under section 
        102(a) or the Office designated under section 102(b).
            (8) Research.--The term ``research'' means a systematic 
        investigation, including research development, testing and 
        evaluation, designed to develop or contribute to generalizable 
        knowledge, and those activities for which a Federal department 
        or agency has specific responsibility for regulating as 
        research activities.
            (9) Research facility.--The term ``research facility'' 
        means any public or private entity, agency (including Federal, 
        State, and other agencies) or person that--
                    (A) uses human subjects in research involving 
                interstate commerce; or
                    (B) receives support under a grant, loan, contract, 
                or other award from a department, agency, or 
                instrumentality of the United States for the purpose of 
                carrying out research using human subjects.
            (10) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (11) State.--The term ``State'' means a State of the United 
        States, the District of Columbia, the Commonwealth of Puerto 
        Rico, the Virgin Islands, Guam, American Samoa, or any other 
        territory or possession of the United States.

                 TITLE I--GENERAL RESEARCH REQUIREMENTS

SEC. 101. APPLICATION OF COMMON RULE REQUIREMENTS AND PROTECTIONS.

    (a) In General.--Except as provided in subsection (b), the 
requirements and protections provided under part 46 of title 45, Code 
of Federal Regulations, as in effect on the date of enactment of this 
Act, shall apply to research conducted by research facilities using 
human subjects.
    (b) Exception When in Conflict with Act.--The provisions of this 
Act shall supersede any provision of part 46 of title 45, Code of 
Federal Regulations, if such provisions are in conflict.

SEC. 102. OFFICE FOR PROTECTION OF RESEARCH SUBJECTS.

    (a) Establishment.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall establish within the Office 
of the Secretary an office to be known as the ``Office for Protection 
of Human Research Subjects'' or make the designation described in 
subsection (b).
    (b) Designation.--Not later than 90 days after the date of 
enactment of this Act, the Secretary may reassign the Office for 
Protection from Research Risks to the Office of the Secretary and 
designate such Office to carry out the duties of the Office under this 
Act.
    (c) Funding.--The Secretary shall ensure the availability of such 
sums as may be necessary to enable the Office to conduct all activities 
under this Act, as well as to conduct appropriate oversight and 
implementation activities.

SEC. 103. REGISTRATION OF FACILITIES.

    (a) In General.--To conduct research using human subjects, a 
research facility shall have in effect a valid registration with the 
Secretary in accordance with this section and with such regulations as 
the Secretary may promulgate.
    (b) Requirements.--An application for registration under subsection 
(a) shall include--
            (1) a statement of the principles of the applicant research 
        facility with respect to the protection of the rights and 
        welfare of humans subjects of research conducted or supported 
        by the research facility;
            (2) a designation of the official responsible for all human 
        subject research conducted or supported by the applicant 
        research facility;
            (3) a designation of, and membership roster or rosters for, 
        each board that is responsible for reviewing human subject 
        research conducted or supported by the applicant research 
        facility; and
            (4) an assurance that the applicant research facility is 
        complying and will continue to comply with the requirements 
        for--
                    (A) board membership;
                    (B) the functions and operations of the board;
                    (C) the review of research by the board;
                    (D) the approval of research by the board;
                    (E) the suspension or termination of board approval 
                of research;
                    (F) the maintenance of records by the board; and
                    (G) obtaining and documenting informed consent from 
                human subjects, consent from children, and permission 
                from parents or guardians as provided for in the common 
                rule protections.
    (c) Period of Registration.--The registration of a research 
facility shall be valid for the 3-year period beginning on the date on 
which the Secretary approves the application for registration, except 
that such registration may be suspended, revoked or deemed to be 
incomplete or otherwise insufficient by the Secretary.
    (d) Affect of Assurances.--Upon the notification of the Secretary 
by the official designated under subsection (b)(2), a research facility 
shall be deemed to be in compliance with the registration provisions of 
this section, if that research facility has in effect a valid assurance 
negotiated with the Department of Health and Human Services.
    (e) Failure to Register.--A research facility may not conduct an 
activity covered by this Act if the facility is not registered with the 
Secretary under this section or an assurance described in subsection 
(d) is not in effect.

SEC. 104. INSPECTION AND INVESTIGATION.

    (a) In General.--The Secretary may carry out such inspections or 
investigations as may be necessary to enable the Secretary to determine 
whether any research facility has violated or is violating any 
provision of this Act.
    (b) Access to Facilities and Records.--To enable the Secretary to 
carry out subsection (a), the Secretary shall, after providing 
reasonable notice, be provided with access to a research facility and 
the records required to be kept by the facility pursuant to section 
103(b)(4) and the common rule protections.
    (c) Penalties.--Title 18, United States Code, is amended by 
inserting after chapter 89 the following:

   ``CHAPTER 90--PROTECTION OF HUMAN SUBJECTS BY RESEARCH FACILITIES

``Sec. 1841. Protection of human subjects
    ``(a) In General.--Whoever forcibly assaults, resists, opposes, 
impedes, intimidates, or interferes with any person while such person 
is engaged in the performance of his or her official duties under the 
Human Research Subject Protections Act of 1997, or because such person 
has carried out such duties, shall be fined not more than $10,000, or 
imprisoned not more than 3 years, or both.
    ``(b) Use of Weapon.--Whoever in the commission of an act that is a 
violation of subsection (a), uses a deadly or dangerous weapon shall be 
fined not more than $25,000, or imprisoned not more than 10 years, or 
both.
    ``(c) Homicide.--Whoever kills any human being while that human 
being is engaged in the performance of his or her official duties under 
the Human Research Subject Protections Act of 1997, or because such 
human being has carried out such duties, shall be fined or imprisoned 
as provided for under sections 1111 and 1114.''.

SEC. 105. ENFORCEMENT.

    (a) Suspension of Registration.--If the Secretary has reason to 
believe that any research facility registered under section 103 has 
violated or is in violation of any provision of this Act, or of any of 
the rules or regulations or standards promulgated by the Secretary 
under this Act, the Secretary may suspend the registration of that 
research facility for a period of not to exceed 30 days, and after 
notice and opportunity for a hearing, may suspend such registration for 
any additional period as the Secretary may determine appropriate. Upon 
a determination by the Secretary that such a violation has occurred the 
Secretary may continue such suspension or revoke the registration.
    (b) Penalties.--Any employee of a research facility that knowingly 
violates any provision of this Act shall, on conviction thereof, shall 
be fined not more than $10,000, or imprisoned not more than 3 years, or 
both. Such violation shall be referred by the Secretary to the United 
States Department of Justice for prosecution.

SEC. 106. REGULATIONS.

    The Secretary may promulgate such regulations as the Secretary 
determines to be necessary to carry out this Act.

                     TITLE II--CLASSIFIED RESEARCH

SEC. 201. PROHIBITION.

    Notwithstanding any other provision of law, no Federal funds shall 
be expended for the conduct of any classified research where a board 
has waived informed consent as defined in the common rule protections 
or where a determination has been made that the research is exempt from 
review by such a board.

SEC. 202. ADDITIONAL REQUIREMENTS.

    In addition to the requirements applicable under the common rule 
protections, the human subjects involved in any classified research 
that receives Federal funding shall be provided with the following 
additional information:
            (1) The identity of the Federal agency providing funds in 
        connection with the conduct of such research.
            (2) A statement that the research involves classified 
        information.
            (3) An unclassified description of the purpose of the 
        research.
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