text of S.193 Marsha Green 12 Feb 1997 10:59 EST

 Here is the full text of S.193 (Glenn Legislation) compliments of
 Sheri Alpert from the IRB Discussion Group.

 Marsha Green
 UNLV

______________________________ Forward Header __________________________________
Subject: text of S.193
Author:  Sheri Alpert <xxxxxx@osf1.gmu.edu> at SMTP-UNS
Date:    2/12/97 8:08 AM

Figured I would respond to you offline.  Below is Glenn's bill.

sheri alpert
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FILE s193.is
          S 193 IS
          105th CONGRESS
          1st Session
          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.
           [Italic->]   Be it enacted by the Senate and House of
          Representatives of the United States of America in Congress
          assembled, [<-Italic]
          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:
              [BOLD->] `CHAPTER 90--PROTECTION OF HUMAN SUBJECTS BY RESEARCH
                                   FACILITIES [<-BOLD]
          `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.