Human Research Subject Protection Act of 1997, Bill S.193
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.
his Act may be cited as the ``Human Research Subject Protections
ct 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 ensure 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 2(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
f 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 ct shall supersede any provision of part 46 of title 45, Code of
Federal Regulations, if such provisions are in conflict.
. 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.''.
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
. 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.
<all> telnet
Copied from a US Congressional database through Telnet.
Phone: 202-515-1661
Copied this public document with no market value under
the " fair use" provision, for educational purposes._