Protections For Human Research Subjects; Sen. John Glenn’s S. 193- 105th Congress

Text: S.193 — 105th Congress (1997-1998)All Information (Except Text)
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Introduced in Senate (01/22/1997)
[Congressional Bills 105th Congress]
[From the U.S. Government Printing 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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