I
106TH CONGRESS
2D SESSION
H. R. 4605
To amend the Public Health Service Act with respect to the protection
of human subjects in research.
IN THE HOUSE OF REPRESENTATIVES
JUNE 8, 2000
Ms. DEGETTE (for herself, Mr. MICA, Mr. WAXMAN, Mr. DINGELL, Mr.
BROWN of Ohio, Mr. LATOURETTE, Mr. TOWNS, Mr. STARK, and Mr.
KUCINICH) introduced the following bill; which was referred to the Com-
mittee on Commerce
A BILL
To amend the Public Health Service Act with respect to
the protection of human subjects in research.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Human Research Sub-
ject Protections Act of 2000’’.
SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—The Congress finds as follows:
(1) The first principle of the Nuremberg code
states that with respect to human research, the vol-
untary consent of the human subject is absolutely
essential. The Nuremberg code further asserts that
such consent must be competent, informed and com-
prehending.
(2) In 1974, the Department of Health, Edu-
cation 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, subpart A of
these regulations was adopted by 16 additional Fed-
eral agencies to apply to any research which these
agencies may conduct or sponsor.
(3) Between 1974 and 1983, Congress enacted
two Public Laws that established ethical advisory
bodies. Public Law 91–348 established the National
Commission for the Protection of Human Subjects
of Biomedical and Behavioral 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 Presi-
dent and Congress to expand protections for human
research subjects. Some of these recommendations
have been incorporated into the Federal regulation
(45 CFR 46).
(4) In 1995, the President’s Advisory Com-
mittee on Human Radiation Experiments found that
there are significant deficiencies in some aspects of
the current system for the protection of human sub-
jects. In particular, the Committee found that some
consent forms currently in use are flawed in morally
significant aspects.
(5) 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 exemp-
tion or waiver. The Committee further recommended
that in all cases, potential subjects should be in-
formed of the identity of the sponsoring Federal
agency and that the project involves classified infor-
mation.
(6) In 1996, Congress enacted the Health In-
surance Portability and Accountability Act, which
established an August 21, 1999, deadline to enact
comprehensive health privacy rules. Failure to meet
that deadline triggered a requirement for the Sec-
retary of Health and Human Services to issue final
health privacy regulations by February 2000.
(7) In 1998 and 2000, the Department of
Health and Human Services’s Inspector General
found that the effectiveness of Institutional Review
Board was ‘‘in jeopardy’’ and attention needed to be
directed to enhancing human subject protections for
a widening scope of clinical investigation.
(8) In 1998 and 1999, the National Bioethics
Advisory Commission found that Federal protections
do not always contain specific protections for certain
vulnerable populations and that existing regulations
do not adequately address issues involving human bi-
ological materials.
(9) Some agencies of the Federal government
sponsor research involving human subjects, but these
agencies have not adopted the Common Rule or vul-
nerable-populations protections as provided for in
part 46 of title 45, Code of Federal Regulations,
specifically subparts B, C, and D.
(10) Private individuals or institutions that do
not receive any Federal funding or that are not
seeking the approval of the Food and Drug Adminis-
tration for a drug, device, or biologic and that spon-
sor research involving human subjects, do not need
to abide by the requirements of part 46 of title 45,
Code of Federal Regulations.
(11) Research institutions that receive Federal
funds for conducting research involving human sub-
jects are not required to apply the protections of
part 46 of title 45, Code of Federal Regulations, to
all research conducted at the institution. Many, but
not all, research institutions have voluntarily made
this commitment.
(12) Notwithstanding paragraphs (1) through
(8), no provision of United States law explicitly re-
quires that informed consent and independent review
of all research involving human subjects be obtained.
(13) The human research subject activities de-
scribed in this section are either in interstate (or
foreign) commerce or substantially affect such com-
merce or the free flow thereof, and the regulation of
those activities as provided for in this Act is nec-
essary 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 and vulnerable-pop-
ulations protections to all human research subjects
independent of setting and funding source;