[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1966 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 1966
To direct the Comptroller General of the United States to complete a
study on barriers to participation in federally funded cancer clinical
trials by populations that have been traditionally underrepresented in
such trials.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 28, 2019
Mr. Cummings (for himself, Mr. Sarbanes, and Mr. Ruppersberger)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Armed
Services, and Veterans' Affairs, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To direct the Comptroller General of the United States to complete a
study on barriers to participation in federally funded cancer clinical
trials by populations that have been traditionally underrepresented in
such trials.
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 ``Henrietta Lacks Enhancing Cancer
Research Act of 2019''.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Only a small percent of patients participate in cancer
clinical trials, even though most express an interest in
clinical research. There are several obstacles that restrict
individuals from participating including lack of available
local trials, restrictive eligibility criteria, transportation
to trial sites, taking time off from work, and potentially
increased medical and nonmedical costs. Ultimately, about 1 in
5 cancer clinical trials fail because of lack of patient
enrollment.
(2) Groups that are generally underrepresented in clinical
trials include racial and ethnic minorities and older, rural,
and lower-income individuals.
(3) Henrietta Lacks, an African-American woman, was
diagnosed with cervical cancer at the age of 31, and despite
receiving painful radium treatments, passed away on October 4,
1951.
(4) Medical researchers took samples of Henrietta Lacks'
tumor during her treatment and the HeLa cell line from her
tumor proved remarkably resilient.
(5) HeLa cells were the first immortal line of human cells.
Henrietta Lacks' cells were unique, growing by the millions,
commercialized and distributed worldwide to researchers,
resulting in advances in medicine.
(6) Henrietta Lacks' prolific cells continue to grow and
contribute to remarkable advances in medicine, including the
development of the polio vaccine, as well as drugs for treating
the effects of cancer, HIV/AIDS, hemophilia, leukemia, and
Parkinson's disease. These cells have been used in research
that has contributed to our understanding of the effects of
radiation and zero gravity on human cells. These immortal cells
have informed research on chromosomal conditions, cancer, gene
mapping, and precision medicine.
(7) Henrietta Lacks and her immortal cells have made a
significant contribution to global health, scientific research,
quality of life, and patient rights.
(8) For more than 20 years, the advances made possible by
Henrietta Lacks' cells were without her or her family's
consent, and the revenues they generated were not known to or
shared with her family.
(9) Henrietta Lacks and her family's experience is
fundamental to modern and future bioethics policies and
informed consent laws that benefit patients nationwide by
building patient trust; promoting ethical research that
benefits all individuals, including traditionally
underrepresented populations; and protecting research
participants.
SEC. 3. GAO STUDY ON BARRIERS TO PARTICIPATION IN FEDERALLY FUNDED
CANCER CLINICAL TRIALS BY POPULATIONS THAT HAVE BEEN
TRADITIONALLY UNDERREPRESENTED IN SUCH TRIALS.
(a) In General.--Not later than 2 years after the date of enactment
of this Act, the Comptroller General of the United States shall--
(1) complete a study that--
(A) reviews what actions Federal agencies have
taken to help to address barriers to participation in
federally funded cancer clinical trials by populations
that have been traditionally underrepresented in such
trials, and identifies challenges, if any, in
implementing such actions; and
(B) identifies additional actions that can be taken
by Federal agencies to address barriers to
participation in federally funded cancer clinical
trials by populations that have been traditionally
underrepresented in such trials; and
(2) submit a report to the Congress on the results of such
study, including recommendations on potential changes in
practices and policies to improve participation in such trials
by such populations.
(b) Inclusion of Clinical Trials.--The study under subsection
(a)(1) should include review of cancer clinical trials that are largely
funded by Federal agencies, including the National Institutes of
Health, the Department of Defense, the Department of Veterans Affairs,
the Agency for Health Research and Quality, the Food and Drug
Administration, and such other Federal agencies as the Comptroller
General of the United States may identify.
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