[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1966 Enrolled Bill (ENR)]
H.R.1966
One Hundred Sixteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Friday,
the third day of January, two thousand and twenty
An Act
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) shall include review of cancer clinical trials that are largely
funded by Federal agencies.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.