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 obsta-
cles that restrict individuals from participating in-
cluding lack of available local trials, restrictive eligi-
bility criteria, transportation to trial sites, taking 
time off from work, and potentially increased med-
ical 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 Hen-
rietta 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 distrib-
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uted worldwide to researchers, resulting in advances 
in medicine. 
(6) Henrietta Lacks’ prolific cells continue to 
grow and contribute to remarkable advances in med-
icine, 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 chromo-
somal conditions, cancer, gene mapping, and preci-
sion 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 gen-
erated were not known to or shared with her family. 
(9) Henrietta Lacks and her family’s experience 
is fundamental to modern and future bioethics poli-
cies and informed consent laws that benefit patients 
nationwide by building patient trust; promoting eth-
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ical research that benefits all individuals, including 
traditionally underrepresented populations; and pro-
tecting 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 par-
ticipation in federally funded cancer clinical 
trials by populations that have been tradition-
ally underrepresented in such trials, and identi-
fies challenges, if any, in implementing such ac-
tions; and 
(B) identifies additional actions that can 
be taken by Federal agencies to address bar-
riers to participation in federally funded cancer 
clinical trials by populations that have been tra-
ditionally underrepresented in such trials; and 
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(2) submit a report to the Congress on the re-
sults of such study, including recommendations on 
potential changes in practices and policies to im-
prove participation in such trials by such popu-
lations. 
(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 Depart-
ment 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 iden-
tify. 
Æ 
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