    [United States Statutes at Large, Volume 134, 116th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 116-291
    116th Congress

    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.

    [[Page 4895]]

    (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.

    Approved January 5, 2021.

    LEGISLATIVE HISTORY--H.R. 1966:
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    CONGRESSIONAL RECORD, Vol. 166 (2020):
    Dec. 9, considered and passed House.
    Dec. 18, considered and passed Senate.