Title: Henrietta Lacks Enhancing Cancer Research Act of 2019
Policy area: Health

Summary:
Henrietta Lacks Enhancing Cancer Research Act of 2019
This bill requires the Government Accountability Office to complete a study reviewing how federal agencies address barriers to participation in federally-funded cancer clinical trials by individuals from underrepresented populations and provide recommendations for addressing such barriers.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 946 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                 S. 946

 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 SENATE OF THE UNITED STATES

                             March 28, 2019

 Mr. Van Hollen (for himself and Mr. Cardin) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 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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