Henrietta Lacks Enhancing Cancer Research Act of 2019

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.

[116th Congress Public Law 291]
[From the U.S. Government Publishing Office]



[[Page 134 STAT. 4894]]

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. <<NOTE: Jan. 5, 2021 -  [H.R. 1966]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Henrietta Lacks 
Enhancing Cancer Research Act of 2019.>> 
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 134 STAT. 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) <<NOTE: Deadline. Reviews.>>  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) <<NOTE: Reports. Recommenda- tions.>>  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.

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