I 

116TH CONGRESS 

1ST SESSION H. R. 1966 

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 HOUSE OF REPRESENTATIVES 

MARCH 28, 2019 

Mr. CUMMINGS (for himself, Mr. SARBANES, and Mr. RUPPERSBERGER) introduced the following bill; which was referred to the Committee on Energy 

and Commerce, and in addition to the Committees on Armed Services, 

and Veterans’ Affairs, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Henrietta Lacks En5 hancing Cancer Research Act of 2019’’. 


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•HR 1966 IH

1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) Only a small percent of patients participate 

4 in cancer clinical trials, even though most express an 

5 interest in clinical research. There are several obsta6 cles that restrict individuals from participating in7 cluding lack of available local trials, restrictive eligi8 bility criteria, transportation to trial sites, taking 

9 time off from work, and potentially increased med10 ical and nonmedical costs. Ultimately, about 1 in 5 

11 cancer clinical trials fail because of lack of patient 

12 enrollment. 

13 (2) Groups that are generally underrepresented 

14 in clinical trials include racial and ethnic minorities 

15 and older, rural, and lower-income individuals. 

16 (3) Henrietta Lacks, an African-American 

17 woman, was diagnosed with cervical cancer at the 

18 age of 31, and despite receiving painful radium 

19 treatments, passed away on October 4, 1951. 

20 (4) Medical researchers took samples of Hen21 rietta Lacks’ tumor during her treatment and the 

22 HeLa cell line from her tumor proved remarkably 

23 resilient. 

24 (5) HeLa cells were the first immortal line of 

25 human cells. Henrietta Lacks’ cells were unique, 

26 growing by the millions, commercialized and distribVerDate Sep 11 2014 01:33 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1966.IH H1966

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1 uted worldwide to researchers, resulting in advances 

2 in medicine. 

3 (6) Henrietta Lacks’ prolific cells continue to 

4 grow and contribute to remarkable advances in med5 icine, including the development of the polio vaccine, 

6 as well as drugs for treating the effects of cancer, 

7 HIV/AIDS, hemophilia, leukemia, and Parkinson’s 

8 disease. These cells have been used in research that 

9 has contributed to our understanding of the effects 

10 of radiation and zero gravity on human cells. These 

11 immortal cells have informed research on chromo12 somal conditions, cancer, gene mapping, and preci13 sion medicine. 

14 (7) Henrietta Lacks and her immortal cells 

15 have made a significant contribution to global 

16 health, scientific research, quality of life, and patient 

17 rights. 

18 (8) For more than 20 years, the advances made 

19 possible by Henrietta Lacks’ cells were without her 

20 or her family’s consent, and the revenues they gen21 erated were not known to or shared with her family. 

22 (9) Henrietta Lacks and her family’s experience 

23 is fundamental to modern and future bioethics poli24 cies and informed consent laws that benefit patients 

25 nationwide by building patient trust; promoting ethVerDate Sep 11 2014 01:33 Apr 11, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1966.IH H1966

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1 ical research that benefits all individuals, including 

2 traditionally underrepresented populations; and pro3 tecting research participants. 

4 SEC. 3. GAO STUDY ON BARRIERS TO PARTICIPATION IN 

5 FEDERALLY FUNDED CANCER CLINICAL 

6 TRIALS BY POPULATIONS THAT HAVE BEEN 

7 TRADITIONALLY UNDERREPRESENTED IN 

8 SUCH TRIALS. 

9 (a) IN GENERAL.—Not later than 2 years after the 

10 date of enactment of this Act, the Comptroller General 

11 of the United States shall— 

12 (1) complete a study that— 

13 (A) reviews what actions Federal agencies 

14 have taken to help to address barriers to par15 ticipation in federally funded cancer clinical 

16 trials by populations that have been tradition17 ally underrepresented in such trials, and identi18 fies challenges, if any, in implementing such ac19 tions; and 

20 (B) identifies additional actions that can 

21 be taken by Federal agencies to address bar22 riers to participation in federally funded cancer 

23 clinical trials by populations that have been tra24 ditionally underrepresented in such trials; and 


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1 (2) submit a report to the Congress on the re2 sults of such study, including recommendations on 

3 potential changes in practices and policies to im4 prove participation in such trials by such popu5 lations. 

6 (b) INCLUSION OF CLINICAL TRIALS.—The study 

7 under subsection (a)(1) should include review of cancer 

8 clinical trials that are largely funded by Federal agencies, 

9 including the National Institutes of Health, the Depart10 ment of Defense, the Department of Veterans Affairs, the 

11 Agency for Health Research and Quality, the Food and 

12 Drug Administration, and such other Federal agencies as 

13 the Comptroller General of the United States may iden14 tify. 

Æ 


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