Henrietta Lacks Enhancing Cancer Research Act of 2019

II 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, Edu- cation, 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Henrietta Lacks En- 4 hancing Cancer Research Act of 2019’’. 5 SEC. 2. FINDINGS. 6 Congress finds as follows: 7 VerDate Sep 11 2014 23:47 Apr 04, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S946.IS S946 kjohnson on DSK79L0C42 with BILLS 2 •S 946 IS (1) Only a small percent of patients participate 1 in cancer clinical trials, even though most express an 2 interest in clinical research. There are several obsta- 3 cles that restrict individuals from participating in- 4 cluding lack of available local trials, restrictive eligi- 5 bility criteria, transportation to trial sites, taking 6 time off from work, and potentially increased med- 7 ical and nonmedical costs. Ultimately, about 1 in 5 8 cancer clinical trials fail because of lack of patient 9 enrollment. 10 (2) Groups that are generally underrepresented 11 in clinical trials include racial and ethnic minorities 12 and older, rural, and lower-income individuals. 13 (3) Henrietta Lacks, an African-American 14 woman, was diagnosed with cervical cancer at the 15 age of 31, and despite receiving painful radium 16 treatments, passed away on October 4, 1951. 17 (4) Medical researchers took samples of Hen- 18 rietta Lacks’ tumor during her treatment and the 19 HeLa cell line from her tumor proved remarkably 20 resilient. 21 (5) HeLa cells were the first immortal line of 22 human cells. Henrietta Lacks’ cells were unique, 23 growing by the millions, commercialized and distrib- 24 VerDate Sep 11 2014 23:47 Apr 04, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S946.IS S946 kjohnson on DSK79L0C42 with BILLS 3 •S 946 IS uted worldwide to researchers, resulting in advances 1 in medicine. 2 (6) Henrietta Lacks’ prolific cells continue to 3 grow and contribute to remarkable advances in med- 4 icine, including the development of the polio vaccine, 5 as well as drugs for treating the effects of cancer, 6 HIV/AIDS, hemophilia, leukemia, and Parkinson’s 7 disease. These cells have been used in research that 8 has contributed to our understanding of the effects 9 of radiation and zero gravity on human cells. These 10 immortal cells have informed research on chromo- 11 somal conditions, cancer, gene mapping, and preci- 12 sion medicine. 13 (7) Henrietta Lacks and her immortal cells 14 have made a significant contribution to global 15 health, scientific research, quality of life, and patient 16 rights. 17 (8) For more than 20 years, the advances made 18 possible by Henrietta Lacks’ cells were without her 19 or her family’s consent, and the revenues they gen- 20 erated were not known to or shared with her family. 21 (9) Henrietta Lacks and her family’s experience 22 is fundamental to modern and future bioethics poli- 23 cies and informed consent laws that benefit patients 24 nationwide by building patient trust; promoting eth- 25 VerDate Sep 11 2014 23:47 Apr 04, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S946.IS S946 kjohnson on DSK79L0C42 with BILLS 4 •S 946 IS ical research that benefits all individuals, including 1 traditionally underrepresented populations; and pro- 2 tecting research participants. 3 SEC. 3. GAO STUDY ON BARRIERS TO PARTICIPATION IN 4 FEDERALLY FUNDED CANCER CLINICAL 5 TRIALS BY POPULATIONS THAT HAVE BEEN 6 TRADITIONALLY UNDERREPRESENTED IN 7 SUCH TRIALS. 8 (a) IN GENERAL.—Not later than 2 years after the 9 date of enactment of this Act, the Comptroller General 10 of the United States shall— 11 (1) complete a study that— 12 (A) reviews what actions Federal agencies 13 have taken to help to address barriers to par- 14 ticipation in federally funded cancer clinical 15 trials by populations that have been tradition- 16 ally underrepresented in such trials, and identi- 17 fies challenges, if any, in implementing such ac- 18 tions; and 19 (B) identifies additional actions that can 20 be taken by Federal agencies to address bar- 21 riers to participation in federally funded cancer 22 clinical trials by populations that have been tra- 23 ditionally underrepresented in such trials; and 24 VerDate Sep 11 2014 23:47 Apr 04, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S946.IS S946 kjohnson on DSK79L0C42 with BILLS 5 •S 946 IS (2) submit a report to Congress on the results 1 of such study, including recommendations on poten- 2 tial changes in practices and policies to improve par- 3 ticipation in such trials by such populations. 4 (b) INCLUSION OF CLINICAL TRIALS.—The study 5 under subsection (a)(1) should include review of cancer 6 clinical trials that are largely funded by Federal agencies, 7 including the National Institutes of Health, the Depart- 8 ment of Defense, the Department of Veterans Affairs, the 9 Agency for Health Research and Quality, the Food and 10 Drug Administration, and such other Federal agencies as 11 the Comptroller General of the United States may iden- 12 tify. 13 Æ VerDate Sep 11 2014 23:47 Apr 04, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S946.IS S946 kjohnson on DSK79L0C42 with BILLS