A resolution calling for international ethical standards in genome editing research.

III 116TH CONGRESS 1ST SESSION S. RES. 275 Calling for international ethical standards in genome editing research. IN THE SENATE OF THE UNITED STATES JULY 15, 2019 Mrs. FEINSTEIN (for herself, Mr. RUBIO, and Mr. REED) submitted the fol- lowing resolution; which was referred to the Committee on Foreign Rela- tions RESOLUTION Calling for international ethical standards in genome editing research. Whereas genome editing enables scientists to make changes to the genome in organisms by removing, adding, or re- placing genetic material; Whereas there is tremendous hope that genome editing tech- nologies will lead to new therapies and cures for diseases; Whereas unintended effects during the development of new medical technologies can stop or delay the development of successful new therapies; Whereas pregnancies using genome-edited human embryos have not been shown to be safe; Whereas the Declaration of Helsinki of the World Medical Association— VerDate Sep 11 2014 20:50 Jul 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6300 E:\BILLS\SR275.IS SR275 pamtmann on DSKBFK8HB2PROD with BILLS 2 •SRES 275 IS (1) was first adopted in 1964; (2) has been revised over time; and (3) has provided guidance to the international com- munity on ethical principles for medical research involv- ing human subjects; Whereas there are media reports— (1) of experiments carried out overseas in 2018 using genome-edited human embryos in pregnancies; (2) that those experiments resulted in the live birth of 2 babies; (3) that the primary scientist responsible for those experiments recognized that the experiments were carried out too quickly and without necessary open dialogue with regulators, the scientific community, and the public; and (4) that an additional pregnancy with genome-edited human embryos is underway; Whereas the reported experiments in 2018 using genome- edited human embryos in pregnancies failed to meet the standards of human research ethics called for in the Dec- laration of Helsinki; Whereas the National Academies of Science, Engineering, and Medicine has concluded that more research and broadly inclusive public deliberation are needed before clinical trials of germline editing of human embryos and gametes should be permitted; Whereas the National Institutes of Health has declared sup- port for an international moratorium on clinical applica- tion of germline genome editing and is working with other Federal agencies, international agencies, health and science organizations, patient communities, and the pub- lic to engage in a substantive debate about the benefits and risks of germline genome editing research; VerDate Sep 11 2014 20:50 Jul 15, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6300 E:\BILLS\SR275.IS SR275 pamtmann on DSKBFK8HB2PROD with BILLS 3 •SRES 275 IS Whereas the World Health Organization has created an ex- pert advisory committee on developing standards for the governance and oversight of human genome editing; Whereas an international commission has been convened by the National Academy of Medicine, the National Acad- emy of Sciences, and the Royal Society of the United Kingdom to identify the scientific, medical, and ethical requirements that should be considered before heritable human genome editing should proceed; and Whereas, as of July 2019— (1) the use of genome-edited human embryos for re- production is prohibited in many countries; and (2) no international agreement exists as to whether clinical trials using genome-edited human embryos should proceed: Now, therefore, be it Resolved, That the Senate— 1 (1) opposes the experiments that resulted in 2 pregnancies using genome-edited human embryos de- 3 scribed in November 2018 media reports; 4 (2) recognizes that the question of whether to 5 proceed with heritable genome editing touches on all 6 of humanity; 7 (3) supports the international commission con- 8 vened by the National Academy of Medicine, the Na- 9 tional Academy of Sciences, and the Royal Society 10 of the United Kingdom to develop an international 11 framework regarding human germline editing; and 12 VerDate Sep 11 2014 20:50 Jul 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\SR275.IS SR275 pamtmann on DSKBFK8HB2PROD with BILLS 4 •SRES 275 IS (4) encourages the Secretary of State to work 1 with other nations and international organizations, 2 including the United Nations and the World Health 3 Organization, to forge an international consensus re- 4 garding the limits of ethical clinical use of genome- 5 edited human embryos. 6 Æ VerDate Sep 11 2014 20:50 Jul 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\SR275.IS SR275 pamtmann on DSKBFK8HB2PROD with BILLS