July 15, 2019 - Issue: Vol. 165, No. 118 — Daily Edition116th Congress (2019 - 2020) - 1st Session

[Pages S4824-S4825]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         SUBMITTED RESOLUTIONS

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 SENATE RESOLUTION 275--CALLING FOR INTERNATIONAL ETHICAL STANDARDS IN 
                        GENOME EDITING RESEARCH

  Mrs. FEINSTEIN (for herself, Mr. Rubio, and Mr. Reed) submitted the 
following resolution; which was referred to the Committee on Foreign 
Relations:

                              S. Res. 275

       Whereas genome editing enables scientists to make changes 
     to the genome in organisms by removing, adding, or replacing 
     genetic material;
       Whereas there is tremendous hope that genome editing 
     technologies 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--
       (1) was first adopted in 1964;
       (2) has been revised over time; and
       (3) has provided guidance to the international community on 
     ethical principles for medical research involving 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 
     Declaration 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 
     support for an international moratorium on clinical 
     application of germline genome editing and is working with 
     other Federal agencies, international agencies, health and 
     science organizations, patient communities, and the public to 
     engage in a substantive debate about the benefits and risks 
     of germline genome editing research;
       Whereas the World Health Organization has created an expert 
     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 Academy 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 reproduction 
     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) opposes the experiments that resulted in pregnancies 
     using genome-edited human embryos described in November 2018 
     media reports;
       (2) recognizes that the question of whether to proceed with 
     heritable genome editing touches on all of humanity;
       (3) supports the international commission convened by the 
     National Academy of Medicine, the National Academy of 
     Sciences, and the Royal Society of the United Kingdom to 
     develop an international framework regarding human germline 
     editing; and
       (4) encourages the Secretary of State to work with other 
     nations and international organizations, including the United 
     Nations and the World Health Organization, to forge an 
     international consensus regarding the limits of ethical 
     clinical use of genome-edited human embryos.

  Mrs. FEINSTEIN. Mr. President, I rise today to introduce a Senate 
Resolution calling for the international

[[Page S4825]]

community to come together and determine the ethical limits of gene-
editing technology to avoid future misuse like what was recently 
discovered in China.
  Gene editing is a powerful new technology that has the potential to 
lead to new therapies for devastating and previously untreatable 
diseases. Today, there are already promising clinical trials using 
gene-editing technology that hope to treat cancer, sickle cell disease 
and other terrible diseases.
  However, like any new technology, there is potential for misuse and 
that is what happened with recent experiments in China. These 
experiments involving gene-edited human embryos failed in every measure 
to meet the ethical and scientific standards for research with human 
subjects.
  First and foremost, the scientist put the health of the mother and 
her children at risk by using an unproven technology without adequate 
safeguards.
  Furthermore, human clinical research must be conducted for a 
legitimate medical purpose. In this case, gene-editing was used to 
prevent the children from being able to acquire HIV. There are already 
safe and effective ways to prevent HIV infection that do not involve 
the use of gene-editing technology.
  In addition, clinical research participants should never be misled 
when obtaining informed consent. According to reports, the scientist in 
charge of the experiments told the participants that the study would be 
testing a new vaccine for HIV, which is a gross mischaracterization of 
the gene-editing technology.
  Finally, the scientist reportedly proceeded with the experiments 
knowing the genetic changes he created were different from what he 
originally intended. As a result, the children likely possess genetic 
mutations that did not undergo any pre-clinical testing and have never 
before existed in humans, leaving their long-term health in question.
  Moreover, these unethical experiments have the potential to create 
new genetic diseases that could be passed down to future generations.
  The international community must come together to condemn unethical 
human experimentation and prevent this from happening again. No one 
country can make this decision alone. International standards must be 
established to prevent unethical researchers from moving to whichever 
country has the loosest regulations.
  Already, the World Health Organization and the United States' 
National Academies of Sciences, along with the Chinese Academy of 
Sciences, have begun this important work.
  Our resolution makes clear that unethical human experimentation has 
no place in a modern society and encourages collaborative international 
efforts to continue.
  I am proud to introduce this resolution today. I hope my Senate 
colleagues will join us to ensure that gene-editing research is 
conducted in a responsible and ethical manner moving forward. Thank 
you, Mr. President. I yield the floor.

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