[Congressional Record Volume 165, Number 118 (Monday, July 15, 2019)]
[Senate]
[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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