Rice CRISPR Treats

Dua Khan, Sophia Orlando, Silvia-Antonia Rus, Sarina Sandhu, Stephanie Wu

Honors 220, Medical Ethics

 The Use of CRISPR/Cas9 in Humans Act of 2017

Preamble

Genome editing is a rapidly growing field of research that has the potential for

extraordinary medical improvements as well as immense harm. It is unethical to ignore the

potential for CRISPR/Cas 9 to dramatically improve the life quality of human individuals. It is

also unethical to allow for uses of CRISPR/Cas 9 that may jeopardize the health and wellbeing of

future generations. Therefore, international legislation regarding the use of CRISPR-cas 9

technology in humans is necessary to ensure its use occurs in a way that balances risks and

benefits and mitigates negative consequences.

Introduction

CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology is a

targeted gene editing platform. This law aims to balance the relief of human suffering from

disease and genetic maladies made possible by CRISPR technology against the potential for

negative effects. Thus its practice shall only be regulated for human gene therapy in which

somatic cells are targeted.

According to the National Institutes of Health, gene therapy is defined as a technique that

is “designed to introduce genetic material into cells to compensate for abnormal genes or to

make a beneficial protein”. This law defines abnormal genes as those that directly lead to an
active disease state. There must be a statistically significant correlation between a gene sequence

and disease outcome as determined through genome-wide association studies, which use a p

value threshold of 5 × 10​-8​ (GWAS). Furthermore, the disease must be included within the 10th

version of the World Health Organization’s International Classification of Diseases (ICD-10).

Both of these conditions must be met in order for CRISPR technology to be applied as gene

therapy for a particular disease state.

The following law includes a United Nations binding resolution that will be effective

immediately after enactment. This resolution falls under the jurisdiction of a newly formed

United Nations Committee on the Ethical Use and Regulation of CRISPR Technology.

Implementation of this resolution will be determined independently by each sovereign nation

member of the United Nations. The law that follows includes an outline of this resolution as well

as regulations for CRISPR use in the United States of America.

CRISPR shall not be allowed for editing human germline cells or embryos. Using

CRISPR technology to create heritable changes in the human genome, including the creation of

designer babies, may result in serious potential consequences in the form of exacerbating

systemic oppression, enabling the creation of super-authorities, enabling the creation of

subjugated humans, and widespread practice of eugenics.

People who have undergone CRISPR therapy shall not be allowed to reproduce after

treatment, but will gain expedited adoption benefits. CRISPR therapy can extend the lifespan of

an individual who might not otherwise live past reproductive age. Without regulation, this would

increase the prevalence of current and newly created severely deleterious alleles in the

population and undermine the health and wellbeing of future generations.

 The Law

Section I. Name of Law

Section II. Definitions

Section III. Uses of CRISPR

Section IV. Reproductive Restrictions

Section V. United Nations Resolution

Section VI. Regulation

Section VII. Penalties and Enforcement

Section VIII. Amendments

Section X. Effective Date

Section I. Name of Law

This law shall hereafter be known as The Use of CRISPR/Cas9 in Humans Act of 2017.

Section II. Definitions

I. Gene therapy: a medical treatment that uses genetic material to treat and prevent diseases.

a. Approaches include replacing a mutated gene that causes disease with a healthy copy of

the gene, inactivating, or “knocking out,” a mutated gene that is functioning improperly

and introducing a new gene into the body to help fight a disease.

II. Disease: those formally listed by the 10th version of the World Health Organization’s

International Classification of Diseases (ICD-10).

III. Eugenics: improving hereditary qualities of a race or breed by controlling mating

Section III. Uses of CRISPR

I. Use of CRISPR technology in humans shall be restricted to human gene therapy in which

somatic cells are targeted.

II. CRISPR shall not be allowed for editing human germline cells or embryos, due to

concerns including:

a. Exacerbated systemic oppression such as racism, classism, sexism, ableism, etc.

b. Wide-scale social upheaval and increase in social inequality

c. Creation of super-authorities

d. Creation of subjugated humans

e. Widespread practice of eugenics and creation of “designer babies”

f. Decreased genetic variation and resilience to diseases among future human populations

g. Complications due to interactions between genes, uncertain gene expression, and

malfunctioned CRISPR technology that may have serious unintended consequences

III. CRISPR shall be allowed for human gene therapy in somatic cells for the purposes of:

a. Reducing human suffering from disease and genetic maladies

b. Reducing the morbidity and mortality associated with disease

c. Increasing the lifespan and quality of life of human individuals

d. Providing a simple, efficient, and effective option for gene therapy treatment
Section IV. Reproductive Restrictions

I. To prevent the drastic increase of severely deleterious alleles in the population,

individuals who have undergone CRISPR therapy shall not be allowed to reproduce after

treatment.

a. This concern is substantiated by the ability of CRISPR therapy to extend the lifespan of

an individual who might not otherwise live past reproductive age.

b. Without regulation, this would increase the prevalence of current and newly created

deleterious alleles in the population, particularly if use of CRISPR increases significantly,

and therefore dramatically decrease the health of the world population.

c. Restrictions on post-treatment reproduction control for the rapid influx of deleterious

alleles in the human population.

d. Reproductive restrictions do not apply to individuals who have not yet undergone

CRISPR therapy.

II. To compensate for this requirement, individuals who have undergone CRISPR therapy

will gain expedited adoption benefits.

Benefits include:

a. Access to governmental adoption professionals for ease and help during adoption

process.

b. Priority in reading adoption paperwork.

c. Priority for the fire inspection and home study process.

d. Elimination of fees pertaining to usage of an adoption agency.

Section V.​ ​United Nations Resolution

I. The United Nations will provide an international standard regarding the usage of

CRISPR/Cas9 gene therapy.

a. There will be a new formed United Nations Committee on the Ethical Use and

Regulation of CRISPR Technology.

b. The United Nations Committee shall provide an Ethical Resolution of CRISPR/Cas9 Use

that states: the usage of CRISPR/Cas9 shall be limited to gene therapy. Uses of

CRISPR/CAS9 for uses on embryos shall be strictly prohibited. The use of CRISPR/Cas9

to make designer babies, or a super-race shall also be strictly prohibited.

c. Failure to follow the United Nations Ethical Resolution of CRISPR/Cas9 Use shall result

in review of the country’s violation by the United Nations International Court of Justice,

which is the principal judicial organ of the United Nations. The violation is also subject

to review by the Security Council, which is responsible for the maintenance of

international peace and security.

d. The United Nations International Court of Justice shall review the ethical violation, and

convene with the United Nations Committee on the Ethical Use and Regulation of

CRISPR technology, to ensure that the actions committed by the country in question are a

violation of the United Nations Ethical Resolution of CRISPR/Cas9 Use.

e. The United Nations International Court of Justice, along with the United Nations

Committee on the Ethical Use and Regulation of CRISPR Technology shall also

determine if the country’s violation requires internal control, if the country can amend
 their violations through national regulations, or if external regulations or punishment is

required, which shall be enacted through the United Nations Security Council.

f. Due to the immense threat of unethical usage of CRISPR/Cas9 technology, there is a

direct risk to international peace and security. If the United Nations International Court of

Justice and the United Nations Committee on the Ethical Use and Regulation of CRISPR

Technology determine that the country’s violation of the Ethical Resolution of

CRISPR/Cas9 Use require external control, then the United Nations Security council

shall convene and review the ethical violation of the country.

g. The United Nations Security council will determine if the violation of the resolution is an

act of aggression, or a threat to peace, and the United Nations Security Council is

responsible for determining the punishment of the country that violates the resolution

regarding ethical usage of the CRISPR/Cas9 technology. The United Nations Security

Council will also determine how the punishment or regulation is enacted.

h. Punishment of the country for violating the CRISPR/Cas9 resolution includes, but it not

limited to, suspension of the country in question from the United Nations, deployment of

United Nations peacekeeping forces, trade embargoes, or fines.

i. As seen fit by the United Nations Security Council, the cases of ethical violations may

also be referred to the International Criminal Court, which works independently of the

United Nations, and can conduct further investigation and prosecute individuals for

crimes.
Section VI. Regulation

The following regulations will solely pertain to the United States of America effective

immediately as the The Use of CRISPR/Cas9 in Humans Act of 2017 is passed by the United

Nations Congress. Because CRISPR/Cas9 is intended as a form of gene therapy, its practice and

regulation will be overseen by the Food and Drug Administration as per usual in the case of new

medicines and treatments:

I. Receiving permission to use the CRISPR/Cas9 technology for research on therapeutic

purposes or for therapy:

a. The interested party must apply for permission to the Food and Drug Administration.

b. The applicant must have a P.h.D. in the biological sciences, M.D. D.O. or D.D.S. and be

associated with a public institution (university, college, laboratory, or hospital) to qualify

for application.

c. Once given permission, the Food and Drug Administration provides a procedure in which

the applicant studies the ethical implications and safe practice of CRISPR/Cas9

technology.

d. After the completion of the program, the Food and Drug Administration will award a

certificate that approves the applicant’s proposed use of CRISPR/Cas9 for therapeutic

research or therapeutic treatment.

II. CRISPR/Cas9 technology availability will be limited to public institutions (university,

college, laboratory, or hospital) that have the responsibility to submit progression records

on a yearly basis to the Food and Drug Administration.

III. Legal possession of CRISPR/Cas9 technology

 a. The CRISPR/Cas9 technology possession will be limited to the approved public research

institutions, which are defined as public universities, federally owned laboratories, or

public hospitals that have at least one team of researchers certified by the FDA.

IV. Records of CRISPR/Cas9 therapy:

a. This section pertains to the strict use of CRISPR/Cas9 as therapy provided in a hospital

setting by a CRISPR/Cas9 certified doctor.

b. The doctor using CRISPR/Cas9 as gene therapy is obligated by law to record the

treatment in the patient’s permanent medical records. Failure to do so will result in

revocation of the certificate and a ban for reapplication for five years.

c. I​ n the case of patients (either biological parents) who had CRISPR/Cas9 therapy and are

expecting a baby, the federal government will subsidize the abortion of the fetus as far in

the pregnancy as the last day of week 27 (second trimester). In the case of a pregnancy

further than 27 weeks, the government will take the parents into custody, and place the

child in the foster care system, upon birth. The parents will be punished according to

Section VIII of the The Use of CRISPR/Cas9 in Humans Act of 2017.

V. Accessibility to CRISPR/Cas9 therapy:

a. The federal government will subsidize the therapeutic use of CRISPR/Cas9 to make it

more equitable to United States residents by adopting it on the same status as dialysis.

VI. Funding for Research

a. The funding source for CRISPR research efforts will be provided out of the federal

research budget in the form of government grants awarded by the National Institutes of

Health (NIH), National Science Foundation, or other federally funded sources.

Section VII. Penalties and Enforcement

It shall be a federal offense:

I. To possess CRISPR gene-editing technology in the absence of a license and FDA

approval.

II. To have a child if you or the child’s other genetic parent has undergone CRISPR

technology.

III. To utilize CRISPR gene-editing technology in any ways that go against Section III of this

law.

Peoples who violate parts I-III of Section VIII of this law must see penalties as distributed by

authorities of their nation of residence.

Section VIII. Amendments

Amendments can be added to the The Use of CRISPR/Cas9 in Humans Act of 2017 according to

the amending procedure outline in the United States Constitution:

I. Amendments may be proposed by Congress with a two-thirds majority vote in either

Chamber of Congress or by a constitutional convention called for two-thirds of State

legislatures.

II. This law shall be reviewed and amended as seen fit every five years from the date of

enactment in Congress based on the new information.

Section X. Effective Date

This Act shall become effective immediately enactment, except (a) that the UN may extend

the delay in effective date of any provision of this Act up to sixty days thereafter if they

find that such time is necessary in permitting adjustments to the provisions hereof, and (b)

that on or after the date of enactment the UN is authorized to issue such rules and

regulations as may be necessary to carry out its provisions.

Date of Publication: December 14, 2017

Signed:

Dua Khan- ​Genetics Consultant

Sophia Orlando- Ethics Consultant
Silvia-Antonia Rus- M.D. Consultant
Sarina Sandhu- President of the United States
Stephanie Wu- United Nations Representative
References:

1. Statement on NIH funding of research using gene-editing technologies in human

embryos. (2015, August 28). Retrieved December 04, 2017, from
https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-fundin
g-research-using-gene-editing-technologies-human-embryos
2. "Therapeutic." Merriam-Webster.com. Merriam-Webster, n.d. Web. 5 Dec. 2017.
3. US Government. “Executive Order 13435—Expanding Approved Stem Cell Lines in
Ethically Responsible Ways.” Federal Register: (2007) 34951-53.
http://edocket.access.gpo.gov/2007/pdf/07-3112.pdf​ (Accessed November 9, 2009).
4. Brunham, L., & Hayden, M. (2017). ​Hunting human disease genes: lessons from the past,
challenges for the future.​ Retrieved 10 December 2017, from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3654184/
5. "Constitutional Amendment Process." National Archives, 2017,
https://www.archives.gov/federal-register/constitution​.
6. International Classification of Diseases. (2016). Retrieved December 4, 2017, from
http://www.who.int/classifications/icd/en/
7. http://www.ejil.org/pdfs/16/5/329.pdf
8. When a Country Breaches International Human Rights Law. (n.d.). Retrieved December
10, 2017, from
http://www.abouthumanrights.co.uk/when-country-breaches-international-human-rights-l
aw.html
9. https://www.genome.gov/10004764/
Sarina Sandhu, Sophia Orlando, Dua Khan, Stephanie Wu, Silvia-Antonia Rus
Honors 220, Medical Ethics
CRISPR law

You are to write legislation, The CRISPR Law that serves to regulate, prohibit, or
declare CRISPR ​res judicata​. (a done deal, not matter of law)

The components are:

A ​Preamble​: State the over-all supposition -- the basis for the need for the legislation

An ​introduction:

● State the background of the issue

● Define the scope of the law (broadly)
● List the assumption of fact
● Declare the policy -- the moral and ethical arguments for the legislation ​(this
is the equivalent of the papers that you have written)

The Law​ This is the main body of the document. It may be written formally -- complete
with Whereas and Therefore, but that is not necessary. You will find this to be the most
difficult part of the project, actually declaring what is legal.

The References ​No particular format, but we have time to check them, so be complete.

Optionally​, you might consider stating the type of regulation that you propose and how
it would be enforced. The latter would describe what body would govern the regulations
and how. For example, NIH, NSF, EPA, CDC, CIA... FSB.... You could consider
whether you are writing restrictions (perhaps on activities, funding, or resource access)
or whether you are writing a civil or criminal law. While this is not a civics course, this is
an interesting exercise in understanding the role of ethics in medicine and clinical
research.

Ethic​: There are more risks than benefits to using CRISPR therapy in embryos.
We are trying to prevent the propagation of diseased alleles throughout the population. We are
thinking about this from a population genetics/public health perspective.

CRISPR should only be used as for therapeutic purposes. As a method of gene therapy,
CRISPR has the potential to save significant numbers of lives, but the risks of CRISPR-related
heritable change outweigh the benefits.

There is a concern that CRISPR will develop a new race of humans

Look at executive order BUsh made (Bush 2, executive number 1), look for ethic in first
paragraph
Bush’s Executive Order 13435: ​https://www.gpo.gov/fdsys/pkg/FR-2007-06-22/pdf/07-3112.pdf
Revenge porn law - criminalizes net activity:

Human embryonic research is bad because…

If you do this we will…

Questions for Moon: Does our law have to be comprehensive?

Assumption of law= ethic (stated)

IVF- screening for babies (selective)

- Not banning genotype on babies
- How will we know if the babies have CRISPR used on them

CRISPR is allowed for therapeutic uses only. If CRISPR is done, the person cannot have
biological children.
But they can have special adoption rights.

No embryos
Therapeutic usage (non-germ line, non-embryonic)
Using embryonic stem cells, but not for another organism

Sickle cell anemia- usually die before kids (cystic fibrosis)

- Limit kids, if we do CRISPR (can’t have kids)

Definition of therapeutic: ​of or relating to the treatment of disease or disorders by remedial

agents or methods
Definition of disease

Regulations:
 - Ensure all those who are given permission to use CRISPR technology have passed
certification requirements and are accredited a CRISPR licence from a national
accreditation board
- Only allow CRISPR by public institutions
- Limit legal possession of CRISPR technology to specific established laboratories (maybe
government labs?) that have FDA approval to use the technology
- Criminal offense for possession of CRISPR gene-editing technology in the absence of a
license and FDA approval
- Prevent plasmid from being distributed
- Criminal offense for having a child if you or the child’s other genetic parent has had
CRISPR technology. Child is placed in the care of the state.
- Or lose health insurance?
- Carried out by local authorities?
- If you are pregnant and you or the fetus’s other genetic parent has had CRISPR
technology, you must have an abortion. Failure to do so results in a criminal punishment
and removal of the child from your care.
-

Resources
Comprehensive recommendations on gene editing:
http://nationalacademies.org/cs/groups/genesite/documents/webpage/gene_177260.pdf

https://www.washingtonpost.com/news/speaking-of-science/wp/2017/02/14/ethicists-advise-caut
ion-in-applying-crispr-gene-editing-to-humans/?utm_term=.565cc90ed0d3

More gene editing:

https://www.genome.gov/10004764/
https://www.wired.com/2015/07/crispr-dna-editing-2/

"Therapeutic." Merriam-Webster.com. Merriam-Webster, n.d. Web. 5 Dec. 2017.

Ethics of designer babies:

https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen

CRISPR benefits:
- Reverse mutations that cause blindness
- Stop cancer cells from multiplying
- Make cells immune to developing AIDS

Dangers of Using CRISPR in embryos:

● Deleterious alleles
 ● “Consumer eugenics”
● A single point mutation can cause terrible and debilitating diseases including
Huntington’s and sickle cell anemia. CRISPR could cause similar mutations. CRISPR
may not always work correction and may result in serious errors
● Only the wealthy could afford the procedure- those who can’t would be deemed “lesser”
humans; well-off exploit technologies that make them even better off, while world’s poor
have even worse health status; increased wealth inequality with and between societies
and more social instability
● Heritable changes in the human population
● Stigmatizing those with disabilities - social consequences and threat to wellbeing of
people
● Difficult, expensive, and uncertain way to achieve what can mostly be achieved in other
ways, through selection of an embryo that has or lacks the gene in question
● Using genes to predict what kind of person an embryo will be is really complicated (DNA
isn’t destiny). Environmental factors are just as important. And interactions between
genes and uncertain gene expression will have much more serious consequences when
used on embryos, because the person who will ultimately have to live with those
consequences will not have been the one who made the decision
● We only have limited knowledge of the multiple functions of genes right now, so
correction of a “diseased” gene in future generations could have consequences we
haven’t considered

Other CRISPR concerns:

- Gene modification in body cells can inadvertently lead to germline gene transfer:
- Transfection may transfer the modified gene to a germline cell
- Using CRISPR for “enhancement” rather than treating disease
- Informed consent issues with children
- Subjugated populations (clones for organ harvesting)

Other Notes

Currently, the process of developing human trials for cosmetic CRISPR experiments is illegal
What about gene therapy?
Why would editing embryos be more beneficial than doing the same thing in an adult?
- Most hereditary diseases manifest during early development phases, so editing embryos
or germ-line therapy is more efficient and simpler than somatic gene therapies which
may have to reach billions of cells
(​https://www.gesundheitsindustrie-bw.de/en/article/news/call-for-a-moratorium-on-germ-li
ne-experiments-in-humans/​)
“Germline” cells
Moratorium forever? Or until more discussion on the experimental, ethical, and legal aspects of
it has occured?
We recognize the benefits of using CRISPR to fix diseases, and thus we think that its practice
shall be allowed only for therapeutic purposes in which somatic cells are targeted. CRISPR shall
not be allowed for editing germline cells for that could lead to deleterious changes being added
to and transmitted to future generations, as well as it could lead to an exacerbation of systemic
racism, classism, sexism, and to the practice of eugenics. Furthermore, to avoid the risk of
affecting the germline through “CRISPR therapy” and pass that change onto the offspring, we
enforce that people who had undergone the procedure should not have biological children.
Possible ideas of punishing the breaking of the law:
● Parent should be jailed and child placed for adoption
○ What about the parent who had no CRISPR done?
■ Could they care for the child while the other parent is away?
● Parent should lose health insurance and government benefits

What if they have IVF done to make sure that their children do not have the CRISPR’ed gene?
-how ethical would such a practice be?

Approaches include replacing a mutated gene that causes disease with a healthy copy 
of the gene, inactivating, or “knocking out,” a mutated gene that is functioning 
improperly, introducing a new gene into the body to help fight a disease. 

Sterilization info:
- Sterilization is the most common form of contraception in the United States when female and
male usage is combined.
- 16.7% of women aged 15–44 used female sterilization as a method of contraception in
2006–2008
- 59% of women with three or more children used female sterilization
- Compulsory sterilization - governmental policies put in place as a form of eugenics
- UN joint statement on eliminating forced, coercive, and otherwise involuntary sterilization
- Sterilized populations include women, people with disabilities, intersex persons, and
transgender persons

Tuesday Presentation
Our law states that CRISPR shall not be allowed for editing germline cells in humans.
Germline cells pass on genetic material to their progeny and include sperm, eggs and
gametes. This would therefore prohibit the use of CRISPR on embryos as well.
Expedited adoption process. More adoption of kids with disabilities and deformities in
orphanages
Federal law
Redundancy- include embryos part
Get rid of sperm, egg gamete part
“Disease states” - if want to remove, must remove germ-line cells
Gene drive
What about things that aren’t genetic predispositions?
May not be able to treat single point mutation diseases such as sickle cell anemia
Create a draft. Read the preamble and seven or eight bullet point summaries (like a
memo).
Parallel: diabetes who receive insulin cannot have children
Definition of disease and delineate what causes disease - already diagnosed or just
predispositions? CDC and DSM-V
Internally regulated
Can undo CRISPR treatment

This law avoids two dangerous uses of CRISPR. First, it prevents the creation of
“designer babies”. The creation of genetically crafted infants could lead to a superior
race of humans, “consumer eugenics,” or unexpected deleterious mutations. This way
of altering the genome could also lead to an exacerbation of systemic racism, classism
and sexism. Further, if the procedure was only accessible to those who were well-off,
then wealth and health inequalities would increase and result in more social instability.
 The Use of CRISPR/Cas9 in Humans Act of 2017

Preamble
Genome editing is a rapidly growing field of research that has the potential for
extraordinary medical improvements as well as immense harm. It is unethical to ignore
the potential for CRISPR/Cas 9 to dramatically improve the life quality of human
individuals. It is also unethical to allow for uses of CRISPR/Cas 9 that may jeopardize
the health and wellbeing of future generations. Therefore, international legislation
regarding the use of CRISPR-cas 9 technology in humans is necessary to ensure its
use occurs in a way that balances risks and benefits and mitigates negative
consequences.

Introduction
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)
technology is a targeted gene editing platform. This law aims to balance the relief of
human suffering from disease and genetic maladies made possible by CRISPR
technology against the potential for negative effects. Thus its practice shall only be
regulated for human gene therapy in which somatic cells are targeted.
According to the National Institutes of Health, gene therapy is defined as a
technique that is “designed to introduce genetic material into cells to compensate for
abnormal genes or to make a beneficial protein”. This law defines abnormal genes as
those that directly lead to an active disease state. There must be a statistically
significant correlation between a gene sequence and disease outcome as determined
through genome-wide association studies, which use a p value threshold of 5 × 10​-8
(GWAS). Furthermore, the disease must be included within the 10th version of the
World Health Organization’s International Classification of Diseases (ICD-10). Both of
these conditions must be met in order for CRISPR technology to be applied as gene
therapy for a particular disease state.
The following law includes a United Nations binding resolution that will be
effective immediately after enactment. This resolution falls under the jurisdiction of a
newly formed United Nations Committee on the Ethical Use and Regulation of CRISPR
Technology. Implementation of this resolution will be determined independently by each
sovereign nation member of the United Nations. The law that follows includes an outline
of this resolution as well as regulations for CRISPR use in the United States of America.
CRISPR shall not be allowed for editing human germline cells or embryos. Using
CRISPR technology to create heritable changes in the human genome, including the
creation of designer babies, may result in serious potential consequences in the form of
exacerbating systemic oppression, enabling the creation of super-authorities, enabling
the creation of subjugated humans, and widespread practice of eugenics.
People who have undergone CRISPR therapy shall not be allowed to reproduce
after treatment, but will gain expedited adoption benefits. CRISPR therapy can extend
the lifespan of an individual who might not otherwise live past reproductive age. Without
regulation, this would increase the prevalence of current and newly created severely
deleterious alleles in the population and undermine the health and wellbeing of future
generations.

The Law
Section I. Name of Law
Section II. Definitions
- Gene therapy: a medical treatment that uses genetic material to treat and
prevent diseases.
- Approaches include replacing a mutated gene that causes disease with a
healthy copy of the gene, inactivating, or “knocking out,” a mutated gene
that is functioning improperly and introducing a new gene into the body to
help fight a disease.
- Disease: those formally listed by the 10th version of the World Health
Organization’s International Classification of Diseases (ICD-10).
- Eugenics: improving hereditary qualities of a race or breed by controlling mating
Section III. Uses of CRISPR
- Use of CRISPR technology in humans shall be restricted to human gene therapy
in which somatic cells are targeted.
- CRISPR shall not be allowed for editing human germline cells or embryos, due to
concerns including:
- Exacerbated systemic oppression such as racism, classism, sexism,
ableism, etc.
- Wide-scale social upheaval and increase in social inequality
- Creation of super-authorities
- Creation of subjugated humans
- Widespread practice of eugenics and creation of “designer babies”
- Decreased genetic variation and resilience to diseases among future
human populations
 - Complications due to interactions between genes, uncertain gene
expression, and malfunctioned CRISPR technology that may have serious
unintended consequences
- CRISPR shall be allowed for human gene therapy in somatic cells for the
purposes of:
- Reducing human suffering from disease and genetic maladies
- Reducing the morbidity and mortality associated with diseases
- Increasing the lifespan and quality of life of human individuals
- Providing a simple, efficient, and effective option for gene therapy
treatment
Section IV. Reproduction
- CRISPR therapy can extend the lifespan of an individual who might not otherwise
live past reproductive age. Without regulation, this would increase the prevalence
of current and newly created severely deleterious alleles in the population,
especially if use of CRISPR increases significantly, and therefore dramatically
decrease the health of the world population.
- To prevent the drastic increase of severely deleterious alleles in the population,
people who have undergone CRISPR therapy shall not be allowed to reproduce
after treatment.
- To compensate for this requirement, individuals who have undergone CRISPR
therapy will gain expedited adoption benefits
Section V. Research
- CRISPR gene therapy must undergo FDA approval procedures for each
proposed disease treatment
Section VI. United Nations Resolution
Section VII. Regulation
- All those who are given permission to use CRISPR technology must pass
certification requirements and are accredited a CRISPR licence from a national
accreditation board
- Only allow CRISPR by public institutions
- Limit legal possession of CRISPR technology to specific established laboratories
(maybe government labs?) that have FDA approval to use the technology
- Prevent plasmid from being distributed
- If you are pregnant and you or the fetus’s other genetic parent has had CRISPR
technology, you must have an abortion. Failure to do so results in a criminal
punishment and removal of the child from your care.
- The federal government will subsidize the therapeutic use of CRISPR to make
access more equitable
Section VIII. Penalties and Enforcement
 It shall be unlawful:
(1) 1To possess CRISPR gene-editing technology in the absence of a license and
FDA approval
(2) To have a child if you or the child’s other genetic parent has undergone CRISPR
technology
(3) To utilize CRISPR gene-editing technology in any ways that go against Section
III of this law
Peoples who violate parts 1-3 of Section VIII of this law must see penalties as
distributed by local authorities

Section IX. Amendments

- This law will be reviewed and amended as seen fit after every five years after the
date this law is enacted.

http://www.who.int/classifications/icd/en/
https://www.eeoc.gov//laws/statutes/adea.cfm

References:

10. Statement on NIH funding of research using gene-editing technologies in human

embryos. (2015, August 28). Retrieved December 04, 2017, from
https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-
funding-research-using-gene-editing-technologies-human-embryos
11. "Therapeutic." Merriam-Webster.com. Merriam-Webster, n.d. Web. 5 Dec. 2017.
12. US Government. “Executive Order 13435—Expanding Approved Stem Cell Lines in Ethically
Responsible Ways.” Federal Register: (2007) 34951-53.
http://edocket.access.gpo.gov/2007/pdf/07-3112.pdf​ (Accessed November 9, 2009).
13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3654184/
14. "Constitutional Amendment Process." National Archives, 2017,
https://www.archives.gov/federal-register/constitution.

Feedback from Tuesday:

● Make our own definition of therapeutic and of diseases
● Make 7 or 8 bullet point summary of law to present on thursday (present like a memo)
● Other medical treatments where you can still have kids
Why international vs national:
- No weaponization in other countries - arms race

What happens if someone lied to you about having CRISPR and you have a child

Honors 220, Medical Ethics

Rice CRISPR Treats

Sarina Sandhu, Sophia Orlando, Dua Khan, Stephanie Wu, Silvia-Antonia Rus

● The use of CRISPR technology in humans shall be restricted to human gene

therapy in which somatic cells are targeted.
○ As defined by the NIH, gene therapy is a medical treatment that uses
genetic material to treat and prevent diseases. Diseases covered by this
law are formally defined as those listed by the Center for Disease Control
and Prevention’s A-Z index of diseases and conditions.
● CRISPR shall not be allowed for editing human germline cells or embryos.
○ Risks of CRISPR-enabled heritable change include exacerbated systemic
oppression, increased social instability, creation of super-races, creation
of subjugated humans, and widespread practice of eugenics.
 ○ Complications due to interactions between genes, uncertain gene
expression, and malfunctioned CRISPR technology have serious
unintended consequences when used on embryos
● To prevent the drastic increase of current and novel severely deleterious alleles
in the population, people who have undergone CRISPR therapy shall not be
allowed to reproduce after treatment. Violating said law will be a criminal offense,
punishable by imprisonment.
○ People who have undergone CRISPR therapy will gain expedited adoption
benefits.
● This law falls under the jurisdiction of a newly formed United Nations Committee
on the Ethical Use and Regulation of CRISPR Technology. Enforcement and
regulation of the law will be delegated to sovereign nations.
● In the United States, CRISPR technology may only be employed by public
institutions that have passed certification requirements and are accredited a
CRISPR licence from a national accreditation board. It will be a criminal offense
to possess CRISPR technology without a licence.
● CRISPR therapy will be subsidized by the federal government.

Sarina: CRISPR gene-editing technology has the potential to create extraordinary

change in the human genome. It has the power to reduce suffering and improve the
lives of millions across the world. It also has the power to create devastating effects by
exacerbating systemic oppression, enabling the creation of super-races, enabling the
creation of subjugated humans, and widespread practice of eugenics.

Sophia: It is unethical to ignore the potential for CRISPR/Cas 9 to dramatically improve

the life quality of human individuals. It is also unethical to allow for uses of CRISPR/Cas
9 that may lead to wide-scale social upheaval, jeopardize the health and wellbeing of
future human populations, and decrease genetic variation and resilience to diseases
among future generations. Complications due to malfunctioned CRISPR technology and
unregulated usage of CRISPR can also introduce deleterious mutations into the
population, particularly if use of CRISPR increases significantly, and this may
dramatically decrease the health of the world population. This law aims to reduce the
potential for these negative effects while using the technologies at our disposal to
relieve human suffering from disease and genetic maladies.

Dua: Given those goals, we have decided that the use of CRISPR technology in
humans shall be restricted to human gene therapy in which somatic cells are targeted.
Gene therapy is defined as a medical treatment that uses genetic material to treat and
prevent diseases. Diseases covered by this law are formally defined as those listed by
the Center for Disease Control and Prevention’s A-Z index of diseases and conditions.
CRISPR shall not be allowed for editing human germline cells or embryos.

Stephanie: To prevent the drastic increase of current and novel severely deleterious
alleles in the population, people who have undergone CRISPR therapy shall not be
allowed to reproduce after treatment. Violating said law will be a criminal offense,
punishable by imprisonment. To compensate for this requirement, individuals who have
undergone CRISPR therapy will gain expedited adoption benefits.

Antonia: This law falls under the jurisdiction of a newly formed United Nations
Committee on the Ethical Use and Regulation of CRISPR Technology that is
responsible for enforcing international standards for ethical use of CRISPR.
Enforcement and regulation of the law will be delegated to sovereign nations. In the
United States of America, CRISPR technology will only be available for clinical use in
humans by public institutions that have passed certification requirements and are
accredited a CRISPR licence from a national accreditation board. It will be a criminal
offense to possess CRISPR technology without such a licence. The federal government
will subsidize the therapeutic use of CRISPR to make access more equitable.