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 

 

 

 



   󰜚

           





            





             













            

󰜚





www.amajournalofethics.org

1056

AMA Journal of Ethics

December 2019, Volume 21, Number 12: E1056-1058

AMA CODE SAYS

AMA Policies and

Code of Medical Ethics

’ Opinions Related to Human Genome

Editing

Abigail Scheper

Abstract

Recent research using gene editing technologies has made such tools

more accessible and easier to use, fueling the promise of their

therapeutic capacity. However, development of gene editing tools

reminds professionals and the public that these technologies’ potential

use extends beyond treating somatic disease to germline editing, with

consequences yet unknown. This article canvasses AMA

Code of Medical

Ethics

’ opinions and policies relevant to gene editing.

Innovation

According to Opinion 1.2.11 of the American Medical Association (AMA)

Code of Medical

Ethics

, “Ethically Sound Innovation in Medical Practice,” innovative treatments and

technologies incur special responsibilities for the medical professionals who develop or

adopt them in practice.

Specifically, the AMA

Code

recommends that innovations be

designed “so as to minimize risks to individual patients and maximize the likelihood of

application and benefit for populations of patients” and with “aware[ness] of influences

that may drive the creation and adoption of innovative practices for reasons other than

patient or public benefit.”

This opinion emphasizes the need for foresight with regard to

potential consequences of innovation

. In the context of gene editing, then, physicians

motivating genetic innovations should consider how gene editing might be applied

therapeutically while keeping in mind that this technology could be used for purposes

other than treating diseases, such as to create “designer babies” or for human

enhancement.

Additionally, physicians who use new or changing innovations in their practice should

engage in active and transparent conversation with other physicians about both positive

and negative outcomes “to promote patient safety and quality.”

In general, physicians

should encourage dialogue within the medical community about new ideas, as other

physicians might have valuable insights about outcomes or the resources needed for

effective use of therapies.

Research in Gene Editing

Opinion 7.3.6, “Research in Gene Therapy and Genetic Engineering,” addresses ethical

questions about gene editing directly.

The AMA

Code

reaffirms medicine’s focus on

beneficence in the use of new genetic technologies by stating the following:

AMA Journal of Ethics

, December 2019

1057

In medicine, the goal of gene therapy and genetic engineering is to alleviate human suffering and disease. As

with all therapies, this goal should be pursued only within the ethical traditions of the profession, which

gives primacy to the welfare of the patient.

In general, genetic manipulation should be reserved for therapeutic purposes. Efforts to enhance “desirable”

characteristics or to “improve” complex human traits are contrary to the ethical tradition of medicine.

Because of the potential for abuse, genetic manipulation of nondisease traits or the eugenic development of

offspring may never be justifiable.

Physicians are limited to using clinical applications that will benefit their patients and are

expected to exercise caution in using these technologies.

The AMA

Code

also addresses the extension of gene editing from somatic to germline

interventions:

Moreover, genetic manipulation can carry risks to both the individuals into whom modified genetic material

is introduced and to future generations. Somatic cell gene therapy targets nongerm cells and thus does not

carry risk to future generations. Germ-line therapy, in which a genetic modification is introduced into the

genome of human gametes or their precursors, is intended to result in the expression of the modified gene in

the recipient’s offspring and subsequent generations. Germ-line therapy thus may be associated with

increased risk and the possibility of unpredictable and irreversible results that adversely affect the welfare of

subsequent generations.

Thus in addition to fundamental ethical requirements for the appropriate conduct of research with human

participants, research in gene therapy or genetic engineering must put in place additional safeguards to

vigorously protect the safety and well-being of participants and future generations.

This opinion serves as a kind of checkpoint or safeguard by reminding physicians of

unique, long-term considerations attached to germline editing, and it details conditions

under which gene-based research using human subjects is ethically permissible,

including restriction of research

to somatic cell interventions.

Personalized Medicine

Other AMA

Code

opinions and House policy complement the guidance outlined in Opinion

7.3.6. In H-460.908, “Genomic-Based Personalized Medicine,” the AMA addresses the

growth of gene-based interventions and their social, ethical, and legal implications.

Furthermore, the AMA notes the importance of genetic discrimination in H-65.969,

“Genetic Discrimination and the Genetic Information Nondiscrimination Act.”

Opinion

4.1.2, “Genetic Testing for Reproductive Decision Making,” underscores the importance

of informed consent and respecting patients’ autonomy

in decisions related to

interventions, such as genetic screening, and above all aims to protect those choosing to

utilize genetic technology.

References

1. American Medical Association. Opinion 1.2.11 Ethically sound innovation in

medical practice.

Code of Medical Ethics

. https://www.ama-assn.org/delivering-

www.amajournalofethics.org

1058

care/ethics/ethically-sound-innovation-medical-practice. Accessed May 24,

2019.

2. American Medical Association. Opinion 7.3.6 Research in gene therapy and

genetic engineering.

Code of Medical Ethics

. https://www.ama-

assn.org/delivering-care/ethics/research-gene-therapy-genetic-engineering.

Accessed May 24, 2019.

3. American Medical Association. Genomic-based personalized medicine H-

460.908.

https://policysearch.ama-

assn.org/policyfinder/detail/h%20460.908?uri=%2FAMADoc%2FHOD.xml-0-

4156.xml. Accessed May 24, 2019.

4. American Medical Association. Genetic discrimination and the Genetic

Information Nondiscrimination Act H-65.969.

https://policysearch.ama-

assn.org/policyfinder/detail/H-65.969?uri=%2FAMADoc%2FHOD.xml-0-

5098.xml. Accessed May 24, 2019.

5. American Medical Association. Opinion 4.1.2 Genetic testing for reproductive

decision making.

Code of Medical Ethics

. https://www.ama-assn.org/delivering-

care/ethics/genetic-testing-reproductive-decision-making. Accessed May 24,

2019.

Abigail Scheper

is a fourth-year undergraduate at North Carolina State University in

Raleigh, where she is pursuing a degree in philosophy with a concentration in law and

minors in genetics, bioethics, and art and design. During the summer of 2019, she was

an intern for the American Medical Association’s Ethics Group, in which capacity she

completed various projects for the Council on Ethical and Judicial Affairs and the

AMA

Journal of Ethics

. After completing her bachelor’s degree, she plans to attend law school

and specialize in health policy and the intersections of science and the law.

Citation

AMA J Ethics

. 2019;21(12):E1056-1058.

DOI

10.1001/amajethics.2019.1056.

Conflict of Interest Disclosure

The author(s) had no conflicts of interest to disclose.

The viewpoints expressed in this article are those of the author(s) and do not

necessarily reflect the views and policies of the AMA.

ISSN 2376-6980