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Should We Lift the 14 Day Limit? The Pros and Cons of this Controversial Question

There are days where the world feels like it is moving faster than ever. New, inspired technology is announced daily and once far fetched ideas are suddenly becoming reality. Nowhere is this more apparent than in the medical world. Innovative research studies across all fields of medicine are giving us better insight into the complex puzzle that is the human body. But, these studies also tend to generate more questions than answers. This is especially true for embryogenesis, or the study of embryo development.

April 19, 2021
Nora Tomer

There are days where the world feels like it is moving faster than ever. New, inspired technology is announced daily and once far fetched ideas are suddenly becoming reality. Nowhere is this more apparent than in the medical world. Innovative research studies across all fields of medicine are giving us better insight into the complex puzzle that is the human body. But, these studies also tend to generate more questions than answers. This is especially true for embryogenesis, or the study of embryo development. 

For decades, scientists have been forced to adhere to a strict 14 day rule when it comes to using in vitro zygotes for experimentation. However, there has recently been a call for the lifting of these restrictions. Some researchers believe that studying embryos beyond the 14 day mark may lead to the answers they have been seeking for years.

What is The 14 Day Rule?

The 14 day rule is a national and international law stating that laboratory embryos may not be experimented on or kept viable without implantation beyond 14 days. 

Day 14 of zygote development was chosen as the cutoff date as it is when the primitive streak emerges. The primitive streak is a thick line that appears along the zygote, running from bottom to top. Its presence indicates the beginning of radical growth, including the establishment of bilateral symmetry, gastrulation, and new tissue layers. It also marks the time when a cell can no longer divide into identical embryos. Day 14 is also significant as it is the last day when an embryo is able to be implanted.

A woman stands in a science lab with her back to the viewer. She wears a white lab coat and has her hair pulled back into a ponytail. She is surrounded by beakers, vials, bottles, and other instruments.
In the past, keeping an embryo viable in a lab for 14 days was unthinkable. Now, scientists are looking to push the boundaries. 

Where Did The Rule Come From?

The 14 day rule was created in the 1970s during a series of scientific discussions regarding bioethics. At the time, in vitro fertilization was transitioning from the world of science fiction to fact. 1978 would see the first successful IVF conception and birth, introducing a new slew of questions surrounding the ethicality of embryonic experimentation. 

The first official declaration of the 14 day experimentation limit came in 1979 from the Ethics Advisory Board, once a section of the United States Department of Health Education and Welfare. The Committee of Inquiry Into Human Fertilisation and Embryology, a UK organization later referred to as the Warnock Committee, also convened in 1982 to further discuss the future ethics of embryonic experimentation. In a document known as The Warnock Report, they also recommended strict adherence to a 14 day limit. From there, lawmakers across the globe followed suit, many making experimentation on a zygote beyond 14 days a criminal offense.

At the time, they never could have imagined how far and how fast science would advance. Keeping an embryo workable in a lab for more than 14 days sounded like a far off dream. But, those far off possibilities are now hurtling toward us as medical science continues to advance. New questions about infertility, ectogenesis, and embryonic development has brought more researchers forward to advocate for a revision of the 14 day limit.

The Report

Published in Science Magazine, a group of researchers from Case Western Reserve, including lead writer and bioethics professor Dr. Insoo Hyun, has called for the 14 day embryo rule to be reassessed by the International Society for Stem Cell Research. The researchers argue that by experimenting on zygotes over 14 days old, scientists will be able to gather new data on the early developmental period. And while the paper is in favor of reevaluating the 14 day limit, it also calls for meticulous standards when it comes to determining if an experiment using human embryos is justified. Six principles, including regular embryo evaluation and constant peer reviewing, have been proposed by the researchers.

Dr. Hyun and his colleagues’ proposal is not the first of its kind. In fact, there has been a call for a change for the 14 day limit for several years now. Some have suggested the new limit go as high as 28 days, but they are not without opposition.

A close up of a person looking into the eye piece of a microscope. They wear safety goggles and a white medical mask.
Altering the 14 day rule could give us greater insight into early human development.

Common Arguments

The suggestion of reevaluating the 14 day rule has led to strong opinions from both supporters and detractors. These voices come from the scientific community, ethicists, and the public alike. 

With so many contributors to the conversation, it can be hard to weigh the pros and the cons of lifting the 14 day limit. But, to give you a helping hand, here is a quick rundown of the main arguments made by those in favor and those opposed.

In Favor

  • Referred to as the “black box” of human development, the 14-28 day period of zygote growth is notoriously difficult to study and remains largely a mystery. Extending the 14 day limit would allow for better study of this period.
  • It would lead to further development of IVF processes, moving toward greater success rates in conception, implantation, and birth.
  • There would be greater insight into the development of early tissues and the primitive nervous system.

Opposed

  • Some groups argue that gastrulation (when a single layer cell becomes multilayered and happens at 14 days) is when the first example of individuality in a body begins. 
  • There is a misconception that the primitive streak is an indicator of an embryo beginning to have sensory awareness. This argument is often used by those against experimentation beyond 14 days, despite it being untrue. Even by the 28 day mark, embryos have no neural connections and therefore no ways of experiencing pain or pleasure.
  • By going lax on the 14 day rule, more and more extensions on how long an embryo may be experimented on will be accepted.
Two people sit at a glass table by large windows and a sliding glass door. They are both wearing medical uniforms, including scrubs, lab coats, stethoscopes, and hair coverings. One works on the computer while the other uses a tablet. There is a blood pressure cuff on the table in front of them.The two people are looking at each other in conversation.
With discussions only just beginning, it may be some before we see any definite action regarding the 14 day limit.

Moving Forward

While many scientists are in favor of adjusting the 14 day limit, including well known IVF specialist Simon Fishcel who claims, “...extend[ing] the limit for embryo research to around 28 days would transform our understanding of ourselves…,” it is clear that this will be no easy decision for medical groups. Thorough and open discussions between many different disciplines must be conducted in order to fully understand the risks and rewards of such an endeavor.

As scientific and medical advancements continue, there also comes a necessary reevaluation of our scientific principles and ethics. We are barreling toward a future many of us never thought we would see in our lifetime and in order to meet it with our best foot forward we must ask the questions without easy answers. And while this is easier said than done, it is our best way of ensuring a better tomorrow.

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