Science Policy For All

Because science policy affects everyone.

Science Policy Around the Web – May 24, 2016

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By: Allison Burrell, MS, MPhil

photo credit: koya979/Shutterstock

Human Development

Embryology policy: Revisit the 14-day rule

Human developmental biology is at a crossroads. Recently, two labs reported a breakthrough that advances the field of embryology, but ushers in ethical and legal quandaries. Human embryos were grown in vitro for 12-13 days, well beyond the previous 9-day record and nearly double the typical 7-day survival. In vitro research uses cells outside their normal environment. Currently the regulatory and legal statute, going back decades, limits in vitro human-embryonic research to 2 weeks. Also known as the 14-day rule, this regulation is based upon a delineation in development called the ‘primitive streak’ that occurs after the first 14 days after fertilization. Following the formation of this streak, the embryo loses its ability to split into two independent embryos, thus solidifying its status as a biological individual; although, in vivo this also represents the completion of implantation. In vivo means within the organism, and in this context refers to an embryo naturally growing inside a woman’s womb. However, in the lab when culturing embryos in vitro, implantation does not occur, whereas in vivo embryogenesis implantation into the placenta would occur after the 14-day mark. Therefore, since these experiments are completed in vitro the 14-day rule shouldn’t be considered the boundary when moral status begins, and legal research tissue ends. Now, with the impetus of researchers forging past this so-called ‘line in developmental sand,’ regulators must reevaluate the limit.

First suggested in 1979, by the US Department of Health’s Ethics Advisory Board, the 14-day limit is now law in at least 12 countries, and referenced in numerous other reports and guidelines related to embryonic research throughout the world. With re-evaluation of the limit on the table, this could conjure up philosophical and ethical debates. It must be firmly stated that the 14-day rule is a policy tool, written to ensure a figurative space for embryonic research in a pluralistic society.

One could argue that the rules should not necessarily be changed just because researchers are now able to grow embryos beyond the 14-day boundary. It was initially created not only because 14 days was unattainable, but due to a physiological observation. Yet this policy tool is just that, a tool. A tool used to preserve the trust of the public while still allowing for research to move forward. The regulations that govern the circumstances surrounding embryonic growth in vitro must be amended. And in doing so, the emendation of the 14-day rule will address scientific, as well as moral concerns. To encourage a thoughtful revision, developmental biologists should communicate, to the public as well as to international policy makers, why embryonic research is important, and how a possible extension of the 14-day rule will aid that research.

In the interim, the International Society for Stem Cell Research (ISSCR)  has released updated guidelines for stem cell research and clinical translation. Even with the publication of guidelines, the interdisciplinary task force that led the revision must maintain close collaborations with international foundations and governments to prevent public criticism and the implementation of restrictions that hinder the progression of the embryonic research field. (Insoo Hyun, Amy Wilkerson, and Josephine Johnston; Nature)

Microbiology – BREAKING NEWS

Rebuilding trust in biology : An opinion ahead of the NSABB microbiology biosecurity meeting

Today (May 24, 2016), the National Science Advisory Board for Biosecurity (NSABB) will meet at the National Institutes of Health (NIH) to discuss and vote to approve the revised NSABB report. Back on January 7-8, 2016, the NSABB met to consider the risks, benefits, ethics, and policy surrounding gain of function studies, particularly regarding infectious pathogens, leading to the final report. This debate officially started 18 months ago, and will culminate today.

The primary purpose of meetings like this is to implement biosecurity policies designed to protect the public from research projects that could pose a risk to national, and global safety. The promise that new biological technologies will be beneficial and safe is still on shaky ground and public trust in this research is flagging. Infractions are still occurring, as just last week it became apparent that certain labs at the Centers for Disease Control and Prevention (CDC) were subjected to secret sanctions and suspensions for mishandling bioterror pathogens. Prior to that, the NIH stumbled upon a 30-year old smallpox virus in a neglected freezer when the virus should have only been safely secured at either of two dedicated storage facilities in the world, in which this freezer was not located. And additionally, the US military erroneously sent live infectious anthrax from a secured facility to over 200 labs in the world.

These infractions barely touch the surface, since smaller minor breaches are not regularly reported in the news. That this is occurring ad nauseam in countries with strict biosafety regulations, makes one wonder how many incidents slip through the cracks in these countries as well as ones with lesser regulations.

The NSABB’s focus today on debating gain of function mutations run the risk of jeopardizing the reputation of the “global biomedical research enterprise.” One way to gain public trust is to provide transparency in the process, which is why the report and meeting minutes are published online, and the meeting is also public. A second way is to give scientists leading this research the responsibility of helping encourage responsible behavior amongst colleagues to prevent accidental and premeditated misuses of biology. Thirdly, accountability is an imperative tenet towards gaining public trust. Creation and enforcement of new scientific norms that do not detract from the goal of honesty through accountability are changes that can’t come too soon. Lastly, transparency must be reiterated in relation to potentially hazardous experiments, such as inserting a gene, or genes, responsible for airborne transition to a virus that currently can only be transmitted via mosquito bite. This experiment may inform scientists how said gene(s) are responsible for airborne evolution, and thus enable the prevention of future deleterious outbreaks. But if this airborne mutant recombinant pathogen were to be accidentally released, or fall into the wrong hands, it could quickly become an epidemic or bioterrorism tool. Science that enforces trustworthiness, accountability, transparency, open communication and feedback, organized vetting of new technologies, and responsibility can, and will, allow for the growth of science in a safe and beneficial path. (Filippa Lentzos and Nicholas Evans, The Guardian)

Have an interesting science policy link?  Share it in the comments!

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Written by sciencepolicyforall

May 24, 2016 at 11:00 am

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