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Posts Tagged ‘DURC

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)

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Written by sciencepolicyforall

May 24, 2016 at 11:00 am

Science Policy Around the Web – January 5, 2016

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By: Nivedita Sengupta, Ph.D.

Scanning electron micrograph of neutrophil ingesting methicillin-resistant Staphylococcus aureus bacteria. Credit: NIAID. Photo source: Wikimedia Commons

Dual Use Research of Concern (DURC)

U.S. oversight of risky pathogen research could be better, draft report concludes

Gain of function (GOF) mutation studies that manipulate dangerous pathogens to develop treatment and vaccines can pose significant threat to public safety in event of an accidental or intentional release of the modified infectious agent. A recently released report by an expert advisory group, National Science Advisory Board for Biosecurity (NSABB) to the U.S. government concludes that though just a small subset of the GOF studies pose such a risk, current policies regulating such studies required further policy supplementation.

The debate on GOF studies came into prominence in 2011 when two research groups reported GOF studies on H5N1 avian influenza virus resulting in a more virulent and readily transferable virus. This led to a controversy over publication of the results and fear of pandemic in case of escape of these agents from the laboratory. In 2014, the U.S. government suspended 18 funded GOF studies involving pathogenic viruses such as influenza and SARS. The National Institutes of Health (NIH) later exempted few of the studies while NSABB and National research council (NRC) continued to review the risks and benefits of such studies. Following the NRC meeting, NIH commissioned an independent firm to evaluate the risk and benefits of such studies.

The report submitted by the firm analyzed the probability of both lab accidents and security breaches and concluded that “only a small fraction of laboratory accidents would result in a loss of containment; of those, only a small fraction would result in a laboratory-acquired infection, and of those, only a fraction would spread throughout the surrounding community (or global population).” It further states that some types of GOF experiments may not pose any security threat. The report also highlights the regulatory gap overseeing this kind of research. There are some regulatory requirements for handling the lethal viruses and bacteria classified as select agents; however GOF studies involving MERS virus and seasonal influenza viruses does not seems to be regulated by any of the current policies.

The draft report also proposes multistep guidelines while making funding decisions on research proposals related to GOF studies. In the initial step, reviewers would evaluate three criteria to determine whether the study needs further special evaluation. Studies requiring further evaluation would have to undergo a seven step review process before making a funding decision. In the final step, all the funded studies would be regularly reviewed by the sponsoring institution and federal funding agencies.

Although the NSABB reports details a thorough risk benefit analysis and recommends a set of policy guidelines for research funding for GOF studies, it is expected to draw extensive comments during the upcoming NSABB meeting. However, some scientists believe that due to the perception of a larger scale benefits of these studies, the recommendations of the report may not lead to stricter policy guidelines. (David Malakoff, ScienceInsider)

Antibiotic Resistance

Spread of antibiotic-resistance gene does not spell bacterial apocalypse — yet

The worldwide emergence of bacteria resistance to colistin – one of the “last resort” antibiotics – was  recently reported in numerous countries. Colistin is one of the few antibiotics which are rarely used in humans as it can cause kidney damage; thus, bacterial resistance due to overuse in humans has not occured. However, mutations conferring colistin resistance have been previously reported in soil bacteria, and most recently it has been identified in plasmids, those small sections of circular DNA which are readily shared among bacteria. The ease of this transfer of plasmids between bacteria has resulted in the emergence of colistin-resistant bacterial species. As colistin is considered as a last resort drug, the appearance of resistant bacterial species has resulted in an outcry in the medical field.

However, not all researchers and physicians are considering this as the worst possible news, since colistin is not the only last resort antibiotic available. They suggest that even with the emergence of colistin-resistant bacteria, the drug can still be used for treatment in conjunction with other antibiotics. Moreover, they state that all antibiotics have a spectrum of activity and thus a larger dose may overcome the apparently resistant bacteria.

Even though the appearance of colistin-resistant bacteria now may not be the end of the antibiotic line, it is only a matter of time before that becomes fact. The last new class of antibiotics, lipopeptides, were discovered in the 1980s and the newest antibacterial compound teixobactin has a long way to go before it can be used beneficially as an antibiotic. Though a lot of antibiotics have been developed in past years, the functional basis of all these drugs are quite similar and thus may not work any better (or prevent resistance from occurring) than each other.

Government incentives for companies that continue to develop new antibiotics are a good thing, so long as bacteria do not quickly develop resistance against these new drugs. So, in addition to the important work of developing new antibiotics, we must also try to use our existing drugs in a better way and try to find a different alternatives to treat bacterial infections. In this regard, current policies for the proper use of antibiotics should be regularly revisited with preventing antibiotic-resistance in mind. This will require further policies which dissuade the misuse of antibiotic in farm animals and agriculture, as well as in hospitals. Furthermore, worldwide cooperation is needed to create global policies to prevent the misuse and overuse of antibiotics in the near future. (Sara Reardon, Nature Trend Watch)

Women in STEM

Why Are There Still So Few Women in Science?

The 2015 Noble prize in physiology or medicine was awarded to Dr. Youyou Tu for her discoveries regarding a novel therapy for malaria. The Noble prizes in Chemistry, Literature, Physics, and Physiology or Medicine were first awarded in 1901 and since then 18 women have received the Noble prize. Current statistics show that approximately 50% of doctoral candidates are women; however, less than 20% of them end up in a tenured research position. So what is the cause of fewer women in science? Clearly it is not the quality of work done by the women, as this has already been substantiated in many ways.

A significant reduction in number of women in science occurs during the postdoctoral years, after receiving PhDs and before reaching tenure. This drop in number of female scientists can be caused by a number of factors. For instance, the most widely accepted issue is trying to balance a career with motherhood. In addition, the current academic system does not make the job easier by demanding long hours at work to earn tenure, leaving little time for anything else. Even after overcoming all these obstacles the accomplishments of a woman is seen with bias and skepticism as mentioned by Dr. Virginia Valian in her book, Why So Slow? The Advancement of Women. Dr. Meg Urry, a professor of physics at Yale, thinks that the accomplishments of women in science are under appreciated in such a way that they themselves lose the confidence to continue further. Some of the other challenges faced by women in science are subtle but unique, and are so overtly ignored that it even escapes notice by women. Some of these challenges are unconscious institutional bias and lack of proper mentoring. A study done in 2012 found that both male and female professors would offer a job to the male applicant, when presented with identical curriculum vitae  of two imaginary applicants one male and one female. Moreover, if they did hire the female applicant, her salary was nearly $4,000 lower than male counterpart. This bias is not only limited to the salary and extends even to promotions and office space and professional interactions.

Though there are many policies in science to address these gender imbalances, current circumstances warrant that these policies be re-evaluated. One policy for all may not be the best way to deal with the present situation. Policies should be crafted to attempt to remove any bias in salaries, allocation of research space, and promotions, in addition to raising public awareness regarding importance of women in scientific field. This in turn, might result in motivating women to continue in the scientific field. (Eileen Pollack, The New York Times Magazine)

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Written by sciencepolicyforall

January 5, 2016 at 9:00 am

Dual Use Research of Concern (DURC) Funding Pause: A Risky Response

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By: Kaitlyn Morabito

photo credit: AJC1 via photopin cc

On October 17th, the Obama administration announced a funding pause on new gain of function (GOF) research and a voluntary moratorium of current research on Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), and both highly pathogenic and low pathogenic influenza viruses. The re-evaluation of the potential risks and benefits of federally funded GOF research will be pioneered by the National Science Advisory Board for Biosecurity (NSABB) and National Research Council (NRC) of the National Academies. These organizations will consult with the biomedical community and are responsible for developing a new policy on “dual use of research of concern” (DURC), which includes GOF research, using a deliberate process that is expected to be decided in 2015. Formation of the new policy will determine what DURC research can be done and whether the funding pause will be lifted. Although this funding pause is limited to MERS, SARS, and influenza, this policy will have implications for many other areas of research. While a discussion on the future of DURC is merited, the funding pause has broader implications that may affect our ability to prepare for potential pandemics.

When life science research has the potential to be used for malicious as well as beneficial intentions, it may fall into the category of DURC. Although a lot of the recent debate has surrounded GOF studies involving avian flu virus transmission, the definition of DURC is wide reaching. Infectious pathogen research is a major component of DURC, with a particular focus on agents and toxins which fall into the Federal Select Agent Program, including Ebola and anthrax among others. There are seven kinds of experiments that may be considered DURC and are generally referred to as GOF research. These involve creating mutations within the pathogen, allowing it to gain a function such as increased host range or tropism, transmissibility, or ability to be disseminated. Additionally, changes to pathogens that lead to resistance to prophylactic or therapeutic agents, or make a vaccine or natural immunity less effective, are considered DURC experiments. The final categories involve enhancing vulnerability of a host population and generation of new pathogens or regeneration of previously eradicated or extinct Select Agents. These experiments are considered to be biosecurity threats since modified agents can be used for bioterrorism or accidently released. There has been a lack of open discussion between researchers and policy makers regarding DURC research and there are four major issues that need to be addressed. What dual-use research should be allowed to be done? Should the public fund this research? Who should determine which research can and cannot be done? Should the details and results of these studies be published and available to the public? While these issues are important and need to be discussed and a DURC policy developed, the moratorium on GOF research is not the solution.

The major problem with the GOF moratorium is the overall vagueness of it. There is no end date to the moratorium in which a new policy has to be decided. The initial controversy regarding avian flu transmission studies appeared over two years ago; however, prior to the funding pause, NSABB has failed to hold any scientific meetings to work on DURC policy. Although they have already organized a meeting of scientists in December, without a deadline for the funding pause, there is no motivation to determine the policy. Additionally, the definition of the types of research that fall into this category is vague; the funding pause applies to any work by which researchers could “reasonably anticipate” an increase in pathogenicity or transmission. This definition could apply to nearly any research involving passaging or mutating these viruses.

The timing of this moratorium may hinder work on pandemic preparedness particularly in the case of the recently emerged MERS coronavirus. There is currently no small animal model for the pathogenesis of MERS. Animal models that recapitulate human disease are often developed by passaging a virus through a small animal such as a mouse. However, this type of research is not allowed under the funding pause because the virus may be gaining host range or pathogenicity in the animal. Animal models allow researchers to better understand the virus as well as test treatments and vaccines. Without these models, there is a real hindrance in the development of new prophylactics and treatments, which may prevent epidemics from becoming pandemics.

Another important aspect of pandemic preparedness is surveillance of naturally occurring genetic mutations in viruses. By collecting samples from sick patients or animals and then sequencing the viruses, a researcher can monitor the spread and mutation of different viruses throughout the world. This surveillance is a powerful tool in predicting outbreaks, drug susceptibility, and determining the contents of the influenza vaccine. However, monitoring genetic changes without understanding the level of functional changes is not very informative. This surveillance needs to be used in conjunction with reverse genetics in the laboratory to determine the effects of these changes on pathogenicity, transmission, drug susceptibility, treatment, and immunization. Using laboratory data to supplement surveillance is one aspect of the relationship between surveillance and GOF research. It is also very important to have the reverse relationship with laboratory research informing surveillance. Genetic mutation in viruses is fairly noisy, with many changes having little or no effect on the virus or a detrimental effect. Determining potential mutations in the laboratory that may increase pathogenicity can help determine signals above the noise. Without the ability to supplement knowledge gained by surveillance in the laboratory, the data obtained through surveillance is insufficient to understand the potential outcomes of genetic mutation in viruses.

When talking about DURC, it is impossible for one to avoid the debate swirling around two avian flu studies (1, 2), which involved increased transmission among ferrets. In these studies, an important aspect is often overlooked. Increased transmission among ferrets decreased the pathogenicity of these viruses, with fewer ferrets dying from the transmitted virus. So while this study increased one aspect of GOF, transmission, there was a compensatory loss of function since lethality decreased. This is an important aspect of DURC. By doing these GOF experiments, researchers can also discover loss of function (LOF) mutations, which can be exploited for drug development and also better understand the potential costs of these mutations to the pathogen.

The risk of dual-use research or accidental release of these altered pathogens is real.   This moratorium comes on the heals of a number of highly publicized laboratory incidents including the discovery of a vial of smallpox in an FDA laboratory and the CDC’s distribution of anthrax that had not properly been inactivated. However, the pausing of new research and cessation of current research involving these viruses, which have the potential to cause pandemics, is a bigger threat. A new policy and guidelines for DURC and oversight of research is needed, but until that has been established, researchers should be trusted to determine which DURC should be done.



1) Science – Avian Flu Transmission in Ferrets Paper

2) Nature – Avian Flu Transmission in Ferrets Paper

3) Office of Science and Technology Policy – Doing Diligence to assess Risk and Benefits of GOF

4) mBio – Influenza-Gain of-Function Experiments

6) mBio – Moratorium on Research intended to create Novel Potential Pandemic Pathogens

7) mBio – Vagueness and Cost of GOF Funding Pause







Written by sciencepolicyforall

January 21, 2015 at 9:00 am

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