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Posts Tagged ‘bioethics

Science Policy Around the Web – June 27, 2017

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By: Sarah Hawes, PhD

Source: pixabay

Influenza

An Arms Race with Nature

H7N9, a new bird flu emerging in China, has infected roughly 1,500 people and killed 40% of them. The virus is contracted directly from infected birds but is not yet easily transmissible between humans, however researchers at The Scripps Research Institute have evidence H7N9 could potentially become transmissible between humans fairly easily. They examined a fragment of the virus that interacts with receptors on animal cells to gain entrance, and identified three minor mutations that could cause the fragment to shift from preferentially entering avian cells to preferentially entering human cells. If these mutations were to occur, it could rapidly result in a pandemic.

Tests in a viral fragment do not prove functionality in the intact virus; that would require mutating H7N9 itself. A 2014 moratorium on mutating three types of viruses (SARS, MERS, influenza) to more dangerous forms is expected to lift when the Department of Health and Human Services finishes current work drafting a new policy establishing reviews designed to assess benefit/risk ratios before funding research.

The subject is divisive, even among scientists in the field. Stanford researcher David Relman says he would support efforts to test mutations in a weakened strain of flu, but not in the H7N9 virus.  Bioterrorism expert Thomas Inglesby opposes increasing the contagious lethality of a virus, and opposes publishing such procedures due to concern that less benevolent actors would be enabled to replicate the process. NIH funded researcher, Ron Fouchier in the Netherlands, whose alteration of H5N1 to become highly contagious between ferrets (the animal model for humans) in 2011 influenced the moratorium, believes examining dangerous virus mutations in a controlled lab environment is important to identify potential pandemic viruses.

Many of these topics were discussed at the recent Immunology and Evolution of Influenza Symposium, and are sure to be a hot topic at the July 16 – 19 Centers of Excellence for Influenza Research and Surveillance meeting. With policy guidance needed on benefit/risk, potentially safer models, security, and publication limitations, the new HHS policy will be critical. (Nell Greenfieldboyce, NPR)

Conservation

Modeling with Dough – Pick your Species

The Supreme Court found the Endangered Species Act was “intended to halt and reverse the trend toward species extinction—whatever the cost.” Today, in light of the cost, conservation policy makers are being invited to triage species extinctions. Fish and Wildlife Service representatives recently met with ecologist Dr. Leah Gerber to discuss her proposed use of an algorithm guiding conservation funding.

A self-proclaimed environmentalist, Gerber says her model suggests that defunding “costly failures,” including the spotted owl, golden-cheeked warbler and gopher tortoise, could help save about 180 other species. Gerber says policy makers may opt to continue to support species that her algorithm rejects, as was done for the koala in Australia where algorithm triage has been used. In this case, a popularity contest may determine who lives and who goes extinct.

Details of the algorithm are not explicit, but Dr. Gerber’s recent publication in PNAS is a straightforward return-on-investment calculation analyzing the mathematical relationship between funds requested, spent, and species success or decline.  Gerber finds “the cost–success curve is convex; funding surpluses were common for the species least likely and most likely to recover” so it’s not simply ‘money in – species out’. Other factors – endemism, keystone status, level of species risk – are also important, though Gerber acknowledges they are not currently included.

While proponents call use of the equation “doing the best you can with what you have,” lack of data on its predictive validity make it a frightening policy tool governing something as permanent as species extinction. What if region affects costs, population growth is slower in species reaching sexual maturity later, a break-through in understanding one species’ requirements is just around the corner or we haven’t yet discovered the significance of the niche occupied by another species? What if business or political interests conflict with a species’ needs? What if the algorithm developer seeks intellectual property legal status, as is happening now with a proprietary algorithm used in parole and sentencing situations? Algorithms impacting public policy should be vetted by multiple experts in germane disciplines, validated, and kept publicly accessible for healthy scrutiny. (Sharon Bernstein, Reuters)

 

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June 27, 2017 at 11:42 am

Science Policy Around the Web – June 10, 2017

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By: Allison Dennis, BS

Source: pixabay

Animal Testing

Lack of Clarity Puts Chemical Safety and Animal Welfare at Odds

In the lineup of American stereotypes, the health-nut who cares about the chemicals in his shampoo is often the same person who cares if that shampoo was tested on animals or not. However, a bill signed June 22, 2016, known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act, may be placing those two views at odds. The bill requires the U.S. Environmental Protection Agency (EPA) to implement a risk-based process to evaluate the safety of chemical substances currently being used in the marketplace and approve the use of new chemicals before their introduction. The bill was passed with bipartisan support and offered EPA the new-found power to fully regulate the use of well-known carcinogens like asbestos.

Yet the pathway forward for the EPA is daunting. More than 62,000 substances find their way into and onto our bodies through the products we use and our environment. While many of these substances have become associated with disease over time, how can the EPA certify the risks associated with different exposures to varying amounts of each substance on such an extensive list? The Act itself suggested that once the EPA has evaluated the existing information on the 62,000 substances currently in use, it spend the next twelve months triaging chemicals according to their potential risk. Next, the highest priority chemicals will be evaluated on a three-year deadline to develop knowledge of their toxicity and guidelines for their regulation. Ultimately, by clearly cataloging the risk of common chemicals the Frank R. Lautenberg Chemical Safety for the 21st Century Act promises to greatly reduce the amount of animal testing needed in the long-term.

In the meantime, however, the companies that use to-be-regulated substances in their products may be inclined to undertake independent toxicity testing, collecting enough data to guarantee that their favorite substances meet the low-risk criteria and avoid a drawn-out evaluation. Defining toxicity requires careful experimentation, which can sometimes be carried out in human cells outside of the body, but often require evaluation in animals. Animal rights groups like the Human Society find concern with the lack of transparency in the pre-prioritization process. They fear the eagerness of companies to provide data without any clear guidelines about how that data will be evaluated or what substances will require extensive evaluation could result in extensive and unnecessary animal testing. Further they suggested that the EPA require any new pre-approval data obtained by companies to be collected using non-animal methods. (Maggie Koerth-Baker, FiveThirtyEight)

CRISPR

Small Study may Reveal Big Concerns over CRISPR-Based Therapy

A one-page letter published in Nature Methods last week reports unexpectedly high levels of unintended changes to the genomes of mice that underwent a CRISPR-based therapy. Since it’s renaissance as a therapeutic tool in 2012, CRISPR has occupied the imaginations of scientists, doctors, patients, investors, and ethicists. CRISPR technology provides a relatively straight-forward and reproducible means to gene editing on the cellular level, but its applications to create heritable mutations in the human germ line is on hold until more is understood about the long-term effects such treatments would have.

The original study sought to explore potential long-term effects of germline manipulation by CRISPR in a mouse model. Guide RNA along with the Cas9 enzyme were injected into mouse zygotes, which introduced a correction in a mutation in the rd1 gene of otherwise blind mice. Initiating this change before the first cell division enabled this corrected mutation to be inherited by all cells arising in the developing mouse, consequently restoring the ability for the eyes to develop normally. In a follow-up experiment described in their one page letter, the researchers looked for mutations in the genomic DNA of two CRISPR-treated adult mice compared with a control mouse, revealing over 2,000 unintended mutations following CRISPR treatments. None of these mutations appeared to affect the mice, suggesting that deep genomic sequencing may be required to reveal unanticipated changes in an outwardly healthy mouse. Further, the nature of these unintended mutations offered few clues explaining how they might have occurred.

This result stands in contrast with other reports quantifying the extent of these unintended changes, which found CRISPR to be highly specific. While the CRISPR-Cas9 system has been observed to sometimes alter off-target regions of the genome, this activity can usually be curbed through the careful design and evaluation of the guide RNA. The limitations of this small study have been discussed extensively since its publication. However, the findings have sparked the need for further investigation into the long-term-whole-animal effects of germline-editing by CRISPR. As human germline-editing creeps closer to reality, the FDA will be tasked with developing an entirely new means of evaluating the safety of such technologies (Megan Molteni, Wired)

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June 10, 2017 at 11:33 am

How Science Policy Affects Pandemic Pathogen Research

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By: Samuel Porter, PhD

         In 2012, a pair of studies were published in Nature and Science weeks apart igniting one the biggest national debates about science in recent memory. These studies demonstrated that a few mutations in the highly pathogenic H5N1 strain of influenza virus (colloquially known as “bird flu”) could enable it to be transmitted through the air to mammals. At the heart of controversy was the question of whether scientists should be creating more virulent and/or pathogenic strains of deadly viruses in the lab. This controversial research is known as “gain of function” studies.

Critics claimed that the research was too dangerous that the risk of an accidental or deliberate release of these lab strains was far greater than the scientific and public health benefits. In an attempt to respond to the growing concern over their work, the community of researchers working with these pathogens voluntarily agreed to suspend this gain of function research for 60 days to discuss new policies on conducting the research safely.

But that was not enough to satisfy critics of the research, who continued to lobby the Obama administration to take official action. On October 17, 2014 the White House Office of Science and Technology Policy (OSTP), abruptly announced a pause on all U.S. Government funding of gain of function research on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome (SARS) coronavirus until the National Science Advisory Board for Biosecurity (NSABB) could make recommendations for policy regulating the research going forward. The NSABB was formed in 2005 (in the wake of the anthrax attacks in 2001), and is composed of scientists from universities around the nation, and administrators from 14 separate agencies in the federal government. The board reports to the Secretary for Health and Human Services (HHS) and is tasked primarily with recommending policies to the relevant government entities on preventing published research in the biological sciences from negatively impacting national security and public health.

The move drew harsh criticism from researchers in the field, many of whom thought that it was too broad. They claimed it would jeopardize their ability to predict, detect, and respond to potentially emerging pandemics. In the private sector, several companies said that the order would prevent them from working on new antiviral drugs and vaccines. Furthermore, many young scientists worried that an inability to do their experiments could jeopardize their careers. In an effort to bring attention to the issue, many scientists (including the two flu researchers whose research triggered the pause) formed the group Scientists for Science, which advocates against blanket bans on research. In addition, researchers were especially upset by the recommendation of the NSABB to censor the publications resulting from the experiments due to fears that this research could have a “dual use” that would threaten national security. However, not all researchers in the field support gain of function research (the opposition group is called Cambridge Working Group) and maintain that the risks of the research outweigh benefits.

The moratorium lasted until January 9th, 2017, when the OSTP released the guidelines for funding this research in the future. The new rules are essentially the same recommendations put forth by the NSABB seven months earlier. The NSABB had concluded that these studies involving “potentially pandemic pathogens” (PPP) do indeed have important benefits to public health, but warranted additional screening prior to funding approval. It directed federal agencies to create a pre-funding review mechanism using eight criteria (including whether the pathogen is likely to cause a naturally occurring pandemic, and if there are alternative methods of answering the scientific question). The results of these reviews must be reported to the White House OSTP. Importantly, the policy was implemented in the final days of the Obama administration rather than leave it to the incoming Trump administration, who, as of this date, has yet to fill nearly any top science positions, and may not have issued guidance for months, if at all.  Researchers welcomed the decision to finally lift the ban, but questioned when the projects would be allowed to resume.

What can we learn from this situation from a science policy perspective? First, we must learn not to overreact to hysteria regarding the risks of this type of research. Indeed, there are risks in performing research on potentially pandemic strains of influenza and other pathogens, as there are with other types of research. But issuing overly broad, sweeping moratoriums halting ground breaking research for years is not the answer, nor is government censorship of academic publication. While in the end, the studies were given the green light to resume, and were published without modification, there is no making up for the lost time. These studies are not machines than can simply be turned on and off on a whim without repercussions. When we delay research into learning how viruses become pandemic, we hurt our ability to detect and respond to naturally occurring outbreaks. Additionally, when American scientists are prevented from doing research that other countries are still pursuing, American leadership in the biomedical sciences is at a competitive disadvantage. (The European Academies Science Advisory Council also recently updated its recommendations for PPP research in 2015, but did not institute a moratorium.) What we learn from these studies could potentially save countless lives. Secondly, the freedom to publish without any government censorship must be valiantly defended in any and all fields, especially with a new administration with an aggressively anti-science and anti-climate stance. Lastly, the scientific community must do a better job educating the public both on the importance of these studies from a public health perspective, and on the precautions put into place to ensure that these studies are conducted safely.

In the future, there will inevitably be debates over the safety or ethics of the latest experiments in a particular field. In attempting to wade through the murky waters of a complex controversy, science policy makers should make decisions that balance public health, safety, and ethics, rather than reactionary policies like censorships and moratoriums.

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April 21, 2017 at 8:47 am

Science Policy Around the Web – September 30, 2016

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By: Jessica Hostetler, PhD

Source: Flickr, under Creative Commons

Human Genetic Manipulation

World’s first baby born with new “3 parent” technique

On September 27, 2016, the New Scientist reported the birth of a baby born with DNA from three people. The now five-month old healthy baby boy was born in New York to a Jordanian couple who had struggled for years to have a healthy child. The baby’s mother had genes for the lethal Leigh syndrome, a neurological disorder typically resulting in death in 1-3 years after birth, from which her first two children had died. These genes were carried in about 25% of her mitochondria, the energy producers for cells, which contain 37 genes separated from the thousands of other genes held inside the cell’s nucleus. Mitochondrial genes are only passed down from mothers through the mitochondria present in the mother’s egg before being fertilized by a father’s sperm.

The couple worked with US-based fertility expert John Zhang from the New Hope Fertility Center in New York City to undergo an approach for mitochondrial replacement therapy (MRT) called spindle nuclear transfer. Dr. Zhang transferred the nucleus of one of the mother’s eggs into a donor egg, which had the nucleus removed but contained healthy mitochondria. Several of these eggs were then fertilized with the father’s sperm to make 5 embryos with nuclear genes from both the father and the mother and mitochondria from the donor. The only healthy embryo was then implanted into the mother, and resulted in the birth of a healthy baby boy, with 99% healthy mitochondria.

This type of egg manipulation is now legal in the UK, though effectively banned in the US, so the team completed the fertility work in Mexico, which lacks clear regulations for the procedure. While several people such as Sian Harding who reviewed ethics for the UK guidelines, and legal scholar Rosario Isasi (from a Nature article), have acknowledged that Zhang’s group appears to have followed ethical guidelines, questions remain about the ethics, quality and safety of the technique.

The report was covered in a number of additional articles and commentaries, including in the New York Times, Science, and Nature. The commentaries note that researchers are eager for more information on a host of fronts such as the choice of using Mexico as the site of the work (as opposed to a more regulated and rigorous scientific environment) and the threshold of contaminating maternal mitochondria used in transfers (5%). These and other specifics are likely to come up when Dr. Zhang and team report on the case at the American Society for Reproductive Medicine meeting in October, 2016. (Jessica Hamzelou, New Scientist)

Health Policy

Why do obese patients get worse care? Many doctors don’t see past the fat

One in three Americans is obese; despite this fact, doctors and the healthcare system remain ill equipped in “attitudes, equipment and common practices” to treat obese patients. Beyond equipment issues, such as 90% of ERs and 80% of hospitals lacking M.R.I. machines built to accommodate very obese patients, research into bias against obese patients (both conscious and unconscious) shows that healthcare providers spend less time with such patients and refer them for fewer diagnostic tests. The same review reports that doctors feel less respect for obese patients and are more likely to stereotype them as “lazy, undisciplined and weak-willed,” all of which can negatively impact communication in the doctor-patient relationship, which in turn affects quality of care. In an effort to address the problem, the American Board of Obesity Medicine was founded to educate physicians about patient care and provide certification for achieving “competency in obesity care.”

Currently, these attitudes can lead health care providers to misdiagnose symptoms as being obesity-related instead of fully investigating other, potentially life threatening causes. Drug dosing may often be incorrect for obese people, particularly for cancer drug regimens for which obese individuals have worse outcomes across the board. Many orthopedists refuse joint hip and knee replacement surgery for obese patients unless they lose weight, though a review committee from the American Association of Hip and Knee Surgeons recommends a measured approach including options for surgery in some patients after the risks are discussed. The problems obese patients face may be exacerbated by the risk-averse hospital culture where adverse event scores affect Medicare reimbursements; thus pushing hospitals to avoid helping higher-risk patients. Beyond this there is a distinct lack of guidance from drug makers for correct dosing of anethesia drugs, with only a few examples, for instance a report from Dr. Hendrikus Lemmens out of Stanford University. Dr. Lemmens notes that 20-30% of obese-patient stays in intensive care after surgery are due to anesthetic complications and are likely frequently caused by drug dosing errors. Providing quality healthcare will likely only increase as the numbers of obese patients continue to increase in the US. (Gina Kolata, New York Times)

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September 30, 2016 at 9:00 am

Broadening the Debate: Societal Discussions on Human Genetic Editing

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By: Courtney Pinard, Ph.D.

Licensed via Creative Commons

In one of the most impressive feats of synthetic biology so far, researchers have harnessed the ability of bacteria to fight and destroy viruses, and have been able to precisely and cheaply edit genetic code using a genetic technology called clustered, regularly-interspaced short palindromic repeats (CRISPR) and CRISPR-associated endonuclease protein 9 (Cas9). CRISPR has been used to find and detect mutations related to some of the world’s most deadly diseases, such as HIV and malaria. Although CRISPR holds great promise for treating disease, it raises numerous bioethical concerns, which were sparked by the first report of deliberate editing of the DNA of human embryos by Chinese researchers. Previous blog posts have described scientific discussion surrounding the promise of CRISPR. At least three scientific research papers per day are published using this technique, and biotech companies have already begun to invest in CRISPR to modify disease-related genes. However, the use of CRISPR, or any genetic editing technology, to permanently alter the genome of human embryos is an issue of concern to a much broader range of stakeholders, including clinicians, policymakers, international governments, advocacy groups, and the public at large. As CRISPR moves us forward into the realm of the newly possible, the larger global, social and policy implications deserve thorough consideration and discussion. Policies on human genetic editing should encourage extensive international cooperation, and require clear communication between scientists and the rest of society.

There is no question that CRISPR has the potential to help cure disease, both indirectly and directly. CRISPR won the Science Breakthrough of the Year for 2015, in part, for the creation of a “gene drive” designed to reprogram mosquito genomes to eliminate malaria. Using CRISPR-Cas9 technology, investigators at the Universities of California (UC) have engineered transgenic Anopheles stephensi mosquitoes to carry an anti-malaria parasite effector gene. This genetic tool could help wipe out the malaria pathogen within a targeted mosquito population, by spreading the dominant malaria-resistant gene in 99.5% of progeny. The gene snipping precision of CRISPR can also treat certain genetic diseases directly, such as certain cancers, and sickle cell disease. CRISPR can even be used to cut HIV out of the human genome, and prevent subsequent HIV infection.

There are limitations of CRISPR, which include the possibility of off-target genetic alterations, and unintended consequences of on-target alterations. For example, the embryos used in the Chinese study described above, were non-viable, less than 50% were edited, and some embryos started to divide before the edits were complete. Within a single embryo, some cells were edited, while other cells were not. In addition, researchers found lack of specificity; the target gene was inserted into DNA at the wrong locus. Little is known about the physiology of cells and tissues that have undergone genome editing, and there is evidence that complete loss of a gene could lead to compensatory adaptation in cells over time.

Another issue of concern is that CRISPR could lead scientists down the road to eugenics. On May 14th 2015, Stanford’s Center for Law and the Biosciences and Stanford’s Phi Beta Kappa Chapter co-hosted a panel discussion on editing the human germline genome, entitled Human Germline Modification: Medicine, Science, Ethics, and Law. Panelist Marcy Darnovsky, from the Center for Genetics and Society, called human germline modification a society-altering technology because of “the potential for a genetics arms race within and between countries, and a future world in which affluent parents purchase the latest upgrades for their offspring.” Because of its potential for dual use, genetic editing was recently declared a weapon of mass destruction.

In response to ethical concerns, the co-inventor of CRISPR, Dr. Jennifer Doudna, called for a self-imposed temporary moratorium on the use of CRISPR on germline cells. Eighteen scientists, including two Nobel Prize winners, agreed on the moratorium. Policy recommendations were published in the journal Science. In addition to a moratorium, recommendations include continuing research on the strengths and weaknesses of CRISPR, educating young researchers about these, and holding international meetings with all interested stakeholders to discuss progress and reach agreements on dual use. Not all scientists support such recommendations. Physician and science policy expert Henry Miller disagrees on a moratorium, and argues that it is unfair to restrict the development of CRISPR in germline gene therapy because we would be denying families cures to monstrous genetic diseases.

So far, the ethical debate has been mostly among scientists and academics. In her article published last December in The Hill Congress Blog, Darnovsky asks: “Where are the thought leaders who focus, for example, on environmental protection, disability rights, reproductive rights and justice, racial justice, labor, or children’s welfare?” More of these voices will be heard as social and policy implications catch up with the science.

In early February, the National Academy of Sciences and National Academy of Medicine held an information-gathering meeting to determine how American public attitudes and decision making intersect with the potential for developing therapeutics using human genetic editing technologies. The Committee’s report on recommendations and public opinion is expected later this year. One future recommendation may be to require Food and Drug Administration (FDA) regulation of genetic editing technology as a part of medical device regulation. Up until recently, the FDA has been slow to approve gene therapy products. Given the fast pace of CRISPR technology development, guidelines on dual use, as determined by recommendations from the National Academies, should be published before the end of the year. So far, U.S. guidelines call for strong discouragement of any attempts at genome modification of reproductive cells for clinical application in humans, until the social, environmental, and ethical implications are broadly discussed among scientific and governmental organizations.

International guidelines on the alteration of human embryos are absolutely necessary to help regulate genetic editing worldwide. According to a News Feature in Nature, many countries, including Japan, India, and China, have no enforceable rules on germline modification. Four laboratories in China, for example, continue to use CRISPR in non-viable human embryonic modification. Societal concerns about designer babies are not new. In the early 2000s, a Council of Europe Treaty on Human Rights and Biomedicine declared human genetic modification off-limits. However, the U.K. now allows the testing of CRISPR on human embryos.

In a global sense, employing tacit science diplomacy to developments in synthetic biology may mitigate unethical use of CRISPR. Tacit science diplomacy is diplomacy that uses honesty, fairness, objectivity, reliability, skepticism, accountability, and openness as common norms of behavior to accomplish scientific goals that benefit all of humanity. The National Science Advisory Board for Biosecurity (NSABB) is a federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government. Although NSABB only acts in the U.S., the committee has the capacity to use tacit science diplomacy by providing guidance on CRISPR dual use concerns to both American citizen and foreign national scientists working in the U.S.

Under tacit science diplomacy, scientific studies misusing CRISPR would be condemned in the literature, in government agencies, and in diplomatic venues. Tacit science diplomacy was used when the Indonesian government refused to give the World Health Organization (WHO) samples of the bird flu virus, which temporarily prevented vaccine development. After five years of international negotiations on this issue, a preparedness framework was established that encouraged member states to share vaccines and technologies. A similar preparedness framework could be developed for genetic editing technology.

Institutional oversight and bioethical training for the responsible use of genetic editing technology are necessary, but not sufficient on their own. Tacit science diplomacy can help scientists working in the U.S. and abroad develop shared norms. Promoting international health advocacy and science policy discussions on this topic among scientists, government agencies, industry, advocacy groups, and the public will be instrumental in preventing unintended consequences and dual use of genetic editing technology. 

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March 9, 2016 at 9:01 am

Science Policy Around the Web – January 8, 2016

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By: Sophia Jeon, Ph.D.

This could be your blood! Photo source: photopin.com

Bioethics and Health Policy

Your Cells. Their Research. Your Permission?

Since 2011, the U.S. Department of Health and Human Services has been involved in a major effort to revise the Federal Policy for Protection of Human Subjects, or more commonly known as the “Common Rule,” that governs any research involving human subjects. Rebecca Skloot, the author of “The Immortal Life of Henrietta Lacks” recently wrote an opinion piece in the New York Times, encouraging the public to weigh in on what researchers can or cannot do with their biospecimens. This timely article was published just a week before the public comment period for the Common Rule closed this past Wednesday on Jan 6th.

The current Rule has a loophole where biospecimens could be used without consent as long as they are unidentifiable and cannot be traced back to the individual. This is why one of the major proposed changes to the new Rule that is receiving much attention is the concept of “broad consent.” Because the new rule will require consent whether or not the biospecimens are identifiable, broad consent allows researchers to store and use unidentifiable biospecimens indefinitely (except for the case of new sample collection, which is allowed only up to 10 years following consent) once participants give consent to any “broad” range of future, unspecified research. This is similar to a recent change E.U. has made in their legislation regarding personal health data.

There are concerns that not many non-scientist citizens know about this change while it is mainly the scientist community who have been giving public input for the new rule. Respecting autonomy and letting participants have control over their own tissues and cells is important but others also voice the concern that the new rule may increase the administrative burden on researchers and clinicians. (Rebecca Skloot, New York Times)

Research Workforce and Career Development

Fellowships are the future

Do you see any overworked, under-appreciated, and dissatisfied post-docs in your lab? If the answer is yes, there are many reasons for this: poor job prospects (here is how you may get around that issue); research culture that does not leave room for proper work-life balance; a lack of freedom in career development; and a feeling that you are stuck in a limbo phase where you are neither a trainee or an employee.

Currently, the majority of post-docs are treated as trainees under supervision of their PIs. Only about 16% of US post-docs are paid through a training grant or fellowship while most post-docs are supported by their PI’s grants. This means that post-docs have very little independence both scientifically as well as financially, which leaves almost no time for their own career development activities. In order to succeed as an independent scientist, or to prepare for next steps in their career, post-docs should be able to develop and pursue their own scientific interests, or explore different career options and gain relevant experience.

In last month’s issue of Nature, Viviane Callier and Jessica Polka suggest that government-funded post-doctoral fellowship awards may be the stone that kills two birds. With more post-docs who are independently funded, they argue that this mechanism would not only train post-docs to be better scientists, but also solve the problem of creating too many post-docs in the first place, as they would have to successfully compete for a limited number of fellowships. (Viviane Callier & Jessica Polka, Nature)

Technology and Regulatory Science

Brain game-maker fined $2 million for Lumosity false advertising

Lumos Labs, the company that sells a subscription-based game called Lumosity, has been fined $2 million by Federal Trade Commission (FTC) for falsely claiming that Lumosity can not only help perform better at work but also reduce cognitive impairment associated with diseases such as Alzheimer’s disease and post-traumatic stress. The money will be used to compensate consumers who purchased the game under the false impression that it would make them smarter.

There recently has been an explosive growth in number of medical mobile apps and devices that claim to enhance brain function. Unfortunately, many of these claims are unfounded or without strong scientific evidence. Since 2014, some healthcare mobile apps are considered as medical devices by the Food and Drug Administration (FDA)’s definition and therefore, FDA has authority to exercise enforcement over these apps if they are marketed, promoted or intended for use in the diagnosis, prevention or treatment of disease. Unlike FDA that mainly regulates “labeling,” FTC regulates both labeling and advertising that includes endorsements on blogs and social media. (Emily Underwood, ScienceInsider)

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January 8, 2016 at 9:00 am

Science Policy Around the Web – December 29, 2015

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By: Emily Petrus, Ph.D.

photo credit: DSC03602.JPG via photopin (license)

Biotechnology

And Science’s Breakthrough of the Year is …

Designer babies used to be the stuff of science fiction, however now they are potentially within reach. As such, Science’s 2015 “Breakthrough of the Year” is ….. CRISPR. CRISPR is a method originally discovered in bacteria which has launched us into a new era of gene editing. Although other methods of inserting, deleting, and switching genes on and off have been around for some time, CRISPR is more efficient, less expensive and easy to reproduce in a variety of species, including human embryos. This new technology means that being able to edit out harmful genes or splice in beneficial genes into human babies is technologically possible; however, this raises serious ethical implications in the policy realm.

A summit earlier this month in Washington, DC (December 2015) organized by the National Academy of Science and others from China and the UK confronted the issues surrounding the ethics and legality of editing human genomes. Conclusions from the summit included a call for extensive basic/preclinical research into the effects of editing human embryos and germline cells, but these experiments should not be used to establish a pregnancy. In addition, gene editing used in humans to target diseases – such as modifying red blood cells in Sickle Cell Anemia or deleting the Huntington’s Disease gene from reproductive cells also should be carefully studied before implementation. Germline editing is especially fraught with ethical issues, as altering human DNA for offspring equates to evolution on the generational scale. The deletion of “undesirable” traits could enhance social inequality. Overall the summit concluded that gene editing may have potential benefits, but a yearly summit designed to address the sure to come legal and ethical issues is imperative to carefully implement this new technology. Finally although we are able to edit our genes, in the end, do we want to? (John Travis, Science)

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December 29, 2015 at 9:00 am

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