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Posts Tagged ‘research ethics

Science Policy Around the Web – June 06, 2017

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By: Kseniya Golovnina, PhD

Source: Flickr, by USDA, via Creative Commons     (CC BY 2.0)

Food Security

What if Food Crops Failed at the Same Time?

When one group of people is fighting with climate change and another considers it “mythical”, researchers specialized in the study of social-ecological systems are developing food supply risk assessment models. Food crops are one of the most important sources of human being existence, and less than one-fourth of the planet (“breadbaskets”) produces three-fourth of the staple crops that feed the world’s population. In fact, climate change could cause crop losses in most of the breadbaskets.

Two important factors included in the models are shocks to major land crop production and economy. Shocks like droughts and heat waves in Ukraine and Russia in 2007 and 2009 almost wiped out wheat crops, and caused global wheat prices to spike. And demand assessments project that food production may have to double by 2050 to feed a growing population. Together, the potential environmental and economic stresses are making the world food production system less resilient, and will affect both rich and poor nations. To measure the fragility of the system, researchers developed scenarios of small shocks (10 percent crop loss) and large shocks (50 percent crop loss). These were then applied to corn, wheat or rice output using an integrated assessment model, the Global Change Assessment Model, which was developed by the U.S. Department of Energy.

Among the critical findings are that “breadbasket” regions respond to shocks in different ways. For example, South Asia, where most of the arable land is already in use, is quite unresponsive to shocks occurring elsewhere in the world, because the total amount of land in agricultural production cannot be changed significantly. In Brazil the situation is opposite, it has a lot of potential to bring new land into production if large shocks occur. However, cleaning Brazil’s forests requires significant effort and would add significantly to global climate change. Within the research agenda of the Pardee Center, these risks and preventive actions are discussed in more detail. The warning is clear: humankind needs to be aware and prepared for potential multiple “breadbaskets” failure if we want to reduce the potential for catastrophe. (Anthony Janetos, The Conversation)

Reproducibility in Science

Research Transparency: Open Science

Increasing amounts of scientific data, complexity of experiments, and the hidden or proprietary nature of data has given rise to the “reproducibility crisis” in science. Reproducibility studies in cancer biology have revealed that only 40 % or less peer-reviewed analyses are replicable. Another large-scale project attempting to replicate 100 recent psychology studies was successful in replicating less than 50% of the original results.

These findings are driving scientists to look for ways to increase study reliability, and make research practices more efficient and available for evaluation. A philosophy of open science, where scientists share their primary materials and data, makes analytical approaches more transparent and allows common research practices and standards to emerge more quickly. For scientific journals and associations, open science methods enable the creation of different ways to store and utilize data. Some journals are specifically dedicated to publishing data sets for reuse (Scientific DataJournal of Open Psychology Data), others require or reward open science practices like publicly posting materials and data.

The widespread use of online repositories to share study materials and data helps to store large data sets and physical materials to help mitigate the problems of reproducibility. However, open science practice is still very much in development, and faces some significant disincentives. Habits and reward structures are two major forces work against. Researchers are used to being close, and hide their data from being stolen. Journal editors tend to favor publishing papers that tell a tidy story with perfectly clear results. This causes researchers to omit “failed” studies that don’t clearly support their theories.

While efforts to overcome these obstacles are difficult, development of fully transparent science should be encouraged, as openness helps improve understanding, and acknowledges the truth that real data are often messy. (Elizabeth Gilbert and Katie Corker, The Conversation)

 

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June 6, 2017 at 9:00 am

Science Policy Around the Web – December 13, 2016

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By: Allison Dennis, BS

Source: pixabay

Whistleblowers in Science

Keep your reviewers close and your online, anonymous, post-publication reviewers closer

A recent ruling by the Michigan Court of Appeals has ruled that anonymous online scientific reviews are a protected form of speech. Fazlul Sarkar, a former researcher at Wayne State University, had sued the site PubPeer in 2014 in an attempt to reveal the identity of several anonymous online reviewers to mixed success. Sarkar claimed that the defamatory and public nature of several online reviews posted anonymously to PubPeer had cost him a forthcoming tenure position at the University of Mississippi, one that came with a $350,000 a year salary. These reviews brought into question the validity of several images found in his published works.

While the initial ruling in March of 2015 largely sided with PubPeer to protect the anonymity of their online posters, a follow-up just two weeks later compelled PubPeer to reveal the IP address of a user who had gone as far as to repost quotes from an email response from the Senior Executive Assistant to the President of Wayne State University confirming their knowledge of the online allegations.

PubPeer filed an appeal of the decision by the end March, which garnished the collective support of science and internet moguls, Bruce Alberts, and Harold Varmus, Google, and Twittter in addition to the ACLU who filed amicus briefs in support of online anonymity. The summer brought more trouble for Sarkar as thirteen of his papers were retracted.

On December 9, 2016, the Michigan Court of Appeals found upon further review that Sarkar was “not entitled to unmask the identities of any speakers on pubpeer.com” citing “anonymity protections afforded by the First Ammendment.” Although this ruling does not dismiss Fazlul Sarkar’s case against John and Jane Doe, the protection of anonymity makes the suit moot. (Adam Marcus and Ivan Oranksy, STAT)

Federal Funding

Bipartisan cure found for stalled 21st Century Cures Initiative

In an end of the year push, the House and Senate passed the 21st Century Cures Initiative, a bill aimed at bringing legislation and regulation up to speed with biomedical research. At the end of November, a draft of the bill emerged from negotiations that were largely palatable to both Republican and Democrats across the House and Senate. A previous draft of the bill had successfully passed the House in July. However agreement over the source of funding could not be reached, arresting any further progress of the bill. The passing months brought Fred Upton, the Republican Representative who had originally spearheaded the bill close to the term limit afforded, as the chair of the Energy and Commerce Committee. The results of the recent elections seemed to be enough to incentivize compromise for Democrats in the final months of the Obama administration. Both parties returned to negotiations settling on a combination of funds derived from the selling of petroleum reserves and the Affordable Care Act.

In the end, the bill won 392-26 in the House and 94-5 in the Senate. Highlights of the bill under the title of Development include the accepted substitution of “data summaries” for full clinical trials when a new indication is to be added for a previously approved drug and expansion of off label-uses. The FDA has been tasked with evaluating evidence from the real world in an effort to speed-up and improve patient access. Highlights under the title of Discovery include a $4.8 billion boost to the NIH budget and $1.8 billion power pack for Joe Biden’s Cancer Moonshoot. A complete play-by-play of the winners and losers of the final version of the bill can be found in Sheila Kaplan’s article on STATnews. (Sheila Kaplan, STAT)

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December 13, 2016 at 10:38 am

Science Policy Around the Web – June 21, 2016

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By: Fabrício Kury, MD

Photo source: pixabay.com

Personalized Medicine Costs

The Paradox of Precision Medicine

Precision medicine has been hailed by President Obama as a multi-hundred-million “moonshot” meant to revolutionize medicine in a way never seen before. Its rationale derives from the recent field of research called Genome-Wide Association Studies (GWAS), which seeks to discover, in large and accelerated scale, the genetic basis of disease, novel targets for drugs, and what treatments work for which patients and at what moments and doses. This very rationale, however, can be self-limiting in a capitalist market where economics of scale is required to provide patients with access to otherwise prohibitively expensive treatments. In this lucid review, Janeen Interlandi from Scientific American demonstrates that old-fashioned, non-personalized treatments have recently been demonstrated not only be tremendously cheaper than “bespoke” drugs, but also just as clinically effective. (Janeen Interlandi, Scientific American)

Research Ethics

Scientists Are Just as Confused About the Ethics of Big-Data Research as You

Dubbed “the fourth paradigm” of science (book available for free download here), big data research poses novel ethical questions that might not be appropriately addressable by the current paradigm of ethics centered on the Common Rule and oversight by Institutional Review Boards (IRBs). A study can be ruled exempt from IRB approval if it only utilizes publicly available data – but what is it “publicly available,” exactly? In this article, Sarah Zhang from Wired magazine reviews recent cases of controversy in utilization of large datasets for studies, such as the Facebook Emotion Experiment, and suggests that IRBs might need new sets of skills to safeguard human subjects in the evolving landscape of research. (Sarah Zhang, Wired)

Data Science

The Doctor Who Wants You to Be a Research Parasite

After the editor-in-chief of the New England Journal of Medicine published in January, 2016 a stingy editorial affirming that some clinical researchers regard data scientists as “research parasites,” a wave of controversy exploded and culminated with personalities such as U.S. Chief Data Scientist DJ Patil and National Academy of Sciences President Marcia McNutt publicly using the hashtag #IAmAResearchParasite in defiance. In this article, Taylor Mayol from Ozy introduces Dr. Atul Butte, recently-appointed head of Clinical Informatics at the University of California, who sustains a bold call for more “research parasites” in health care, while additionally characterizing lack of entrepreneurship among academics as “a tragedy” because it is “the right way to truly change the world, by going beyond writing papers.” (Taylor Mayol, Ozy)

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June 21, 2016 at 9:00 am

Science Policy Around the Web – August 25, 2015

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By: Eric Cheng, Ph.D.

Photo source: pixabay.com

Climate Change

New U.S. climate rules target methane leaks

The U.S. Environmental Protection Agency (EPA) proposed new measures to cut methane emissions from the oil and gas sector by 40 to 45 percent from 2012 levels by 2025. These new measures will mainly target industrial sources which will include the capturing of natural gas from hydraulically fractured oil wells, as well as limiting emissions from new and modified pneumatic pumps and other equipment used at natural gas transmission compression stations.

Methane, the main component of natural gas, has been found to be 80 times more powerful as a greenhouse gas than carbon dioxide when measured over a 20-year period. Preventing the escape of methane from gas fields and pipelines is predicted to have a measurable affect on reducing gases which contribute to global warming by reducing the equivalent of 7.7 to 9 million metric tons of carbon dioxide. In addition, reduction in carbon dioxide released into the atmosphere is estimated to have a net climate benefit of $120 to $150 million in 2025.

Critics of the new proposals argue that there is already a “strong economic incentive to capture and utilize methane” and “that producers have already made deep cuts in methane emissions through voluntary measures and best practices.” U.S. Senator Jim Inhofe (R–OK), chair of the U.S. Senate Environment and Public Works Committee, in a statement believes that these new measures are “not only unnecessary, but another example of the [Obama] administration’s punitive expansion of their war on fossil fuels.” The EPA will take comments on the proposals for 60 days after they are published in the Federal Register. (Eli Kintisch, ScienceInsider)

Infectious Diseases

Tackle Nepal’s typhoid problem now

Nepal continues to struggle to rebuild their infrastructure stemming from the two earthquakes in April and May of 2015. This damage to the country’s infrastructure has disrupted the water resources of up to 1.3 million people as well as sanitation support for up to 1.7 million. In addition to the disruption to water and sewage systems, thousands still live in temporary shelters and camps. All these issues along with the current monsoon season has lead to an increase in typhoid outbreaks which can easily lead to an epidemic in the hardest hit areas such as the Sindhupalchowk and Gorkha districts of Nepal.

Typhoid fever, a potentially fatal multisystemic illness caused by Salmonella enterica, can be treated with antibiotics. However, Salmonella enterica strains resistant to antibiotics such as fluoroquinolones and azithromycin are emerging. Currently, prevention of infection is key to tackling the typhoid problem. Clean water and sanitation is still the best way to prevent typhoid, but it will take decades for Nepal to repair and build the necessary infrastructure to pre-earthquake levels. Typhoid can also be prevented through vaccination. However, the Nepalese government does not have sufficient funds to vaccinate millions of people using the vaccine recommended by the WHO.

There are cheaper vaccines that Nepali health officials can deploy that are not pre-qualified by the WHO, and it is unclear why they have not yet done so. What is known is that buying and delivering enough doses will almost certainty require outside financial support for Nepal. This support could come from institutions such as Gavi, the Vaccine Alliance, based in Geneva, Switzerland, which is committed to increasing access to vaccination in poor countries, or support could come from the profits of pharmaceutical companies. (Buddha Basnyat, Nature: News & Comment)

Ethics in Research

Apparent ‘pay to cite’ offer sparks Internet outrage

This past June Cyagen, a contract research organization and cell culture product manufacturer, sent out an email entitled: “Cite us in your publication and earn $100 or more based on your journal’s impact factor!” Based on Cyagen’s formula: Voucher Value = (impact factor) * $100, a citation in Science magazine (impact factor = 30) could entitle the author to $3,000. It is only in recent days that this email promotion was picked up by Twitter and bloggers about the possible conflict of interest involved with participating in this promotion.

Upon more careful reading of the promotion, the deal is not what it appears at first glance. The reward is not cash, but store credit for a future purchase from the company. In addition, the citation Cyagen requires for the store credit is nothing more than a notation in the materials and methods section of the journal that a Cyagen product or service was used in that particular paper. This notation is something that is already required by most scientific journals in order assist in other researchers to be able to faithfully replicate a particular experiment. Some believe this promotion is akin to receiving “undisclosed funds in exchange for a citation.” While others such as a developmental biologist from the University of Amsterdam do not believe that this promotion would generate any conflict of interest because it does not appear any different “from any other discount you often get when buying lab equipment, antibodies, transgenic services.” (John Bohannon, ScienceInsider)

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August 25, 2015 at 9:00 am