Science Policy For All

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Posts Tagged ‘trump and science

Scientific Activism: Voting to Speed Up Discovery with Preprint Publishing

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By: Thaddeus Davenport, PhD

Source: Public Library of Science, via Wikimedia

         The election of Donald Trump to the Oval Office and the early actions of his administration have sparked a wave of protests in support of women’s rights and immigration, among other issues. Like other citizens, scientists have some cause to be concerned about the administration’s early actions that reveal a general disregard for facts and scientific evidence. In response, organizers have planned the March for Science for this Saturday, April 22nd, as an opportunity for people to gather in cities around the world to voice their support for factual information and scientific research. And while it is important to denounce the actions of the Trump administration that are harmful to science and health, it may be even more critical to acknowledge the underlying partisan divisions that created a niche for his rhetoric and to begin the difficult work of bridging the divide. For example, a Pew Research Center poll from 2015 indicates that 89% of liberal Democrats believe government investment in basic science pays off in the long-run, while only 61% of conservative Republicans feel the same way. Additionally, American adults with less knowledge of scientific topics are more likely to believe that government funding of basic science does not pay off. This suggests that improved science education and outreach will be important in building public support for scientific research. However, scientists often lead very busy lives and have little time outside of their professional activities to devote to valuable pursuits like science outreach. How, then, might scientists work towards building a better relationship with the public?

The products of science – knowledge, medicines, technology – are the clearest evidence of the value of research, and they are the best arguments for continued research funding. Efficiency in science is good not only for scientists hoping to make a name for themselves, but also for the public, who as the primary benefactors of academic research, must benefit from the products of that research. If taxpayers’ demand for scientific inquiry dissipates because of a perceived poor return on their investment, then the government, which supposedly represents these taxpayers, will limit its investment in science. Therefore, in addition to communicating science more clearly to the public, scientists and funding agencies should ensure that science is working efficiently and working for the public.

Information is the primary output of research, and it is arguably the most essential input for innovation. Not all research will lead to a new product that benefits the public, but most research will yield a publication that may be useful to other scientists. Science journals play a critical role in coordinating peer review and disseminating new research findings, and as the primary gatekeepers to this information, they are in the difficult position of balancing accessibility to the content of their journals with the viability of their business. This position deserves some sympathy in the case of journals published by scientific societies, which are typically non-profit organizations that perform valuable functions including scientific outreach, education and lobbying. However, for-profit journals are less justified in making a significant profit out of restricting access to information that was, in most cases, obtained through publicly-funded research.

Restricting access to information gathered in the course of research risks obscuring the value of research to a public that is already skeptical about investing in basic science, and it slows down and increases the cost of innovation. In light of this, there is growing pressure on publishers to provide options for open-access publishing. In 2008, the National Institutes of Health adopted a public access policy, which requires that “investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, that the NIH shall implement the public access policy in a manner consistent with copyright law.” This policy was extended through an executive order from the Obama Administration in 2013 to include all federal agencies with research budgets greater than $100 million, with additional requirements to improve accessibility.

These requirements are changing scientific publishing and will improve access to information, but they remain limited relative to the demand for access, as evidenced by the existence of paper pirating websites, and the success of open access journals like PLoS and eLife.  Additionally, other funding agencies like the Bill and Melinda Gates Foundation and the Wellcome Trust have imposed even more stringent requirements for open access. Indeed, researchers will find a spectrum of open-access policies among the available journals, with the most rapid access to information allowed by so-called ‘preprint’ publishers like biorxiv.org. Given that many research manuscripts require months or years of revision and re-revision during submission to (usually multiple) journals, preprint servers accelerate the dissemination of information that is potentially valuable for innovation, by allowing researchers to post manuscripts prior to acceptance in a peer-reviewed journal. Many journals have now adopted explicit policies for handling manuscripts that have been previously submitted to bioRxiv, with many of them treating these manuscripts favorably.

Given that most journals accept manuscripts that have been previously published on bioRxiv, and some journals even look to bioRxiv for content, there is little incentive to submit to journals without also submitting to bioRxiv. If the goal is, as stated above, to improve the transparency and the efficiency of research in order to make science work for the public, then scientists should take every opportunity to make their data as accessible as possible, and as quickly as possible. Similarly, funding agencies should continue to push for increased access by validating preprint publications as acceptable evidence of productivity in progress reports and grant applications, and incentivizing grant recipients to simultaneously submit manuscripts to preprint servers and peer-reviewed journals. Scientists have many options when they publish, and by voting for good open-access practices with their manuscripts, they have the opportunity to guide the direction of the future of scientific publishing. These small, but important, actions may improve the vitality of research and increase the rate at which discoveries tangibly benefit taxpayers, and, in combination with science outreach and education, may ultimately strengthen the relationship between scientists and the public.

March for Science this Saturday, if it feels like the right thing to do, and then strive to make science work better for everyone by sharing the fruits of research.

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Written by sciencepolicyforall

April 20, 2017 at 11:44 am

Science Policy Around the Web – February 24, 2017

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By: Alida Palmisano, PhD

Source: usda [Public domain], via Wikimedia Commons

Public Access to Data

Lawsuit Aims to Force USDA to Repost Scrubbed Animal Welfare Records

“Put the records back on the internet.”

An article published in Science discusses a lawsuit filed on February 13 against the U.S. Department of Agriculture (USDA) by an animal law expert at Harvard University. According to the plaintiffs, USDA violated the federal Freedom of Information Act (FOIA) when it removed thousands of animal welfare inspection reports and other records from a publicly accessible website. USDA generated records that document animal facility inspections, enforcement actions, animal censuses, and other information collected by the agency in the course of enforcing the federal Animal Welfare Act.  The law covers animals in more than 7800 facilities, including zoos, roadside circuses, and research laboratories at government agencies and academic medical centers.

The decision to remove the public access to these records may have been a response to a lawsuit involving another law, the Horse Protection Act. The plaintiffs in a 2016 Texas lawsuit accused USDA of violating their rights under the Privacy Act by posting inspection documents required by the Horse Protection Act. A resulting USDA review of all its public postings led the agency to scrub from its website documents generated under both the Horse Protection Act and the Animal Welfare Act.  In the future, the agency announced, people who want access to those records will need to file a FOIA request. The agency’s most recent FOIA report states that it takes an average of 94 days for the agency to respond to a simple FOIA request and 234 days on average for more complicated requests.

In February 13’s lawsuit, the plaintiffs invoke a section of FOIA that requires agencies to make publicly available electronically all records that it has released under FOIA which “because of the nature of the subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.” (Meredith Wadman, ScienceInsider)

Science and Immigration

Grad Students, Postdocs with U.S. Visas Face Uncertainty

While U.S. courts are busy handling President Donald Trump’s travel ban on immigration from seven majority-Muslim countries, the temporary shut down of the executive order, the appeal to reinstate the travel ban, the rejection of the immediate restoration of the ban, and more appeals and rulings, graduates and postdoctoral students already in the United States are weighing their options and trying to plan rationally in an unpredictable and fluid situation.

Many scientists in the U.S. are on student or other working visas. All these visas may not be renewable, depending on future executive orders and regulations. The dilemma “simply ruins their future. It’s a catastrophe,” says a Yemeni biologist who is on a university faculty on an H-1B, a 3-year visa for professionals. For years, lawmakers in Washington have tried to reform abuses of visa regulations by companies using visas to bring workers to the U.S. to learn the ropes, and then send the trained workers to other countries where the job can be done cheaply. The H-1B system is contentious: on one side labor advocates want the exploitation of the H-1B system to stop supporting an outsourcing business model. On the other hand, tech companies like Google and Facebook say they can’t get enough visas for top foreign talent, as the cap on the number of H-1Bs issued every year means that sometimes foreign graduates from top U.S. universities, places like the Massachusetts Institute of Technology and the University of California, Berkeley, can’t get one. The travel ban already has harmed the top universities in the U.S., stranding students, faculty and scholars abroad, and making foreign schools more attractive to some of the world’s brightest students.

In papers filed in Brooklyn federal court, the schools (that include Columbia, Duke, Harvard, Johns Hopkins, Princeton, Stanford, Yale, Massachusetts Institute of Technology and several more) said that the order blocking travel from seven predominantly Muslim countries threatens their abilities to educate future leaders from every continent. They said the executive order has “serious and chilling implications” and that the ban “casts doubt on the prospect and value of studying and working here for everyone,” the papers said. (Meredith Wadman, Richard Stone, Science)

Genetic Engineering

US Science Advisers Outline Path to Genetically Modified Babies

“Scientists should be permitted to modify human embryos destined for implantation in the womb to eliminate devastating genetic diseases such as sickle-cell anaemia or cystic fibrosis — once gene-editing techniques advance sufficiently for use in people and proper restrictions are in place. That’s the conclusion of a 14 February report from the US National Academies of Science, Engineering, and Medicine.”

The report follows a 2015 National Academies summit between scientists, ethicists, legal experts and patient groups from around the world. At the time of the meeting, given the outstanding scientific, ethical and legal questions surrounding the issue, the organizers concluded that scientists shouldn’t yet perform germline editing on embryos intended for establishing a pregnancy. However, the organizers also stated that altering human embryos for basic research was acceptable.

The latest iteration of this ongoing CRISPR debate moves the bar a little further. The report recommends restricting the technique to severe medical conditions for which no other treatment exists. Eric Lander, president of the Broad Institute of MIT and Harvard, said, “It’s a very careful, conservative position that’s just a little bit beyond an absolute bar.” In the report, the committee also called for international cooperation, strict regulatory and oversight framework, public input into decisions and long-term follow-ups of children who have edited genomes. The report adds that for now, genome editing should not be used for human enhancement, such as improving a person’s intelligence or giving them super-strength.

The report drew immediate criticism from a California-based non-profit organization called the Center for Genetics and Society. “This report is a dramatic departure from the widespread global agreement that human germline modification should remain off limits,” said Marcy Darnovsky, executive director of the center. “It acknowledges many of the widely recognized risks, including stigmatizing people with disabilities, exacerbating existing inequalities, and introducing new eugenic abuses. Strangely, there’s no apparent connection between those dire risks and the recommendation to move ahead.” (Sara Reardon, Nature)

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Written by sciencepolicyforall

February 24, 2017 at 11:23 am

Science Policy Around the Web – February 10, 2017

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By: Saurav Seshadri, PhD

Source: pixabay

Sleep

The Purpose of Sleep? To Forget, Scientists Say

Humans spend approximately one third of their lifetime sleeping, yet the purpose of sleep is still largely unknown. A pair of recent studies in the journal Science suggest that a key function of sleep is to give the brain a chance to rewire itself, specifically by cutting down connections between neurons, which naturally scale up during wakefulness, and especially during learning.

In one paper, researchers used 3D electron microscopy to measure the sizes of these connections, called synapses, in mouse brain slices. They found that sleep produced a significant decrease in the size of synapses. Interestingly, this effect was more pronounced in smaller synapses, which were likely strengthened by general information processing while awake, than large ones (~20% of synapses), which may encode more well-established memories. In the other, researchers used two-photon imaging in live mice to observe sleep-induced changes in synapses. They found a similar decrease in synaptic strength, and went on to identify the signaling pathway that caused this effect; blocking this pathway prevented a normal reduction in the scope and magnitude of a learned behavioral response.

These findings underscore the importance of sleep, especially for memory consolidation involved with learning. Studies like these can have far-reaching effects on the public’s perception of sleep, influencing individual habits as well as policy related to education. For example, they suggest that prioritizing sleep when setting school start times (an issue currently under debate in Montgomery County schools) could improve students’ lesson retention and ultimately their test performance. They also point to important cellular and molecular processes that take place during sleep, which could help explain how existing sleep aids adversely affect brain functioning and memory (a public health concern), and ultimately lead to the development of better drugs. (Carl Zimmer, The New York Times)

Drug Policy

Massive Price Hike for Lifesaving Opioid Overdose Antidote

Increased public exposure to the epidemic of opioid abuse, which continues to intensify in the US, has made it increasingly influential in politics, possibly including the recent presidential election.  A crucial tool for communities at the forefront of this public health crisis is naloxone, which can reverse potentially fatal symptoms associated with overdose. The Evzio naloxone auto-injector, produced by Kaleo, is one of two such products approved by the FDA. Kaleo has recently come under fire for increasing the price of Evzio from $690 to $4,500.

Kaleo cites several justifications for the price hike. Firstly, they offer coupons to patients whose insurance doesn’t cover Evzio. Second, they argue that large insurance companies and government agencies (such as the Veterans Health Administration, which sees a high rate of opioid use) can negotiate prices, while other organizations are currently well funded (thanks to public concern) to absorb the increase. Thirdly, they are expanding their donation supply to allow smaller groups to apply for free devices. However, experts say that the increase is not justified by production costs, and some organizations have been forced to switch to alternative drugs.

News of the decision arrives at a time when the public is particularly sensitive to drug pricing, and have made their concern clear to lawmakers. Negotiation with drug companies over prices has been a prominent campaign issue in recent elections. Public outcry following similar moves by investor Martin Shkreli and Mylan led to hearings by a special congressional committee. Soon after the last election, a bill that would have allowed patients to import cheaper drugs from Canada became a high-profile occasion for posturing in the Senate, where it failed despite overwhelming public support. These stories highlight the often antagonistic relationships between the American public, its government, and the pharmaceutical industry, and illustrate how disruptive drug pricing can directly affect policy. (Shefali Luthra, Scientific American)

Scientists in Politics

Geneticist Launches Bid for US Senate; while Empiricists Around the Country Will March for Science

Donald Trump’s agenda of self-serving lies and denial of evidence has led to unprecedented levels of engagement and activism across the country. The scientific community has been especially impacted by Trump’s brand of broad, allegedly populist anti-intellectualism. Thus, although the empirical facts uncovered by scientific research are inherently apolitical and should be treated as such, scientists are beginning to mobilize to oppose the Trump administration in several ways.

One essential path to policy change is increased representation. With that in mind, evolutionary biologist Dr. Michael Eisen, an HHMI-funded investigator at UC Berkeley and co-founder of the People’s Library of Science (PLOS), recently announced his candidacy for the US Senate in 2018. Dr. Eisen’s platform seems to center on bringing a scientific perspective to Senate proceedings, and working towards comprehensive yet practical solutions to issues such as climate change. More of Dr. Eisen’s views can be found on his twitter feed and blog.

Protests are another way for individuals to make their voices heard by policy makers. The March for Science, which currently has over 350,000 followers on Facebook, will be an opportunity for ‘scientists and science enthusiasts’ to both call for and demonstrate support for the scientific community, and promote solidarity between science and the public. The main march will be held on April 22nd, 2017 in Washington D.C.; satellite marches are scheduled in over 100 additional cities. Organizers hope to maintain the momentum gained by January’s Women’s Marches, which saw historic attendance. (Sara Reardon, Nature News; Lindizi Wessel, ScienceInsider)

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Science Policy Around the Web – February 3, 2017

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By: Eric Cheng, PhD

Source: pixabay

Trump and Science

Scientists’ Lives Upended by Trump’s Immigration Order

New executive orders have been signed by President Trumpthat suspend immigration into the United States from “terror-prone regions.” The target countries listed are Iran, Iraq, Libya, Somalia, Syria, Sudan, and Yemen. These new immigration orders have caused chaos at U.S. airports to people from these countries, including people with a valid U.S. visa or green card who were traveling outside of the U.S. when the order was signed. It is also affecting scientists who are currently in the United States, but are visiting from the affected countries. For example:

Ehssan Nazockdast was planning to attend his sister’s wedding in Tehran in March. One hitch: The specialist on fluid dynamics at New York University in New York City is an Iranian citizen. That leaves him vulnerable under an executive order signed by U.S. President Donald Trump on Friday that calls for the rigorous vetting of applicants for U.S. visas from Iran and six other predominantly Muslim nations, and bars the entry of any citizen from those nations for 90 days while procedures for that vetting are put in place. Nazockdast has lived in the United States for nearly a decade, has a green card, and has two young daughters with a wife who is a U.S. citizen. But now that Nazockdast is branded with a scarlet letter, he dare not leave. “I’m living in a big prison called the United States of America,” he says.

A federal judge has issued an emergency stay that halts deportations of refugees with valid U.S. entry documents. Two days after executive order was signed, John Kelly, Secretary for Homeland Security, issued a statement deeming “the entry of lawful permanent residents to be in the national interest,” which was interpreted as allowing the re-entry of green card holders. from nations covered by the order, although they could receive extra scrutiny. The Council on American-Islamic Relations still intends to file a lawsuit in the U.S. District Court Western District of Virginia challenging the constitutionality of what it calls the “Muslim ban.”

Over 7000 scientists of all nationalities and religions, including 43 Nobel laureates, have signed an open letter, warning that Trump’s order “significantly damages American leadership in higher education and research” and calls it “inhumane, ineffective, and un-American.” (Richard Stone and Meredith Wadman, ScienceInsider)

Science Policy

Scientists ‘Partly to Blame’ for Skepticism of Evidence in Policymaking, says AAAS CEO

In addition to access to high-quality technical experts to handle science-related global crisis, an United States president also needs to believe that scientific evidence is useful in setting government policy says American Association for the Advancement of Science (AAAS) CEO Rush Holt. At the winter meeting of the American Physical Society in Washington, D.C., Dr. Holt remarked how scientists are partly to blame for the decreased priority of scientific evidence in U.S. policymaking.  One potential explanation for this devaluation of evidence may be due to scientists’ way of presenting evidence that is too “condescending and hierarchical. We might say, ‘Let me try to explain this to you. Maybe even you can understand this.’ And that is not very effective. So we are partly to blame,” stated Dr. Holt.

Dr. Holt believes that “reverence for evidence” has been part of the nation’s political discussion since the United States was founded, and traditionally covers both parties. The biggest challenge now will be to try and empower policymakers to think about any scientific evidence presented to them and to evaluate the validity of the conclusion based on the evidence for themselves. (Jeffery Mervis, ScienceInsider)

Public Health

Senate Finance Committee OKs Tom Price, MD, for HHS Chief

The Senate Finance Committee voted 14-0 to approve the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS). All votes were from the Republican members of the committee because 12 Democratic members boycotted the executive session to confirm Dr. Price. Although the committee normally requires at least one member from each party present to reach its quorum requirement, the rule was suspended prior to the vote. Now Dr. Price’s nomination will go before the Senate for a vote, which will only need a simple majority of 51 votes for confirmation. (Robert Lowes, Medscape)

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Written by sciencepolicyforall

February 3, 2017 at 10:01 am

Science Policy Around the Web – January 24, 2017

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By: Leopold Kong, PhD

Landfill by Dhscommtech at GFDL, via Wikimedia Commons

Environment

New Discovery Could Lead to a Safer Solution to Plastic Pollution

Polyethylene terephthalate (PET) is a commonly used resin of the polyester family used in the fibers for clothing and liquid containers. In 2015 alone, 56 million tons of PET was produced. Although recyclable, with 1.5 billion pounds recovered annually in the United States, PET is not biodegradable and is a major presence in landfills. Screening 250 samples of contaminated soil, waste water and sludge from a bottle recycling factory for microorganisms that can grow on PET, a team of Japanese scientists has discovered a bacterium, Idoenella sakaiensis, that can break down this tough plastic. Recently spotlighted as a major breakthrough of 2016 by the American Chemical Society, research on the bacterium continues as scientists seek to unlock the mechanism behind the biodegradation pathway that was previously thought to be impossible. Professor Kenji Miyamoto, one of the study authors, said, “This is the first PET-degrading bacterium found [with potential] to develop a new and nature-friendly system”. (Research Highlights, Keio University).

Biomedical Research

Trump Asks NIH Director Francis Collins to Stay On

Last Thursday, on the eve of the inauguration, the National Institutes of Health (NIH) announced that Dr. Francis Collins has been asked to continue his role as NIH director by the Trump administration for an unspecified time. This eleventh hour development came as Collins received back the letter of resignation he had sent late last year, something all presidential appointees do. If asked to stay on through this presidential term, Collins, part of Obama’s science ‘dream team’, would be the first NIH director since the 1970s to be chosen by two presidents.

Ezekiel Emanuel, a bioethicist at the University of Pennsylvania said, “In general, I think more than eight years has not been a good idea. There’s a cycle, and eight years is hard to have new ideas and new energy.”  Nonetheless, Collins, a National Academy of Sciences member who led the human genome project and a highly vocal Christian apologist, would serve as an effective bridge between the research community and the new Republican administration to secure much needed funding for basic research. Tony Mazzashi, senior director for policy and research at the Association schools and Programs of Public Health in Washington DC said, “ I think everyone in the research community will be thrilled.” (Jocelyn Kaiser, Science)

Public Health

Novavax Starts New Clinical Trial in Bid to Prove Failed RSV Vaccine

Respiratory Syncytial Virus (RSV) is a significant public health burden, infecting almost all children by age 2, with 5 to 20 out of 1,000 requiring hospitalization and with a mortality rate of 8 to 34 out of 10,000. Unfortunately, the development of an effective vaccine has been challenging. In the late 1960s, an RSV vaccine for infants devastatingly failed clinical trials with 80% of children receiving the shot being hospitalized. Recent advances in immunology and the RSV vaccine target has led to a new generation of potentially safer and more effective vaccine candidates from industry giants Novavax, GlaxoSmithKline, Global Vaccines, AstraZeneca and MedImmune. Also being explored is vaccination of expectant mothers to protect infants.

However, the field took a hit last year when Novavax’s candidate vaccine failed its phase 3 clinical trials, resulting in a 30% layoff of its workforce. Nonetheless, last Thursday, the company announced that it has started a new phase 2 trial on older adults in the southern hemisphere.  “We expect the results from this trial to inform the next steps in our older adults program and would ensure we maintain our leadership position in this very attractive market opportunity,” said Stanley Erck, president and CEO of Novavax. (Tina Reed, Washington Business Journal)

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January 24, 2017 at 10:04 am

Science Policy Around the Web – January 20, 2017

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By: Jessica Hostetler, PhD

Climate Change

Earth Sets a Temperature Record for the Third Straight Year

The New York Times reports that scientists named 2016 the hottest year on record. This follows the record set in 2015, which followed the record set in 2014 and marks the first time in history a temperature record was set three years in a row. The data is in agreement from three governmental institutions: the USA’s NOAA and NASA and the United Kingdom’s Met Office. The findings were based on “measurements from ships, buoys and land-based weather stations” used to compute an average global temperature of the earth’s surface. The El Niño weather pattern “released a huge burst of energy and water vapor into the atmosphere” and intensified warming in 2015 and 2016, but scientists agree the upward trend over many years is caused by increasing carbon dioxide and greenhouse gasses in the atmosphere.

The warming increases were particularly pronounced in the arctic with “temperatures in the fall running 20 to 30 degrees Fahrenheit above normal across large stretches of the Arctic Ocean” potentially exacerbating sea ice melting and coastal erosion. The heating of the ocean has implications for rises in ocean levels and increased tidal flooding. The calculations from NASA showed over a half a degree Fahrenheit of warming from 2013 to 2016 which is the largest three-year increase since records were started in 1880 and of “the 17 hottest years on record, 16 have now occurred since 2000.” Both NOAA and NASA will soon report to cabinet members appointed by the Trump Administration, with concerns raised from “agencies about whether their data will now be subject to political manipulation.” (Justin Gillis, New York Times)

Human Research Policy

New Rules Ease Consent Requirements for Scientists Using Patient Specimens

STAT News reports that the outgoing Obama Administration issued new rules on Wednesday, January 18th for conducting research with human participants referred to as the “Common Rule” , which include “stepping back from proposals that would have imposed significant new regulatory requirements on scientists.” Earlier versions of the proposal would have required informed, written consent for the use of biospecimens such as “cells, blood, tumor samples, DNA” etc. that were obtained during medical procedures even if the samples had all identifying information removed. Scientists argued that such a change would stifle research; for instance if researchers wanted to use specimens from a previous study where consent was given for a new study, a new consent would be required which would require tracking down each participant.  This would prove challenging for several new White House initiatives such as the Precision Medicine Initiative or the Cancer Moonshot. The proposed change drew 2100 comments during a 90-day public comment period following release in September 2015, and the Department of Health and Human Services responded by making changes to the proposal. (Sharon Begley, STAT News)

The final rule, as posted by the HHS website, includes the following:

  • The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
  • Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the NPRM has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
  • For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the current rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
  • The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the HIPAA rules.
  • Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • Requirement that consent forms for certain federally funded clinical trials be posted on a public website.

(Sharon Begley, STAT News)

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Written by sciencepolicyforall

January 20, 2017 at 10:58 am