By: Nivedita Sengupta, Ph.D.
The Common Rule and human testing
Science academies blast US government’s planned research-ethics reforms
The ultimate advancement in human health and welfare depend on research with human subjects. To achieve this, properly controlled studies with human subjects is imperative for eliminating abuse of human subjects and proper protection of the data. To address these concerns the “Common Rule” was established in 1991 influenced by the Belmont Report, a 1978 document which laid out principles for ethical research with humans, such as minimizing patient harm and maximizing the benefit to society. The ‘Common Rule’ is the current human subject regulation policies which addresses ethical issues such as informed consent, storage of study participants’ biological specimens and many others. However with technological advances over time, achieving these goals has become more complicated and thus imposes difficulties in maintaining patient privacy. Hence in September, 2015 the US government proposed revisions for regulations governing studies of human subjects.
Recently however, an independent advisory panel proposed that the US government’s proposed overhaul of the Common Rule is flawed and should be withdrawn. On June 29th the US National Academies of Sciences, Engineering and Medicine said that the government’s proposed changes are “marred by omissions and a lack of clarity”. They indicated that it would slow down research and will do little to improve protections of patients enrolled in studies. The panel recommended that the government should appoint an independent commission to craft new rules for such research.
The changes proposed by the US Department of Health and Human Services (HHS) attempted to address concerns that have arisen since the ‘Common Rule’ was established. For instance, the HHS reforms suggests a requirement for participants’ consent to use stored samples, such as blood or tissue, for future research. But the US academies’ panel pointed that the new consent requirements would slow research unnecessarily because little harm is likely to come to a person as a result of the use of stored samples. Moreover the extra consent forms can link the samples to the person’s name and thus increasing risk of identification.
Currently HHS is reviewing more than 2,100 public comments to its proposal and many of these comments were critical. However, the US academies’ panel says that the proposal should be scrapped and HHS should start fresh by appointing an independent commission to recommend reforms for the Common Rule. Meanwhile an HHS spokesperson said that the government is still pondering over the public’s comments and the report. She adds that the proposal comes after “many years of work,” and “that starting over would require many more.” (Sara Reardon, Nature News)
Beat it, impact factor! Publishing elite turns against controversial metric
Journal Impact factor (JIF) – one of the most promoted and controversial metric system in the field of science is currently facing negative reviews from the scientific community. Impact factor is a measure of the average number of citations that articles published by a journal in the previous two years have received in the current year which is calculated by various companies. It is solely aimed to indicate the quality of journals said Heidi Siegel, a spokesperson for Thomson Reuters, the major publisher of JIFs. However, the irony is researchers often use the JIF to judge individual papers instead and in some cases even the authors.
On July 5th, several leading science publishers posted a paper to the preprint server bioRxiv asking all journals to consider a different metric which will capture the range of citations that a journal’s articles acquire. Also the American Society for Microbiology in Washington DC announced its plans to discard impact factor from its journals and website, and also from marketing and advertising.
Stephen Curry, a structural biologist at Imperial College London and also the lead author on the bioRxiv preprint paper said that sadly many researchers evaluate papers by the impact factor of the journals and this can also influence decisions made by hiring committees and funding agencies. Curry’s team highlighted some limitations by plotting the distribution of citations (used to calculate the 2015 impact factors) for articles published in 2013–14 in 11 journals, including Science, Nature, eLife. They showed that most of the papers gathered fewer citations than the impact factor for the journal: 74.8% of Nature articles were cited below its impact factor of 38.1, and 75.5% of Science papers were cited fewer than 35 times with its impact factor of 34.7. Highly cited papers are the cause of this disconnect as Nature’s most cited paper in the analysis was referenced 905 times and Science’s 694 times. Curry and his team highly recommends the use of citation distribution curves instead of JIF as it provides a more informative snapshot of a journal’s standing.
However, Ludo Waltman, a bibliometrics researcher at Leiden University in the Netherlands, thinks that citation distributions are more relevant than impact factors for making decisions in hiring and promotion. But he feels that impact factors can be useful for researchers in some cases. Nonetheless anti-impact-factor campaigners believes that it will take time and pressure from various directions to diminish the influence of impact factor as it has become a cultural thing in the scientific field. (Ewen Callaway, Nature News)
Brain research advancements
Human brain mapped in unprecedented detail
Neuroscientists have long sought to divide the brain into smaller pieces to better appreciate how it works as a whole. On July 20th, Nature published the new unprecedented map of the brain’s outermost layer — the cerebral cortex — subdividing each hemisphere and valley-like folds into 180 separate areas. Ninety-seven of these areas have never been previously described despite showing clear differences in structure, function and connectivity from the neighboring areas.
“Until now, most brain maps were based on a single type of measurement which provides an incomplete view of the brain’s inner workings” says Thomas Yeo, a computational neuroscientist at the National University of Singapore. This new map is based on multiple MRI measurements which measures the flow of blood in response to different mental tasks, which Yeo says “greatly increases confidence that they are producing the best in vivo estimates of cortical areas.”
The map was constructed by a team of people led by neuroscientist Mathew Glasser at Washington University Medical School. They collected imaging data from 210 healthy young adults participating in the Human Connectome Project, an National Institutes of Health-funded initiative to map the brain’s structural and functional connections. They collected information of cortical thickness; brain function; connectivity between regions; topographic organization of cells in brain tissue; and levels of myelin — fatty substance that speeds up neural signaling. The borders on the map was delineated by areas which showed significant changes in two or more of these properties. Analysis of all the data confirmed the existence of 83 previously reported brain areas while identifying 97 new ones. Scientists further tested the map generated by Glasser and his team, and found it accurate by looking for these regions in the brains of additional 210 people. But the size of the areas varied from person to person and these differences may reveal new insights into individual variability in cognitive ability and opens up the possibility to explore further the unique intersection of individual talents with intellectual and creative abilities.
But the map is limited in some important ways as it reveals little about the biochemical basis of the brain and about the activity of single neurons or small groups. However, Glasser says that “We’re thinking of this as version 1.0, that doesn’t mean it’s the final version, but it’s a far better map than the ones we’ve had before.” (Linda Geddes, Nature News)
Have an interesting science policy link? Share it in the comments!