In what is being considered a win for the Canadian scientific community, changes made by Canada’s primary health science funder to its proposal review system are being partially rolled back. On July 13, approximately fifty practicing scientists met with Canadian Institutes of Health Research (CIHR) President Alain Beaudet to discuss reforms to the grantsmaking process, the problems they caused, and the scientific community’s subsequent crisis of confidence in the integrity of the process.
Roughly four year ago, in response to an international review panel, Beaudet introduced three simultaneous reforms to the CIHR funding process, focusing on overhauling funding streams, the process of proposal submission, and the proposal review system. These controversial reforms replaced the previous grant programs with a system that awards two kinds of grants: large “Foundation” grants of up to $1.16 million annually to support open-ended work of individual researchers, and smaller “Project” grants of up to $581,000 annually to fund more focused research projects. 
The reform of gravest concern to the scientific community, however, relates to proposal review, as described in a June 27 open letter to Canada’s Minister of Health Jane Philpott, signed by over 1,300 scientists.  Under the old system of proposal review, panels of experts met face-to-face to discuss the merit of each proposal. Each of the 53 panels was discipline-specific and met annually to rank the proposals in their area of expertise.  Under the reform, CIHR switched to an online review process in which applications are pooled together and assigned to four reviewers, who participate in an “asynchronous” electronic discussion moderated by 140 scientists known as Virtual Chairs. 
Earlier in 2016, the first Project grant competition was held after two previous competitions had been canceled due to lack of funds. According to the open letter, “the majority of this country’s health researchers applied to the latest competition” and CIHR struggled to recruit sufficient reviewers, “at least some of whom were inexperienced or unqualified.”  Though the new system was intended to reduce reviewer fatigue and increase the approvals of multidisciplinary proposals, the online system resulted in reviewers assessing proposals in disciplines completely unrelated to their own.  Additionally, the Virtual Chairs responsible for overseeing the online review discussions “consistently reported that a significant fraction of reviewers simply didn’t participate in the asynchronous, online discussions” and described occasions of poor professional behavior that had not occurred in the previous face-to-face review sessions.  Under the new system, the scientific community lost confidence in the integrity of the selection processes. As stated in the letter, “there is little hope that the best ideas and projects will be funded. [The signatories] posit this represents a fundamental failure of CIHR’s primary mandate.” 
In the June 27 letter, the critics of the reforms called for CIHR to “reinstate expert panel-based reviewing where scientists meet and discuss in person.”  On July 5, Minister Jane Philpott requested that CIHR convene a working meeting with representatives from the research community, calling on CIHR to “ensure that the very best health research across all pillars is funded according to the highest international standards of research excellence.”  At the resultant July 13 meeting, the community representatives were successful in convincing Beaudet to partially reverse the reform of the proposal review system. Instead of a completely online system, CIHR will implement a “hybrid” peer-review system, in which the online system will remove approximately 60% of grants from consideration. The remaining 40% will be considered by the in-person panels of the old system to determine actual winners. Though Beaudet said that during the meeting there was “a strong feeling…that the community can really trust CIHR to do the best possible work in reviewing,” it remains to be seen whether community faith in the fairness and integrity of the review system will be fully restored.  CIHR continues to work on issues regarding the size and membership of the expert panels, the use of teleconferencing in early stage review, and the algorithms used to match applications to reviewers, issues which will need to be resolved prior to the next competition for both “Foundation” and “Project” grants, scheduled for fall 2016.
 http://www.sciencemag.org/news/2016/07/ update-canadas-health-funder-agrees-meet-researchers-outraged-peer-review-changes
The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) released joint guidelines aimed at improving communication between pharmaceutical companies and health professionals.  The guidelines call on the Food and Drug Administration to clarify what information pharmaceutical companies can share with stakeholders beyond the information now found on FDA labels.  These companies often collect data about treatments after they are marketed, so allowing them to share these data with health professionals may lead to better treatment options and care for patients. 
The nine guidelines are focused around three areas: a commitment to science-based communications (increasing access to scientific data and analyses), providing appropriate context about data (ensuring health professionals are informed about emerging data on the safety and effectiveness of treatments) and accurately representing data (communications should be clearly communicated and incorporated into the existing knowledge of the intended audience).  The guidelines state that, “biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of the medications they research, develop, and bring to patients.” 
Both pharmaceutical companies and insurers agree that increased communication could help address the high cost of specialty drugs.  When costly specialty drugs are introduced to the market after insurers have set their rates for the year, it falls to the insurer or the patient to pay for the drug.  Regulations regarding how much communication insurers and pharmaceutical companies can have about drugs that have yet to hit the market are unclear.  This includes information gathered before and after a drug is approved that is not included on the label.  Currently, the “very limited safe harbors” of sharing information outside of FDA-approved labeling have prevented discussions from happening, said Jeff Francer, Vice President of Law at PhRMA. 
Francer says the guidelines are intended to guide the establishment of responsible, science-based parameters for accurate information-sharing under a modernized regulatory framework.  He adds that updates to the federal regulations governing information-sharing should reflect the rapidly evolving science, and increased pace of the development and understanding of innovative treatments.  When information outside of an FDA label is shared, the guidelines urge that the data be held to high standards, be scientifically sound, and include details about a study’s design in order to benefit patient care. The guidelines state that “the wealth of information about medicines is more comprehensive and complex than ever before. Scientific knowledge and new findings go far beyond data sets produced from clinical trials, often are outside the scope of the parameters established by the Food and Drug Administration regulations, and often outdate the FDA-approved labeling.”  Francer argues that removing current regulatory barriers and clarifying the ability of a pharmaceutical company to share information will ensure the physicians are well informed and patients receive the optimal treatment. 
Consumer genomics company 23andMe has launched a new platform to integrate its services into clinical trials.  The Genotyping Services for Research program (GSR) makes widely available the services that 23andMe has provided on an ad-hoc basis to research institutions for some time.  GSR offers researchers the capacity to collect genetic data from their study participants by outsourcing all aspects of the collection, analysis, and data processing to 23andMe. There is increasing interest in integrating genetic information into clinical research, but many researchers may not have the background, personnel, equipment, or funds to collect those data.
23andMe anticipates that the option to receive personalized DNA results will incentivize people to take part in clinical trials, an added benefit to researchers. Researchers will cover the cost of the tests, and 23andMe will send saliva kits directly to participants or to the clinical trial site. Participants will then submit saliva samples to 23andMe, and receive individual results directly from the company by email. The genotypic analysis that 23andMe performs produces details of phenotypic traits, ancestry, and carrier status – whether an individual possesses a genetic variant that will make offspring more likely to inherit a genetic disorder such as sickle cell anemia or cystic fibrosis.
Researchers will access participants’ genotypic data through a GSR portal, to be curated, downloaded, and analyzed. They cannot interpret data for diagnostic purposes or to offer medical care. In addition to consenting to an IRB-approved trial in the first place, participants must also give consent for 23andMe to share their personal data with the research study, and may also consent to contributing anonymized data to 23andMe’s proprietary database. As a result, the GSR service has the potential to dramatically increase the overall size of the 23andMe data set.
Through its successful direct-to-consumer model, 23andMe now has information on the DNA of over one million individuals. In a highly publicized disclosure about its data-selling practices, 23andMe reported that it struck a deal with Genentech for access to aggregated data about Parkinson’s patients for $10 million.  The same protections for 23andMe commercial customers will apply to study participants using the GSR model. 23andMe will not share individuals’ data with third parties, nor use the data for in-house research, without explicit consent.  All data collected through the GSR comes from patients who have already consented to IRB-approved trials.
Americans are concerned by potentially negative impacts of new biotechnological innovations, and yet they expect these technologies to be widespread within the next 50 years, according to a new Pew Research Center study. Researchers surveyed almost 5000 people to explore public attitudes towards scientific breakthroughs that may change what it means to be human. They found that the majority of Americans fear that new technologies to make humans stronger, smarter, and healthier will increase inequality, and be implemented without sufficient understanding and oversight. Pew published a detailed report of its findings in July, which concludes that on the topic of human enhancement “concern outpaces excitement.” 
Pew defined enhancement as “biomedical interventions intended to increase human abilities.”  The survey posited three hypothetical enhancements not currently available to the public, but all of which are currently undergoing research and development for therapeutic applications. The forecasted scenarios were using gene editing to reduce the risk of serious diseases in infants, implanting computer chips in the brain to improve cognition, and introducing synthetic blood into the body to improve physical capabilities. Respondents were closely divided over whether these technologies constituted “meddling with nature,” or were merely a new approach to current methods of human improvement, with well over two-thirds stating they morally opposed these enhancements or were unsure of their morality.  The most common moral objections were that the proposed enhancements were “disrupting nature” and “changing God’s plan.” 
While responses did not vary significantly by race, geographic region, class, or age, there were trends related to sex and religion. Women tended to anticipate greater negative impacts on society from human enhancements, and were more wary than men of embracing the three technologies proposed by the survey. Religious commitment was also correlated with wariness about potential enhancement, with the most religious respondents tending to see enhancements as interfering with the natural order.  The survey results also demonstrated that people would view enhancements in a more positive light if their effects were temporary or could be controlled by the individual recipient. 
To gain deeper insight into how Americans develop perspectives on the morality of scientific breakthroughs, Pew conducted a series of focus groups that drew from the same nationally representative sample as the survey.  Themes emerging from focus group conversations corroborated the findings of the national survey, but yielded particular insights into how the public views different technologies. For example, the possibility of implanting brain chips raised more concern than gene editing because it would potentially impact individual personalities, rather than overall health. “The brain is precious territory to people,” write the report authors. 
Few individuals had clearly defined ideas about what kinds of technological innovations were and were not morally acceptable. In general, fears about potential negative consequences focused on shifts in society, such as increased inequality between people who have access to enhancements and those that do not, and fundamental changes in interpersonal and professional relationships.  The focus groups also illuminated the sources people draw on when thinking about the future, including sci-fi movies like “Gattaca” and “I, Robot,” specific passages from the Bible, and examples from history. The current controversy around doping in sports commonly surfaced during discussions about the use of synthetic blood to enhance physical performance.  Many participants expressed a lack of trust in “the government” and feared that new technologies would not be appropriately regulated.  Consensus was most broad on the topic of consent. Focus group participants felt strongly that individuals should be able to choose whether or not to receive enhancements. 
In addition to researching public attitudes, Pew also interviewed bioethicists, scientists, and religious biomedical human enhancements. Perspectives ranged from strong condemnation, to cautious optimism, to endorsing “transhumanism,” the movement which champions the acceleration of human enhancement through the application of new technology.  Researchers currently focusing on innovations like synthetic blood and gene editing are by and large working on their therapeutic applications. Many people surveyed by Pew felt that those with the greatest needs should have access to any therapeutic technologies available, but objected to their use in healthy people. Indeed, most Americans think that science is most beneficial to society for its impact on health and medicine, and believe that the net impact of science and technology on society is positive.  This finding is consistent with the results of a 2014 Pew Research Survey on the public’s views on science and society. 
 Pew Research Center, July, 2016, “U.S. Public Way of Biomedical Technologies to ‘Enhance’ Human Abilities,” p. 4
 Ibid, p. 8
 Ibid, p. 16
 Ibid, p. 17
 Ibid, pp. 5-6
 Ibid, p. 25
 Pew Research Center, July 2016, “American Voices on Ways Human Enhancement Could Shape Our Future.”
 Ibid, pp. 17-18
 Ibid, pp. 6-7
 Ibid, p. 18
 Ibid, p. 14
 Ibid, p. 15
 Pew Research Center, July, 2016, “U.S. Public Way of Biomedical Technologies to ‘Enhance’ Human Abilities” pp. 97-98
 Pew Research Center, January 29, 2015, “Public and Scientists’ Views on Science and Society”
A team of British researchers, led by the paleoanthropologist Isabelle de Groote, have found new evidence of the techniques used to create the Piltdown Man, one of the most famous scientific frauds in history. De Groote’s study was published in Royal Society Open Science in early August.  Named for the town of Piltdown, Sussex in the U.K., where the fossils were allegedly excavated, the Piltdown Man was widely accepted as the “missing link” between apes and humans in the fossil record when it first came to light in 1912. The discovery was disproved in 1953, when advances in fossil analysis showed definitively that the bones were less than 1000 years old, comprised of human and orangutan remains, and had been artificially stained and filed to imitate aging.
The latest research used DNA evidence and CT scans to understand how the Piltdown Man was created, and supports the conclusion that the forgery was the work of a single individual – Charles Dawson, the same man who had claimed to discover the fossils. Although he was trained as a lawyer, Dawson was well acquainted with the geological community. Such familiarity would have been crucial in designing the forgery, which catered to geologists’ desire for confirmation of ideas about human evolution based on a small number of fossil remains, and would have validated Dawson’s well-known scientific aspirations.
The forgery satisfied the prevailing theory that a large brain was the distinctive evolutionary development that set humans apart, which has subsequently been shown to be a much later development.  The fraud’s long-standing success exposed the scientific community’s preoccupation with verifying the dominant understanding – especially when skeletal remains subsequently discovered in South Africa were largely ignored because they did not corroborate the Piltdown findings. Nationalism and race also played an important role.  At the time of the Piltdown “discovery,” human ancestors had been found only in Europe, and there was substantial national pride at stake in believing Britain to be birthplace of modern humans, rather than southern Africa. De Groote, the leader of the modern research team, hopes that her findings will reinforce caution against being too quick to accept discoveries that validate or solve long-standing problems. 
Transitional fossils, as “missing links” are known in paleontology, can still be controversial. One of the most well-known is the Archeopteryx, a feathered animal that may evidence the transition between dinosaurs and birds, but whose exact place in the evolutionary tree has been debated since the nineteenth century . In 1999 a triumphant discovery of a fossil definitively linking dinosaurs and birds was soon shown to be a composite of a dinosaur and bird, probably glued together to increase its market value and deemed the “Piltdown bird.” 
De Groote and colleagues write that while transparency is still an issue in paleoanthropology, there is reason to hope that the norms of the discipline are changing. The authors cite the discovery of Homo naledi in South Africa, which has shown “how rapid dissemination of data and replicas, and free access to publications and to the original specimens can create much greater openness in paleoanthropology.” 
 De Groote et. al, Royal Society Open Science 2016 3 160328; DOI: 10.1098/rsos.160328. Published 10 August 2016
 Hecht, Jeff. "Piltdown Bird." New Scientist Archive 165.2223 (2000): 12.
NIH announced a plan to lift its moratorium on research that combines human stem cells with animal embryos on August 14, 2016.  Scientists using this technique are interested in a variety of experiments--from growing human tissues and organs in animals, creating disease models, or studying human development.  The NIH moratorium had been in place since September 2015 , during which time NIH considered the ethical concerns associated with chimera research, and hosted a workshop on the topic on November 2015. The subsequent NIH policy was subject to a 30-day public comment period. At the end of this period, the agency released an FAQ document addressing the most common concerns with chimera research.  The agency expects new experiments to begin next year.
An internal steering committee at NIH composed of scientists, ethicists, and animal welfare experts will now review proposals for chimera research. The revised policy focuses specifically on primate stem cells and chimera breeding, and tightens previous rules rather than creating new ones. The first change is to mandate that no human embryonic stem cells or cells derived from adult tissues may be integrated into non-human primate embryos, whereas previously early-stage primate embryos were exempt. The second is to prohibit breeding of animals where the introduction of human cells may create human egg or sperm.  The Catholic community has voiced some opposition to the changes, but scientists have been largely supportive of the new rules.