On November 6, recently elected Canadian Prime Minister, Justin Trudeau, revoked the rules and regulations muzzling Canadian government scientists and experts, allowing them to speak freely about their work. Scientists can now speak to the media about their work without first having to seek approval.
In 2006, the Conservative government, led by Stephen Harper, introduced strict procedures on how government scientists could speak about their research to the media. Scientists who worked for the federal government were required to get pre-approval from their minister’s office before speaking to members of the national or international media. In addition, journalists had to go through government communications officers wanting to know the line of questioning in advance.  This led to journalists not having access to experts soon enough to report on the news or being denied all together. The increase in bureaucracy and scientific restriction frustrated many Canadian scientists, leading to protests,  a 2013 investigation by Canada’s information commissioner (which was still ongoing as of October 2015),  and even a protest song by federal scientists who were subsequently placed on administrative leave. 
The change in policies was announced by Minister of Innovation, Science, and Economic Development Navdeep Bains, who said in a statement , “Our government values science and will treat scientists with respect. That is why government scientists and experts will be able to speak freely about their work to the media and the public. We are working to make government science fully available to the public and will ensure that scientific analyses are considered in decision making.”
Increasing scientific freedom by reversing many of the policies enacted by the Conservative Party was a major component of the Liberal Party platform in the recent election.  In addition to unmuzzling scientists, Prime Minister Trudeau created positions for two ministers responsible for science. Kirsty Duncan was appointed to the newly established post of Minister of Science and Navdeep Bains was appointed to the newly renamed post of Minister of Innovation, Science, and Economic Development. Trudeau is also expected to appoint a Chief Science Advisor, a position which only existed from 2004-2008 in the Canadian government. 
European Report Advises on Contentious Gain of Function Research
by Gaurav Dhiman
A new report, “Gain of function: experimental applications relating to potentially pandemic pathogens,” published on October 21, 2015 by the European Academies’ Science Advisory Council (EASAC) explores the critical issues of contentious research involving gain of function studies. Those issues include: self-governance and scientific responsibility based on codes of conduct; benefit–risk assessment; consistency in research review and management systems; harmonizing good practice; bioethics; addressing scientific concerns; global regulation; dissemination of results; biosecurity; and public engagement.
In genetic gain of function (GoF) studies, genes are experimentally modified to analyze the link between genotype and phenotype. Recent GoF studies to modify avian influenza of subtype H5N1 have been controversial, raising concerns over biosafety and biosecurity, leading to the United States instituting a de facto moratorium on specific research in 2014.  European scientists have also expressed their concerns over the benefits and risks of such research.
The report’s recommendations and conclusions are organized under eight categories to address the critical issues raised; the main recommendations under these categories are as follows:
- Self-regulation and harmonization: We endorse the commitment to good practice that is already in place in Member States, exemplified in our report, and which depends on: (1) conforming with regulations and codes of conduct; (2) justification of research to funders and peers on a case-by-case basis; and (3) attention to safety conditions according to established procedures of biorisk management.
- Benefit–risk assessment: Assessments cannot be regarded as a ‘once and for all’ calculation but, rather, as a continuing, collective commitment to understand and communicate the issues.
- Collating information on biosafety and biosecurity procedures already in place: Building a commitment by researchers and their institutions to sharing information.
- Are new biosafety and biosecurity bodies required? There is no need for a new advisory body at the EU level; however, all Member States should have a clear national advisory approach.
- Should there be a repository of data on key studies for collective learning: The notion of a collective repository is interesting, but there are practical problems. For example, it may be difficult to define the limits on the scope of studies to include in the repository.
- Publication of sensitive information: Continuing the current procedure whereby many journals seek appropriate advice.
- Public engagement: Academies and others in the scientific community should actively participate in public dialogue, articulating objectives for research, the potential for benefits, and the biorisk management practices adopted.
- Global Context: Further consideration should be given to the proposal in the Fink report for an international forum to sustain dialogue between the life sciences and policymaking communities, and with other stakeholder involvement. 
International Bioethics Committee Report on Human Genome and Human Rights
by Gaurav Dhiman
The International Bioethics Committee (IBC) of UNESCO published a report on October 2, 2015 updating its reflection on the human genome and human rights. Following an introduction of the topic, the report addresses the ethical challenges of recent advancements in human genetics, followed by practical recommendations for five selected areas of application: direct-to-consumer tests and non-health care related analysis, precision/personalized medicine, biobanks, non-invasive prenatal testing, and emerging techniques for engineering gametes and editing the human genome. The report concludes with the IBC’s final recommendations on moving forward responsibly with human genomics.
The IBC report details five ethical principles, balancing the challenges of regulations to protect individuals with the freedom of research not to be inhibited by strict regulations:
- Respect for autonomy and privacy: an individual’s genetic data are among the most “personal” data. The individual must consent to any personal genetic data collection;
- Justice and solidarity: genetics promises to offer an unprecedented contribution to improve health care. These advancements should be shared with society as a whole and with the international community; any discrimination has to be avoided;
- Understanding of illness and health: it might be emotionally relieving or, on the contrary, upsetting for an individual to know about his or her genetic endowment. At the same time, behavioral, social, and environmental determinants of health play a crucial role. Underestimation of the complexity of factors influencing health should be avoided;
- Cultural, social and economic context of science: globalization, access to information and growing pluralism strengthen the necessity of deeper reflection on the value, meaning, and direction of science as well as on a legal framework consistent with respect for fundamental human rights;
- Responsibility towards future generations: great and specific attention is required in the field of genome editing.
The report analyzes the ethical challenges of the application, while further developing the ethical principles described previously. It concludes each application’s analysis with practical recommendations for moving forward with a more responsible approach to the technology.
Among the report’s recommendations are the following:
- An international legally binding instrument to ban human cloning for reproductive purposes
- A moratorium on genome engineering of the human germline
- Cooperation on establishing a shared effort and global standard in relation to engineering the human genome
- Adoption of legislation and other measures in order to: ensure that quality-assured information be provided with regard to direct-to-consumer tests, organize health care systems so that the new opportunities offered by precision/personalized medicine be shared with society as a whole, develop a trustworthy form of governance for biobanks, and ensure that genetic screening comply both with the right to autonomous choices and the principles of respect for every human being in her or his uniqueness.
- Consideration of a revision to the existing UNESCO Declarations
- Promoting the use of genetic tests only for health purposes
- Renouncing the pursuit of spectacular experiments that do not comply with the respect of fundamental human rights
- Economic actors and for-profit companies to refrain from circumventing restrictions in a particular country and to comply with principles and regulations that ensure the highest standard of quality and safety.
The full report is posted here: http://bit.ly/1jZfbaL.
Researchers Speak Out Against Proposed Fetal Tissue Ban
by Ellen Platts
State legislation criminalizing the use of fetal tissue is advancing in the wake of the summer 2015 controversy surrounding hidden-camera footage of Planned Parenthood officials discussing researcher requests for fetal tissue. On September 9, a Wisconsin state assembly committee approved a bill that would make it a felony for scientists to use fetal tissue or cells. It is expected to win the support of the full assembly. Science policy analysts predict that this is the first of what will be a series of efforts by states to ban the use of fetal tissue.
Current federal law prohibits the sale of fetal tissue for any profit. The new bill would make it illegal to acquire, provide, receive, or use a body part from a fetus aborted after January 1, 2015 for any purpose, regardless of whether it is for profit or not. Proponents of the bill have said that it targets those taking part in “negotiating and brokering for these body parts.”  An amendment that would have excluded fetal tissue used for research purposes from these regulations was rejected. 
The bill has sparked a vocal response from Wisconsin researchers. In a letter co-signed by 700 University of Wisconsin faculty members, Dr. Michael Sussman writes, “The legislation will simply close off avenues of hope for patients. It will also send a strong message to biomedical scientists and the biotechnology industry that Wisconsin is no place to do business.”  In addition to defending researchers’ belief that their work benefits humanity and helps millions of patients, the letter makes reference to the competitive disadvantages created by the bill. Wisconsin is home to a large biomedical research community that would be adversely affected. Though researchers would still be able to use fetal tissue obtained before January 1, 2015, it is predicted that once the supply of older tissue is depleted, some researchers will leave Wisconsin entirely. 
The Wisconsin Technology Council issued a resolution opposing the bill stating, “The unintended consequences of a unilateral Wisconsin restriction on research would likely be devastating to its efforts to build a high-tech economy. Adoption of research restrictions will send a signal that Wisconsin has a hostile regulatory environment for tech-based research.”  The Council warns that these restrictions would only drive business and talent out of the state, while failing to make a net impact on fetal tissue research elsewhere.
The UW faculty letter notes that research on fetal tissue aided in the development of the polio vaccine, and is currently being used to treat diseases such as cancer, Parkinson’s disease, diabetes, and epilepsy. The letter questions whether legislators have fully considered the ethical implications of banning fetal tissue research, and makes reference to the federal advisory committees that endorsed fetal tissue research under President Reagan and the federal support received under the George W. Bush and Obama administrations. 
Wisconsin is not the only state to introduce legislation on fetal tissue research. Representatives in California and Ohio, among other states, have filed similar legislation.  The Wisconsin bill has been recommended for passage by the Committee on Health and Human Services, but as of December 22 had not been scheduled for a vote by the Senate.
 http://news.sciencemag.org/policy/ 2015/09/proposed-fetal-tissue-ban-raises-alarm-wisconsin-researchers
 http://docs.legis.wisconsin.gov/2015 /proposals/sb260
 http://www.channel3000.com/news /opinion/letter-uw-faculty-group-opposes-bill-banning-use-of-fetal-tissue/34932006
 http://www.sciencemag.org/content /349/6254/1267.full
 http://wisconsintechnologycouncil. com/2015/tech-council-resolution-opposes-proposed-ban-on-legal-fetal-tissue-research
 http://leginfo.legislature.ca.gov/faces /billNavClient.xhtml?bill_id=201520162AB12; https://www.legislature.ohio.gov/ legislation/legislation-summary?id=GA131-SB-203
International Summit Publishes Position Statement on Human Gene Editing
by Gaurav Dhiman
Organized by the US national academies of sciences and medicine, the Royal Society in London and the Chinese Academy of Science, the International Summit on Human Gene Editing was held from December 1-3 in Washington, DC to discuss the scientific, ethical and governance issues associated with human gene-editing. After the meeting, the organizing committee issued a statement on this research and its potential applications, including uses that could alter the human germline.
The statement includes the following four conclusions :
- Basic and Preclinical Research: Basic and preclinical research should proceed, subject to appropriate legal and ethical rules and oversight, on (i) technologies for editing genetic sequences in human cells, (ii) the potential benefits and risks of proposed clinical uses, and (iii) understanding the biology of human embryos and germline cells. If, in the process of research, early human embryos or germline cells undergo gene editing, the modified cells should not be used to establish a pregnancy.
- Somatic Clinical Use: There is a need to understand the risks, such as inaccurate editing, and the potential benefits of each proposed genetic modification. Because proposed clinical uses are intended to affect only the individual who receives them, they can be appropriately and rigorously evaluated within existing and evolving regulatory frameworks for gene therapy, and regulators can weigh risks and potential benefits in approving clinical trials and therapies.
- Germline Clinical Use: It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application. Moreover, any clinical use should proceed only under appropriate regulatory oversight. At present, these criteria have not been met for any proposed clinical use: the safety issues have not yet been adequately explored; the cases of most compelling benefit are limited; and many nations have legislative or regulatory bans on germline modification. However, as scientific knowledge advances and societal views evolve, the clinical use of germline editing should be revisited on a regular basis.
- Need for an Ongoing Forum: The international community should strive to establish norms concerning acceptable uses of human germline editing and to harmonize regulations, in order to discourage unacceptable activities while advancing human health and welfare. We therefore call upon the national academies that co-hosted the summit to take the lead in creating an ongoing international forum to discuss potential clinical uses of gene editing; help inform decisions by national policymakers and others; formulate recommendations and guidelines; and promote coordination among nations. The forum should be inclusive among nations and engage a wide range of perspectives and expertise.
Although the summit highlighted the need to resolve a host of ethical and safety issues before embryos are modified for clinical applications, it did not recommend banning such research.
An open letter by the Center for Genetics and Society signed by over 180 scientists and professionals around the world echoes similar concerns over heritable human genetic modification highlighted at the summit. However, rather than revisiting the issue as one of safety and efficacy, the letter calls for, “a prohibition on such germline modification and a robust and broadly inclusive discussion on the socially responsible uses of this and other emerging genetic technologies.” 
 Conclusions are abridged, to read the full statement go to: http://bit.ly/1QWLlS8
 http://www.geneticsandsociety.org /article.php?id=8999&&printsafe=1
ORI Awards Funding for Seven Projects on Research Integrity
by Ellen Platts
The Office of Research Integrity (ORI) has funded seven grants through its Research on Research Integrity (RRI) program, the most new grants in one year since 2007. The RRI program, started in 2001, supports empirical research on factors that affect research integrity, defined by the ORI as the “use of honest and verifiable methods in proposing, performing, and evaluating research and reporting research results with particular attention to adherence to rules, regulations, guidelines, and commonly accepted professional codes or norms.”  In 2015 ORI funded two research grants and five conference grants.
Both research grants take the form of Phase I grants, during which the investigators aim to “establish project merit and feasibility and to generate preliminary data.”  Successful Phase I grant recipients are eligible to apply for Phase II grants, intended to build upon Phase I results.
The first research grant will “assess scholars’ perceived frequency of a full range of forms of scientific misconduct.”  The study aims to investigate how scholars perceive the seriousness and prevalence of misconduct in research and create a list of survey items that can be used for future research. The second research grant will support the investigation of the frequency and severity of requests presented to U.S. biostatisticians that violate bioethical standards. The investigators will then “explore the patterns of responses to the bioethical violations questions” in order to assess what impact bioethical violations would have on research. 
Five grants were awarded to support conferences across the United States. The conferences focus on the following topics: prevention and management of misconduct related retractions; research integrity at primarily undergraduate institutions; sequestration; survey data fabrications; and research integrity when studying sensitive populations.
More updates on the ORI and its activities can be found on the ORI updates page.
Non-Profit Artificial Intelligence Research Company Launched to Promote Responsible Research
by Gaurav Dhiman
Prominent executives in the technology industry that include Tesla and SpaceX boss Elon Musk, PayPal cofounder Peter Thiel and LinkedIn co-founder Reid Hoffman have backed the non-profit artificial research company, OpenAI.
OpenAI, which launched December 11, specifically aims for responsible artificial intelligence development, “Our goal is to advance digital intelligence in the way that is most likely to benefit humanity as a whole, unconstrained by a need to generate financial return.” 
Recent advancements in areas of machine learning have brought society closer to the extreme possibility of human-level artificial intelligence [2, 3, 4]. As OpenAI recognizes, “It's hard to fathom how much human-level AI could benefit society, and it's equally hard to imagine how much it could damage society if built or used incorrectly.” 
OpenAI seeks to, “have a leading research institution which can prioritize a good outcome for all over its own self-interest.” To do this, “Researchers will be strongly encouraged to publish their work, whether as papers, blog posts, or code, and our patents (if any) will be shared with the world. We'll freely collaborate with others across many institutions and expect to work with companies to research and deploy new technologies.” 
Musk, co-chair of OpenAI, has previously mentioned the possible harm from artificial intelligence, expressing a need to be cautious, telling MIT students that, “If I had to guess at what our biggest existential threat is, it’s probably that.”  Prominent scientists and leaders signed a letter in early 2015 echoing similar possible pitfalls of unchecked AI research. 
 http://www.theguardian.com/ technology/2015/jun/18/google-image-recognition-neural-network-androids-dream-electric-sheep
 http://www.bloomberg.com/ features/2015-preschool-for-robots/
 http://www.theguardian.com/ technology/2014/oct/27/elon-musk-artificial-intelligence-ai-biggest-existential-threat