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In the News: Professional Ethics Report Winter 2016

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Chinese Survey Reveals Public Perceptions of Scientists
by Gaurav Dhiman

China’s annual report on science communication revealed how the Chinese public perceived scientists in their country. The survey of approximately 1,000 residents in Beijing, Shijiazhuang, and Chengdu overwhelmingly (90%) expressed doubts about the credibility of scientists appearing in advertisements for consumer products, nearly 33% stated they, “definitely mistrust” them [1].

While the majority of respondents described the image of scientists in their country as “fairly good” or “very good,” respondents who were well-educated and between the ages of 26-35 held a poorer image of scientists. Jin Yi, the report’s co-author, attributed this to the two groups’ inclination to challenge authority and established ideas.

The survey also found that the National Space Administration had the highest public image out of the 14 government organizations listed. In addition, the survey revealed that scientists are perceived to have a relatively weak impact on social life. “Scientists, especially those without administrative positions, rarely play a major role in the final decision of government matters. Scientists are regarded as professional and abstract icons, far away from the daily interactions of society, making it hard for them to win public trust,” the report's authors conclude.

Jin Yi told SciDev.net, “The stereotyped image of present-day scientists has remained at the level of the 1980s. It can even be inferred that science has not been accepted by pop culture and scientists have not entered the public's awareness.” To overcome this, Jin recommends scientists engage more with the public, uphold ethical standards, and increase the production of science-related films and shows.

[1] http://www.scidev.net/global/ communication/news/scientist-salesmen-fail-to-convince-chinese-public.html

Medical Journal Editors Propose Sharing of Clinical Trial Data
by Gaurav Dhiman

The International Committee of Medical Journal Editors (ICMJE) announced a proposal for the responsible sharing of data generated from interventional clinical trials before trial results would be considered for publication [1]. The ICMJE, whose membership includes the editors of The Journal of the American Medical Association (JAMA), The Lancet and the New England Medical Journal, announced the proposal one year after a report by the Institute of Medicine called on stakeholders to address the key challenges associated with sharing clinical trial data so as to “foster a culture in which data sharing is the expected norm” [2].

The ICMJE proposal supports the notion that “Sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of results, an essential tenet of the scientific process. It will foster the development and testing of new hypotheses. Done well, sharing clinical trial data should also make progress more efficient by making the most of what may be learned from each trial and by avoiding unwarranted repetition. It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society” [1]. The proposal includes the following requirements:

  • As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.
  • That authors include a plan for data sharing, including information about where and how the data will be stored as a component of clinical trial registration and consideration for publication.
  • Safeguards to ensure the reasonable rights of investigators and trial sponsors are protected through the following proposals: First, ICMJE editors will not consider the deposition of data in a registry to constitute prior publication. Second, authors of secondary analyses using these shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. Third, they must reference the source of the data using a unique identifier of a clinical trial's data set to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Fourth, authors of secondary analyses must explain completely how theirs differ from previous analyses. In addition, those who generate and then share clinical trial data sets deserve substantial credit for their efforts.
  • If enacted, requirements would be deferred for 1 year to allow investigators, trial sponsors, and regulatory bodies time to plan for their implementation.

The proposal places a strong emphasis on a shared responsibility for successful data sharing, writing “Editors of individual journals can help foster data sharing by changing the requirements of the manuscripts they will consider for publication in their journals. Funders and sponsors of clinical trials are in a position to support and ensure adherence to IPD sharing obligations. If journal editors become aware that IPD sharing obligations are not being met, they may choose to request additional information; to publish an expression of concern; to notify the sponsors, funders, or institutions; or in certain cases, to retract the publication” [1].

However, some skeptics have expressed concerns over the ICMJE proposal. They argue that “a new class of research person will emerge — people who had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited” [3]. These data scientists who analyze the data of others have disparagingly been called “research parasites” and skeptics have expressed their concern with the dynamic shift the ICMJE proposal would have. “How would data sharing work best? We think it should happen symbiotically, not parasitically” [3].

Because many questions and details have yet to be resolved - How will data sharing work? How will appropriate credit be recognized? Who will pay for it? - the ICMJE is encouraging public feedback on the proposed requirements at www.icmje.org until April 18.

[1] http://www.icmje.org/news-and-editorials/M15-2928-PAP.pdf

[2] http://www.nap.edu/catalog/18998/ sharing-clinical-trial-data-maximizing-benefits-minimizing-risk

[3] http://www.nejm.org/doi /pdf/10.1056/NEJMe1516564

Report Concludes Mitochondrial Replacement Techniques to be Ethically Permissible
by Gaurav Dhiman

A committee assembled by the Institute of Medicine of the National Academies of Sciences, Engineering, and Medicine released a report, Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations, supporting clinical investigations of mitochondrial replacement techniques (MRT) in humans as ethically permissible as long as significant conditions and principles are met. The committee found, “that the most germane ethical, social, and policy issues could be avoided through limitations on the use of MRT or are blunted by meaningful differences between the heritable genetic modification on nuclear DNA and that of MRT” [1].

Mitochondrial replacement techniques (MRT) entail the modification of human oocytes and zygotes to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. This is done by creating an embryo with nuclear DNA (nDNA) from the intended mother and mtDNA from a woman with nonpathogenic mtDNA; two primary techniques being considered are maternal spindle transfer and pronuclear transfer. As the committee explains, “If effective, MRT could satisfy the desire of women seeking to have a genetically related child with a significantly reduced risk of passing on mtDNA disease, yet the techniques raise ethical, social, and policy issues” [1].

To address these issues, “the committee recommends that any initial MRT clinical investigations focus on minimizing the future child’s exposure to risk while ascertaining the safety and efficacy of the techniques.” As stated in the report, these initial conditions for clinical investigations of MRT include [2]:

  • Clinical investigations limited to investigators and centers with demonstrated expertise in and skill with the relevant techniques;
  • Limiting clinical investigations to women who are at risk of transmitting a serious mtDNA disease, where the mutation’s pathogenicity is undisputed, and the clinical presentation of the disease is predicted to be severe, as characterized by early mortality or substantial impairment of basic functions; and
  • Transferring only male embryos for gestation to avoid introducing heritable genetic modification during initial clinical investigations.

In addition to proposing several conditions for initial investigations, the report recommends principles to guide the potential trajectory of MRT from research to clinical applications. These include: transparency through timely public sharing of information; public engagement; partnership with other regulatory authorities within and outside the US; maximizing data quality; and circumscribed use of MRT; and long-term follow-up of children born as a result of MRT.

The FDA, which would regulate MRT and had requested the report, is prohibited from moving forward due to the language in a budget bill. The omnibus fiscal 2016 budget bill (H.R.2029 - Consolidated Appropriations Act 2016) passed in December 2015 contained language prohibiting the government from using funds for experiments that genetically alter human embryos. The FDA released a statement explaining that the congressional ban prohibits the agency from reviewing applications "in which a human embryo is intentionally created or modified to include a heritable genetic modification. As such, human subject research utilizing genetic modification of embryos for the prevention of transmission of mitochondrial disease cannot be performed in the United States in FY 2016” [3].

In the United Kingdom a law passed early last year made the UK the first country to explicitly allow MRT. The law permits the country’s Human Fertilisation and Embryology Authority (HFEA) to allow the technique to be used in fertility clinics on a case-by-case basis [4].

[1] http://www.nap.edu/catalog/21871 /mitochondrial-replacement-techniques-ethical-social-and-policy-considerations

[2] See the complete list of conditions at: http://www.nap.edu/read/21871/chapter/10#112

[3] https://www.washingtonpost.com /news/speaking-of-science/wp/2016/02/03/to-prevent-disease-ethicists-approve-creation-of-embryos-with-three-genetic-parents/ 

[4] http://www.sciencemag.org/news /2016/02/boys-only-panel-endorses-mitochondrial-therapy-says-start-male-embryos

Researchers Propose Using Big Data to Predict Life Expectancy, Statistically Speaking
by Ellen Platts

Researchers at the University of East Anglia (UEA), Norwich, UK, recently began a project that aims to use big data to predict life expectancy. Professor Elena Kulinskaya of UEA’s School of Computing Sciences will lead the research team that will include technical experts from Aviva, a British multinational insurance company. [1]

The team will develop software tools that identify statistical life expectancy trends, based on primary care data collected during routine medical visits by 3.4 million British citizens. In an interview with CNN, Kulinskaya emphasized the Big Data nature of the project, noting that it was collected over a long period of time and is completely anonymous. [2] Goals of the project include (1) identifying statistical trends in key factors affecting mortality, such as lifestyle and other medical conditions; (2) modeling these trends across time; (3) evaluation of potential future scenarios; and (4) creation of software tools to forecast longevity. [3] Special interest will be placed on how chronic diseases and their treatments play a role in these trends.

The research team says that benefits of knowing predicted longevity include the ability to make more informed healthcare decisions by both physicians and patients, especially regarding the prescription of particular drugs for chronic diseases. Additionally, Kulinskaya noted that predicting life expectancy can provide a framework for planning retirement. She also stressed that the data will only provide estimates on average, not for particular individuals. [1] Though it is assumed that the findings will be used primarily by life insurance companies, they will be available to the public. [2]

The research program is supported by the Institute and Faculty of Actuaries (IFoA) and will receive £800,000 in funding. In August 2015, IFoA published a Call for Research that sought proposals for large scale research projects in actuarial science. This project, entitled “Use of Big Health and Actuarial Data for Understanding Longevity and Morbidity Risks,” was one of three winning proposals, and will become part of the core of IFoA’s newly expanded Actuarial Research Centre. [1]

[1] https://www.uea.ac.uk/about/-/could-a-computer-tell-you-when-your-time-is-up-

[2] http://www.cnn.com/2016/04/01 /health/east-anglia-computer-lifespan-feat/index.html

[3] https://www.actuaries.org.uk/learn-and-develop/research-and-knowledge/arc-actuarial-research-centre/research-programmes/use-big-health-and-actuarial-data-understanding-longevity-and-morbidity-risks

World Conference on Research Integrity Summary Report
by Gaurav Dhiman

The summary report of the 4th World Conference on Research Integrity (WCRI), held between May 31 and June 3, 2015 in Rio de Janeiro, Brazil, was recently released. The conference was attended by over 400 delegates from 42 countries to discuss the overall theme of, Research Rewards and Integrity: Improving Systems to Promote Responsible Research [1]. The conference theme addressed the link between research integrity with the way research is decided on, conducted, reported, and rewarded in the research environment [2].

The summary report of the conference highlights the following topics:

  • The role of research integrity in assessing the quality of research as well as the reward mechanisms adopted by research systems;
  • The reliability of the scientific literature, reproducibility initiatives and their relationship with publication ethics;
  • The types and development of institutional initiatives to handle research misconduct, including consideration of legal issues, such as confidentiality during investigations; and
  • The role of research integrity in the very structure of contemporary science, addressing cultural practices in its publication system, current ethical challenges in peer review and its consequences regarding the reliability of the research record.

The conference also included, for the first time, three pre-conference workshops and a doctoral forum. The doctoral forum gave 10 PhD students working on research integrity related issues the opportunity to consult with a panel of international specialists. Four of the doctoral students were awarded the Excellence in Doctoral Research Award [3].

Started in 2007, the World Conference on Research Integrity was launched in Europe as a combined effort of the European Science Foundation and the US Office of Research Integrity. The first conference raised awareness of the importance of research integrity and globally, the emphasis was on misconduct, its definitions and causes. The second and third conferences – held in 2010 and 2013, respectively – published official statements laying down fundamental principles that support research integrity [2].

The next WCRI will be held in Amsterdam on May 28, 2017. Registration will open on July 1, 2016 and can be accessed at: http://www.wcri2017.org/.

[1] http://wcri2015.org/4WCRI_Rio_2015_Final_Summary_Report.pdf 

[2] http://www.thelancet.com/journals /lancet/article/PIIS0140-6736(15)61005-4/abstract

[3] http://wcri2015.org/excellence-in-doctoral-research-award.html

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Author

Joel Ericsen

Program Assistant