Journal articles: 'Regulatory Scientists'

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Narayana, D. B. Anantha. "NEED FOR REGULATORY AFFAIRS PERSONNEL DEVELOPMENT." INDIAN DRUGS 57, no. 09 (November 5, 2020): 5–6. http://dx.doi.org/10.53879/id.57.09.p0005.

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Dear Reader, Scientists seldom try to read regulations, let alone understand or interpret them. Most pharmacy students would have studied a subject called Forensic Pharmacy and read the almost bible like book by late Prof. B M Mittal with the same title. Late Mr. KattiShettar, the then Drugs Controller of Karnataka taught me this subject. He used to bring printed cartons, labels, literature while teaching Drugs and Cosmetics Act and Rules in 1970-71. He used to tell me “what kind of research scientist would you become if you don’t know regulations?”

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Woosley, R. L. "Is It Possible for FDA Regulatory Scientists and Industry Scientists to Work Together?" Clinical Pharmacology & Therapeutics 91, no. 3 (March 2012): 390–92. http://dx.doi.org/10.1038/clpt.2011.304.

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Wu, Irene. "Who Regulates Phones, Television, and the Internet? What Makes a Communications Regulator Independent and Why It Matters." Perspectives on Politics 6, no. 4 (November 13, 2008): 769–83. http://dx.doi.org/10.1017/s1537592708081905.

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More political scientists should engage in the debates surrounding regulation of communications networks, the infrastructure on which telecom, media, and Internet services ride. In 1990 there were 14 communications regulators worldwide, by 2007 there were 148. To fulfill World Trade Organization Agreement on Basic Telecommunications commitments, many countries aim to create regulatory agencies that are “independent.” What characterizes independence? Regulators are embedded in a political context that includes three main constituencies : other government institutions, industry, and consumers. Independent regulators are able to take action autonomously from other government institutions and industry while serving as advocates for consumers. In a survey of 18 countries, several traits emerge; a leader who cannot be dismissed arbitrarily, regulatory authority clearly distinct from policymaking, independent funding, minimal staff exchange between regulator and regulated firm, and dedicated support for consumers. It is usually easier for a regulator to be independent if operators are privatized. In a study of 4 countries, independent regulators follow decision-making procedures that give the public notice about proposed rule changes, opportunities to provide comments, and final decisions with explanation. Also, independent regulators have gift, conflict of interest, and post-employment rules, which set ethical standards and expectations for staff.

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DiFranza, Joseph R. "An Overview of Tobacco Addiction for Tobacco Regulatory Scientists." Tobacco Regulatory Science 1, no. 1 (April 1, 2015): 10–23. http://dx.doi.org/10.18001/trs.1.1.2.

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Rees, Hubert L., Jeffrey L. Hyland, Ketil Hylland, Colleen S. L. Mercer Clarke, John C. Roff, and Suzanne Ware. "Environmental indicators: utility in meeting regulatory needs. An overview." ICES Journal of Marine Science 65, no. 8 (November 1, 2008): 1381–86. http://dx.doi.org/10.1093/icesjms/fsn153.

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Abstract Rees, H. L., Hyland, J. L., Hylland, K., Mercer Clarke, C. S. L., Roff, J. C., and Ware, S. 2008. Environmental indicators: utility in meeting regulatory needs. An overview. – ICES Journal of Marine Science, 65: 1381–1386. The utility of environmental indicators in meeting regulatory needs was addressed at an international symposium held in November 2007. This paper summarizes the attributes and range of uses of indicators and highlights key points from theme sessions and a workshop on unifying concepts. The symposium attracted regulators and scientists, who supported the need to promote dialogue during the construction of indicator-based management frameworks and at key stages towards operational use. Scientists expressed willingness to engage with the wider societal context for indicator applications, which is essential to the development of ecosystem-based management. For the latter to be effective, more effort is needed to combine indicators with thresholds to guide management actions and, in the process, to assess the full range of consequences of non-compliance. There are clear benefits to periodic interdisciplinary reviews of progress in this area, and a follow-up event with a regulatory emphasis is suggested.

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Fenwick, NP, and D. Fraser. "The Three Rs in the pharmaceutical industry: perspectives of scientists and regulators." Animal Welfare 14, no. 4 (November 2005): 367–77. http://dx.doi.org/10.1017/s0962728600029705.

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AbstractSix drug regulatory reviewers and 11 pharmaceutical industry scientists were interviewed to explore their perspectives on the obstacles and opportunities for greater implementation of the Three Rs (replacement, reduction, refinement) in drug research and development. Participants generally supported the current level of animal use in the pharmaceutical industry and viewed in vitro methods as supporting, but not replacing, the use of animals. Obstacles to greater use of the Three Rs cited by participants included the lack of non-animal alternatives; requirements for statistical validity; reluctance by industry and regulators to depart from established patterns of animal use; the priority of commercial objectives ahead of the Three Rs; and concern that less animal testing could jeopardise human safety. Opportunities identified for the Three Rs included the development of better animal models including genetically modified (GM) animals; pursuit of more basic knowledge, notably drug action on gene expression; re-use of animals; greater use of pilot studies; using sufficient numbers of animals per test to avoid repeating inconclusive studies; regular review of animal data in regulatory requirements; and following the regulatory option of combining segments of reproductive toxicology studies into one study. In some areas, greater implementation of the Three Rs seemed well aligned with industry priorities, for example, phenotypic characterisation of GM animals and validation of alternative methods. In other areas, wider use of the Three Rs may require building consensus on areas of disagreement including the usefulness of death as an endpoint; the suitability of re-using animals; and whether GM animals and the use of pilot studies contribute to reduction.

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Beaudrie, Christian E. H., Terre Satterfield, Milind Kandlikar, and Barbara H. Harthorn. "Scientists versus Regulators: Precaution, Novelty & Regulatory Oversight as Predictors of Perceived Risks of Engineered Nanomaterials." PLoS ONE 9, no. 9 (September 15, 2014): e106365. http://dx.doi.org/10.1371/journal.pone.0106365.

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Ekeigwe, Abigail, Bethany McGowan, Loran Parker, Steven Byrn, and Kari Clase. "Describing competency requirements for competency-based regulatory sciences education in sub-Saharan Africa – A qualitative systematic review." Pharmacy Education 22, no. 4 (September 18, 2022): 42–62. http://dx.doi.org/10.46542/pe.2022.224.4262.

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Background: Competency-based regulatory sciences education could expand the workforce of regulatory scientists in sub-Saharan Africa. A competency framework is foundational to developing competency-based education. Objective: To identify the entry-level competency requirements of regulatory scientists in sub-Saharan Africa. Method: This research was a systematic review of the literature based on a pre-registered protocol. The research used the "framework synthesis" systematic review model to deductively identify competencies and code them into clusters with NVivo 12 software. Result: Three broad clusters of competencies were identified – enabling behaviours, knowledge, and skills. The knowledge and skills clusters were further subdivided into sub-clusters: the knowledge cluster into administrative, regulatory governance/framework, and scientific knowledge, and the skills cluster into functional and technical skills. Conclusion: The identified competencies will assist in developing an entry-level competency framework required for competency-based regulatory sciences education in sub-Saharan Africa.

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Berman, Micah L., and Annice E. Kim. "Bridging the Gap between Science and Law: The Example of Tobacco Regulatory Science." Journal of Law, Medicine & Ethics 43, S1 (2015): 95–98. http://dx.doi.org/10.1111/jlme.12227.

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In the 20th century, public health was responsible for most of the 30-year increase in average life expectancy in the United States.1 Most of the significant advances in public health (e.g., vaccinations, water fluoridation) required the combined effort of scientists and attorneys. Scientists identified public health threats and the means of controlling them, but attorneys and policymakers helped convert those scientific discoveries into laws that could change the behavior of industries or individuals at a population level. In tobacco control, public health scientists made the groundbreaking discovery that smoking caused lung cancer, but attorneys and policymakers developed and implemented the policies and litigation strategies that helped reduce smoking rates by more than half over the past 50 years.

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Zyryanov, Sergey Mikhailovich, and Anastasia Valentinovna Kalmykova. "Regulation – the area of inter-branch knowledge application." SHS Web of Conferences 118 (2021): 01010. http://dx.doi.org/10.1051/shsconf/202111801010.

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The purpose of the study is to justify the feasibility of using regulatory policy and sectoral scientific tools in the daily activities of regulatory bodies. The study used a wide range of sources containing empirical data reflecting modern theoretical concepts of regulation. The authors used general scientific and special methods of cognition, methods of analysis and synthesis, formal logic, comparative jurisprudence, and interpretation of law. The result of the study was an overview of the points of view of modern scientists on regulation problems and the use of an intersectoral approach. In addition, the article provides a rationale for the need to use an intersectoral approach in regulation; the possibilities of attracting psychologists and criminologists, historians and political scientists have been identified. The novelty of the results obtained is due to the author’s approach to the study of the activities of regulatory bodies and lies in the fact that it has shown that in modern conditions, regulation takes on the character of scientific activity that requires broad knowledge. Currently, in the world practice, there are no examples of the inclusion of criminologists, political scientists, historians, sociologists, and ecologists in the staff structure of regulatory bodies as experts on a wide range of issues that managers have to solve when developing regulatory policy, choosing models, and developing regulatory strategies. Nowadays, all these issues are solved by the heads of regulatory bodies mostly intuitively, guided by their life experience and ideas about what should be done or subjective assessments, which does not contribute to the successful achievement of regulatory goals. Continuation of research on this topic will contribute to the development of theoretical ideas about the activities of regulatory bodies and the development of practical proposals aimed at increasing the efficiency and effectiveness of regulation.

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Varela, Justo Corti. "Synthetic Cells and Their Regulatory Challenges." European Journal of Risk Regulation 1, no. 3 (September 2010): 259–63. http://dx.doi.org/10.1017/s1867299x00000428.

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On May 20th, Professor Daniel Gibson and his team at the J. Craig Venter Institute announced in a paper published in Science the creation of a “chemical synthesis of a living organism”. The researchers have constructed a bacterium's genetic software and transplanted it into a host cell. The resulting organism looked and behaved like the species ruled by the synthetic DNA. The main difference between this technique and traditional biotechnology is that, for the first time in history, scientists have not only manipulated existing DNA but have created synthetic DNA and introduced it into a host organism that had been rebooted previously.

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Duda, Heike, Janina Hesse, Birgit Haschberger, Anneliese Hilger, and Christine Keipert. "The German Hemophilia Registry: Growing with Its Tasks." Journal of Clinical Medicine 9, no. 11 (October 24, 2020): 3408. http://dx.doi.org/10.3390/jcm9113408.

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Hemophilia is a rare heredity bleeding disorder that requires treatment for life. While few therapeutic options were available in the past, multiple recent breakthroughs have fundamentally altered and diversified hemophilia therapy, with even more new therapeutic options forthcoming. These changes are mirrored by significant regulatory and legal changes, which have redefined the role of hemophilia registries in the European Union (EU). This dual paradigm shift poses new regulatory, scientific but also structural requirements for hemophilia registries. The aim of this manuscript is to enumerate these significant challenges and to demonstrate their incorporation into the redesign of the German Hemophilia Registry (Deutsches Hämophilieregister, dhr). To identify the spectrum of hemophilia therapies and the degree of regulatory changes, a horizon screening was performed. Consequently, a core dataset for the dhr was defined by harmonization with regulatory guidelines as well as other hemophilia registries and by heeding the needs of different stakeholders (patients, clinicians, regulators, and scientists). Based on this information, a new registry structure was established, which is optimized for capturing data on new and established hemophilia therapies in a changing therapeutic and regulatory landscape

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Vasiliev, Anton, and Yulia Pechatnova. "The Legal Status of Scientists in Russia and Abroad." Science Governance and Scientometrics 16, no. 4 (December 30, 2021): 523–40. http://dx.doi.org/10.33873/2686-6706.2021.16-4.523-540.

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Introduction.The article examines the ambiguity of the terms ‘scientist’, ‘research associate’ etc. in Russia and abroad, indicates the absence of a clear, regulation-backed definition of the concept of ‘scientist’ and emphasises the imperfection of the doctrinal approach to defining this term, reflected in the model legislation in particular. The study aims to analyse the legal status of scientists in Russia and abroad, considering the regulatory ambiguity and the existence of numerous adjacent terms. Methods.The methodological basis of the study is represented both by general scientific methods and specialised (legal) methods, as well as a set of concepts, approaches and principles relevant to the legal regulation of the status of actors involved in research activity in Russia and abroad. We also use the comparative legal method, which helps us draw a parallel between the legal status of Russian and foreign scientists. In turn, the formal legal method gets applied while analysing the current legislation and doctrinal approaches to the legal meaning behind the term ‘scientist’ and adjacent categories. The methods used do have some notable limitations: for instance, it is impossible to fully apply the formal legal approach.Results and Discussion.Based on the results of the study and assessment of the opinions of researchers that have already discussed similar issues, we arrive at three main conclusions. Firstly, in order to make terminology legally unambiguous, clear distinctions must be drawn between the names of essential science-related professions: scientist, researcher, educator etc. Secondly, the development of international research collaboration requires unified global standards that determine the legal status of scientists. Thirdly, we suggest improving the system of science funding to prevent the ‘drain’ of research personnel.Conclusion.We emphasise that the ongoing modernisation of national legislation on science is already making progress in bringing the legal status of scientists in Russia in line with international standards. That said, so far, the results of the work done indicate only superficial terminological borrowings, without any significant content processing.

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Doern, G. Bruce, and Ted Reed. "Science and scientists in regulatory governance: a mezzo-level framework for analysis." Science and Public Policy 28, no. 3 (June 1, 2001): 195–204. http://dx.doi.org/10.3152/147154301781781480.

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Podobed, Natalia, and Vitalii Podobed. "MAIN REGULATORY LEGAL ACTS ON LABOR PROTECTION IN FISHING." Fisheries 2020, no. 6 (December 7, 2020): 73–76. http://dx.doi.org/10.37663/0131-6184-2020-6-73-76.

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The article analyzes regulatory legal acts on labor protection in fishing. The article presents the shortcomings and comments of leading organizations and scientists on the software rules labor protection in the production and processing of fish and seafood. Recommendations for development and improvement of regulatory legal acts on labor protection in fishing.

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McAllister, Mark, Talia Flanagan, Karin Boon, Xavier Pepin, Christophe Tistaert, Masoud Jamei, Andreas Abend, Evangelos Kotzagiorgis, and Claire Mackie. "Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives." Pharmaceutics 12, no. 1 (December 23, 2019): 19. http://dx.doi.org/10.3390/pharmaceutics12010019.

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A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that were involved in product development shared their experiences with in vitro dissolution and in silico modeling approaches to establish clinically relevant dissolution specifications. The regulators shared their perspectives on the acceptability of these different strategies for the development of acceptable specifications. The meeting also reviewed several collaborative initiatives that were relevant to regulatory biopharmaceutics. Following the scientific presentations, a roundtable session provided an opportunity for delegates to discuss the information that was shared during the presentations, debate key questions, and propose strategies to make progress in this critical area of regulatory biopharmaceutics. It was evident from the presentations and subsequent discussions that progress continues to be made with approaches to establish robust CRDS. Further dialogue between industry and regulatory agencies greatly assisted future developments and key areas for focused discussions on CRDS were identified.

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Christian, Mildred S. "Differences in International Regulatory Needs and Approaches." Journal of the American College of Toxicology 9, no. 1 (January 1990): 21–25. http://dx.doi.org/10.3109/10915819009078714.

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The purpose of this symposium is to educate the scientists working in the various areas of research and regulation in developmental and reproductive toxicology regarding differences and commonalities in regulatory needs and concerns. Multiple agencies and professional societies are attempting to develop guidelines for performing safety evaluations that will allow single tests to meet the requirements of more than one agency in order to reduce animal usage and decrease testing costs. This presentation, and the two that follow, describe some of the problems addressed, the approaches used, and the current regulatory requirements of Japan and the U.S. EPA.

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Klein, Agnes Victoria, Jian Wang, Brian G. Feagan, and Mark Omoto. "Biosimilars: State of Clinical and Regulatory Science." Journal of Pharmacy & Pharmaceutical Sciences 20, no. 1 (September 12, 2017): 332. http://dx.doi.org/10.18433/j3vk90.

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On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada. An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists. Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace.

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Krylov, Denys, and Anton Chub. "THE CONCEPT, ESSENCE AND ROLE OF REGULATORY POLICY INECONOMY DEVELOPMENT." Scientific bulletin of Polissia, no. 1(22) (2021): 6–15. http://dx.doi.org/10.25140/2410-9576-2021-1(22)-6-15.

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The article proves that the main controllers of the effectiveness of regulatory policy are independent analitical centres, business associations and other non-governmental organizations. As reasons for the low quality of legal support, it is noted the complete secrecy of public authorities from citizens during the submission, discussion and decision-making.The main task of the study is to analyze the experience gained and generalize the existing conceptual framework to determine the nature and role of regulatory policy in the development of a market economy.It was found that from the point of view of system analysis and methodology of functional modeling, the control system of the object of public administration is called the regulator and provides its adaptive properties through feedback. Since public administration organizations cannot physically regulate the activities of all business entities without exception in the manual mode, the regulatory framework at the macro level is the regulatory field. This determines the rules of the market, the rights and obligations of all parties, as well as the relationship between them. At the same time, in the frameworkof the implementation of state regulatory policy, the existing regulatory framework is in itself an object of management. The regulator, in this case, are state bodies endowed with these functions, in accordance with the Law of Ukraine.The work provides a complex dynamic system with several levels of government: the first level of government, directly represents the state regulatory activity, where the object is the regulatory field, and the regulator -government agencies; the second level of management provides socio-economic development in the desired direction, where the object is the national economy or its individual sectors, small businesses, etc. Accordingly, the regulator is represented by the existing regulatory framework. The future formalization of this approach in the definition of regulatory policy will establish a causal relationship between public administration and economic development and ensure the effectiveness of such activities. The scientific novelty of this work is the further development of the concept and role of regulatory policy in ensuring the effective development of the economic system based on the analysis of research results of domestic scientists, which in contrast to existing tools state regulatory activity and strategic development of the country.

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Semendeferi, Ioanna. "Legitimating a Nuclear Critic: John Gofman, Radiation Safety, and Cancer Risks." Historical Studies in the Natural Sciences 38, no. 2 (2008): 259–301. http://dx.doi.org/10.1525/hsns.2008.38.2.259.

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Whether low-level ionizing radiation has an effect on humans has been a polarizing issue for the last fifty years. The epicenter of this controversy has been the validity of the linear non-threshold dose-response model, according to which any amount of radiation, however small, causes damage to human genes and health. In the late 1960s and early 1970s, the nuclear scientist and medical researcher John Gofman (1918––2007) played a pivotal role in the debate. Historical accounts have treated Gofman as a radical antinuclear scientist whose unscientific arguments put enormous political pressure on the nuclear power industry and regulatory agencies. Gofman's bitter struggle with the Atomic Energy Commission, which funded his research at Lawrence Livermore National Laboratory, partly accounts for this view. However, my analysis of Gofman's involvement in the low-level radiation debate shows how he also helped shift the focus in radiation safety from the risks of genetic damage or leukemia to somatic or cancer risks. His arguments led to the introduction of the linear nonthreshold radiation model as a means of numerically estimating cancer risks. This was a watershed event in radiation-safety science and politics. Gofman's case sheds light on the process by which a scientist could secure legitimation even when his technical arguments threatened the government's interests. I conclude that it also points to an open issue in the history of antinuclear scientists, or of other politically active scientists or technology critics: treating them as critics should not preclude historians from treating them as scientists.

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McAllister, Mark, Talia Flanagan, Susan Cole, Andreas Abend, Evangelos Kotzagiorgis, Jobst Limberg, Heather Mead, et al. "Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series." Pharmaceutics 14, no. 5 (May 7, 2022): 1010. http://dx.doi.org/10.3390/pharmaceutics14051010.

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A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scientists, together with regulatory and academic scientists, came together through a series of six webinars, to discuss progress in the field, emerging trends, and areas for continued collaboration and harmonisation. Each webinar also hosted a Q&A session where participants could discuss the shared topic and information. Although it was clear from the presentations and Q&A sessions that we continue to make progress in the field of CRDSs and the utility/success of PBBM, there is also a need to continue the momentum and dialogue between the industry and regulators. Five key areas were identified which require further discussion and harmonisation.

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Staff, Nathan P., Bethany Kinseth Runge, and Anthony J. Windebank. "Breaking Down Translation Barriers: Investigator’s Perspective." Science Translational Medicine 6, no. 252 (September 3, 2014): 252cm7. http://dx.doi.org/10.1126/scitranslmed.3008252.

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23

Whitehouse, Peter. "Regulatory Perspectives: One Academic Viewpoint From the United States." International Psychogeriatrics 15, S1 (July 2003): 277–81. http://dx.doi.org/10.1017/s1041610203009335.

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The development of new drugs to treat vascular dementia and other conditions in which cognitive impairment is due at least in part to vascular pathology will require future interaction among academic, industry, and government regulatory clinicians and scientists. This article offers the author's perspective on the positive involvement of the Food and Drug Administration in development of conceptual frameworks and practical approaches to treatment of conditions characterized by vascular burden of the brain.

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Gupta, P. D. "Functional Interdependency between Intestinal Microbiota and Biological Clock." New Medical Innovations and Research 2, no. 3 (May 3, 2021): 01–04. http://dx.doi.org/10.31579/2767-7370/015.

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In the human body, practically all organs work in coordination in co-operation with other organs since they are regulated by neurological, hormonal, environmental signals. Scientists have lately found out another regulatory factor the intestinal microbiota. The quality and the quantity of microbiota are also dependent on many internal and external factors. The composition of the intestinal microbiota also affects those systems which are regulated by circadian rhythms, in other words, circadian rhythms and microbiota is a two-way street. In this review, we have discussed the cross-talk between these two regulators.

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Singh, Supriya. "Research Ethics for Social Scientists: Between Ethical Conduct and Regulatory Compliance [Book Review]." Qualitative Research Journal 8, no. 1 (2008): 85–86. http://dx.doi.org/10.3316/qrj0801085.

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Vasconcelos, Vitor, Mafalda Batista, Rosa Cianca, Joana Azevedo, and Marisa Silva. "103. Emergent Marine Toxins in Europe: New Challenges for Scientists and Regulatory Authorities." Toxicon 60, no. 2 (August 2012): 147. http://dx.doi.org/10.1016/j.toxicon.2012.04.104.

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Matijašević, Martin, and Dejan Kostić. "Regulatory framework in the field of environmental protection." Biljni lekar 50, no. 1 (2022): 48–55. http://dx.doi.org/10.5937/biljlek2201048m.

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Regardless of the existence of significant differences at the national and regional level, plans, programs, actions and improvements in environmental protection are a global problem, which requires global solutions. Modern society must faster and better understand the warning of scientists and experts about the state of the environment, ie. the fact that there are fewer and fewer free, original and unpolluted environments, with a staggering tendency to further decline. On the other hand, the endangered, degraded and devastated ones are more and more, with a tendency to grow and much faster than it seems at first glance, faster than the science from the end of our century could have imagined. At the same time, it is important to point out that by disturbing the ecological balance and ecosystem, the future of man and his survival is endangered. The subject of the analysis is the legal regulation of environmental protection in the Republic of Serbia and the European Union, both in the theoretical and practical domain of its application, and therefore special attention will be paid to regulations in the field of environmental protection.

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Graham, John. "Scientists Debate Nuclear Source Terms." Journal of the IEST 28, no. 6 (November 1, 1985): 17–23. http://dx.doi.org/10.17764/jiet.1.28.6.9576573654361842.

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The nuclear source term, defined as the quantity, timing, and characteristic of the release of radioactive material to the environment following a core-melt accident, was thoroughly debated in 1985. This debate, summarized here, turns on the Nuclear Regulatory Commission's (NRC) source term for radioactive iodine, which is postulated as potentially the most life-threatening radionuclide that might escape in a nuclear power-plant accident. A generic radioiodine source term has been used by NRC as the surrogate for all others; thus, it has become one of the bases on which nuclear-safety regulations are founded. Following the Three Mile Island (TMI) accident, from which only traces of radioiodine escaped, scientists began arguing that nuclear regulations based on source-term calculations are erroneous and should be modified. The American Nuclear Society (ANS) and industry researchers have concluded that warranted reductions in the NRC source terms could range from a factor of ten to several factors of ten in most accident scenarios. The American Physical Society (APS), after agreeing with a large body of the conclusions from the other research groups, has told NRC that its source-term data base is still inadequate because of the existence of a number of uncertainties it found therein. Although APS presented no such conclusion, its findings made clear to NRC that an early reduction of all source terms is not warranted. The anti-nuclear lobby agrees with APS. The NRC has taken a cautious, conservative approach to the revision of its regulations based on new source-term data, although it too concedes that its old methodologies and conclusions must be revised and ultimately superceded.

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Song, Runxian, Faujiah Nurhasanah Ritonga, Haiyang Yu, Changjun Ding, and Xiyang Zhao. "Plant Melatonin: Regulatory and Protective Role." Horticulturae 8, no. 9 (September 3, 2022): 810. http://dx.doi.org/10.3390/horticulturae8090810.

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Melatonin is an antioxidant that is widely distributed in plants and animals. It is a conservative molecule. In early studies, scientists often used isolation and identification techniques to observe whether the endogenous melatonin cycle in plants was related to the external photoperiod, plant growth, and development cycles, including seed germination, plant rooting, and floral induction. With the development of isolation and identification technology, there is ample evidence that plants possess a variety of melatonin-synthesis pathways. The comprehensive application of molecular biology, genomics, and computational biology has also led to a comprehensive understanding of the physiological functions of plant melatonin. In this paper, we not only highlight the candidate genes from Arabidopsis thaliana and Oryza sativa that might be contributing to increasing plant endogenous melatonin but also elucidate and characterize the role of melatonin in plant growth and development in response to biotic and abiotic stresses.

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Moshi, Happiness Anold, Daniel Abel Shilla, Ismael Aaron Kimirei, Catherine O’ Reilly, Wim Clymans, Isabel Bishop, and Steven Arthur Loiselle. "Community monitoring of coliform pollution in Lake Tanganyika." PLOS ONE 17, no. 1 (January 28, 2022): e0262881. http://dx.doi.org/10.1371/journal.pone.0262881.

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Conventional water quality monitoring has been done for decades in Lake Tanganyika, under different national and international programs. However, these projects utilized monitoring approaches, which were temporally limited, labour intensive and costly. This study examines the use of citizen science to monitor the dynamics of coliform concentrations in Lake Tanganyika as a complementary method to statutory and project-focused measurements. Persons in five coastal communities (Kibirizi, Ilagala, Karago, Ujiji and Gombe) were trained and monitored total coliforms, faecal coliforms and turbidity for one year on a monthly basis, in parallel with professional scientists. A standardized and calibrated Secchi tube was used at the same time to determine turbidity. Results indicate that total and faecal coliform concentrations determined by citizen scientists correlated well to those determined by professional scientists. Furthermore, citizen scientist-based turbidity values were shown to provide a potential indicator for high FC and TC concentrations. As a simple tiered approach to identify increased coliform loads, trained local citizen scientists could use low-cost turbidity measurements with follow up sampling and analysis for coliforms, to inform their communities and regulatory bodies of high risk conditions, as well as to validate local mitigation actions. By comparing the spatial and temporal dynamics of coliform concentrations to local conditions of infrastructure, population, precipitation and hydrology in the 15 sites (3 sites per community) over 12 months, potential drivers of coliform pollution in these communities were identified, largely related to precipitation dynamics and the land use.

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Coffin, Scott, Holly Wyer, and J. C. Leapman. "Addressing the environmental and health impacts of microplastics requires open collaboration between diverse sectors." PLOS Biology 19, no. 3 (March 30, 2021): e3000932. http://dx.doi.org/10.1371/journal.pbio.3000932.

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Public concern over the environmental and public health impacts of the emerging contaminant class “microplastics” has recently prompted government agencies to consider mitigation efforts. Microplastics do not easily fit within traditional risk-based regulatory frameworks because their persistence and extreme diversity (of size, shape, and chemical properties associated with sorbed chemicals) result in high levels of uncertainty in hazard and exposure estimates. Due to these serious complexities, addressing microplastics’ impacts requires open collaboration between scientists, regulators, and policymakers. Here we describe ongoing international mitigation efforts, with California as a case study, and draw lessons from a similarly diverse and environmentally persistent class of emerging contaminants (per- and polyfluoroalkyl substances) that is already disrupting traditional regulatory paradigms, discuss strategies to address challenges associated with developing health-protective regulations and policies related to microplastics, and suggest ways to maximize impacts of research.

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Sokolova, Tatyana V. "Peculiarities of the Attestation of Scientific Workers." Labor law in Russia and abroad 2 (June 17, 2020): 51–54. http://dx.doi.org/10.18572/2221-3295-2020-2-51-54.

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This article is devoted to the features of certification of employees holding the positions of scientific workers in scientific organizations, in scientific organizations involved in scientific and technical activities, as well as organizations, educational programs and programs in the field of education. The article explores the concepts and significance of certification of workers, analyzes the regulatory legal acts on certification of scientists, and analyzes the actual issues of certification of scientists, etc.

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Turner, Patricia V., and R. Wayne Barbee. "Responsible Science and Research Animal Use." ILAR Journal 60, no. 1 (2019): 1–4. http://dx.doi.org/10.1093/ilar/ilz020.

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Abstract This issue of the ILAR Journal focuses on the topic of responsible science as it relates to animal research. We start with the concept of the scientist as a responsible citizen and then move through multiple phases of research including careful experimental planning, reporting, and incorporation of laboratory animal science. The work of the Institutional Animal Care and Use Committee (IACUC) or animal ethical/oversight body in reviewing both animal use and contributing to scientific excellence is explored. Additional topics include protection of animal handlers from multiple experimental hazards, use of agricultural animals and wildlife studies, regulatory ambiguities, and harmonization of animal research. Rounding out the issue is a discussion of how animal care and use programs can enhance animal welfare while mitigating regulatory burden, and our responsibility to clearly communicate the ethical use of animals in advancing biomedical research. A deeper understanding of these topics can assist scientists in simultaneously advancing their research and animal welfare.

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Bure, Irina V., Marina V. Nemtsova, and Ekaterina B. Kuznetsova. "Histone Modifications and Non-Coding RNAs: Mutual Epigenetic Regulation and Role in Pathogenesis." International Journal of Molecular Sciences 23, no. 10 (May 22, 2022): 5801. http://dx.doi.org/10.3390/ijms23105801.

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In the last few years, more and more scientists have suggested and confirmed that epigenetic regulators are tightly connected and form a comprehensive network of regulatory pathways and feedback loops. This is particularly interesting for a better understanding of processes that occur in the development and progression of various diseases. Appearing on the preclinical stages of diseases, epigenetic aberrations may be prominent biomarkers. Being dynamic and reversible, epigenetic modifications could become targets for a novel option for therapy. Therefore, in this review, we are focusing on histone modifications and ncRNAs, their mutual regulation, role in cellular processes and potential clinical application.

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Gubanov, Nikolai I., and Nikolai N. Gubanov. "Basic norms of the scientific ethos." Vestnik of Saint Petersburg University. Philosophy and Conflict Studies 37, no. 3 (2021): 416–27. http://dx.doi.org/10.21638/spbu17.2021.304.

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The article aims to formulate and differentiate the norms of classical science, modern fundamental science, and applied science as wel as determine the areas where they intersect. The four standards of scientific ethos (CUDOS) proposed by R. Merton are considered: 1) Communalism: belief in the common achievements of scientific knowledge; 2) Universalism: the truth of statements should be evaluated regardless of the age, gender, race, authority and titles of scientists; 3) Disinterestedness: the primary stimulus of a scientist’s activity is a disinterested search for truth; 4) Organized Skepticism: the scientist is responsible for evaluating the soundness what other colleagues have done as well as the reliability of their results. Using the golden rule of morality, 12 more norms are formulated (5–16 in the text). A tendency of abandoning of Merton’s norms has arisen with the development of applied science and its commercialization. As an example, standards of the PLACE system by J. Ziman are described (ownership, patent; solution of local problems determined by authoritarian management; work orders; implementation of work by a limited circle of experts). When rejecting Merton’s norms, the features of fundamental and applied science are not taken into account. The article shows that Merton norms and the norms provided in paragraphs 5–16 relate to classical science and modern fundamental science. Ziman’s norms as well as the norms in the paragraphs noutid are applicable to applied science. The norms (5–16) are common to fundamental and applied science. Violations of the norms of scientific ethics, such as falsification of empirical material, plagiarism, incorrect quotation, undeserved authorship, and sale of dissertations, are highlighted the article. Their objective and subjective reasons are revealed. Although the behavior of scientists does not fully coincide with the norms of scientific ethos, it produces an important regulatory influence on the scientific community as an ideal, orienting scientists to achieve maximum objectivity of knowledge and its use for the benefit of society.

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Sveshnikova, Olga Nikolaevna. "Documentation as acceptance of accounting and digitalization." KANT 38, no. 1 (March 2021): 54–58. http://dx.doi.org/10.24923/2222-243x.2021-38.12.

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The article is devoted to the problem of justifying a uniform approach to the fundamental basic category of accounting – documentation. The relevance is due to the need for terminology to match the changes taking place in its subject of research - the economic life of an economic entity. The author conducts a comparative analysis of the interpretation of accounting reception "documentation", "documenting", based on educational publications of leading scientists, current regulatory documents in the field of management documentation. The author conducts a comparative analysis of the interpretation of accounting reception "documentation", "documenting", based on educational publications of leading scientists, current regulatory documents in the field of management documentation. As a result, the author formulates the concept of "documentation", which contains features that correspond to the modern understanding of the role and significance of this accounting technique in the formation of accounting information.

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Porter, Gerard, Anita Kotwani, Lovleen Bhullar, and Jyoti Joshi. "Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation." Medical Law International 21, no. 2 (June 2021): 147–73. http://dx.doi.org/10.1177/09685332211020786.

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This article assesses the regulatory framework relating to over-the-counter (OTC) sales of antibiotics for human use in India. The OTC sale of antibiotics is recognised as a pathway for the emergence of antimicrobial resistance (AMR); a serious public health challenge in need of urgent regulatory responses. Analytically, this article identifies opportunities within existing laws in India and highlights gaps that need to be filled by modifying existing laws or developing new ones. Conceptually, it suggests a need to reflect on the limits of traditional, top-down, ‘command-and control’ regulation and to think about alternative approaches. The article therefore advocates for an approach to regulation that incorporates two elements. First, it argues for a broader concept of regulation that encompasses binding as well as non-binding regulatory instruments and initiatives aimed at influencing stakeholder behaviour (including soft regulation, economic incentives, information campaigns and uses of technology). Second, it makes the case for enhanced stakeholder participation in regulatory design. The article will be relevant for health policy and drug regulators in India and other low- and middle-income countries, as well as legal scholars, social scientists and others interested in the regulation of OTC sales of antibiotics for AMR containment.

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Kayumov, Bakhtiyor. "Public-Private Partnership In The Republic Of Uzbekistan: Foreign Theory And Problems Of Defining The Regulatory Sector." American Journal of Political Science Law and Criminology 03, no. 04 (April 11, 2021): 10–15. http://dx.doi.org/10.37547/tajpslc/volume03issue04-02.

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In this article, the author examines the problems of defining public-private partnership (PPP) from the point of view of the international theory and the experience of the Republic of Uzbekistan in this area. The views of foreign theorists, relevant international organizations, and scientists of the Republic of Uzbekistan regarding the term PPP are studied in detail. The author analyzes the relationship of PPP with the civil law contract and administrative law and concludes that the PPP agreement is classified as an unnamed contract in the Civil Code of the Republic of Uzbekistan. In conclusion, the author gives a proposal for improving the legislation of the Republic of Uzbekistan in the field of PPP.

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Sidhu, K. S., T. M. Stewart, and E. W. Nelton. "Information Sources and Support Networks in Toxicology." Journal of the American College of Toxicology 8, no. 5 (September 1989): 1011–26. http://dx.doi.org/10.3109/10915818909018062.

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This paper compiles sources of information dealing with environmental toxicology. Special emphasis has been put on information available from various computer databases and support networks. The information compiled will be useful for professionals entering the regulatory agencies as toxicologists or environmental health scientists.

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Yanow, Dvora, and Peregrine Schwartz-Shea. "Reforming Institutional Review Board Policy: Issues in Implementation and Field Research." PS: Political Science & Politics 41, no. 03 (June 18, 2008): 483–94. http://dx.doi.org/10.1017/s1049096508080864.

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Political science as a discipline has largely ignored research regulatory policies associated with institutional review boards (IRBs). Many political scientists—especially those in the senior ranks—are either oblivious to the existence of IRBs or actively decide to sidestep them by not submitting their proposals for review. Based on research conducted since 2004, we hold that APSA members at all ranks of the profession, along with political scientists worldwide, need to be concerned, not to say alarmed, about IRB policy. Why this sense of urgency, and why now?

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Christiansen, Jens Sandahl, Philippe F. Backeljauw, Martin Bidlingmaier, Beverly M. K. Biller, Margaret C. S. Boguszewski, Felipe F. Casanueva, Philippe Chanson, et al. "Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations." European Journal of Endocrinology 174, no. 6 (June 2016): C1—C8. http://dx.doi.org/10.1530/eje-16-0111.

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Objective The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). Participants A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Evidence Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Consensus process Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors. Conclusions LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.

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Yanow, Dvora, and Peregrine Schwartz-Shea. "Encountering Your IRB 2.0: What Political Scientists Need to Know." PS: Political Science & Politics 49, no. 02 (April 2016): 277–86. http://dx.doi.org/10.1017/s1049096516000202.

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ABSTRACTThis essay corrects and updates one that was originally published inQualitative & Multi-Method Researchand, in a condensed version, in three other APSA Organized Section newsletters. Our research into IRB policy has shown that many political scientists are not familiar with some of its key provisions. The intent of the essay is to increase awareness of the existing policy’s impact on political scientific research and, in particular, on graduate students and junior faculty. We remain concerned that at present, faculty are leaving discussions of research ethics to IRBs (and their counterparts worldwide), whereas these Boards largely focus on complying with the regulatory details of governmental policy. Even though this essay seeks to clarify the latter, we remain convinced that research ethics ought to be vigorously taken up within disciplinary and departmental conversations.

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Johnson, David. "The Canadian Regulatory System and Corporatism: Empirical Findings and Analytical Implications." Canadian journal of law and society 8, no. 1 (1993): 95–120. http://dx.doi.org/10.1017/s0829320100002799.

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AbstractThis article directs attention to the regulatory system in Canada and highlights certain important organizational developments that have been largely ignored by political scientists and legal academics in their studies of this system. Most analysts assessing the nature and functioning of the regulatory system in this country have used pluralist approaches to understand the political and legal phenomena in question, and have explicitly or implicitly rejected the validity of corporatist approaches to this task. This is unwise. Evidence from various regulatory agencies in this country indicates that meso corporatist forms of organization are present in this country's regulatory system. The presence of these forms thus calls for recognition and analysis. The author argues that while a modest degree of corporatism does not invalidate the general worth of pluralist interpretative approaches, our understanding of the regulatory system can only be enhanced through an appreciation of how and why meso corporatist forms of organization arise in particular regulatory agencies and how these developments pose a challenge to agency accountability

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Omenn, Gilbert S. "Commentary on Scientific Peer Review to Inform Regulatory Decision Making: Roles and Perspectives of Scientists." Risk Analysis 26, no. 1 (February 2006): 37–39. http://dx.doi.org/10.1111/j.1539-6924.2006.00733.x.

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Pasenov, A. N. "THE CONTENT AND ESSENCE OF THE CONCEPT OF SUSTAINABLE DEVELOPMENT." Scientific Notes of V. I. Vernadsky Crimean Federal University. Juridical science 6 (72), no. 2 (2020): 319–27. http://dx.doi.org/10.37279/2413-1733-2020-6-2-319-327.

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The article is devoted to the research of the essence and content of the concept of sustainable development. The author considers various approaches to understanding the category «sustainable development» in domestic science. The views of scientists on the content of the concept of sustainable development, which consist in the allocation of various components, among which the most established are considered economic, social and environmental. The views of scientists on the essence of the concept of sustainable development, expressed in the identification of the concept as a political theory, scientific doctrine or regulatory concept of the future development of mankind are studied.

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Bale, Tim. "Other People's Words: Creating a Market for Interview Material in Political Science." Politics 16, no. 1 (February 1996): 63–67. http://dx.doi.org/10.1111/j.1467-9256.1996.tb00147.x.

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Political scientists have long enjoyed computerised access to other people's data. But most of this data is quantitative rather than qualitative. Efforts to make interview transcripts, for example, as accessible as statistics have until very recently been uncoordinated and unusual due to a failure of supply and to a lack of demand. Both are rooted not merely in practical difficulties, but also in deeply held convictions about intellectual property and academic professionalism. Regulatory action is needed to find ways round these obstacles in order that political scientists as a community do not continue deny themselves rich research opportunities.

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Williams, John. "Congress, the President, and the Federal Reserve: The Politics of American Monetary Policy-Making. By Irwin L. Morris. Ann Arbor: University of Michigan Press, 2000. 190p. $45.00 cloth, $22.95 paper." American Political Science Review 96, no. 4 (December 2002): 829–30. http://dx.doi.org/10.1017/s000305540253046x.

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Political scientists have been fascinated with the role of the Federal Reserve in making monetary policy. It has long been recognized that the Fed has a tremendous amount of power for a regulatory agency that has so much independence from political bodies. Students of comparative monetary institutions have marveled at the contrast of United States policy to that of the rest of the world, with the exception of Germany's Bundesbank. Yet political scientists and economists continue to try to identify how politics shapes American monetary policy. Irwin Morris's book offers a major corrective to some of the flaws of earlier efforts.

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Hamed, Raed I., S. I. Ahson, and R. Parveen. "A New Approach for Modelling Gene Regulatory Networks Using Fuzzy Petri Nets." Journal of Integrative Bioinformatics 7, no. 1 (March 1, 2010): 1–16. http://dx.doi.org/10.1515/jib-2010-113.

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SummaryGene Regulatory Networks are models of genes and gene interactions at the expression level. The advent of microarray technology has challenged computer scientists to develop better algorithms for modeling the underlying regulatory relationship in between the genes. Fuzzy system has an ability to search microarray datasets for activator/repressor regulatory relationship. In this paper, we present a fuzzy reasoning model based on the Fuzzy Petri Net. The model considers the regulatory triplets by means of predicting changes in expression level of the target based on input expression level. This method eliminates possible false predictions from the classical fuzzy model thereby allowing a wider search space for inferring regulatory relationship. Through formalization of fuzzy reasoning, we propose an approach to construct a rule-based reasoning system. The experimental results show the proposed approach is feasible and acceptable to predict changes in expression level of the target gene.

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Sleeboom-Faulkner, Margaret. "Regulatory brokerage: Competitive advantage and regulation in the field of regenerative medicine." Social Studies of Science 49, no. 3 (June 2019): 355–80. http://dx.doi.org/10.1177/0306312719850628.

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This article concerns the roles of entrepreneurial scientists in the co-production of life science research and regulation. Regulatory brokerage, defined as a mode of strategic planning and as the negotiation of regulation based on comparative advantage and competition, is expressed in scientific activities that take advantage of regulatory difference. This article is based on social science research in Japan, Thailand, India and the UK. Using five cases related to Japan’s international activities in the field of regenerative medicine, I argue that, driven by competitive advantage, regulatory brokerage at lower levels of managerial organization and governance is emulated at higher levels. In addition, as regulatory brokerage affects the creation of regulation at national, bilateral and global levels, new regulation may be based on competition in regulatory advantage rather than on ethical and scientific values. I argue that regulatory brokerage as the basis for regulatory reform bypasses issues that need to be decided by a broader public. More space is needed for international and political debate about the socio-political consequences of the global diversity of regulation in the field of the life sciences.

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Smoligovets, Oleg. "Possibilities of Development Technologies of Contemporary Science Subject: Philosophical Grounds and Regulatory Requirements." Logos et Praxis, no. 3 (December 2018): 19–27. http://dx.doi.org/10.15688/lp.jvolsu.2018.3.3.

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The paper suggests the search for ways of development of modern science subject in the context of post-non-classical scientific rationality. The logic of the functioning of science as a system assumes that the activities of the subjects perform the regulatory function of the whole system. The development of the subject of science appears as a systemic problem, which includes not only professional development, but also the formation of multidimensional responsibility of scientists, which is manifested both in the interaction of science and society, and in the processes taking place within the science itself. The subject of technological impact is not an individual scientist or a team, but an integrated system, which is the science itself. The author concludes that such a system should have the status of a subject (metasubject), since its effects on scientists are manifested not as a determination, but as the opening of the space of freedom, the preservation of uncertainty in the system. Social technologies are relied upon as a mechanism for the formation and maintenance of metasubject status of science. Social technologies are supposed to be extremely flexible, because in the semantic space of science as a subject there is a higher level of freedom and subjectivity. The key technological requirement here is the growth of autonomy of the subject, which voluntarily and interestedly moves into the sphere of metasubject science. The potential of such a subject implies the requirement to identify the hidden potential of the system state. The notion of metasubject denotes a higher level of subjectivity than individuals and groups (subjects in the traditional sense). Metasubject acts as a source of space of scientific intersubjectivity. As a fundamental requirement for the activity of the subject of science the author points out the need to update the solution of strategic tasks on a par with the current ones. Taking into consideration all the stated above the study specifies a number of post-non-classical rationality norms: cognition is understood as a subject-subject process; reflection on the value measurement of knowledge is assumed; the self-developing nature of cognizable systems is postulated; the necessity of correlation of three forms of subjectivity in science (personality, collective, Institute); the communicative basis of human existence, the need to rely on the principle of cooperation is realized; understanding is fixed as a method of modern science; the nature of the connection between fundamental and applied research is clarified; the requirement of the analysis of knowledge riskiness is put forward.

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Journal articles on the topic 'Regulatory Scientists'

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