Rationality in Context: Regulatory Science and the Best Scientific Method

2021 ◽  
pp. 016224392110276
Author(s):  
Oliver Todt ◽  
José Luis Luján
Keyword(s):  
Scientific Method ◽  
Best Practice ◽  
Wide Spectrum ◽  
Regulatory Science ◽  
Academic Science ◽  
Scientific Methodology ◽  
Data Generation ◽  
Regulatory Decision ◽  
Methodological Choices ◽  
Regulatory Processes

Is there such a thing as a “best scientific methodology” in regulatory (decision-oriented) science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition, in regulatory science, the most suitable methodologies often differ from what is considered best practice in knowledge-oriented (academic) science. In data generation for regulatory purposes, we are faced with a wide spectrum of preferred methodologies as well as controversy as to methodological choice. What goes by the most adequate scientific method can and will—justifiably and rationally—vary significantly according to context and use. In order to make this argument, we analyze four case studies, two from risk assessment and two from benefit assessment. Our analysis shows that it is the noncognitive objectives of a particular regulatory process that determine what counts as the most appropriate scientific method. We use the concept of bounded rationality to indicate that those methodological choices, despite being context-dependent, can be interpreted as rational.

scholarly journals Structured Hypothesis Development in Criminal Investigation: A method aimed at providing a broad and objective starting point for a criminal investigation

2020 ◽  
pp. 0032258X2098232
Author(s):  
Nina Sunde
Keyword(s):  
Cognitive Psychology ◽  
Best Practice ◽  
Logical Reasoning ◽  
Scientific Methodology ◽  
Criminal Investigation ◽  
Legal Principles ◽  
Starting Point ◽  
Objective Investigation

The Structured Hypothesis Development in Criminal Investigation (SHDCI) method aims to assist detectives in developing an adequate set of hypotheses, which prepares the ground for a broad and objective investigation. The method aims to protect the innocent, while also enabling the detectives to discover the full scope of the incident under investigation. SHDCI builds on theory and principles from cognitive psychology, scientific methodology, logical reasoning, law and criminal investigation best practice. The method is developed in a Norwegian context, but builds on universally accepted legal principles, and SHDCI may therefore be relevant for implementation in other jurisdictions.

scholarly journals Methodology of Sociological Instrumentation in Modern Cultural Studies (Problem Statement)

2021 ◽  
Vol 21 (3) ◽  
pp. 62-69
Author(s):  
V.N. Yarskaya ◽  
◽  
N.S. Bozhok ◽  
Keyword(s):  
Cultural Studies ◽  
Scientific Method ◽  
Scientific Methodology ◽  
Problem Statement ◽  
Social Functions ◽  
Intellectual Movements

The instrumentalism of sociology in the system of cultural studies as a scientific method on the example of the development of the culture of reconstructivism is considered. Cultural studies are presented as a direction accumulating the instrumental experience of sociology. Interdisciplinarity as a principle of scientific methodology assimilates the experience of various intellectual movements, problematization of the value content and social functions of culture, its diverse phenomena. The new possibilities of developing the culturological concept of temporalism are revealed.

OP04 Cardiac Implant Registries: Systematic Review Of Global Practices

2018 ◽  
Vol 34 (S1) ◽  
pp. 2-2
Author(s):  
Peter Kolominsky-Rabas ◽  
Shixuan Zhang ◽  
Sebastian Gaiser
Keyword(s):  
Data Collection ◽  
Medical Device ◽  
Best Practice ◽  
Electronic Device ◽  
Data Entry ◽  
Joint Decision ◽  
World Picture ◽  
Regulatory Decision ◽  
Long Term Follow Up ◽  
Regulatory Decisions

Introduction:The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in post-marked surveillance has been recognized and approved, but there is a lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006–2016) and to provide recommendations on “best practice” approaches.Methods:A systematic search on CIR was employed in line with the PRISMA guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect, EMBASE and the Scopus database. After identifying the existing CIR, an inductive approach was used to explore key elements emerging in the identified registries.Results:The following eighty-two registries were identified: eighteen ICD registries, seven CRT registries, five pacemaker registries, and six Cardiovascular Implantable Electronic Device (CIED) registries which combined ICD, pacemaker and CRT implantation data; as well as twenty-two coronary stent registries and twenty-four TAVI registries. While seventy-one national or local registries are from a single country, forty-four are from European countries, and nine are located in USA. The following criteria have been summarized from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.Conclusions:For HTA as well as regulatory decision making, medical device registries provide a “real-world” picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and approval issues of medical devices; for payers CIRs provide evidence on the medical device benefits and drive the decision as to whether the product should be reimbursed or not; for hospitals data from CIRs are important for sound procurement decisions, and CIRs also help patients and their physicians to reach a joint decision on which of the products is the most appropriate. However, many current CIRs are still lacking standards to inform on patient safety and ensure transparency.

scholarly journals Towards Experimental Handbooks in Catalysis

2020 ◽  
Vol 63 (19-20) ◽  
pp. 1683-1699
Author(s):  
Annette Trunschke ◽  
Giulia Bellini ◽  
Maxime Boniface ◽  
Spencer J. Carey ◽  
Jinhu Dong ◽  
...  
Keyword(s):  
Heterogeneous Catalysis ◽  
High Performance ◽  
Best Practice ◽  
Data Science ◽  
Theoretical Description ◽  
Scientific Data ◽  
Oxidation Catalysis ◽  
Mixed Metal Oxide ◽  
Data Generation ◽  
Mixed Metal Oxide Catalysts

AbstractThe “Seven Pillars” of oxidation catalysis proposed by Robert K. Grasselli represent an early example of phenomenological descriptors in the field of heterogeneous catalysis. Major advances in the theoretical description of catalytic reactions have been achieved in recent years and new catalysts are predicted today by using computational methods. To tackle the immense complexity of high-performance systems in reactions where selectivity is a major issue, analysis of scientific data by artificial intelligence and data science provides new opportunities for achieving improved understanding. Modern data analytics require data of highest quality and sufficient diversity. Existing data, however, frequently do not comply with these constraints. Therefore, new concepts of data generation and management are needed. Herein we present a basic approach in defining best practice procedures of measuring consistent data sets in heterogeneous catalysis using “handbooks”. Selective oxidation of short-chain alkanes over mixed metal oxide catalysts was selected as an example.

Mediums and Science in Early 20th Century Europe

Nuncius ◽  
2018 ◽  
Vol 33 (1) ◽  
pp. 104-136
Author(s):  
Lorenzo Leporiere
Keyword(s):  
20Th Century ◽  
Scientific Method ◽  
Scientific Methodology ◽  
Early 20Th Century ◽  
Scientific Instruments ◽  
Psychical Research ◽  
Physical Medium ◽  
Epistemological Views

Abstract This paper investigates and contextualizes the contribution made by the Italian physiologist Filippo Bottazzi (1867–1941) to research on mediumistic phenomena in Europe at the beginning of the 1900s, focusing on his investigation of the claims of Eusapia Palladino’s powers, a well-known Italian physical medium who inspired the “conversion” of Cesare Lombroso. Bottazzi’s work, conducted between 1906 and 1909, is compared to that of colleagues in Italy and elsewhere and analysed in the light of the scientific methodology that he used in his research as a physiologist. This paper will review the events that led Bottazzi to take an interest in mediumship, and analyse how he designed and conducted his experiments and the conclusions that he drew from them. Particular attention will be focused on the methods and the scientific instruments that he used in his psychical research, which were in keeping with his Positivist epistemological views, as is shown by an essay on the scientific method that he wrote in the same period.

Scientific Method and the Appraisal of Religion

1985 ◽  
Vol 21 (3) ◽  
pp. 319-329
Author(s):  
Keith J. Cooper
Keyword(s):  
Scientific Method ◽  
Large Scale ◽  
Scientific Methodology ◽  
Epistemic Status ◽  
Scientific Theories ◽  
Existence Of God ◽  
Conceptual Systems ◽  
Belief In God ◽  
Truth Claims ◽  
The Right

In looking for criteria by which to assess religious conceptual systems, many philosophers have turned for help to scientific methodology. Perhaps this is because they felt philosophers of science were themselves looking in the right epistemological direction, and had a viable way of describing what they saw. Richard Swinburne has provided a strong, sustained treatment of the application of scientific method to religious truth claims, in The Existence of God. He there makes use of what he sees as ‘the close similarities which exist between religious theories and large-scale scientific theories’ in assessing the epistemic status of belief in God. The goal of this paper will be to give enough of Swinburne's position to see what criteria might be plucked therefrom, to subject both the criteria and the underlying methodology to scrutiny, and to assess where one must go from here in appraising the truth-claims of religion.

Power and Knowledge in Psychiatry and the Troubling Case of Dr Osheroff

2005 ◽  
Vol 13 (4) ◽  
pp. 343-350 ◽  
Author(s):  
Michael Robertson
Keyword(s):  
Scientific Knowledge ◽  
Scientific Method ◽  
Best Practice ◽  
Narrative Form ◽  
Current Debate ◽  
Evidence Based ◽  
Scientific Enterprise ◽  
Treatment Of Depression ◽  
Based Medicine ◽  
Forms Of Knowledge

Objective: To consider the state of knowledge in psychiatry with reference to the ‘Osheroff debate’ about the treatment of depression. Method: A review of the key philosophical issues regarding the nature of knowledge applied to the Osheroff case. Results: There is an apparent dichotomy between knowledge derived from a reductionist scientific method, as manifest in evidence-based medicine, and that of a narrative form of knowledge derived from clinical experience. The Focauldian notion of knowledge/power and knowledge as discourse suggests that scientific knowledge dominates over narrative knowledge in psychiatry. The implication of this applied to the Osheroff case is the potential annihilation of all forms of knowledge other than science. Conclusions: Knowledge in psychiatry is a pluralist, rather than singularly scientific enterprise. In the Osheroff case, the potential for scientific knowledge to abolish other forms of knowledge posed a serious threat of weakening the profession. In the light of the current debate about best practice, there is a need for reconsideration of the implications of Osheroff.

Evaluating Regulatory Impact Assessments in Education Policy

2018 ◽  
Vol 40 (3) ◽  
pp. 335-353
Author(s):  
Clive R. Belfield ◽  
A. Brooks Bowden ◽  
Viviana Rodriguez
Keyword(s):  
Cost Analysis ◽  
Federal Government ◽  
Best Practice ◽  
Net Present Value ◽  
Social Benefit ◽  
Present Value ◽  
Benefit Cost Analysis ◽  
Regulatory Decision ◽  
Regulatory Impact ◽  
Benefit Cost

Benefit–cost analysis is an important part of regulatory decision-making, yet there are questions as to how often and how well it is performed. Here we examine 28 Regulatory Impact Assessments performed by the federal government on education regulations since 2006. We find many Regulatory Impact Assessments estimated costs, albeit using informal methods, but most failed to adequately report benefits. Also, most studies did not estimate net present value or clearly report methodological assumptions. In reviewing the relatively high quality studies we identified a number of discrepancies from best practice. Most importantly, few Regulatory Impact Assessments attempted a social benefit–cost analysis: Most examined “administrative burdens” from compliance with legislation. This alternative focus on administrative burdens has significant implications for economic evaluation in practice.

scholarly journals Emerging technologies and their impact on regulatory science

2021 ◽  
pp. 153537022110522
Author(s):  
Elke Anklam ◽  
Martin Iain Bahl ◽  
Robert Ball ◽  
Richard D Beger ◽  
Jonathan Cohen ◽  
...  
Keyword(s):  
New Technologies ◽  
Emerging Technologies ◽  
Cost Effective ◽  
Assessment Tools ◽  
Regulatory Science ◽  
Science Field ◽  
Regulatory Decision ◽  
Technical Advances ◽  
Novel Approaches ◽  
Regulatory Decisions

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.

scholarly journals Verifiability and Falsifiability as Parameters for Scientific Methodology

2017 ◽  
Vol 7 (2) ◽  
pp. 130
Author(s):  
Sandhya Shankar
Keyword(s):  
Scientific Method ◽  
Scientific Methodology ◽  
Karl Popper ◽  
Human Knowledge ◽  
Sense Experience ◽  
Scientific Methods ◽  
The World ◽  
The Mind

The question of „how do we come to know‟ has been the search of mankind since time immemorial. Neither has there been a consensus for that question nor there will be. Many a great minds have looked into this, coming up with various perspectives. Two such varying perspectives in this field are empiricism and rationalism. While the former emphasizes that experience (through senses) is the only source of knowledge the latter upholds that there is something beyond the sense experience, the mind that is the source of knowledge. The shift towards a scientific phase from that of the earlier theological and metaphysical phase gained popularity with positivism, where progress of human knowledge was considered in identifying truths through scientific methods. In this scientific journey towards knowing the world emphasis was on empirically observable things. It was believed that there are no ideas which come into our head without being dependent on our perceptions, thereby on our experience. The basis of classical science was considered getting empirical observations. It had to be a systematic way of studying what is out there. Purpose of science was considered to be limited to things which can be observed, thus being connected to a means of being verified. This paper thus looks into the notion of verifiability as an important parameter of scientific methodology and its importance as asserted by logical positivists. But this criteria of scientific method was challenged by another criteria, that of falsifiability. The next section will look into falsifiability as another parameter of scientific methodology. Since these parameters have been discussed widely among philosophers, this paper shall be focusing on the views of A. J. Ayer and Sir Karl Popper regarding the same. Furthermore, its application and relevance to the field of linguistics will also be discussed.

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