The worldwide development of the revolution in science and technology is still in its initial stage. However, the characteristics of a qualitatively higher stage are already becoming evident in the area of the development of the system of labor, and therefore systematic philosophical study on the basis of the available data is a pressing task. Theory plays a special role precisely in periods when a phenomenon is not yet evident in final form. It is especially then that an acute need (...) arises for scientifically foreseeing, in its major outlines, the course of its development in the future. Within the bounds of the present article we shall attempt to do this with respect to certain aspects of the process of interaction between man and nature. (shrink)

Is there a role for aesthetic judgements in science? One aspect of scientific practice, the use of thought experiments, has a clear aesthetic dimension. Thought experiments are creatively produced artefacts that are designed to engage the imagination. Comparisons have been made between scientific (and philosophical) thought experiments and other aesthetically appreciated objects. In particular, thought experiments are said to share qualities with literary fiction as they invite us to imagine a fictional scenario and often have a narrative form (...) (Elgin 2014). But philosophical discussions of aesthetics in science have focused mainly on the epistemic role of beauty and elegance when it comes to theories and mathematical proofs, and thought experiments have been widely overlooked. My aim in this chapter is to address how the aesthetic choices scientists make in the design of a thought experiment contribute to its function: to communicate, convince, or explain a theory or phenomenon. A key issue is whether any aesthetic features in science provide anything beyond catching our attention, or are at best, a mere heuristic aid. I respond to accounts that argue this way and show how formulation is important in scientific thought experiments and, similarly to literary fictions, there is more than one way of interpreting a thought experiment scenario. I end by considering which literary examples are most appropriate when making comparisons with thought experiments. As a result, the difference between representations in art and science raised in current discussions is not as stark as it has been made out to be, and science is a more heterogeneous practice than has been allowed. Part of the value of thought experiments in scientific practice includes the qualities they share with literary works. (shrink)

Rethinking “philosophy” to-day, it is necessary to think first of all about ontological foundations of the modern scientific universe description and rethink them on the ground of modern scientific knowledge, because until now there is no any precise scientific conception of the structure of the universe, of reasons and movingforces of its permanent evolution. All of it create basis to propose various unscientific ideas of creationism. Until now most of philosophers associate the motion of Matter on the (...) whole only with its motion in space and in time, mixing philosophical and physical aspects of these two principle categories. Generally speaking, the present-day ontological model of understanding the World, the Universe is constructed purely on the basis of only these two fundamental categories. However, a more deep reflection of the essence of Being, if to realize it on the basis of only these two global categories, brings us to the disappointing conclusion, that in this case we have nothing more except a mechanical motion, i.e. spatial displacement of a material point (or a system of points) relatively some point of counting off. To make it normal and logic we should add to the ontological model one more essential part – the motion in quality. So, in order to create the full and complete picture of the formation and evolution of the material World it is necessary to observe the motion of material forming in the three equivalentphilosophical categories: in space time quality. The ideas of the new conception of ontological model become actual supplementation of really scientific philosophical knowledge on the way of a more objective ontological comprehension of our Being, of the law of development of the human civilization and the Universe as a whole. This knowledge can be successfully used for the description of the realistic paradigm of Being, in explanations of the meaning of Life. (shrink)

Quality improvement mechanisms increasingly use outcome measures to evaluate health care providers. This move toward outcome measures is a radical departure from the traditional focus on process measures. More radical still is the proposal to shift from relatively simple and proximal measures of outcome, such as mortality, to complex outcomes, such as quality of life. While the practical, scientific, and ethical issues associated with the use of outcomes such as mortality and morbidity to compare health care providers (...) have been well rehearsed, the specific concerns associated with the use of quality of life measures in quality of care research have received little attention. As with much research on quality of life there is a tendency to assume that the disadvantages are outweighed by the general virtue of “listening” to patients. In this paper we disagree with this assumption and argue that quality of life is a process, not an outcome. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent (...) and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Scientific integrity cannot be adequately ensured by appeals to the ethical principles of individual researchers. Research fraud has become a public scandal, exacerbated by our inability accurately to judge its extent. Current reliance on peer review of articles ready for publication as the sole means to control the quality and integrity of the majority of research has been shown to be inadequate, partly because faults in the research process may be concealed and partly because anonymous peer review is (...) itself imperfect. Consequently, the scientific literature is mixed, with the reader unable always to distinguish the good articles from the bad. Scientific research is subject to market forces that will always provide a motivation for a range of misdemeanours. This has led to a ‘market for lemons’. Regulations, and sanctions against miscreants, need to be modelled on those historically found necessary to limit financial fraud. Practical and effective systems of process control and audit have already been devised to ensure the integrity of clinical and pre-clinical research. These should be adapted for use in a much wider range of research activities. (shrink)

The aim of the article is to present the results of bibliometric analyzes of scientific papers on the quality management of medical services published in 2001–2017 and indexed in the Scopus database. The analysis uses basic techniques of bibliometric analysis with the technical support of VOSviewer software. The publication proposes an original procedure for analyzing the literature on the subject. The results of the study allowed to determine the trends in the number of publications from 2010 to 2017. (...) At the same time, an analysis of areas of science was presented, in which issues related to the management of the quality of medical services were analyzed, as well as citation of main authors and research centers. The whole analysis concerning the topic of quality management of medical services and bibliometric analysis of scientific works on the concepts and interrelations studied has identified the main six clusters that related to the management of quality of medical services ranging from broadly understood changes in healthcare organizations, internal quality management factors, development issues and education, regulation and standardization of the concept of quality improvement, and technological aspects of quality management in medical services. It seems, therefore, that the conducted studies can be considered as a specific guide for those interested in risk and uncertainty, despite the fact that they are not free of restrictions, for example, due to the narrowing of the time or criteria concerning the types of documents examined. In this context, the analyzes carried out give a wide range of opportunities to propose new research ideas on the above issues in contemporary organizations. (shrink)

This paper analyses the way articles are published in scientific journals in the field of law in the Republic of Moldova, including an experiment with a previously published article. Lack of compliance with journal publishing standards, including peer reviewing of articles, leads to the fact that virtually any article can be published. The examined journals do not perform their natural functions, but are rather used by researchers to report that they have scientific outcomes. The study allows us to (...) consider that publishing in scientific journals is an indicator of the quality of scientific research, as well as an indicator of compliance with scientific research ethical principles. Scientific misconduct and lack of scientific meritocracy that are characteristic of some of the post-Soviet science, are very well reflected in the law field in the Republic of Moldova. (shrink)

A Scientific Integrity Consortium developed a set of recommended principles and best practices that can be used broadly across scientific disciplines as a mechanism for consensus on scientific integrity standards and to better equip scientists to operate in a rapidly changing research environment. The two principles that represent the umbrella under which scientific processes should operate are as follows: Foster a culture of integrity in the scientific process. Evidence-based policy interests may have legitimate roles to (...) play in influencing aspects of the research process, but those roles should not interfere with scientific integrity. The nine best practices for instilling scientific integrity in the implementation of these two overarching principles are Require universal training in robust scientific methods, in the use of appropriate experimental design and statistics, and in responsible research practices for scientists at all levels, with the training content regularly updated and presented by qualified scientists. Strengthen scientific integrity oversight and processes throughout the research continuum with a focus on training in ethics and conduct. Encourage reproducibility of research through transparency. Strive to establish open science as the standard operating procedure throughout the scientific enterprise. Develop and implement educational tools to teach communication skills that uphold scientific integrity. Strive to identify ways to further strengthen the peer review process. Encourage scientific journals to publish unanticipated findings that meet standards of quality and scientific integrity. Seek harmonization and implementation among journals of rapid, consistent, and transparent processes for correction and/or retraction of published papers. Design rigorous and comprehensive evaluation criteria that recognize and reward the highest standards of integrity in scientific research. (shrink)

This article focuses on scientific integrity and the identification of predisposing factors to scientific misconduct in Brazil. Brazilian scientific production has increased in the last ten years, but the quality of the articles has decreased. Pressure on researchers and students for increasing scientific production may contribute to scientific misconduct. Cases of misconduct in science have been recently denounced in the country. Brazil has important institutions for controlling ethical and safety aspects of human research, but (...) there is a lack of specific offices to investigate suspected cases of misconduct and policies to deal with scientific dishonesty. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent (...) and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

BackgroundPreprint usage is growing rapidly in the life sciences; however, questions remain on the relative quality of preprints when compared to published articles. An objective dimension of quality that is readily measurable is completeness of reporting, as transparency can improve the reader’s ability to independently interpret data and reproduce findings.MethodsIn this observational study, we initially compared independent samples of articles published in bioRxiv and in PubMed-indexed journals in 2016 using a quality of reporting questionnaire. After that, we (...) performed paired comparisons between preprints from bioRxiv to their own peer-reviewed versions in journals.ResultsPeer-reviewed articles had, on average, higher quality of reporting than preprints, although the difference was small, with absolute differences of 5.0% [95% CI 1.4, 8.6] and 4.7% [95% CI 2.4, 7.0] of reported items in the independent samples and paired sample comparison, respectively. There were larger differences favoring peer-reviewed articles in subjective ratings of how clearly titles and abstracts presented the main findings and how easy it was to locate relevant reporting information. Changes in reporting from preprints to peer-reviewed versions did not correlate with the impact factor of the publication venue or with the time lag from bioRxiv to journal publication.ConclusionsOur results suggest that, on average, publication in a peer-reviewed journal is associated with improvement in quality of reporting. They also show that quality of reporting in preprints in the life sciences is within a similar range as that of peer-reviewed articles, albeit slightly lower on average, supporting the idea that preprints should be considered valid scientific contributions. (shrink)

Scientific misconduct is usually assumed to be self-serving. This paper, however, proposes to distinguish between two types of scientific misconduct: ‘type one scientific misconduct’ is self-serving and leads to falsely positive conclusions about one’s own work, while ‘type two scientific misconduct’ is other-harming and leads to falsely negative conclusions about someone else’s work. The focus is then on the latter type, and three known issues are identified as specific forms of such scientific misconduct: biased (...) class='Hi'>quality assessment, smear, and officially condoning scientific misconduct. These concern the improper ways how challenges of the prevailing opinion are thwarted in the modern world. The central issue is pseudoskepticism: uttering negative conclusions about someone else’s work that are downright false. It is argued that this may be an emotional response, rather than a calculated strategic action. Recommendations for educative and punitive measures are given to prevent and to deal with these three forms of scientific misconduct. (shrink)

Objectives—To assess the relationship between the approval of trials by a research ethics committee and the fact that informed consent from participants was obtained, with the quality of study design and methods.Design—Systematic review using a standardised checklist.Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and (...) published by at least one Spanish author during the same period in any other journal were also included.Results—We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groupsConclusion—Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects. (shrink)

The integrity of biomedical research depends heavily on the quality of research data collected. In turn, data quality depends on processes of data collection, a task undertaken by frontline research staff in many research programmes in Africa and elsewhere. These frontline research staff often have additional responsibilities including translating and communicating research in local languages, seeking informed consent for study participation and maintaining supportive relationships between research institutions and study participants and wider communities. The level of skills that (...) fieldworkers need to undertake these responsibilities clearly affects the quality of data collected, the ethics of research ‘on the ground’ and the short and long term acceptability of research.We organised an international workshop in Kenya in July 2014 to discuss the role of frontline staff in scientific research. A total of 25 field managers from 9 African countries and the UK met for 2.5 days to discuss the relationship between data quality and institutional performance management systems and how they affect career progression and supportive supervision policies of research frontline staff.From this workshop, and supporting an expanding literature on the role of fieldworkers in international health research, participants agreed that fieldworkers’ roles present them with practical and ethical challenges that their routine training does not adequately prepare them for. We argue that the common and complex challenges facing fieldworkers should in part be addressed through increased investment and collaborative agreements across types of research institutions in Africa. We call for standardization of core elements of training for this critically important cadre of research staff who perform similar roles and encounter similar challenges in many African settings. Although many valuable training elements are offered in institutions, there is a need to develop broader, more grounded and innovative strategies to address complex realities for fieldworkers, and support the integrity and ethics of health research in these settings. (shrink)

In this commentary, I propose a framework for thinking about data quality in the context of scientific research. I start by analyzing conceptualizations of quality as a property of information, evidence and data and reviewing research in the philosophy of information, the philosophy of science and the philosophy of biomedicine. I identify a push for purpose dependency as one of the main results of this review. On this basis, I present a contextual approach to data quality (...) in scientific research, whereby the quality of a dataset is dependent on the context of use of the dataset as much as the dataset itself. I exemplify the approach by discussing current critiques and debates of scientific quality, thus showcasing how data quality can be approached contextually. (shrink)

This article takes as its point of departure the idea that the adoption of managerial principles to ensure the quality of DNA evidence is an accident of history which has changed the ways forensic biology is conducted and forensic biologists think. I begin by defining managerialism and tracking its entry into the contentious world of forensic biology, asking how it is that a focus on efficiency and precise process control is affecting these labs. My analysis unfolds in two parts. (...) I first look at the external inspection routines that assure quality in forensic labs and the degree to which these routines represent ‘‘self” rather than ‘‘peer” assessment. I next look at the internal lab quality assurance routines that facilitate managerial control of technical and scientific workers, noting that QA is a trope flexible enough to govern both the numerically auditable and quasirobotic activities of technicians along with the less tangible more consensus-based human interactions of scientists. Illustrating that ‘‘science” is being pushed aside by management imperatives, I examine the consequences of this new emphasis for both the lab workers and the criminal justice system. (shrink)

The purpose of the study is to scientifically and technically substantiate the mechanism for the development of food systems within the framework of building an algorithm for ensuring the availability of food products, taking into account the interests of the most vulnerable segments of society. The article focuses on the presence of a variety of available tools in solving the problems of ensuring economic accessibility and assortment sufficiency of food products. However, the authors revealed that the problem of balanced nutrition (...) of children and adolescents has not been worked out due to the presence of both socio-economic and cultural-historical problems. Scientific novelty lies in the development of the theoretical foundations for building the food system of the state based on the application of the Innocenti concept, taking into account the interests of all sectors of society. As a result of the analysis, the need to amend the current legislation aimed at improving the quality of food products is argued. (shrink)

This paper analyses how agricultural policy and science deal with the problem of increasing exploitation of low quality irrigation water and consequent deterioration of water quality in the States of Punjab and Haryana in India. In these cereal growing tracts the policy objective of food security is translated into production technologies, price protection and subsidies. Deterioration of water quality is countered with technocentric solutions. The paper argues that the response of science to the complexities involved in natural (...) resource problems or in the scientific understanding of farmers partial response to technological solutions recommended to improve degraded resources, is due to the existing “administrative rationalism” of natural resource bureaucracies. This administrative rationalism, “the problem-solving discourse which emphasizes the role of the expert rather than the citizen” allows policy and science to maintain their hierarchy in determining policy goals and technological solutions with scant ecological or democratic concerns. Sustainable use of water demands institutional reform in agricultural policy and the agricultural sciences. (shrink)

Two major management philosophies of the 20th Century, scientific management and quality management, are often contrasted. Scientific management is seen as a system that focuses on task efficiencies whereas quality management is described as a collaborative, people-centered process approach to continuous improvement. This paper examines the ethical implications of these diverse approaches, particularly in the way information is used to decide which employees to lay off in times of economic difficulty. The paper uses case examples of (...) quality management as teaching tools to place the conduct of managers within utilitarian, deontological and justice approaches to ethical decision making. Finally, it suggests that a third system, open-book management, may help deal with this ethical dilemma, though not without risk. (shrink)

Different countries worldwide have issues with adapting legal terminology in a multilingual society. Such issues are still prevalent in Kazakhstan, where it is particularly difficult to guarantee the quality of laws written in the state language. This study aims to answer the question of what scientific, methodological, and legal mechanisms can be used to enhance legislative drafting practises in countries with two or more official languages by using Kazakhstan as an example. The Kazakh legal terminology reflects the societal (...) communication requirements for the control of public relations. According to the findings, the current challenges of establishing a legal conceptual framework in Kazakhstan are closely connected to trends in expanding the terminological lexicon. This trend stems from neologisation, optimisation of borrowings of legal terms, and internationalisation of legal discourse. The ways to improve the legislative drafting technique are suggested based on a generalised analysis of texts in the state language of some legislative instruments of the Republic of Kazakhstan. The article offers several recommendations for specialists-translators of legal texts practising in rule-making and lawyers-specialists in legislative drafting and review. (shrink)

Quality control is an important and integrated part of the scientific system. However, developments in science and society are changing quality control into quality monitoring. New, virtual, and fluid organizational forms are emerging. Common boundaries are seen as being broken down as, for example, in the “triple helix” and the “mode 2” concepts. The stakeholders in science are showing an interest in being more involved in science. They want their evaluation criteria to be used, and they (...) want evaluations to be done on a regular basis because they do not trust the new scientific institutions to be left on their own. Quality monitoring changes the requirements for conducting evaluations as part of quality control. Assessing the societal value of research becomes increasingly important. Finally, quality monitoring emphasizes organizational learning rather than controlling quality in scientific organizations. (shrink)

Society and contemporary culture unquestionably assign much importance to the search for quality. So can this kind of research include the mind? In his analysis, Luigi Longhin examines the causes of mental illness and psychic-mental suffering, the notions of individuality, social violence, and utopia; and he suggests a collaboration between the neurosciences and psychoanalysis, within a correct epistemological approach. The relationship between epistemology and psychoanalysis is examined. The objectivistic and relativistic shift in contemporary epistemology, and the problem of the (...) responsibility of the techno-scientific system are emphasized. Why such a privileged connection with philosophy? The contribution of philosophy is primarily epistemological. However, both epistemology and psychoanalysis run a risk; whilst epistemology runs the risk of being a knowledge which does not know, psychoanalysts run the risk of pursuing scientific knowledge without knowing its foundations. Hence there is a need for collaboration between the two forms of knowledge: the philosophical-epistemological and the scientific-psychoanalytic. Psychoanalysis works in two directions: on the one hand, it tries to eliminate the negative components of the mind, on the other hand, it tries to develop the trusting and creative parts of the self. (shrink)

Balancing speed and quality during crises pose challenges for ensuring the value and utility of data in social science research. The COVID-19 pandemic in particular underscores the need for high-quality data and rapid dissemination. Given the importance of behavioural measures and compliance with measures to contain the pandemic, social science research has played a key role in policymaking during this global crisis. This study addresses two key research questions: How FAIR ( findable, accessible, interoperable and reusable) are social (...) science data on the COVID-19 pandemic? Which study features are related to the level of FAIRness scores of datasets? We assess the FAIRness of n = 1131 articles, retrieved through a keyword search in the Web of Science database, employing both automated and manual coding methods. Our study inclusion criteria encompass empirical studies on the COVID-19 pandemic published between 2019 and 2023 with a social science focus and explicit reference to the underlying dataset(s). Our analysis of n = 45 datasets reveals substantial differences in FAIRness for different types of research on the COVID-19 pandemic. The overall FAIRness of data is acceptable, although particularly Reusability scores fall short, in both the manual and the automatic assessment. Further, articles explicitly linked to the Social Science concept in the OpenAlex database exhibit a higher mean overall FAIRness value. Based on these results, we derive recommendations for balancing ethical obligations and the potential tradeoff between speed and data (sharing) quality in social-scientific crisis research. (shrink)

Efforts to bring science into early 19th century breeding practices in Central Europe, organised from Brno, the Hapsburg city in which Mendel would later turn breeding experiments into a body of timeless theory, are here considered as a significant prelude to the great discovery. During those years prior to Mendel's arrival in Brno, enlightened breeders were seeking ways to regulate the process of heredity, which they viewed as a force to be controlled. Many were specialising in sheep breeding for the (...) benefit of the local wool industry while others were showing an interest in commercial plants, especially fruit trees and vines, and later cereals. Breeders explained their problems in regulating heredity in terms of climatic influences disruption due to crossing sports or saltations. Practical experience led them to the concepts of 'inheritance capacity' and the 'mutual elective affinity' of parents. The former was seen to differ among individuals and also among traits; the latter was proposed as a means of adding strength to heredity. The breeders came to recognise that traits might be hidden and yet transmitted as a 'potential' to future generations. They also grew to understand that heredity would be strengthened when a quality was 'fixed' within a lineage by 'pure blood relations.' Continued selection of the desired quality might then lead to 'a higher perfection.' But the ultimate 'physiological' question about breeding, 'what is inherited and how?,' found no answer. Major figures in this development included Abbot Napp, the one who asked this question and who was due to receive Mendel into the monastery in 1843, and Professor Diebl whose lectures on agriculture and natural science at the Brno Philosophical Institute Mendel would attend in 1846. Here we analyse their progress in theorizing about breeding up until about 1840. In discussing this development, we refer to certain international contacts, especially with respect to information transfer and scientific education, within the wider context of the late Enlightenment. (shrink)

Scientific realism, the position that successful theories are likely to be approximately true, is threatened by the pessimistic induction according to which the history of science is full of suc- cessful, but false theories. I aim to defend scientific realism against the pessimistic induction. My main thesis is that our current best theories each enjoy a very high degree of predictive success, far higher than was enjoyed by any of the refuted theories. I support this thesis by showing (...) that both the amount, and quality, of scientific evidence has increased enormously in the recent past, resulting in a big boost of success for the best theories. (shrink)

Recent rulings from the US Supreme Court seem to have effectively narrowed the trend toward allowing patents on artificially produced natural products. All objects must have a structural quality and a genetic quality, and if both are the result of some human intention and meet the other criteria of patent (new, useful, and nonobvious) then they may be patentable. There are millions of natural phenomena that are duplicated by man. Products and processes are mutually exclusive categories. No product (...) is a process, and vice versa. This much, the patent law gets right. All objects are either products (continuants) or processes (occurants). There are two types of each: man‐made and natural, for the purposes of intellectual property law. Any discovery of a law or phenomenon of nature involves some degree of intention, some exercise of consciousness and directedness. (shrink)

Introduction. Cities play a key role in the development of countries and regions. The authors of the article emphasize the importance of the largest cities’ development, which is based on an industrial model that has not exhausted its potential. The authors show possibilities of urban development on the basis of the industrial sector effective functioning in order to improve the citizens’ welfare, meet their needs and improve the life quality. In this regard, the authors formulate a hypothesis that the (...) largest Russian cities developing according to the industrial model have and are able to realize their potential in order to improve the life quality, preserve and increase the population on their territory. The authors set a goal: to identify the possibilities for developing industrial-type megalopolises to improve the population’s life quality of the (PLQ). Methods. The authors use the following information base: strategic documents of different levels, statistical data, scientific literature, analytical documents, and expert assessments of the megalopolises’ development. The authors also use an industrial model for developing the largest cities; they determine conditions under which the potential of megacities can be realized to improve the citizens’ life quality and carry out an analysis of the demographic and social situation in the largest Russian industrial cities. The authors evaluate some approaches and theses of the study as exemplified by the following cities with a million-plus population: Yekaterinburg, Krasnoyarsk, Chelyabinsk, and Omsk and they group the cities according to the signs of growth and decline, which is illustrated by favorable or unfavorable demographic trends. To confirm the identified trends and problems of the largest cities, the authors provide the results of expert assessments on the population’s life quality and the state of the urban environment and emphasize the need for a systemic integrated development of the largest cities of industrial type to improve the life quality of the population of megalopolises. The scientific novelty of the study consists in substantiating the prospects for the socio-economic development of the largest industrial cities of Russia on the basis of an industrial model that provides for the technological transformation of the economy, the use of agglomeration effects, the formation of a friendly urban environment for residents and the achievement of socialization of urban space. Results and conclusions. As a result of the analysis and typology of the largest cities by functional specialization, two groups of cities were identified: one group with signs of demographic growth, the second with signs of decline. The cities of the first group have a greater economic potential, opportunities for agglomeration, provide more comfortable living and consolidation of the population on their territory. On the contrary, cities with signs of decreasing have fewer opportunities (resources), are less diversified, the urban environment in them is less comfortable, which is reflected in the citizens’ life quality and is accompanied by the population’s outflow. At the same time, it was revealed that all analyzed cities actively use digital technologies, realizing, in particular, the concept of a «smart city». At the same time, cities with signs of decreasing show high IQ indicators of cities. Taking into account the identified problems, the authors propose promising directions for the development of industrial megalopolises with signs of decline. (shrink)

This paper outlines a procedure for assessing the quality of failure explanations in engineering failure analysis. The procedure structures the information contained in explanations such that it enables to find weak points, to compare competing explanations, and to provide redesign recommendations. These features make the procedure a good asset for critical reflection on some areas of the engineering practice of failure analysis and redesign. The procedure structures relevant information contained in an explanation by means of structural equations so as (...) to make the relations between key elements more salient. Once structured, the information is examined on its potential to track counterfactual dependencies by offering answers to relevant what-if-things-had-been-different questions. This criterion for explanatory goodness derives from the philosophy of science literature on scientific explanation. The procedure is illustrated by applying it to two case studies, one on Failure Analysis in Mechanical Engineering (a broken vehicle shaft) and one on Failure Analysis in Civil Engineering (a collapse in a convention center). The procedure offers failure analysts a practical tool for critical reflection on some areas of their practice while offering a deeper understanding of the workings of failure analysis (framing it as an explanatory practice). It, therefore, allows to improve certain aspects of the explanatory practices of failure analysis and redesign, but it also offers a theoretical perspective that can clarify important features of these practices. Given the programmatic nature of the procedure and its object (assessing and refining explanations), it extends work on the domain of computational argumentation. (shrink)

: This paper defends the commonsense view that judgments about the quality of human achievement in the arts can be true or false and shown to be so by objective reasoning, as against both subjectivist views and, more particularly, the view that they can be quantitatively expressed and scientifically demonstrated. It focuses on Charles Murray's recent attempt to rank-order the great achievers in an objective manner, arguing that it is fundamentally flawed, especially in confusing the quantification of references with (...) an argument for quality. Any attempt to justify a judgment relating to the quality of achievement must involve expertise in the sense, at least, of a thorough understanding of the nature of the activity in question. Nothing in Murray's lengthy book in fact relates to justification for any of the judgments. The paper concludes that the trappings of science do not make for science; that expertise in a field is necessary for making sound judgments in that field; that the broader the judgment, the harder it is to justify; that objectivity is to be distinguished from precision (as truth is from certainty); and that understanding of what counts as literature (art, sculpture, etc.) is an indispensable part of arguing for the quality of a work or an artist. (shrink)

Measuring outcomes using quantitative analytic methods is the hallmark of scientific research in healthcare. For clinical ethics support services (CESS), tangible outcome metrics are lacking and literature examining CESS quality is limited to evaluation of single cases or the influence on individual healthcare professional’s perceptions or behaviour. This represents an enormous barrier to implementing and evaluating ethics initiatives to improve quality. In this context, Kok _et al_ propose a theoretical framework for how moral case deliberation (MCD) can (...) drive quality at an organisational-level, termed _morisprudence_ 1. By offering mechanistic insights into how MCD can lead to organisational learning and quality improvement (QI), they provide a roadmap for actionable items to measure quality. As conceptualised, _morisprudence_ follows accumulation of organisational practical wisdom from a repertoire of ‘paradigmatic’ MCDs, aiding identification of patterns of morally important features. Here, there are parallels between healthcare professionals’ clinical judgement, where past experience... (shrink)

Scientific integrity cannot be adequately ensured by appeals to the ethical principles of individual researchers. Research fraud has become a public scandal, exacerbated by our inability accurately to judge its extent. Current reliance on peer review of articles ready for publication as the sole means to control the quality and integrity of the majority of research has been shown to be inadequate, partly because faults in the research process may be concealed and partly because anonymous peer review is (...) itself imperfect. Consequently, the scientific literature is mixed, with the reader unable always to distinguish the good articles from the bad. Scientific research is subject to market forces that will always provide a motivation for a range of misdemeanours. This has led to a ‘market for lemons’. Regulations, and sanctions against miscreants, need to be modelled on those historically found necessary to limit financial fraud. Practical and effective systems of process control and audit have already been devised to ensure the integrity of clinical and pre-clinical research. These should be adapted for use in a much wider range of research activities. (shrink)

Lost at times in the heat of debate about stem cell research, or any controversial advanced technology, is the need for precision in debate and discussion. The details matter a great deal, ranging from the need to use words that have precise definitions, to accurately quote colleagues and adversaries, and to cite scientific and medical results in a way that reflects the quality, rigor, and reliability of the work at issue. Regrettably, considerable inaccuracy has found its way into (...) the debates about stem cells, on all sides, with consequent fogging of the issues.A key detail that is often overlooked in the debates about the uses of human embryonic stem cells in research comes from the nature of in vitro fertilization treatment for infertility. Specifically, there are many frozen human embryos that are in excess of reproductive needs of the couple who generated them, and that must be either frozen indefinitely, donated to another couple, or destroyed. (shrink)

Scientific research is based on the division of cognitive labour: every scientist has to trust that other colleagues have checked whether the items that are taken as knowledge, and she cannot check by herself, are reliable enough. I apply ideas from the field known as ‘information economics’ to analyse the scientists’ incentives to produce items of knowledge of an ‘adequate’ quality, under the assumption that a big part of what one observes in her empirical research is not available (...) for the readers of the paper. I also discuss some criticisms to this ‘marketization’ of science studies. (shrink)

The Division of Investigative Oversight within the U.S. Office of Research Integrity (ORI) is responsible for conducting oversight review of institutional inquiries and investigations of possible research misconduct. It is also responsible for determining whether Public Health Service findings of research misconduct are warranted. Although ORI findings rely primarily on the scope and quality of the institution’s analyses and determinations, ORI often has been able to strengthen the original findings by employing a variety of analytical methods, often computer based. (...) Although ORI does not conduct inquiries or investigations, it has broad authority to provide assistance to institutions at all stages of their reviews of allegations. This assistance can range from providing advice on best practices, to legal assistance, to suggestions for how best to investigate specific allegations. When asked, ORI can also conduct certain forensic analyses, such as a statistical examination of questioned digits or a simple examination of a questioned figure in Photoshop. ORI will not provide opinions or render judgment on such analyses while the institution is still conducting its investigation. Such analyses can be done without knowing much else about the case. (shrink)

Background The twenty-first century has witnessed an exponential increase in healthcare quality research. As such activities become more prevalent, physicians are increasingly needed to participate as subjects in research and quality improvement (QI) projects. This raises an important ethical question: how should physicians be remunerated for participating as research and/or QI subjects? Financial versus non-monetary incentives for participation Research suggests participation in research and QI is often driven by conditional altruism, the idea that although initial interest in enrolling (...) in research is altruistic or prosocial, decisions to actually perform study tasks are cost–benefit driven. Thus, the three models commonly employed to appropriately compensate participants (in-kind compensation such as travel reimbursement, paying market rates for the subject’s time, and paying market rates for the activity asked of the participant) are a poor fit when the participant is a clinician, largely due to the asymmetry between cost and benefit or value to the participant. Non-monetary alternatives such as protected time for participation, continuing education or maintenance of certification credit, or professional development materials, can provide viable avenues for reducing this asymmetry. Conclusion Research and QI are integral to the betterment of medicine and healthcare. To increase physician participation in these activities as the subject of study, new models are needed that clarify the physician’s role in research and QI as a subject. Non-monetary approaches are recommended to successfully and ethically encourage research and QI participation, and thus incorporate these activities as a normal part of the ethical clinician’s and successful learning healthcare system’s world view. (shrink)

The fact that Internet companies may record our personal data and track our online behavior for commercial or political purpose has emphasized aspects related to online privacy. This has also led to the development of search engines that promise no tracking and privacy. Search engines also have a major role in spreading low-quality health information such as that of anti-vaccine websites. This study investigates the relationship between search engines’ approach to privacy and the scientific quality of the (...) information they return. We analyzed the first 30 webpages returned searching “vaccines autism” in English, Spanish, Italian, and French. The results show that not only “alternative” search engines but also other commercial engines often return more anti-vaccine pages (10–53%) than Google (0%). Some localized versions of Google, however, returned more anti-vaccine webpages (up to 10%) than Google. Health information returned by search engines has an impact on public health and, specifically, in the acceptance of vaccines. The issue of information quality when seeking information for making health-related decisions also impact the ethical aspect represented by the right to an informed consent. Our study suggests that designing a search engine that is privacy savvy and avoids issues with filter bubbles that can result from user-tracking is necessary but insufficient; instead, mechanisms should be developed to test search engines from the perspective of information quality (particularly for health-related webpages) before they can be deemed trustworthy providers of public health information. (shrink)

Recent and ongoing developments in science and technology - such as the prevention and treatment of disease through genetics and the development of increasingly sophisticated computer systems with wide-ranging applications - hold out the promise of vastly improving the quality of human life, but they can also raise serious ethical, legal, and public policy questions. The thirteen essays in this volume address these questions and related issues from a variety of perspectives. Written by prominent philosophers, economists, and legal theorists, (...) these essays offer valuable insights into the nature of scientific innovation and its implications for our social policies and practices. (shrink)

Recent interpretations of Locke's primary/secondary quality distinction have tended to emphasize Locke's relationship to the corpuscularian science of his time, especially to that of Boyle. Although this trend may have corrected the unfortunate tendency to view Locke in isolation from his scientific contemporaries, it nevertheless has resulted in some over- simplifications and distortions of Locke's general enterprise. As everyone now agrees, Locke was attempting to provide a philosophical foundation for English corpuscularianism and one must therefore look not only (...) at the current scientific hypotheses but also at the nature of the philosophical foundation Locke was attempting to erect. In particular, Locke made an attempt, based on epistemological principles, to give a philosophical justification of atomistic corpuscularianism. Moreover, he was not content to give this justification post hoc—the epistemological foundation was prior to, and determined the framework for, the details of the correct scientific theory. Locke's epistemology made legitimate an atomistic theory, one making crucial use of the notion of solidity in the definition of the elementary particles, although it did not prejudge the details of this theory. (shrink)

This paper presents a theory of scientific study which is regarded as a social learning process of scientific knowledge creation, revision, application, monitoring and dissemination with the aim of securing good quality, general, objective, testable and complete scientific knowledge of the domain. The theory stipulates the aim of scientific study that forms the basis of its principles. It also makes seven assumptions about scientific study and defines the major participating entities. It extends a recent (...) process model of scientific study into a detailed interaction model as this process model already addresses many issues of philosophy of science. The detailed interaction model of scientific study provides a common template of scientific activities for developing logical models in different scientific disciplines, or alternatively for developing ontologies of different scientific disciplines. Differences between research and scientific studies are discussed, and a possible way to develop a scientific theory of scientific study is described. (shrink)

‘Scientific advice to politics’, the ‘nature of expertise’, and the ‘relation between experts, policy makers, and the public’ are variations of a topic that currently attracts the attention of social scientists, philosophers of science as well as practitioners in the public sphere and the media. This renewed interest in a persistent theme is initiated by the call for a democratization of expertise that has become the order of the day in the legitimation of research funding. The new significance of (...) ‘participation’ and ‘accountability’ has motivated scholars to take a new look at the science – politics interface and to probe questions such as "What is new in the arrangement of scientific expertise and political decision-making?", "How can reliable knowledge be made useful for politics and society at large, and how can epistemically and ethically sound decisions be achieved without losing democratic legitimacy?", "How can the objective of democratization of expertise be achieved without compromising the quality and reliability of knowledge?" Scientific knowledge and the ‘experts’ that represent it no longer command the unquestioned authority and public trust that was once bestowed upon them, and yet, policy makers are more dependent on them than ever before. This collection of essays explores the relations between science and politics with the instruments of the social studies of science, thereby providing new insights into their re-alignment under a new régime of governance. (shrink)

Drinking water quality has drawn enormous attention from scientific communities, the industrial sector, and the common public in several countries during the last couple of decades. The scholarship in science and technology studies somehow overlooked this crucial domain. This article attempts to contribute to this gray area by exploring how drinking water quality is understood in Indian water policies, laws, and courtrooms. The article argues that water policies and laws in India were significantly shaped by international treaties (...) and global environmental stewardship. In the courtrooms, the Indian judiciary employed minimum science-based evidence in decision making in the context of drinking water–related cases; rather they used a rights-based approach and minimally engaged with the issue of drinking water quality/standards. Whatever little science used as valid science by the judges in the decision making was entirely expert-based. The reliance of the judges on the scientific expertise of the experts representing regulatory organizations and public institutions was another unique characteristic of the relationship between science and law in India. (shrink)

It is often argued that scientific developments in the area of biomedicine call for new ethical paradigms. Given the inadequacies of the traditional “sanctity-of-life ethics” (SLE), many have argued for a quality-of-life ethics (QLE), based on a non-speciesistic theory ofthe value of life. In this paper, I claim that QLE cannot account for the normativity of moral judgments, which can be explained only within the context of a theory of practical rationality: the peculiarity of moral normativity calls for (...) an ethics based on respect for rational creatures. I then go on to argue that the ethics of respect for persons (ERP) is not equivalent to SLE; that it can ground the moral protection of human “marginal cases”; that it does not rely on a scientifically implausible notion of human nature; and that it is not vulnerable to the charge of speciesism. Lastly, I suggest that ERP is a strictly philosophical interpretation of the Judeo-Christian moral tradition, and that is a better interpretation than SLE. If these assertions are correct, then the necessity of a new moral paradigm is seriously undermined. (shrink)

The purpose of the research is to identify professionally important qualities of the specialists in design, technology, and service, in particular cutters in the postmodern society. At the first stage, a preliminary list of 39 professionally important qualities of the skilled workers in the fashion industry has been formulated by means of theoretical analysis. The list considers the specifics of the cutter`s work at the intersection of three industries – design, technology, and service. At the second stage, a priori ranking (...) of factors has been conducted by interviewing 5 experts. The list, reduced after a priori ranking, has become a basis for surveying 246 respondents from different groups of stakeholders at the third stage. As a result, the lists of input parameters of the model of specialist, which are professionally important qualities of the skilled cutters, are obtained. The lists contain 28 professionally important personal qualities, which are grouped into the following groups: executive and motor manifestations, cognitive processes, memory and thinking, emotions, business qualities, creative features, specific requirements. The obtained results make it possible to develop optimal prognostic models of training the skilled workers in the fashion industry, as well as to conduct a scientifically grounded selection of personnel and career counseling. (shrink)

This study presents a substantial and often radical reinterpretation of some of the central themes of Locke's thought. Professor Alexander concentrates on the Essay Concerning Human Understanding and aims to restore that to its proper historical context. In Part I he gives a clear exposition of some of the scientific theories of Robert Boyle, which, he argues, heavily influenced Locke in employing similar concepts and terminology. Against this background, he goes on in Part II to provide an account of (...) Locke's views on the external world and our knowledge of it. He shows those views to be more consistent and plausible than is generally allowed, demonstrating how they make sense and enable scientific explanations of nature. In examining the views of Locke and Boyle together, the book throws light both on the development of philosophy and the beginnings of modern science, and in particular it makes a considerable and original contribution to our understanding of Locke's philosophy. (shrink)

Why did science emerge in the West and how did scientific values come to be regarded as the yardstick for all other forms of knowledge? Stephen Gaukroger shows just how bitterly the cognitive and cultural standing of science was contested in its early development. Rejecting the traditional picture of secularization, he argues that science in the seventeenth century emerged not in opposition to religion but rather was in many respects driven by it. Moreover, science did not present a unified (...) picture of nature but was an unstable field of different, often locally successful but just as often incompatible, programmes. To complicate matters, much depended on attempts to reshape the persona of the natural philosopher, and distinctive new notions of objectivity and impartiality were imported into natural philosophy, changing its character radically by redefining the qualities of its practitioners.The West's sense of itself, its relation to its past, and its sense of its future, have been profoundly altered since the seventeenth century, as cognitive values generally have gradually come to be shaped around scientific ones. Science has not merely brought a new set of such values to the task of understanding the world and our place in it, but rather has completely transformed the task, redefining the goals of enquiry. This distinctive feature of the development of a scientific culture in the West marks it out from other scientifically productive cultures. In The Emergence of a Scientific Culture, Stephen Gaukroger offers a detailed and comprehensive account of the formative stages of this development---and one which challenges the received wisdom that science was seen to be self-evidently the correct path to knowledge and that the benefits of science were immediately obvious to the disinterested observer. (shrink)