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)

In November of 1997, a letter from my professor AM came to my name. Hoodies from Ternopil Medical Academy named after. V.Ya. Gorbachevsky The letter mentioned that Arsen Richinsky was born in Kremenets'kyi, therefore the Department of Religious Studies at the Institute of Philosophy named after GS Pots of the National Academy of Sciences of Ukraine want to hold a scientific conference, whose participants should be taken immediately. [Mazur P., The immortalism of Arsen Rychinsky's memory on his native land (...) // Arsen Rychinsky - prominent Ukrainian public figure and scholar and religious scholar. Science collection. - Kyiv-Kremenets, 2007. - P. 27-32]. Motivating that the conference should be carefully prepared, we agreed with scientists of the National Academy of Sciences of Ukraine to hold the first Rychinsky readings on the basis of the school in the spring of 1998. (shrink)

National scientists have elaborated the reform's gist, approaches, stages and consequences in the Ukrainian agricultural sector during the XX - XXI centuries. These studies have been conducted by N. Zhulkanych, S. Zhyvora, M. Zyza, M. Lendiel, E. Mazur, O. Malyarchuk, V. Nechytailo and many others. The paper aims to perform the comprehensive study of general trends and peculiar features of the agricultural development of the Ukrainian SSR in 1963-1990 and to define actual advances and drawbacks on the basis of (...) analysis of historical records and scientific literature. The object of research is agriculture as part of socialist economy in the USSR. The subject of research is the implementation features of agricultural policy of the Soviet power in the Ukrainian SSR, using the Western region of the Republic as an example. The economic strategy of the Soviet power involved a long-term industrialization of the agricultural sector. A distinguishing feature of the industrialization process was the use of systems of machinery in all branches of agriculture. The technological chain had to embrace the process from the sporadic application of machinery to the overall mechanization and automation of crop and livestock farming. The industrial background of production predetermined the implementation of the system of machinery with extensive power consumption, i.e. with the new technical bases. The resolutions of the March Plenum of the CPSU Central Committee defined the economic priorities and capacity development of the Republic. Capital investments were the economic basis for the increase of production potential of collective and state farms, solution of social problems in rural regions. The land productivity was increased mainly by means of land reclamation and production chemization, use of organic and mineral fertilizers, pesticides, fungicides, etc. The supply of mineral fertilizers increased, but most of them were of low quality, non-concentrated and unbalanced in nutritional ingredients. In its turn it caused irreparable damage to the environment and polluted agricultural products with chemicals. The chemization undermined the population health and disrupted the ecological balance. Despite ultimate achievements in the rise of the industrial level of agriculture of the Ukrainian SSR, it didn't meet the needs of collective and state farms. A great number of labour-intensive processes in animal and crop farming were performed manually. In state farms, contrary to collective farms, the stock of tractors was newer, but much smaller. For many years the USSR was in the top ten countries of the world in terms of consumption of energy and proteins, contained in food products per capita. However, the food patterns were inconsistent with the scientifically grounded norm. Structural imbalance of the food ration was the manifestation of the food crisis in the USSR. To meet primary needs of Soviet citizens in food products the May Plenum of the CPSU Central Committee adopted the "Food Program of the USSR for the Period until 1990 and Measures of Its Implementation". The main issue of the Food program was to increase grain harvest. Grain production was the basis for food and fodder supply of the country. Alongside with a substantial increase in food products output in public economy the attention was given to the development of subsidiary individual holdings and fruit-and-vegetable cooperatives. The cooperatives and subsidiary holdings produced a great number of dairy and meat products, vegetables and fruits both for their own needs and for sale in collective farm markets. The state food program predetermined the solution of agricultural problems by means of formerly used methods. The major problem of agriculture had to be solved by means of increase in the gross grain harvest. Thus, the implementation of agricultural policy of Soviet power in the Ukrainian SSR lead to great changes in agricultural production. At that time there appeared such new branches of economy specialized in services to agricultural production as waterworks and land reclamation, feed mill industry, farm building, machine engineering for animal farming and fodder production, procurement of agricultural products and agricultural processing. The study of this policy implementation proves that the average annual rates of agricultural production increased but they were inconsistent with high investments. On the one hand, the Food program testified the "food crisis in the USSR", demonstrating the lag of the world socialist community from capitalist states. On the other hand, it had to increase the level of food self-sufficiency, decrease the procurement of agricultural products from abroad and promote the solution of the world food problem in general. (shrink)

Авторы книги - известные философы, не одно десятилетие способствовавшие развитию отечественной философии. Оба отстаивают философию как науку, научную философию, ее связь с жизнью. Книга "Бытие и мы" - свидетельство этому, она публицистична.

The article presents a fragment of the concept developed by the author in recent years [Makarenko V. P., 2018]. It discusses the problems of liberation of mind and conscience from the legacy of the Soviet era, the resuscitation of obscurantism in Russia against the background of the contrast between culture and the state along with the main characteristics of the twentieth century and constants of Russian history. The author also reviews the Old Testament concept of holy war, transformation of war (...) in Christianity, Russian and Soviet state mind, the civilizing dictatorship of the empire in the past and present, the evolution of government philosophy to a system of total lies, modern forms of its embodiment, including collaborationism, and the influence of these factors on the functioning of power in the country. (shrink)

Dieser Buchtitel ist Teil des Digitalisierungsprojekts Springer Book Archives mit Publikationen, die seit den Anfängen des Verlags von 1842 erschienen sind. Der Verlag stellt mit diesem Archiv Quellen für die historische wie auch die disziplingeschichtliche Forschung zur Verfügung, die jeweils im historischen Kontext betrachtet werden müssen. Dieser Titel erschien in der Zeit vor 1945 und wird daher in seiner zeittypischen politisch-ideologischen Ausrichtung vom Verlag nicht beworben.

Of course you know the movie, just by cultural assimilation if not by having seen it. There’s this young elephant, Dumbo, who has laughably big ears and has been pitiably separated from his mom. He’s aided by a friendly talking mouse[ii] into translating those otherwise hapless ears into the power of flight, which he eventually uses to rescue his mom and live happily ever after. The way the wily mouse gets Dumbo to believe that he could fly is to give (...) him a “magic feather” which, held in his trunk, demonstrably imparts the gift of flight. Naturally the mouse believes throughout all this that Dumbo can fly anyway, but he also knows that Dumbo needs the feather as a confidence-builder to do so. At the critical juncture of the tale Dumbo loses the feather after being pushed off a precipice, and he thus plummets perilously towards earth—only to find at the last moment that he can indeed fly on his own. (shrink)

In recent years, the phenomena of hormonal control, embryonic determination and pattern formation have been receiving intensive scrutiny from molecular biologists. In the following «Roots» contribution, Professor Sir Vincent B. Wigglesworth reviews some of the seminal work that he did on these subjects in the insect Rhodnius prolixus.

In my opinion, the so-called revolution in science and technology has virtually no influence on art.