The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by (...) the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

In 1992, The Danish Medical Research Council established a national committee on scientific dishonesty with the twofold task of handling cases of scientific misconduct and taking preventive initiatives. Scientific dishonesty was proven in only five cases, but in another nine cases lesser degrees of deviations from good scientific practice were found. The experiences from a total of 24 treated cases indicated that three key areas were at the basis of most of the accusations and the deviations (...) from good practice: uncertainty about 1) authorship, about 2) rights and duties to use scientific data and about 3) agreements at the initiation of joint studies. As a consequence guidelines on good practice have been issued on these key subjects. (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)

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)

The basic understanding which underlies scientific evidence - ideas such as the structure of experiments, causality, repeatability, validity and reliability- is not straightforward. But these ideas are needed to judge evidence in school science, in physics or chemistry or biology or psychology, in undergraduate science, and in understanding everyday issues to do with science. It is essential to be able to be critical of scientific evidence. The authors clearly set out the principles of investigation so that the reader (...) will be confident in questioning the experts, making an informed choice or arriving at in informed opinion. The book is intended for a wide range of readers including those who want to: } collect their own evidence } be able to question and judge a wide range of science-based issues that we come across in the press or other media in everyday life } teach others how to understand evidence. This book has been developed from the authors' work with first year undergraduates in a combined science course and in primary teacher training for science specialists. It is suitable for students training as primary science specialists, and also for 'A' level and first-year undergraduates in science and science-related subjects. (shrink)

Various human rights issues arise from the intersection of adolescent motherhood and HIV. While health rights may be the most obvious means by which to address such issues through policy development and legislative means, the right to health is not the only human right that may provide recourse or relief in this regard. This article considers an unexplored avenue of approaching such issues through reliance on the right to enjoy the benefits of scientific progress. The International Covenant (...) on Economic, Social and Cultural Rights provides for the ‘right to science’ in article 15(1)(b) and more recently, as elaborated on in General Comment no. 25 of 2020. This article considers how this right can be relied upon to address issues pertaining to adolescent motherhood and HIV. Precedent from a Venezuelan Supreme Court decision is considered, as well as the normative content of the right to enjoy the benefits of scientific progress. This may be another legal means by which to hold states accountable for the health of young mothers and their children, especially as new practices, medicines and treatments emerge regarding HIV. (shrink)

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to “mental privacy.” In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are—at least for now—no different from those raised by other well-understood (...) data collection technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts—healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy. (shrink)

This article introduces an important concept: Transparency by way of Humanistic Intelligence as a human right, and in particular, Big/little Data and Sur/sous Veillance, where “Little Data” is to sousveillance as “Big Data” is to surveillance. Veillance is a core concept not just in human–human interaction but also in terms of Human–Computer Interaction. In this sense, veillance is the core of Human-in-the-loop Intelligence, leading us to the concept of “Sousveillant Systems” which are forms of Human–Computer Interaction in (...) which internal computational states are made visible to end users, allowing users to “jump” into the computational feedback loop whenever or wherever they want. An important special case of Sousveillant Systems is that of scientific exploration: not only is data considered, but also due consideration must be given to how data is captured, understood, explored, and discovered, and in particular, to the use of scientific instruments to collect data and to make important new discoveries, and learn about the world. Science is a domain where bottom-up transparency is of the utmost importance, and scientists have the right and responsibility to be able to understand the instruments that they use to make their discoveries. Such instruments must be sousveillant systems! (shrink)

We speak of the right to know with relative ease. You have the right to know the results of a medical test or to be informed about the collection and use of personal data. But what exactly is the right to know, and who should we trust to safeguard it? This book provides the first comprehensive examination of the right to know and other epistemic rights: rights to goods such as information, knowledge and truth. These rights (...) play a prominent role in our information-centric society and yet they often go unnoticed, disregarded and unprotected. As such, those who control what we know, or think we know, exert an influence on our lives that is often as dangerous as it is imperceptible. Beginning with a rigorous but accessible philosophical account of epistemic rights, Lani Watson examines the harms caused by epistemic rights violations, drawing on case studies across medical, political and legal contexts. She investigates who has the right to what information, who is responsible for the quality and circulation of information and what epistemic duties we have towards each other. This book is essential reading for philosophers, legal theorists and anyone concerned with the protection and promotion of information, knowledge and truth.. (shrink)

In response to Evelyn Pluhar'sWho Can Be Morally Obligated to Be a Vegetarian? in this journal issue, the author has read all of Pluhar's citations for the accuracy of her claims and had these read by an independent nutritionist. Detailed analysis of Pluhar's argument shows that she attempts to make her case by consistent misappropriation of the findings and conclusions of the studies she cites. Pluhar makes sweeping generalizations from scanty data, ignores causal explanations given by scientists, equates hypothesis (...) with fact, draws false cause conclusions from studies, and in one case claims a conclusion opposite of what the scientist published. Such poor reasoning cannot be the basis of an argument for moral vegetarianism. A broader search of the literature and attention to reviews and textbooks in nutrition shows that each of Pluhar's claims is suspect or incorrect. Pluhar has not undermined my central claims: even if animals have certain rights and well-planned vegetarian diets are safe in complex industrialized societies, these diets cannot be so regarded if the presuppositions of high levels of wealth, education, and medical care do not exist; and, women, children, the aged and some ill persons are at greater risk on restrictive vegan diets. Thus, any duty of moral vegetarianism is not categorical but provisional in nature. (shrink)

In a series of experiments done in wartime Nazi Germany, inmates of the Dachau concentration camp were exposed to cold by being immersed in ice water, or kept outside in freezing temperatures; their responses were measured, and various techniques were used in an attempt to revive them. The immediate application of these hypothermia studies was to the war effort, to try to protect or save soldiers exposed to cold water or air. An account of the procedures and results of these (...) experiments was written by an American officer, Major Leo Alexander, on the basis of his post-war discovery of documents and interviews in Germany. These reports reveal the ghastly and abominable details of the experiments.Recent scientific work in British Columbia has caused some ethical debate when it consulted the Alexander report and used some of the Nazi experimental data. The scientists in the Hypothermia Unit of the University of Victoria, unsurprisingly but reassuringly, have no intention of repeating the Nazi atrocities, and condemn them. The current controversy concerns the morality of their using the Alexander data in their study. This out-of-the-way case has some small intrinsic interest; but its consideration leads to broader concerns. (shrink)

The application of the latest technologies in biology and medicine has brought them to a qualitatively new level of possibilities. Worldwide, biobanking is actively developing through the creation of biobanks of various types and purposes, whose resources are used to solve therapeutic or scientific problems. Legal science remains an open question concerning the boundary that runs between the right to data protection and the scope of disclosure of data needed for medical purposes. In this article, the author (...) considers peculiarities of data processing in the context of biobanking activity on the example of Austria and its national legislation. In addition, the article reveals features of the approaches of the European Court of Human Rights (ECtHR) and the Council of Europe to the issue of biobanking in general, its characteristics in the context of data, and legal regulation of this phenomenon in the national law of states. The author devoted an important part of the study to the role of Austria’s experience in the context of data processing for scientific purposes and the development of biobanking for a number of other European states. The aim of the article is to analyze the Austrian legislation on data processing for scientific research and biobanking, the attitude of the Council of Europe to this phenomenon, and the practice of the ECtHR, as well as to consider the impact of the current world situation on these activities. The leading method of research used in the article is the formal-legal method. The article analyzes the Austrian law in the context of data processing in medical research, the relationship of the specifics of personal data protection, and the need to disclose them for scientific purposes. The author pays special attention to the influence of Austrian law on the legislation of other countries, which is reflected in the conclusions to the article. In addition, based on an analysis of the application of the Austrian experience to the legislation of Poland and Ukraine, the author points out the necessary changes that should be made in the laws of these countries. (shrink)

This paper presents the results of an empirical study that reflects monitoring and evaluation of the implementation of some legal acts on the labour of the Republic of Lithuania. The analysis of legal documents at the national and international level is provided. A review of cognate studies conducted by foreign and Lithuanian researchers is presented and the professional situation of a Lithuanian teacher from the employee rights perspective is highlighted. The professional activities contexts and sectors, wherein systematic violations of (...) teachers’ rights to a healthy and safe working environment are possible, are distinguished. A lack of generalized scientific data of employee (especially teacher) working conditions, the actual security of relevant rights and its monitoring and evaluation is still felt both in the country and abroad. A contradiction between: a) insufficient research of the issue and b) its importance to science and practice, exactly presupposes the scientific problems of the empirical study presented in the given paper. The subject of the study: teachers’ rights to a healthy and safe working environment and a fair remuneration for their work. The objective of the study: to conduct monitoring and evaluation of the effective implementation of relevant legal norms and legal acts applying a written sociological survey. The study is based on the results of a mass country-wide written survey of teachers. (shrink)

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a (...) rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data, ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: The role of HDSSs in research using public health data and data-sharing; Ownership and funding are critical factors influencing data-sharing; Other factors discourage data-sharing; Promoting and sustaining data-sharing; Ethical guidance structures; and Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching ‘share’ as a default. (shrink)

During the Third Reich, state‐sponsored violence was linked to scientific research on many levels. Prisoners were used as involuntary subjects for medical experiments, and body parts from victims were used in anatomy and neuropathology on a massive scale. In many cases, such specimens remained in scientific collections and were used until long after the war. International bioethics, for a long time, had little to say on the issue. Since the late 1980s, with a renewed interest in the Holocaust (...) and other Nazi crimes, a consensus has increasingly taken hold that research on human tissues and body parts from the Nazi era is inadmissible, and that such specimens should be removed from scientific collections and buried. The question of what to do with scientific data obtained from these sources has not received adequate attention, however, and remains unsolved. This paper traces the history of debates about the ethical implications of using human tissue or body parts from the Nazi period for scientific purposes, primarily in the fields of anatomy and neuropathology. It also examines how this issue, from after the war until today, influenced the establishment of legal and bioethical norms on the use of human remains from morally tainted sources, with a particular emphasis on Germany and Austria. It is argued that the use of such specimens and of data derived from them is unethical not only because of potential harms to posthumous rights of the victims, but also because such use constitutes a moral harm to society at large. (shrink)

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that (...) such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making. (shrink)

In her recent Counter-Reply to my views, Evelyn Pluhar defends her use of literature on nutrition and restates her argument for moral vegetarianism. In his Vegan Ideal article, Gary Varner claims that the nutrition literature does not show sufficient differences among women, men, and children to warrant concern about discrimination. In this response I show how Professor Pluhar continues to draw fallacious inferences: she begs the question on equality, avoids the main issue in my ethical arguments, argues from irrelevancies, misquotes (...) her sources, equivocates on context, confuses safety with morality, appeals to fear, confuses correlation with cause, fails to evaluate scientific studies, draws hasty conclusions from insufficient data, ignores a large amount of data which would call her views into question, does not follow good scientific or moral argumentation, objectionably exceeds the limits of her expertise, and resorts to scapegoating. I also argue that Professor Varner fails to make his case because he offers virtually no evidence from scientific studies on nutrition, relies on outdated and fallacious sources, makes unsupported claims, ignores evidence that would contravene his claims, draws hasty conclusions based on weakly supported hypotheses rather than facts, employs a double standard, appeals to ignorance, does not evaluate arguments from his sources, and makes anad hominem attack on a respected nutritionist when his focus should be on evaluating the evidence and arguments from the scientific studies themselves. Neither Varner nor Pluhar have responded sufficiently to the real issue in my arguments, that of discrimination and bias in the vegan ideal. (shrink)

As Next Generation Sequencing technologies are increasingly implemented in biomedical research and care, the number of study participants and patients who ask for release of their genomic raw data is set to increase. This raises the question whether research participants and patients have a legal and moral right to receive their genomic raw data and, if so, how this right should be implemented into practice. In a first step we clarify some central concepts such as “raw data”; (...) in a second step we sketch the international legal framework. The third step provides an extensive ethical analysis which comprehends two parts: an evaluation of whether there is a prima facie moral right to receive one’s raw data, and a contextualization and discussion of the right in light of potentially conflicting interests and rights of the data subject herself and third parties; in a last fourth step we emphasize the main practical consequences of the ethical analyses and propose recommendations for the release of raw data. In several legislations like the new European General Data Protection Regulation, patients do in principle have the right to receive their raw data. However, the procedural implementation of this right and whether it involves genetic counselling is at the discretion of the Member States. Even more questions remain with respect to the research context. The ethical analysis suggests that patients and research subjects have a moral right to receive their genomic raw data and addresses aspects which are also of relevance for the legal discussion such as the costs of release of raw data and its impact on academic freedom. Taking into account the specific nature and implications of genomic raw data and the contexts of research and health care, several concerns and potentially conflicting interests of the data subjects themselves and involved researchers, physicians, biomedical institutions and relatives arise. Instead of using them to argue in favor of restrictions of the data subjects’ legal and moral right to genomic raw data, the concerns should be addressed through provision of information and other measures. To this end, we propose relevant recommendations. (shrink)

During the 2020 COVID-19 pandemic, open science has become central to experimental, public health, and clinical responses across the globe. Open science is described as an open commons, in which a right to science renders all possible scientific data for everyone to access and use. In this common space, capitalist platforms now provide many essential services and are taking the lead in public health activities. These neoliberal businesses, however, have a problematic role in the capture of public goods. (...) This paper argues that the open commons is a community of rights, consisting of people and institutions whose interests mutually support the public good. If OS is a cornerstone of public health, then reaffirming the public good is its overriding purpose, and unethical platforms ought to be excluded from the commons and its benefits. (shrink)

While there are many versions of scientific realism, most share the intuition that the remarkable success of some scientific theories is best explained by interpreting their theoretical claims as 'true' or 'approximately true'. Due to a variety of recent anti-realist objections, this intuition must be amended so that realist positions can remain conceptually and historically adequate. This dissertation defends a version of scientific realism, which I call diachronic realism, and includes these amendments. ;Chapter I describes diachronic realism (...) and shows why it is a version of what is called 'metaphysical realism'. Consequently, I argue that recent claims that 'metaphysical realism' is incoherent are unfounded. Chapter II argues that certain anti-realist positions involve an insufficient treatment of 'meaning' and 'reference' for theoretical terms. I review much of the current work on theories of reference and show that these incommensurability positions are bankrupt given either of the two most promising theories of reference. Chapter III argues that certain methodological factors are the main considerations in historical cases of theory choice, and can warrant rational belief in a theory if it has achieved a sufficient level of virtues. Chapter IV defends the intuition that a realist interpretation of scientific theories explains their success by expanding the concepts of 'truth' and 'approximate truth'. I introduce the notions of truthlikeness and being on the right track to distinguish theories that were at least partially theoretically correct , from theories that were only successful in that they correctly organized experimental data. I use these notions with my diachronic approach to analyze two important historical examples. (shrink)

The paper problematises the reliability and ethics of using social media data, such as sourced from Twitter or Instagram, to carry out health-related research. As in many other domains, the opportunity to mine social media for information has been hailed as transformative for research on well-being and disease. Considerations around the fairness, responsibilities and accountabilities relating to using such data have often been set aside, on the understanding that as long as data were anonymised, no real ethical (...) or scientific issue would arise. We first counter this perception by emphasising that the use of social media data in health research can yield problematic and unethical results. We then provide a conceptualisation of methodological data fairness that can complement data management principles such as FAIR by enhancing the actionability of social media data for future research. We highlight the forms that methodological data fairness can take at different stages of the research process and identify practical steps through which researchers can ensure that their practices and outcomes are scientifically sound as well as fair to society at large. We conclude that making research data fair as well as FAIR is inextricably linked to concerns around the adequacy of data practices. The failure to act on those concerns raises serious ethical, methodological and epistemic issues with the knowledge and evidence that are being produced. (shrink)

Background Protecting a person’s right to privacy and confidentiality is important in healthcare services. As future health professionals, nursing students should bear the same responsibility as qualified health professionals in protecting patient privacy. Objectives To investigate nursing students’ practices of patient privacy protection and to identify factors associated with their practices. Research design A cross-sectional study design was adopted. A two-part survey was used to collect two types of data on nursing students: (1) personal characteristics, including demographics, clinical experience (...) and use of information and communication technology and social media and (2) practice of patient privacy protection, collected using the Patient Privacy Scale. Participants and research context: A total of 319 nursing students aged 18 or above, studying pre-registration nursing programmes and who had attended at least one block of clinical placement, were recruited from a university in Hong Kong. Ethical considerations The study received ethical approval from the Survey and Behavioural Research Ethics Committee of the Chinese University of Hong Kong. The participants were informed of the study aim and written consent was obtained before completing the survey. Findings: The mean total score on the Patient Privacy Scale was 119.7 out of 135. Nursing students who were regular users of Instagram and those who had never taken photographs with patients and hence did not need to obtain patient consent were associated with better practices of patient privacy protection (higher total scores on the Patient Privacy Scale). Conclusions The findings improve our understanding of nursing students’ practice of patient privacy protection and the associated factors. This will inform the development and revision of current strategies to enhance nursing students’ practice of patient privacy protection, especially their use of social media. (shrink)

This paper proposes an account of scientific data that makes sense of recent debates on data-driven and ‘big data’ research, while also building on the history of data production and use particularly within biology. In this view, ‘data’ is a relational category applied to research outputs that are taken, at specific moments of inquiry, to provide evidence for knowledge claims of interest to the researchers involved. They do not have truth-value in and of themselves, (...) nor can they be seen as straightforward representations of given phenomena. Rather, they are fungible objects defined by their portability and prospective usefulness as evidence. (shrink)

The IVF ET method is a scientifically recognized infertility treat- ment method. The problem, however, is this method’s unsatisfactory efficiency. This calls for a more thorough analysis of the information available in the treat- ment process, in order to detect the factors that have an effect on the results, as well as to effectively predict result of treatment. Classical statistical methods have proven to be inadequate in this issue. Only the use of modern methods of data mining gives hope (...) for a more effective analysis of the collected data. This work provides an overview of the new methods used for the analysis of data on infertility treatment, and formulates a proposal for further directions for research into increasing the efficiency of the predicted result of the treatment process. (shrink)

The collection and dissemination of data on human and nonhuman organisms has become a central feature of 21st-century biology and has been endorsed by funding agencies in the United States and Europe as crucial to translating biological research into therapeutic and agricultural innovation. Large molecular data sets, often referred to as “big data,” are increasingly incorporated into digital databases, many of which are freely accessible online. These data have come to be seen as resources that play (...) a key role in mediating global market exchange, thus achieving a prominent social and economic status well beyond science itself. At the same time, calls to make all such data publicly and freely available have garnered strength and visibility, most prominently in the form of the Open Data movement. I discuss these developments by considering the conditions under which data journey across the communities and institutions implicated in globalized biology and biomedicine, and what this indicates about how Internet-based communication and the use of online databases affect scientific research and its role within contemporary society. (shrink)

When read as a theory that is supposed to mirror, represent or fit some collection of historical data, critics argue that Kuhn’s theory of paradigm shift in Structure of Scientific Revolutions fails by cherry-picking and underdetermination. When read as the ground for a socio-epistemological conception of rationality, critics argue that Kuhn’s theory fails by either the naturalistic fallacy or underarticulation. This paper suggests that we need not view Structure as a historian’s attempt to accurately depict scientific theory (...) change or a philosopher’s attempt to suggest, more normatively, the factors we ought to consider in theory choice. Instead, we might use Kuhn’s theory as a metaphilosophical frame through which to better understand the limits of otherwise intractable philosophical debates. We can focus on Kuhn’s theory not as a proposition or model to confirm, but as something we might use as a tool for understanding. Philosophers have discussed the justice and care orientations in ethics as two theories for which there will be some common, constraining set of intuitions to confirm one theory over the other, to demonstrate that protecting rights is fundamentally more valuable that fulfilling needs or that fulfilling needs is fundamentally more valuable that protecting rights. Instead of conceptualizing this conversation as a choice between two theories, this paper looks to Ian Hacking’s interpretation of Kuhn’s paradigm concept to suggest that working in the world of justice is very different than working in the world of care, as each orientation is a paradigm with its own cognitive and contextual standards of theory assessment. To start, after Larry Laudan, each has its own ontology, methodology, aims and values. But moreover, after Ian Hacking, each has an even larger, entrenched collection of projectible predicates. Though Carol Gilligan herself uses the metaphor of gestalt shift in a few places to characterize the move from the justice to the care perspective, the insight—that what many assume to be a standard exercise in theory choice is really more of a paradigm shift—has been under theorized by ethicists and ignored by philosophers of science. This paper brings the full resources of Structure and its secondary literature to this metaethical issue, while making the larger point that Structure has an important pragmatic role to play, when it comes to the understanding philosophical debates, even if we cannot secure the truth of Kuhn’s theory. (shrink)

When read as a theory that is supposed to mirror, represent or fit some collection of historical data, critics argue that Kuhn’s theory of paradigm shift in Structure of Scientific Revolutions fails by cherry-picking and underdetermination. When read as the ground for a socio-epistemological conception of rationality, critics argue that Kuhn’s theory fails by either the naturalistic fallacy or underarticulation. This paper suggests that we need not view Structure as a historian’s attempt to accurately depict scientific theory (...) change or a philosopher’s attempt to suggest, more normatively, the factors we ought to consider in theory choice. Instead, we might use Kuhn’s theory as a metaphilosophical frame through which to better understand the limits of otherwise intractable philosophical debates. We can focus on Kuhn’s theory not as a proposition or model to confirm, but as something we might use as a tool for understanding. Philosophers have discussed the justice and care orientations in ethics as two theories for which there will be some common, constraining set of intuitions to confirm one theory over the other, to demonstrate that protecting rights is fundamentally more valuable that fulfilling needs or that fulfilling needs is fundamentally more valuable that protecting rights. Instead of conceptualizing this conversation as a choice between two theories, this paper looks to Ian Hacking’s interpretation of Kuhn’s paradigm concept to suggest that working in the world of justice is very different than working in the world of care, as each orientation is a paradigm with its own cognitive and contextual standards of theory assessment. To start, after Larry Laudan, each has its own ontology, methodology, aims and values. But moreover, after Ian Hacking, each has an even larger, entrenched collection of projectible predicates. Though Carol Gilligan herself uses the metaphor of gestalt shift in a few places to characterize the move from the justice to the care perspective, the insight—that what many assume to be a standard exercise in theory choice is really more of a paradigm shift—has been under theorized by ethicists and ignored by philosophers of science. This paper brings the full resources of Structure and its secondary literature to this metaethical issue, while making the larger point that Structure has an important pragmatic role to play, when it comes to the understanding philosophical debates, even if we cannot secure the truth of Kuhn’s theory. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must also (...) be considered and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

In today’s America the persistence of crushing poverty in the midst of staggering affluence no longer incites the righteous jeremiads it once did. Resigned acceptance of this paradox is fueled by a sense that poverty lies beyond the moral and technical scope of government remediation. The failure of experts to reach agreement on the causes of poverty merely exacerbates our despair. Are the causes internal to the poor – reflecting their more or less voluntary choices? Or do they emanate from (...) structures beyond their control? If both of these explanations are true, poverty experts will need to shift their focus to a hitherto under-theorized concept: coercion. I defend this claim by appealing to distinct areas of philosophical inquiry: social epistemology and moral theory. Poverty knowledge is directly related to both of these inquiries. The aim of poverty knowledge is clearly moral: to reduce suffering and to empower the weak. While the former aim is grounded in utilitarian thinking, the latter aim is grounded in the social contractarian insight that poverty is unjustly coercive, imposing excessive limits on the opportunities and choices of the poor that render them vulnerable to domination by others. Equally obvious is the social nature of poverty knowledge. All knowledge depends on the reliable testimony of others. Poverty knowledge not only ostensibly offers us the most reliable, scientific beliefs about the causes and effects of poverty, thereby determining how we morally judge the poor and their poverty, but it reciprocally bases its understanding of poverty on what the poor themselves have to say about it. What unites both social epistemology and moral theory – at least the social contract variants I will be examining here – is concern about the limits and possibilities of rational choice. As poverty knowledge came of age in the fifties and sixties, it absorbed the language of rational choice prevalent in economics, especially the Keynesian economics whose moral underpinnings can be found in Rawlsian social contract theory. Echoing a different economic theory supported by a different, more libertarian, brand of social contract theory, poverty expertise in the eighties continued to use an abstract model of rational choice. I submit that, in both early and later epochs of poverty expertise, reliance on rational choice reasoning prevented poverty experts from appreciating the coercive impact of poverty on the poor. Social epistemology explains this failure by demonstrating the poverty of rational choice thinking and its mistaken reliance on inflated commonsense expectations about the capacity of individuals to calculate their long-term interests, free from the distortions of social bias. Social epistemology not only exhibits the dangers of not relying on expert testimony, but it also exhibits the dangers of relying on an unreliable source of expert testimony that has removed itself from its human subject matter. In order for poverty experts to become more reliable educators about poverty’s coercive impact on the poor they must return to their discipline’s social epistemological roots. Only a more descriptive and explanatory sociology can narrate a comprehensive story about how the lived experience of poverty relates to the larger social system. The social contractarian model best suited to underwriting this kind of poverty knowledge, I submit, is the discourse theoretic model that has been championed by Jürgen Habermas. When applied as a pedagogical method of dialog and not as a social contractarian model of rational normative consent, discourse theory highlights the unique epistemological advantages of empathetic understanding that are so essential to dispelling stereotypes about the poor. Dispelling these stereotypes is the first step toward respecting the poor as free agents who are nonetheless forced to make suboptimal choices. My defense of these claims proceeds as follows: Part One argues that poverty expertise rightly deserves the opprobrium critics have heaped on it. The charge – leveled by progressives and conservatives alike - that such expertise is ideological is true to the extent that poverty knowledge has all-too-easily accommodated the political aims of the agency that has funded it: the federal government. The shift from the war on poverty to the war on the poor – and the resulting shift from blaming poverty on economic structures to blaming it on the culture of poverty – would not have been possible without an increased emphasis on data gathering aimed at measuring poverty rather than describing it. Part Two assesses the consequences of turning away from qualitative research to statistical analysis: the coercive nature of poverty becomes invisible beneath the surface of aggregate individual choices. The failure to grasp how voluntary choices, ostensibly based on rational, self-interested calculations, can be coerced by social structures - and thereby lead to sub-optimizing behavior – invites the conclusion that the poor have only themselves to blame for their misery. Part Three suggests that this pathologization of the poor directly controverts the major aim of poverty research: to empower the poor as free and equal parties to the social contract. I argue that the different varieties of social contract theory that have justified poverty expertise over the last forty years – the welfarist model pioneered by Rawls and the market-based model defended by Nozick – embrace the same rational choice models favored by poverty experts and so conspire with the latter in neglecting important dimensions of poverty-related coercion. While the welfarist model conceals the coercive nature of bureaucratically administered entitlement programs and top-down urban renewal policies, the market-based model conceals the coercive nature of economic class structures. The discourse-theoretic alternative proposed by Habermas endorses a populist, democratic response to the overly abstract rational choice assumptions embedded in these other models. Despite this advance over its counterparts, the chief advantage of discourse theory for poverty knowledge, I submit, resides less in its proposed procedure of rational collective choice than in its heuristic as a dialogical method of social learning. I demonstrate this claim in Part Four, where I turn to the social epistemological insights of Allen Buchanan. Social epistemology offers a much needed corrective to theories of knowledge that rely on the reasoning capacities of isolated individuals. By stressing the connection between moral response and social belief, on one hand, and the dependence of social belief on epistemic authorities, on the other, social epistemologists suggest ways in which we can learn to distinguish reliable from unreliable authorities and become aware of our own error-prone cognitive proclivities. Their insights need to be supplemented by moral epistemologists who stress the affective dimension of knowledge, above all, the role that empathy plays in understanding the plight of others. Drawing from victim narratives, Diana Meyers shows that switching between first-person experiences of one's own and third-person reconstructions of others' experiences is essential to appreciating the gravity of human rights violations and the seriousness of human rights claims. It goes without saying that such empathy is just as essential to understanding the plight of the poor. Meyers mainly has in mind empathetic understanding that has been facilitated by third-person observation and literary encounter, but the importance of visceral and corporeal representation suggests that face-to-face dialog may sometimes be a more effective way to facilitate empathetic understanding. (shrink)

Businesses increasingly rely on algorithms that are data-trained sets of decision rules (i.e., the output of the processes often called “machine learning”) and implement decisions with little or no human intermediation. In this article, we provide a philosophical foundation for the claim that algorithmic decision-making gives rise to a “right to explanation.” It is often said that, in the digital era, informed consent is dead. This negative view originates from a rigid understanding that presumes informed consent is a static (...) and complete transaction. Such a view is insufficient, especially when data are used in a secondary, noncontextual, and unpredictable manner—which is the inescapable nature of advanced artificial intelligence systems. We submit that an alternative view of informed consent—as an assurance of trust for incomplete transactions—allows for an understanding of why the rationale of informed consent already entails a right to ex post explanation. (shrink)

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my (...) opinion, data from both publicly and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication. (shrink)

This paper identifies the ethical issues associated with college instructors’ use of plagiarism detection software (PDS), specifically the Turnitin program. It addresses the pros and cons of using such software in higher education, arguing that its use is justified on the basis that it increases institutional trust, and demonstrating that two common criticisms of such software are not universally valid. An analysis of the legal issues surrounding Turnitin, however, indicates that the way it is designed and operates raises some ethical (...) issues because it denies students notice, access and choice about the treatment of their personal information. The paper concludes with a set of guidelines for instructors using Turnitin in the classroom. (shrink)

The law sometimes permits what ordinary morality, or widely-shared notions of right and wrong, reproaches. Rights to Do Grave Wrong explores the relationship between law and common morality to clarify law's reliance on society's broad presumption that people will exercise their rights responsibly. More concretely, he argues that certain legal rights rest on tacit sociological assumptions as to who will exercise them, under what circumstances, and how frequently. Further, he argues that we depend on stigma and shame (...) to reduce and circumscribe the law's use. Some examples: though reneging on a debt is considered wrong, the law allows you to declare personal bankruptcy; international law allows museums to retain some masterworks looted from their rightful owners; in many countries abortion is permitted as a means of birth control. Using these examples and more, Osiel presents a "social scientific" analysis of law's interaction with social mores and the extent to which they limit our exercising rights to do wrong. The paradox he intends to elucidate is when and why it is appropriate for societies to champion de jure entitlements even as they successfully limit their de facto usage. (shrink)

Modernity is marked by the advent of technologies capable of storing data almost indefi­nitely. On the other hand, the data collection takes place without the conscious permission of the users. The storage and collection of personal data is a potential problem, since the digital footprint of a person on the Internet has an impact on the social and political rep­resentation of the individual, its perception by other actors. Compromising the content of a digital footprint can expose information (...) that is not intended for others. There is cur­rently an increasing trend of misuse of stored data, both by criminals and by companies that use the data for sale or surveillance. The need to control how data is collected, stored and used leads to the emergence in the academic literature and the legal field of the “right to be forgotten”, which allows a person to actively moderate the process of collecting and storing data, to participate in determining the circle of those to whom they can be accessed, and delete personal data. The adoption of such a right not only allows the state to influence the collection and storage of data, regulating interactions through law-making activities, but also to realize the potential of an autonomous individual. The prospect of legislating the right to be forgotten has sparked debate in the academic and professional community about the destruction of the free marketplace of ideas and the imposition of political censor­ship on the Internet. The article deals with the philosophical, ethical and political founda­tions of the right to be forgotten. The article substantiates the conclusion that the right to be forgotten has a positive heuristic potential, but at the same time it has conceptual flaws, and is also not able to completely correct the current situation of data processing. However, the implementation of the right to be forgotten in the future can have a beneficial effect on the current situation in the field of collection and storage of personal data. (shrink)

ObjectivesTo determine to which degree industry partners in randomised clinical trials own the data and can constrain publication rights of academic investigators.MethodsCohort study of trial protocols, publication agreements and other documents obtained through Freedom of Information requests, for a sample of 42 trials with industry involvement approved by ethics committees in Denmark. The main outcome measures used were: proportion of trials where data was owned by the industry partner, where the investigators right to publish were constrained and (...) if this was mentioned in informed consent documents, and where the industry partner could review data while the trial was ongoing and stop the trial early.ResultsThe industry partner owned all data in 20 trials (48%) and in 16 trials (38%) it was unclear. Publication constraints were described for 30 trials (71%) and this was not communicated to trial participants in informed consent documents in any of the trials. In eight trials (19%) the industry partner could review data during the trial, for 20 trials (48%) it was unclear. The industry partner could stop the trial early without any specific reason in 23 trials (55%).ConclusionsPublication constraints are common, and data is often owned by industry partners. This is rarely communicated to trial participants. Such constraints might contribute to problems with selective outcome reporting. Patients should be fully informed about these aspects of trial conduct. (shrink)

The author argues that the minority homosexual section of our population--a larger minority than, for example, the ethnic minorities section--is more often than not excluded by the 'helping professions' from the right to be parents. The author appeals to the lack of scientific data supporting such exclusion and asks that homosexual parents and their children receive the same care from our institutions as other parents and children. Some instances of lack of care are cited. The paper was presented (...) to the 1983 annual conference of the London Medical Group, 'Human Rights in Medicine'. (shrink)

In this paper, I defend what I call the ‘Inference Principle’. This principle holds that if an agent obtains some information legitimately, then the agent can make any inference she wants based on the information, without violating anyone’s right to privacy. This principle is interesting for at least three reasons. First, it constitutes a novel answer to the timely question of whether the widespread use of ‘data analytics’ to infer personal information about individuals is morally permissible. Second, it contradicts (...) what seems to be a common view of inferences’ ability to violate privacy rights. Third, it offers an account of the theoretically underdeveloped issue of what duties are engendered by the moral right to privacy with regard to inferred information. (shrink)

Hepatitis C is a global public health threat, affecting 56 million people worldwide. The World Health Organization has committed to eliminating hepatitis C by 2030. Although new treatments have revolutionised the treatment and care of people with hepatitis C, treatment uptake has slowed in recent years, drawing attention to the need for innovative approaches to reach elimination targets. One approach involves using existing notifiable disease data to contact people previously diagnosed with hepatitis C. Within these disease surveillance systems, however, (...) competing tensions exist, including protecting individual rights to privacy and autonomy, and broader public health goals. We explore these issues using hepatitis C and Australia’s legislative and regulatory frameworks as a case study. We examine emerging uses of notification data to contact people not yet treated, and describe some of the ethical dilemmas associated with the use and non-use of this data and the protections that exist to preserve individual rights and public health. We reveal weaknesses in rights protections and processes under Australian public health and human rights legislation and argue for consultation with and involvement of affected communities in policy and intervention design before notification data is used to increase hepatitis C treatment coverage. (shrink)

Touching is an integral part of human behaviour; from the moment of birth until they die, people need to be touched and to touch others. Touching is an intimate action that implies an invasion of the individual's personal, private space. In ethical terms, the ques tion of touching is closely related to the patient's right to integrity and inviolability. The purpose of this study was to describe touching as it is experienced by elderly patients and nurses in long-term care. Touching (...) was approached as a form of commu nication and as an important part of nursing practice. The participants, 25 patients and 30 nurses, were interviewed using a semistructured schedule. The data were analysed using the method of content analysis. The patients experienced touching by nurses as gentle, comforting and important. The nurses, for their part, experienced touching by patients as easy and natural. The patients rarely touched nurses more than was neces sary. In some cases, nurses had to cope with violent touching by patients. Some women nurses interpreted touches by male patients as having a sexual nature and as annoying. This had taught male patients to avoid touching nurses. On the other hand, friendly and grateful touches by patients were very important to nurses. When used for emotional purposes only, touching presupposed a good relationship between nurses and their patients. Although touching is extremely common in nursing practice, there has been very little research into its meaning. More work is therefore needed to explore the role and meaning of touching in nursing. (shrink)

Because of the many criticisms of the notion of a theory independent observation language, it is useful to look at a few actual examples of scientific data to see what theories might be implicit and in what way. There are several possibilities. The theories could be previously accepted, under active investigation, or of a kind that has never been systematically examined. The present study explores these possibilities in the data of several scientific journal articles. The conclusion (...) is that theories and regularities of all three kinds can be found as antecedent conditions of data statements. Any descriptive account of scientific inference must find room for such presuppositions. (shrink)

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes. With this in mind, the Science and Values Working Group of the (...) COST Action CHIP ME ‘Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives’ identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research. We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment. (shrink)

In the European Union, the General Data Protection Regulation (GDPR) provides comprehensive rules for the processing of personal data. In addition, the EU lawmaker intends to adopt specific rules to protect confidentiality of communications, in a separate ePrivacy Regulation. Some have argued that there is no need for such additional rules for communications confidentiality. This Article discusses the protection of the right to confidentiality of communications in Europe. We look at the right’s origins to assess the rationale for (...) protecting it. We also analyze how the right is currently protected under the European Convention on Human Rights and under EU law. We show that at its core the right to communications confidentiality protects three individual and collective values: privacy, freedom of expression, and trust in communication services. The right aims to ensure that individuals and organizations can safely entrust communication to service providers. Initially, the right protected only postal letters, but it has gradually developed into a strong safeguard for the protection of confidentiality of communications, regardless of the technology used. Hence, the right does not merely serve individual privacy interests, but also other more collective interests that are crucial for the functioning of our information society. We conclude that separate EU rules to protect communications confidentiality, next to the GDPR, are justified and necessary. (shrink)

Science is the basis for managing the affairs of life and human activities, and living without knowledge is a form of wandering and a kind of loss. Using scientific methods helps us understand the foundations of choice, decision-making, and adopting the right solutions when solutions abound and options are numerous. Operational research is considered the best that scientific development has provided because its methods depend on the application of scientific methods in solving complex issues and the optimal (...) use of available resources in various fields, private and governmental work in peace and war, in politics and economics, in planning and implementation, and in various aspects of life. Its basic essence is to use the data provided for the issue under study to build a mathematical model that is the optimal solution. It is the basis on which decision makers rely in managing institutions and companies, and when operations research methods meet with the neutrosophic teacher, we get ideal solutions that take into account all the circumstances and fluctuations that may occur in the work environment over time. One of the most important operations research methods is the linear programming method. Which prompted us to reformulate the linear models, the graphical method, and the simplex method, which are used to obtain the optimal solution for linear models using the concepts of neutrosophic science. In this research, and as a continuation of what we presented previously, we will reformulate the modified simplex algorithm that was presented to address the difficulty that we were facing when applying the direct simplex algorithm. It is the large number of calculations required to be performed in each step of the solution, which requires a lot of time and effort. (shrink)

The paper discusses the problems in the detection of security information in legal and other administrative data. The authors analyse the prospects of the use of datamining in the solution of two key problems: abundance and indirectness of these data. Security research uses two kinds of data. The first one is scientific data, designed and gathered specially for the verification of certain security theories. They are the data of criminological, sociological, psychological surveys, experimental (...) class='Hi'>data, etc. The second kind is data that are not designed for security research. Most of the data are the by-products of the national legal system, especially its criminal justice, of national and local institutions responsible for the maintenance of public order, and of other public agencies. All the data provide huge amounts of information destined to control and direct the activities of these institutions. There are two kinds of problems in the use of this information in security study. First, this information has to be ‘decoded’ from data describing the activities of related institutions. Second, data on security are lost in huge amounts of other public data. Thus, they have to be ‘mined’. The paper discusses the prospects of the modern information proceeding method—data-mining in the solution of both problems. A new concept of data mining as a meta-procedure is proposed. The object of this meta-procedure is supposed to be the integration of multiple current theories (for example, criminal security) and related statistical procedures. A general algorithm of such data-mining is proposed. (shrink)

Background There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence. Methods Informants were 12 Israelis, aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon (...) discharge. Results Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity. Discussion Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons. Conclusions Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent. (shrink)

Vogelstein cautions medical organizations against jumping into the fray of controversial issues, yet proffers the 2012 American Academy of Pediatrics' Task Force policy position on infant male circumcision as ‘an appropriate use of position-statements.’ Only a scratch below the surface of this policy statement uncovers the Task Force's failure to consider Vogelstein's many caveats. The Task Force supported the cultural practice by putting undeserved emphasis on questionable scientific data, while ignoring or underplaying the importance of valid contrary (...) class='Hi'>scientific data. Without any effort to quantitatively assess the risk/benefit balance, the Task Force concluded the benefits of circumcision outweighed the risks, while acknowledging that the incidence of risks was unknown. This Task Force differed from other Academy policy-forming panels by ignoring the Academy's standard quality measures and by not appointing members with extensive research experience, extensive publications, or recognized expertise directly related to this topic. Despite nearly 100 publications available at the time addressing the substantial ethical issues associated with infant male circumcision, the Task Force chose to ignore the ethical controversy. They merely stated, with minimal justification, the opinion of one of the Task Force members that the practice of infant male circumcision is morally permissible. The release of the report has fostered an explosion of academic discussion on the ethics of infant male circumcision with a number of national medical organizations now decrying the practice as a human rights violation. (shrink)

Using the Schwarzschild calculation of the Relativistic bending of starlight near the sun as an illustration, it is shown that the relationship between theory and data requires a hierarchy of structures of different logical type. An essential feature of this hierarchy is the use of idealizations and approximate truths. On the basis of a counterfactual analysis of these concepts, it is shown that confirmation is possible even though statistical measures of goodness of fit are not satisfied. The consequences of (...) this view of confirmation and hierarchical structure for scientific realism are then considered. (shrink)

Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges (...) associated with the current knowledge deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. (shrink)

Experiments on animals have always been considered as necessary for scientific research, both fundamental and applied. In addition to scientific suitability criteria, this practice also must be justified from a moral point of view. This concern arises from the demand of our civilization that a certain moral value be recognized to animals. In this paper it is discussed in detail that how animals should be handled while doing research and what are animal rights and their uses in (...) biomedical research.Bangladesh Journal of Bioethics 2015 Vol.6 (1):11-14. (shrink)

When courts started publishing judgements, big data analysis within the legal domain became possible. By taking data from the European Court of Human Rights as an example, we investigate how natural language processing tools can be used to analyse texts of the court proceedings in order to automatically predict judicial decisions. With an average accuracy of 75% in predicting the violation of 9 articles of the European Convention on Human Rights our approach highlights the potential of (...) machine learning approaches in the legal domain. We show, however, that predicting decisions for future cases based on the cases from the past negatively impacts performance. Furthermore, we demonstrate that we can achieve a relatively high classification performance when predicting outcomes based only on the surnames of the judges that try the case. (shrink)