Access to detailed, up-to-date and available bioinformatics databases has been identified by the Commission of the European Union as a pillar for the harvesting of the potential of life-sciences and biotechnology. Unconditional access to research data, however, is squarely at odds with the primary interest of every scientist to be the first to make a discovery. This classical dilemma is specifically pressing in the data-driven field of biomedical research, where data-quantity has become a quality on its own, where speed matters (...) and patients can't wait. The dilemma urges a consideration of the principle, the practice and the law regarding access for academic researchers to unpublished research data. The consideration will include the presentation of the outcome of a global and a national survey among biomedical researchers on the accessibility of 'their' research data. The principled arguments pro unconditional access and the laws and practical considerations contra unconditional access offer conflicting perspectives and the resulting situation is compounded by the uncertainty created by the European database-right as to who holds legal title to the databases. Therefore, it is explored whether the two opposing concerns - unconditional access vs. legitimate restrictions - can be accommodated by the adoption and implementation of a general policy for access to biomedical data that greases the wheels of (European) research. (shrink)

Laing contends that the practice of eugenics has not disappeared. Conceptually related to the utilitarian and Social Darwinist worldview and historically evolving out of the practice of slavery, it led to some of the most spectacular human rights abuses in human history. The compulsory sterilization of and experimentation on those deemed “undesirable” and “unfit” in many technologically developed states like the US, Scandinavia, and Japan, led inexorably and most systematically to Nazi Germany with the elimination of countless millions of (...) people for their race, class, political views, sexuality, religion or disability. Biometric databases exposing one’s medical data, DNA defects, IQ, political views, while in some ways appearing socially useful, demonstrates how vulnerable humans are, not just at the hands of political malfeasors and tyrants but insurance companies, government snoopers, false friends and determined social engineers. (shrink)

Directive 96/9/EC of the European Parliament and of the Council on the legal protection of databases of 11 March 1996, which was intended to protect the interests of the makers of databases, determined that databases could be protected by double rights: copyright and sui generis right. The article first of all analyses what persons are entitled to be acknowledged as holders of copyright and sui generis right in respect of a newly created database. As the issue of the (...) owner of copyright is not regulated by the 1996 Directive, this is determined by the application of national provisions. Pursuant to the Law on Copyright and Related Rights of the Republic of Lithuania, the owner of copyright may mean, depending on the situation, a natural person – the author of a database or a group of authors, the holder of the right to a collective work, or an employer. The analysis presented in the articleindicates that predominantly it is the author (authors) of a database who is held to be the owner of the copyright. Courts tend to interpret the rule concerning the transfer of copyright to the employer in a restrictive way; besides, in accordance with the specifics of the Lithuanian legal regulation, economic rights are transferred to the employer only for the period of 5 years. The category of collective work is of a subsidiary character and may be applied only in exclusive cases. Therefore, when a database is created upon the commission of another person, including the employer, the customer is expected to form a written agreement where the transfer of economic rights to the customer is clearly defined. (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)

This article considers individual rights and fundamental tenets of the criminal justice system in the context of DNA evidence, in particular recent advancements in genomics that have significantly advanced law enforcement investigative capabilities in this area. It discusses a technique known as Investigative Genetic Genealogy (IGG) which utilizes genomic data held by commercial direct-to-consumer ancestry and health companies to investigate the identity of suspects linked to serious crimes. Using this technique, even if only a small proportion of the population (...) (e.g. 5%) has submitted genomic data to these companies, almost anyone in the population can be identified. We discuss this phenomenon in the context of the existing literature and arguments in relation to universal forensic DNA databases, as well as relevant recent developments in both liberal democracies and authoritarian states. We introduce the concept of a quasi-universal forensic DNA database and consider associated implications for the criminal justice system and society from the perspectives of privacy, the right not to self-incriminate, joint rights, and collective responsibility. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale (...) for the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale (...) for the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics. (shrink)

Is disagreement about consciousness largely owed to no adequate initial clarification of the subject, to people in fact answering different questions clarified as actual consciousness. Philosophical method like the scientific method includes transition from the figurative to literal theory or analysis. A new theory will also satisfy various criteria not satisfied by many existing theories. The objective physical world has specifiable general characteristics including spatiality, lawfulness, being in science, connections with perception, and so on. Actualism, the literal theory or analysis (...) of actual consciousness, deriving mainly from the figurative database, is that actual consciousness has counterpart but partly different general characteristics. Actual consciousness is thus subjectively physical. So physicality in general consists in objective and also subjective physicality. Consciousness in the case of perception is only the dependent existence of a subjective external physical world out there, often a room. But cognitive and affective consciousness, various kinds of thinking and wanting, differently subjectively physical, is internal – subjectively physical representations-with-attitude, representations that also are actual. They differ from the representations that are lines of type, sounds etc. by being actual. Thus they involve a subjectivity or individuality that is a lawful unity. Actualism, both an externalism and an internalism, does not impose on consciousness a flat uniformuity, and it uniquely satisfies the various criteria for an adequate theory, including naturalism. Actual consciousness is a right subject and is a necessary part of any inquiry whatever into consciousness. All of it is a subject for more science, a workplace. There is no unique barrier or impediment whatever to science, as often said, no want of understanding of the mind-consciousness connection, no known unique hard problem of consciousness, no insuperable difficulty having to do with physicality and the history of science, no arguable ground at all of mysterianism. (shrink)

The privacy concerns discussed in the 1990s in relation to the New Genetics failed to anticipate the relevant issues for individuals, families, geneticists and society. Consumers, for example, can now buy their personal genetic information and share it online. The challenges facing genetic privacy have evolved as new biotechnologies have developed, and personal privacy is increasingly challenged by the irrepressible flow of electronic data between the personal and public spheres and by surveillance for terrorism and security risks. This book considers (...) the right to know and the right not to know about your own and others’ genomes. It discusses new privacy concerns and developments in ethical thinking, with the greater emphasis on solidarity and equity. The multidisciplinary approach covers current topics such as biobanks and forensic databases, DIY testing, group rights and accountability, the food we eat and the role of the press and the new digital media. (shrink)

Introduction The paradigm shift to a knowledge‐based economy has incremented the use of personal information applied to health‐related activities, such as biomedical research, innovation, and commercial initiatives. The convergence of science, technology, communication and data technologies has given rise to the application of big data to health; for example through eHealth, human databases and biobanks. Methods In light of these changes, we enquire about the value of personal data and its appropriate use. In order to illustrate the complex ground on (...) which big data applied to health develops, we analyse the current situation of the European Union and two cases: the Catalan VISC+/PADRIS and the UK Biobank, as perspectives. Discussion and conclusions Personal health‐related data in the context of the European Union is being increasingly used for big data projects under diverse schemes. There, public and private sectors participate distinctively or jointly, pursuing very different goals which may conflict with individual rights, notably privacy. Given that, this paper advocates for stopping the unjustified accumulation and commercialisation of personal data, protecting the interests of citizens and building appropriate frameworks to govern big data projects for health. A core tool for achieving such goals is to develop consent mechanisms which allow truly informed but adaptable consent, conjugated with the engagement of donors, participants and society. (shrink)

A significant development for conducting research on patient rights has been made in Iran over the past decade. This study is conducted in order to review and analyze the previous studies that have been made, so far, concerning patient rights in Iran. This is a comprehensive review study conducted by searching the Iranian databases, Scientific Information Database, Iranian Research Institute for Information Science and Technology, Iran Medex and Google using the Persian equivalent of keywords for ‘awareness', ‘attitude’, (...) and ‘patient rights'. For pertinent Iranian papers published in English, scientific databases PubMed, and Google Scholar were searched using the keyword ‘patient rights' and ‘Iran’. A total of 41 Persian and five English articles were found for these keywords, only 26 of which fulfilled the objective of our study. The increasing number of papers published indicates that from 1999 onwards, this subject has begun to draw the attention of Iranian researchers in a progressive fashion and Iranian papers in English have also been compiled and published in international sources. (shrink)

Compared with data that is initially collected for research purposes, the mandatory authorization of a government database for secondary use deserves greater scrutiny because it consists of information that is collected initially for administrative purposes. Using the case of Taiwan’s National Health Insurance (NHI) Database as an example, this paper analyzes the ethical issues that emerge when the research participants are “participated” in studies without their consent, according to the current policy. The proponents of secondary use for research (...) purposes maintain that the authorized use of the NHI Database is necessary for public interests, while the opponents argue that the potential lack of democratic accountability and the infringement on people’s rights to privacy and information autonomy is unwarranted. Drawing on the solidarity‐based approach, this paper proposes a temporal solution as a possible reform direction for better ethical justification of the secondary use of the NHI Database. (shrink)

Human genetic research databases cast a new light on the controversial issue of which uses of the human body are morally permissible. More specifically, banking human tissue raises issues relating to the ownership of the samples that the participants have donated, to the ownership of the data that are derived through processing the donated samples, and to the management arrangements that better balance the interest of genetic research with the protection of participants' rights. Winickoff & Winickoff suggest that the (...) charitable-trust model is a superior legal arrangement for biobanking compared with private biobanking. This paper critically assesses Winickoff & Winickoff's claim by highlighting some areas of implementation where such a model could be problematic. The charitable trust is certainly an advantageous arrangement because (1) it favors the separation between control and use of the samples, (2) it provides a procedural mechanism that facilitates the participation donor groups in the biobank management and (3) it mediates the different interests that are affected. On the other hand, the charitable-trust model leaves unresolved several issues--among them the ownership of the sample, the right of withdrawal, access and funding mechanism. I conclude that further theoretical and empirical analysis is required in the area. (shrink)

Advances in DNA technology and the discovery of DNA polymorphisms have permitted the creation of DNA databases of individuals for the purpose of criminal investigation.Many ethical and legal problems arise in the preparation of a DNA database, and these problems are especially important when one analyses the legal regulations on the subject.In this paper three main groups of possibilities, three systems, are analysed in relation to databases. The first system is based on a general analysis of the population; the (...) second one is based on the taking of samples for a particular list of crimes, and a third is based only on the specific analysis of each case. The advantages and disadvantages of each system are compared and controversial issues are then examined. We found the second system to be the best choice for Spain and other European countries with a similar tradition when we weighed the rights of an individual against the public's interest in the prosecution of a crime. (shrink)

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be “fair and lawful” and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for (...) so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data. (shrink)

The Second Amendment is accepted as protecting a right, but it is commonly accepted that the right is not unrestricted. I will explore the most commonly suggested restrictions proposed by gun control advocates and show why these restrictions to the Second Amendment are unjustifiably high, especially when compared with restrictions we accept for other Constitutional rights. I argue that these restrictions violate a central function of the Second Amendment—to enable the people to protect themselves against a tyrannical government. The (...) three restrictions I will be discussing are: licensing requirements for gun ownership, gun tracing with a national database of gun owners, and concealed carry restrictions. (shrink)

Ethics is a philosophical branch of inquiry that reasons between what is right and wrong. The moral philosophy of Socrates, Aristotle, and Plato from ancient Greek became the basis of most of the western ethics. These days, ethics can be divided based on its inquiries for example, normative, descriptive, metaethics, and applied ethics or based on its theories like utilitarianism, emotivism, and universal ethics. In context with applied ethics that examines issues involving emerging technologies, this study will look into the (...) ethics of Malaysian stem cell technology based on written literature. It was mainly to identify Malaysian literature on stem cell ethics through conventional search since the mainstream international database indicated an obvious shortage. The critical review of this literature will facilitate in the understanding of unique position of Malaysia towards stem cell and its ethics in reference to the limited number. Despite the limitation, this can be a preliminary study urging for more inquiries and exploration to fulfil the multiple perspectives in ethics such as the diversity of Malaysian ethics, the impact of ethics in stem cell regulation in Malaysia, and if western contemporary ethics influences Malaysian ethics particularly involving stem cell technology. (shrink)

A communitarian approach is applied to DNA testing and databases. It concerns itself both with individual rights and the common good. It finds that DNA testing, although it is highly intrusive, often advances both individual rights and the common good . However given its high level of intrusiveness and the insufficient level of oversight provided by existing checks and balances, the author argues for a national civil review board to provide still more accountability.

Although DNA profiling has been an important forensic research technique since the late 1980s, for a long time, it had not captured much attention from either academics or the public so far.In recent years, this neglect seems to have ended. Not only has wide-spread media coverage of events such as 9/11 and the 2004 tsunami brought about widespread knowledge of the usefulness of forensic DNA identification, the development of large databases containing DNA profiles of both suspected and convicted criminals has (...) in the last few years also triggered a discussion on the intrusiveness of these measures into a number of civil rights.Indeed, although the increasing use of DNA based techniques in the criminal justice system promises to offer some great benefits for a society that is permeated with risk-aversion, at the same time it also gives rise to some worrying ethical and social consequences.In this article, we confine ourselves to an analysis of the practice of DNA sample retention by government agencies that use these samples to derive digital storable DNA profiles. While this practice seems unnecessary for the purpose of criminal investigation, it carries some severe risks for genetic privacy rights which have hardly been explored so far. (shrink)

The issue of large-scale, population based DNA collections has become a world-wide discussion, which is hoped to bring substantial improvements in medicine. Continuous access to clinical data linked to the genetic samples is very important for some research that aims to find significant association between genes and diseases. This raises ethical issues related to privacy and confidentiality of medical records and the genetic information of the individuals who may be involved in the research. Genetic databases can also raise challenges for (...) the protection of the rights of the social groups, in avoiding potential stigmatization or discrimination. Informed consent of voluntary participants is another important issue in genetic research.We consider whether a person has ethical duties to donate a sample to a database if it will be used for the improvement of the health services to which they have benefited from. The balance between individual's privacy and public health is needed in genetic research. A good database will contribute to the good of both donors and society. (shrink)

The reporting of clinical trial data is necessary not only for doctors to determine treatment efficacy, but also to explore new questions without unnecessarily repeating trials, and to protect patients and the public from dangers when data are withheld. This issue is particularly salient in those trials involving invasive neurosurgical interventions, such as deep brain stimulation (DBS), for ‘treatment refractory’ psychiatric disorders. Using the federal database ClinicalTrials.gov, it was discovered that out of the completed or unknown‐status trials related to (...) psychiatric DBS up to November 2018, only two had submitted results to ClinicalTrials.gov. These results suggest that, despite federal requirements to report clinical trial data, reporting on psychiatric DBS trials is problematically minimal. It is argued that a human rights approach to this problem establishes a legal and ethical foundation for the need to report clinical trial results in this area. (shrink)

Abstract Today’s scholarship and policymaking on business and human rights (BHR) urges businesses to better understand their human rights responsibilities and remedy them, when and if abuses do occur. Despite the public discourse about businesses and human rights, the state—as the main duty bearer in international human rights law—plays a fundamental role as the protector and enforcer of human rights obligations. Yet, the existing literature overlooks state involvement as perpetrators of abuse in the corporate context. (...) We develop the term _economic complicity_ to shed light on the state’s role in directly or indirectly abusing human rights within a corporation’s sphere of influence, such as police violence toward nonviolent protesters or granting environmental licenses without adhering to legally required community consultations. We ask: What contributes to the state’s engagement in economic complicity in corporate human rights abuses? We assess hypotheses emergent from the democratic change and development studies literatures with a unique database that includes economic complicity data from Latin America, the Corporations and Human Rights Database (CHRD). This research has important theoretical implications for the business ethics and BHR literatures, as understanding economic complicity highlights the need for business actors to avoid shirking their moral responsibilities to not only ‘do no harm’ but also to protect human rights when they are threatened by the state. (shrink)

This paper argues that debates regarding legal protections to preserve the privacy of data subjects, such as those involving the European Union’s right to be forgotten, have tended to overlook group-level forms of epistemic asymmetry and their impact on members of historically oppressed groups. In response, I develop what I consider an abolitionist approach to issues of digital justice. I begin by exploring international debates regarding digital privacy and the right to be forgotten. Then, I turn to the long history (...) of informational asymmetries impacting racialized populations in the United States. Such asymmetries, I argue, comprise epistemic injustices that are also implicated within the patterns of racialized incarceration in the United States. The final section brings together questions regarding the impact of such epistemic injustices on incarcerated peoples and focuses specifically on the public availability of criminal histories in online search databases as a fundamental issue within conversations regarding digital justice. I thus conclude by building from the work of contemporary abolitionist writers to argue that the underlying concerns of an individualized right to be forgotten should be transformed into a collective effort to undermine societal carceral imaginaries. (shrink)

MicroRNAs are non‐coding regulators of gene expression and key factors in development, disease, and targets for bioengineering. Consequently, microRNAs have become essential elements of already burgeoning draft plant genome descriptions where their annotation is often particularly poor, contributing unduly to the corruption of public databases. Using the Citrus sinensis as an example, we highlight and review common failings of miRNAome annotations. Understanding and exploiting the role of miRNAs in plant biology will be stymied unless the research community acts decisively to (...) improve the accuracy of miRNAome annotations. We encourage genome annotation teams to do it right or not at all. (shrink)

We examine 575 randomly selected articles on Zimbabwean immigrants from the South African Media database to expose discourses of exclusion and the production of the psycho-social condition – moral panic. We use critical discourse analysis, notions of remediation and immediacy to scrutinize discourse structures and other discursive strategies designed to conceal mediation and authorial prejudices, and to make the reader ‘experience’ the actual content. In addition to making the anti-immigrant rhetoric appear legitimate, and the danger immediate and real, we (...) argue that the apparent seamless content is often biased by selection and structured in such a way as to deny voice to immigrants and their advocates. Among other things, we conclude that since the readers’ interpretations are filtered through lenses of subjectivities defined by communicative contexts characterized by job scarcity, poverty, crime and wanting healthcare, the news content heightens anxiety and miseducates more than it enlightens readers on migration issues. Hence there is a danger of SAM becoming unwitting conveyors of the same vices they preach against. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Index to Volume Fifty-SixArticlesBernier, Bernard, National Communion: Watsuji Tetsurō's Conception of Ethics, Power, and the Japanese Imperial State, 1 : 84-105Between Principle and Situation: Contrasting Styles in the Japanese and Korean Traditions of Moral Culture, Chai-sik Chung, 2 : 253-280Buxton, Nicholas, The Crow and the Coconut: Accident, Coincidence, and Causation in the Yogavāiṣṭha, 3 : 392-408Chan, Sin Yee, The Confucian Notion of Jing (Respect), Sin Yee Chan, 2 : (...) 229-252Chong, Kim-chong, Zhuangzi and the Nature of Metaphor, 3 : 370-391Chung, Chai-sik, Between Principle and Situation: Contrasting Styles in the Japanese and Korean Traditions of Moral Culture, 2 : 253-280The Confucian Ideal of Harmony, Chenyang Li, 4 : 583-603The Confucian Notion of Jing.(Respect), Sin Yee Chan, 2 : 229-252The Conventional Status of Reflexive Awareness: What's at Stake in a Tibetan Debate? Jay L. Garfield, 2 : 201-228The Crisis of Knowledge in Islam (I): The Case of al-'āmirī, Paul L. Heck, 1 : 106-135The Crow and the Coconut: Accident, Coincidence, and Causation in the Yogavāiṣṭha, Nicholas Buxton, 3 : 392-408De Reu, Wim, Right Words Seem Wrong: Neglected Paradoxes in Early Chinese Philosophical Texts, 2 : 281-300The Desire You Are Required to Get Rid of: A Functionalist Analysis of Desire in the Bhaga-vadgītā, Christopher Framarin, 4 : 604-617Framarin, Christopher, The Desire You Are Required to Get Rid of: A Functionalist Analysis of Desire in the Bhagavadgītā, 4 : 604-617Garfield, Jay L., The Conventional Status of Reflexive Awareness: What's at Stake in a Tibetan Debate? 2 : 201-228Heck, Paul L., The Crisis of Knowledge in Islam (I): The Case of al-'ā mirī, 1 : 106-135Heidegger's Comportment toward East-West Dialogue, Lin Ma and Jaap van Brakel, 4 : 519-566Ho, Chien-hsing, Saying the Unsayable, 3 : 409-427Kantor, Hans-Rudolf, Ontological Indeterminacy and Its Soteriological Relevance: An Assessment of Mou Zongsan's (1909-1995) Interpretation of Zhiyi's (538-597) Tiantai Buddhism, 1 : 16-68Lai, Karyn, Li in the Analects: Training in Moral Competence and the Question of Flexibility, 1 : 69-83Li, Chenyang, The Confucian Ideal of Harmony, 4 : 583-603Li in the Analects: Training in Moral Competence and the Question of Flexibility, Karyn Lai, 1 : 69-83Ma, Lin, and Jaap van Brakel, Heidegger's Comportment toward East-West Dialogue, 4 : 519-566National Communion: Watsuji Tetsurō's Conception of Ethics, Power, and the Japanese Imperial State, Bernard Bernier, 1 : 84-105Ontological Indeterminacy and Its Soteriological Relevance: An Assessment of Mou Zongsan's (1909-1995) Interpretation of Zhiyi's (538- 597) Tiantai Buddhism, Hans-Rudolf Kantor, 1 : 16-68Right Words Seem Wrong: Neglected Paradoxes in Early Chinese Philosophical Texts, Wim De Reu, 2 : 281-300The Role of Time in the Structure of Chinese Logic, Jinmei Yuan, 1 : 136-152Sakya Pandita and the Status of Concepts, Jonathan Stoltz, 4 : 567-582Saying the Unsayable, Chien-hsing Ho, 3 : 409-427Schiltz, Elizabeth, Two Chariots: The Justification of the Best Life in the Katha Upanishad and Plato's Phaedrus, 3 : 451-468Spackman, John, The Tiantai Roots of Dōgen's Philosophy of Language and Thought, 3 : 428-450Stevenson, Frank W., Zhuangzi's Dao as Background Noise, 2 : 301-331Stoltz, Jonathan, Sakya Pandita and the Status of Concepts, 4 : 567-582The Tiantai Roots of Dōgen's Philosophy of Language and Thought, John Spackman, 3 : 428-450 [End Page 709]Two Chariots: The Justification of the Best Life in the Katha Upanishad and Plato's Phaedrus, Elizabeth Schiltz, 3 : 451-468van Brakel, Jaap, and Lin Ma, Heidegger's Comportment toward East-West Dialogue, 4 : 519-566Yuan, Jinmei, The Role of Time in the Structure of Chinese Logic, 1 : 136-152Zhuangzi and the Nature of Metaphor, Kim-chong Chong, 3 : 370-391Zhuangzi's Dao as Background Noise, Frank W. Stevenson, 2 : 301-331Book NotesFenner, David E. W., Introducing Aesthetics (note by James McRae), 3 : 515-516Introducing Aesthetics, by David E. W. Fenner (note by James McRae), 3 : 515-516McRae, James, a book... (shrink)

"An important contribution to contemporary jurisprudential debate and to legal thought more generally, Just Interpretations is far ahead of currently available work."--Peter Goodrich, author of Oedipus Lex "I was struck repeatedly by the clarity of expression throughout the book. Rosenfeld's description and criticism of the recent work of leading thinkers distinguishes his work within the legal theory genre. Furthermore, his own theory is quite original and provocative."--Aviam Soifer, author of Law and the Company We Keep.