The evaluation of tourism competitiveness is an important tool for analyzing the potential of tourism in a specific context. Enshi Autonomous Prefecture in China is selected as a case through which to explore the potential of mountain tourism and its competitiveness in the tourism industry. This study develops EAP’s mountain tourism competitiveness model focusing on three criteria: core competitiveness of mountain tourism, the economic environment’s competitiveness, and infrastructure competitiveness. Context-specific customized evaluation index has been applied to data collected from EAP (...) Statistical Yearbook for 2005–2014. The study reveals that the value of EAP’s mountain tourism core competitiveness, economic and environmental competitiveness, and infrastructure competitiveness are 84.292, 13.4, and 2.308%, respectively. When tourism core competitiveness is increased by one unit, EAP’s mountain tourism competitiveness will increase by 0.84292 units. Similarly, when economic environment competitiveness is increased by one unit, EAP’s mountain tourism competitiveness will increase by 0.134 units. EAP’s mountain tourism competitiveness increases by 0.02308 units when infrastructure competitiveness increases by one unit. The major reasons for low levels of competitiveness were lack of awareness of the county authority, a low level of cooperation, and weak infrastructure. The recommendations from the study’s findings are as follows. Firstly, the county authority should appropriately improve the relationship between competition and cooperation, maintaining cooperation in competition, and competition in cooperation. Secondly, the county authority should strengthen communication by establishing an effective coordinated mechanism. Thirdly, the county authority should improve the sense of cooperation and jointly develop the mountain tourism market. Fourthly, the county authority should improve the construction of tourism infrastructure and break down the barriers to tourism cooperation. The study’s findings help develop a “win-win” cooperation mechanism within the competition and support the sustainable development of the mountain tourism industry while reducing poverty and promoting the revitalization of the mountains of China. (shrink)

The infant mortality rate in Liberia is 50 times higher than it is in Sweden, whilst a child born in Japan has a life expectancy at birth of more than double that of one born in Zambia. 1 And within countries, we see differences which are nearly as great. For example, if you were in the USA and travelled the short journey from the poorer parts of Washington to Montgomery County Maryland, you would find that ‘for each mile (...) travelled life expectancy rises about a year and a half. There is a twenty-year gap between poor blacks at one end of the journey and rich whites at the other’. (Marmot, 2004, p.2). There are two types of questions which it is important to ask about inequalities in health such as these. The first are social scientific questions about the extent of inequalities in health and the factors which are causally responsible for these inequalities. Examples of social scientific questions to ask might be: how do infant mortality rates in the UK differ according to social class? What is the difference in life expectancy between Japanese who emigrate to the US and those who remain in Japan? Why do civil servants in higher ranked jobs tend to live longer than civil servants in lower ranked jobs? The second type are normative questions about the reasons we have to care about inequalities in health. Important normative questions to answer are: which inequalities in health should we care about (all inequalities or merely some of them)? When is an inequality in health unjust? How should we weigh our concern for equality in health against other factors such as maximising the.. (shrink)

This chapter contains section titled: A Story of Aisling — Part One.

Communication and Conflict Management Training for Clinical Bioethics Committees Content Type Journal Article Pages 341-349 DOI 10.1007/s10730-009-9116-7 Authors Lauren M. Edelstein, Johns Hopkins Medicine’s Howard County General Hospital 5755 Cedar Lane Columbia MD 21044 USA Evan G. DeRenzo, Washington Hospital Center Center for Ethics 110 Irving St Washington, D.C. NW 20010 USA Elizabeth Waetzig, Change Matrix Inc. 485 Maylin St. Pasadena CA 91105 USA Craig Zelizer, Georgetown University Department of Government 3240 Prospect St. Washington, D.C. NW 20057 USA Nneka (...) O. Mokwunye, Washington Hospital Center Center for Ethics 110 Irving St Washington, D.C. NW 20010 USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 21 Journal Issue Volume 21, Number 4. (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)

On Monday, June 25, 2018, H. Tristram Engelhardt, Jr., PhD, MD, co-founder of The Journal of Medicine and Philosophy, was laid to rest in the beautiful Hill Country of Texas near Comal County. Professor Engelhardt co-founded The Journal of Medicine and Philosophy in 1976 with Dr. Edmund Pellegrino. Engelhardt first served as Associate Editor, and then Editor and Senior Editor from 1976 until 2018. The Journal thrived for more than four decades through his energy, vision, and dedication. One of (...) the intellectual founders of the fields that would become known as bioethics and the philosophy of medicine, Engelhardt’s seminal scholarship has framed the philosophical debates surrounding healthcare policy and medical practice throughout the world. The Journal of Medicine and Philosophy mourns his passing. (shrink)

Nanotechnology: Considering the Complex Ethical, Legal, and Societal Issues with the Parameters of Human Performance Content Type Journal Article Pages 265-275 DOI 10.1007/s11569-008-0047-6 Authors Linda MacDonald Glenn, Albany Medical College/Center Alden March Bioethics Institute Albany NY 12208 USA Jeanann S. Boyce, Montgomery College Dept. of Computer Science and Business 7600 Takoma Avenue Takoma Park MD 20912 USA Journal NanoEthics Online ISSN 1871-4765 Print ISSN 1871-4757 Journal Volume Volume 2 Journal Issue Volume 2, Number 3.

How Doctors Think defines the nature and importance of clinical judgment. Although physicians make use of science, this book argues that medicine is not itself a science but rather an interpretive practice that relies on clinical reasoning. A physician looks at the patient's history along with the presenting physical signs and symptoms and juxtaposes these with clinical experience and empirical studies to construct a tentative account of the illness. How Doctors Think is divided into four parts. Part one introduces the (...) concept of medicine as a practice rather than a science; part two discusses the idea of causation; part three delves into the process of forming clinical judgment; and part four considers clinical judgment within the uncertain nature of medicine itself. In How Doctors Think, Montgomery contends that assuming medicine is strictly a science can have adverse side effects, and suggests reducing these by recognizing the vital role of clinical judgment. (shrink)

In his Tractatus Logico-Philosophicus Ludwig Wittgenstein (1889–1951) presents the concept of order in terms of a notational iteration that is completely logical but not part of logic. Logic for him is not the foundation of mathematical concepts but rather a purely formal way of reflecting the world that at the minimum adds absolutely no content. Order for him is not based on the concepts of logic but is instead revealed through an ideal notational series. He states that logic is “transcendental”. (...) As such it requires an ideal that his philosophical method eventually forces him to reject. I argue that Wittgenstein’s philosophy is more dialectical than transcendental. (shrink)

Bangladesh, a Muslim-majority country, has a national organ donation law that was passed in 1999 and revised in 2018. The law allows living-related and brain-dead donor organ transplantation. There are no legal barriers to these two types of organ donations, but there is no legislation providing necessary costs and incentive measures associated with successful organ transplants. However, many governments across the globe provide different types of incentives for motivating living donors and families of deceased donors. This study assesses the merits (...) and demerits of incentive measures already in use around the world and proposes ethical measures that can promote organ donation in Bangladesh. The primary focus of this paper is to present an ethical analysis of the comparison of incentive measures on organ donation between Bangladesh and the Islamic Republic of Iran as two Muslim countries that operate organ donation for transplantation practices according to Islamic principles. In this paper, I mainly argue that providing a fixed bare minimum financial incentive measure to distantly related living donors and families of deceased donors will encourage Bangladeshis to donate organs in a manner that is ethically justifiable, morally permissible, and socio-economically appropriate. The government of Bangladesh should revise the existing biomedical law to include a provision related to incentive measures and set a strict policy to properly regulate these measures as key stewardship that can ethically promote organ donation for transplantation. (shrink)

The Infectious Diseases Act entered into force officially on 14 November 2018 in Bangladesh. The Act is designed to raise awareness of, prevent, control, and eradicate infectious or communicable diseases to address public health emergencies and reduce health risks. A novel coronavirus disease was first identified in Bangladesh on 8 March 2020, and the Ministry of Health and Family Welfare issued a gazette on 23 March, listing COVID-19 as an infectious disease and addressing COVID-19 as a public health emergency. The (...) gazette empowers the government to monitor the spread of infection. Despite there being an infrastructure of research ethics committees in almost all hospitals in Bangladesh, a lack of such committees in the clinical setting often forces healthcare professionals to allocate scarce healthcare resources to the task. These personnel are often either influenced by materialistic matters or guided by the emergency policies, without reaching a consensus on how to allocate scarce resources in times of need, especially in the time of the COVID-19 pandemic. Ethical dilemmas often arise when a number of patients with COVID-19, especially in poor and middle-class areas, are denied care while elites are prioritized to receive such scarce resources. Resource allocation in healthcare during the COVID-19 pandemic in Bangladesh appears to be unethical and in direct conflict with the biomedical principles of non-maleficence and procedural justice. The findings of this study suggest that the Act needs substantive changes in the stipulation of policy directing hospitals in the provision of resource allocation framework. Furthermore, parliament should produce guidance outlining how to successfully implement the law with the aim of protecting public health in times of emergency, especially the COVID-19 pandemic. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Elements of Eleatic Ontology' MONTGOMERY FURTH THE TASKOF AN INTERPRETERof Parmenides is to find the simplest, historically most plausible, and philosophically most comprehensible set of assumptions that imply (in a suitably loose sense) the doctrine of 'being' set out in Parmenides' poem. In what follows I offer an interpretation that certainly is simple and that I think should be found comprehensible. Historically, only more cautious claims are possible, (...) for several portions of the general view from which I 'deduce the poem' are not clearly stated in the poem itself; my explanation of this is that they are operating as tac/t assumptions, and indeed that the poem is best thought of as an attempt to force these very assumptions to the surface for formulation and criticism -that the poem is a challenge. To be sure, there are dangers in pretending, as for dramatic purposes I shall, that ideas are definite and explicit which for Parmenides himself must have been tacit or vague--that Parmenides knew what he was doing as clearly as I represent him; I try to avoid them, but the risk must be taken. I even believe that not to take it, in the name of preserving his thought pure from anachronous contamination, actually prevents us from seeing the extent to which he, pioneer, was ahead of his timc the argument works both ways. So let me hedge my historical claim in this way: the view I shall discuss could have been an active-indeed a controlling---element of Eleaticism; to suppose that Parmenides held it not only explains the poem, but also helps explain the subsequent reactions to Eleaticism of Anaxagoras, Democritus, and Plato (though there is not space to elaborate this here). In addition, it brings his thought astonishingly close to some contemporary philosophical preoccupations. In the first of the following sections, I lay down some sketchy but necessary groundwork concerning the early Greek concept of 'being.' Then in Section 2 an interpretation is given of what I take to be the central Parmenidean doctrine, that 'it cannot be said that anything is not.' This section is the lengthiest and most involved, but it also contains all the moves that appear to be important. Of the remaining sections, Section 3 exp]Mn.qthe principle: 'of what is, all that can be said is: it is,' Section 4 deals briefly with the remaining cosmology of "The Way of Truth," and Section 5 considers the question whether Parmenides himself believed the fantastic conclusions of his argument. There is a short postscript on a point of methodology. 1. A Word on 6v If we are to examine Parmenides' reasoning profitably, an indispensable pre1This paper wasprepared while the author was beneficiary of a Grant-in-Aid of Research from the American Council of Learned Societies, hereby gratefully acknowledged. [111] 112 HISTORY OF PHILOSOPHY liminary is to estabhsh at least a provisional reading for the Greek words translated "is" or "it is" (tar,v), "what is" or "being" (Sv,rb 5v), "to be" (alva0. For while it is evident enough that in his poem Parmenides purports to be delivering an insight of the utmost significance concerning rb tbv (as he calls it), still the construction which he puts upon the term and its cognates, and the understanding which he expects of his listener, are not so clear and have been topics of dispute. Especially notable, and often noted, is the fact that Parmenides' discussion of 'being' shows no sign of the conceptual distinction considered elementary nowadays, between the "is" linking subject and predicate and the "is" of existence; and in fact it needs no documentation here that this distinction was not reflected in either ordinary or philosophical Greek idiom until, at least, a much later date than his, the word tare expressing both concepts. Also highly visible in the poem is the abundance of occurrences of tare used absolutely, unaccompanied by any predicate expression. As a result of this last, the poem can create in the contemporary reader the impression that r5 tSv is being used to mean what is in the existential sense only, to mean what there is; indeed some students of the poem conclude not only that Parmenides... (shrink)

This book is a re-thinking of Aristotle's metaphysical theory of material substances. The view of the author is that the 'substances' are the living things, the organisms: chiefly, the animals. There are three main parts to the book: Part I, a treatment of the concepts of substance and nonsubstance in Aristotle's Categories; Part III, which discusses some important features of biological objects as Aristotelian substances, as analysed in Aristotle's biological treatises and the de Anima; and Part V, which attempts to (...) relate the conception of substance as interpreted so far to that of the Metaphysics itself. The main aim of the study is to recreate in modern imagination a vivid, intuitive understanding of Aristotle's concept of material substance: a certain distinctive concept of what an individual material object is. (shrink)

Place, practice and status have played significant and interacting roles in the complex history of primatology during the early to mid-twentieth century. This paper demonstrates that, within the emerging discipline of primatology, the field was understood as an essential supplement to laboratory work. Founders argued that only in the field could primates be studied in interaction with their natural social group and environment. Such field studies of primate behavior required the development of existing and new field techniques. The practices and (...) sites developed by American primatologist Clarence Ray Carpenter were used to demonstrate that scientific standards could be successfully applied to the study of primates in the field. In an environment in which many field biologists fought for higher scientific status, Carpenter gradually adopted increasingly interventionist techniques. These techniques raised epistemological problems for studies whose value rested on the naturalness of the behaviors observed. Thus, issues of status shaped field practices and subsequently altered Carpenter's criteria for what constituted natural primate behavior. (shrink)

Organ transplantation from living related donors in Bangladesh first began in October 1982, and became commonplace in 1988. Cornea transplantation from posthumous donors began in 1984 and living related liver and bone marrow donor transplantation began in 2010 and 2014 respectively. The Human Organ Transplantation Act officially came into effect in Bangladesh on 13th April 1999, allowing organ donation from both brain-dead and related living donors for transplantation. Before the legislation, religious leaders issued fatwa, or religious rulings, in favor of (...) organ transplantation. The Act was amended by the Parliament on 8th January, 2018 with the changes coming into effect shortly afterwards on 28th January. However, aside from a few posthumous corneal donations, transplantation of vital organs, such as the kidney, liver, heart, pancreas, and other body parts or organs from deceased donors, has remained absent in Bangladesh. The major question addressed in this article is why the transplantation of vital organs from deceased donors is absent in Bangladesh. In addition to the collection of secondary documents, interviews were conducted with senior transplant physicians, patients and their relatives, and the public, to learn about posthumous organ donation for transplantation. Interviews were also conducted with a medical student and two grief counselors to understand the process of counseling the families and obtaining consent to obtain posthumous cornea donations from brain-dead patients. An interview was conducted with a professional anatomist to understand the processes behind body donation for the purposes of medical study and research. Their narrative reveals that transplant physicians may be reticent to declare brain death as the stipulations of the 1999 act were unclear and vague. This study finds that Bangladeshis have strong family ties and experience anxiety around permitting separating body parts of dead relatives for organ donation for transplantation, or donating the dead body for medical study and research purposes. Posthumous organ donation for transplantation is commonly viewed as a wrong deed from a religious point of view. Religious scholars who have been consulted by the government have approved posthumous organ donation for transplantation on the grounds of necessity to save lives even though violating the human body is generally forbidden in Islam. An assessment of the dynamics of biomedicine, religion and culture leads to the conclusion that barriers to posthumous organ donation for transplantation that are perceived to be religious may actually stem from cultural attitudes. The interplay of faith, belief, religion, social norms, rituals and wider cultural attitudes with biomedicine and posthumous organ donation and transplantation is very complex. Although overcoming the barriers to organ donation for transplantation is challenging, initiation of transplantation of vital organs from deceased donors is necessary within Bangladesh. This will ensure improved healthcare outcomes, prevent poor people from being coerced into selling their organs to rich recipients, and protect the solidarity and progeny of Bangladeshi families. (shrink)

The government of Bangladesh approved the human organ transplantation law in 1999 and updated it in 2018. This legislation approved both living‐related donor and posthumous organ transplantation. The law only allows family members to legally donate organs to their relatives. The main focus of this study was to explore how Bangladeshis make donation decisions on familial organs for transplantation. My ethnographic fieldwork with forty participants (physicians and nurses, a healthcare administrator, organ donors, recipients, and their relatives) disclosed that the organ (...) donation decision was family‐based. An assessment of the relationship between religion, culture, and biomedicine leads to the conclusion that deciding on donating organs to relatives is primarily family‐based and is perceived to be steeped in Islamic ethical principles and religious cultural tradition. The family‐based consent and motivation for donor‐recipient pair organ transplantation strengthen an altruistic environment for the family and act as the moral and legal authority that ensures ethical healthcare outcomes for Bangladeshis. (shrink)

This article examined the effect of culture and religiosity on perceptions of business ethics among students in a tertiary institution in Malaysia. A structured questionnaire was developed with scenarios on various aspects of business ethics, and self-administered to the students in the business studies program. The results from 767 respondents showed that there were significant differences among the Malays, Chinese, and Indian students on seven scenarios namely selling hazardous products, misleading instructions, selling defective products, padding expense account, taking sick to (...) take a day off, keeping quiet on defective products, and respond to supplier's take good care of clients attitude. There was also an association between culture and religiosity. The MANOVA results also showed that culture and religiosity have an effect on perceptions of business ethics. (shrink)

The stipulation of living organ transplantation policy and practice in Bangladesh is family-oriented, with relatives being the only people legally eligible to donate organs. There have been very few transplantations of bone marrows, liver lobes, and kidneys from related-living donors in Bangladesh. The major question addressed in this study is why Bangladesh is not getting adequate organs for transplantation. In this study, I examin the stipulations of the policy and practice of living organ donation through the lens of 32 key (...) stakeholders including physicians and nurses, a health administrator, organ donors and recipients, and their family members, as they can shed light on the realities and problems of organ donation for transplantation in Bangladesh. My ethnography reveals that the family members are always encouraged to donate organs for transplantation, and saving the lives of relatives through organ donation is seen as a moral obligation. Many view saving the life of a relative by donating one’s organs as equivalent to saving one’s own life. An assessment of the dynamics of biomedicine, religion, and culture leads to the conclusion that the family-oriented organ donation policy and practice have been widely endorsed and accepted in Bangladesh, and Islamic ethical principles and collective family ethos undergird that policy and practice. However, the unavailability of medical resources, lack of post-operative coverage for organ donors, religious misconceptions and unawareness of the general public, and the absence of posthumously donated vital organs for transplantation are perceived to be the most common barriers to a successful living donor-recipient pair organ transplantation. By overcoming these obstacles, Bangladesh can develop a successful living donor-recipient pair organ transplantation program that will ensure improved healthcare outcomes, promote altruism and solidarity among Bangladeshi families, and protect the poor from having their organs sold to wealthy patients. (shrink)

Assisted Reproductive Technologies (ARTs) have been practiced in Islamic societies within married couples since their introduction. However, there are divergent views over the issue of third-party donation among Sunni and Shia scholars. This paper illustrates the different perspectives of Shia Muslims surrounding, sperm, egg, and embryo donation and ethical aspects thereof. The study reveals that there are different views regarding sperm, egg, and embryo donation among the Shia religious leaders around the world. Many Shia religious scholars, including the Iranian supreme (...) religious leader Ali Hussein Khamenei allow sperm, egg, and embryo donation with certain conditions. However, the conditions stipulated by Shia religious scholars contradict the ethical and legal practices of sperm, egg, and embryo donation. Regarding sperm and egg donation, they declared that the donor child would inherit from a third-party donor and the commissioning parents would be adoptive parents. Thus, according to them, donor anonymity is impossible. Moreover, the Iranian act on embryo donation did not stipulate the right and responsibilities of the donor child and recipient couples and did not clarify the nature and number of embryos that can be donated and implanted. The paper argues that the lack of laws and guidelines on sperm, egg, and embryo donation raises many ethical problems. Based only on religious rulings, third-party donation has been practiced without foreseeing the well-being and safety of donor children, donors, and recipient couples. (shrink)

The topic of this paper is the debate between two accounts of the continuum. On one account the continuum has discrete elements. On the other it has no discrete elements. Each account has its own strengths and weaknesses. The paper introduces several different explications of continuity before stating and discussing an antinomy and some options to resolve it. An assessment follows in which certain astute philosophical views are vetted. If the dispute concerns the reality of the continuum, there seems to (...) be nothing that could further decide the matter. If the dispute concerns our access to the continuum, there are many adequate options. But, in either case, the dispute is not merely verbal. (shrink)

In this classic work, often described as "The History of the Rise, Decline, and Fall of the Love Affair," Denis de Rougemont explores the psychology of love from the legend of Tristan and Isolde to Hollywood. At the heart of his ever-relevant inquiry is the inescapable conflict in the West between marriage and passion--the first associated with social and religious responsiblity and the second with anarchic, unappeasable love as celebrated by the troubadours of medieval Provence. These early poets, according to (...) de Rougemont, spoke the words of an Eros-centered theology, and it was through this "heresy" that a European vocabulary of mysticism flourished and that Western literature took on a new direction.Bringing together historical, religious, philosophical, and cultural dimensions, the author traces the evolution of Western romantic love from its literary beginnings as an awe-inspiring secret to its commercialization in the cinema. He seeks to restore the myth of love to its original integrity and concludes with a philosophical perspective on modern marriage. (shrink)

This guide is an exploration of political reality as understood by Eric Voegelin. Voegelin employed the revolutionary concepts found in ancient Greek noetic and Christian pneumatic philosophy that describe political reality and the means to know it. This guide begins with a biographical sketch of Voegelin, the historical milieu that inspired his resistance to "unreality" and terms and symbols he uses to identify the spiritual sickness he believes is destroying Western civilization's traditional basis of order, it then examines Voegelin's theories (...) of consciousness, philosophy and science fundamental to understanding reality. Given the extensive nature and volume of his work, a consolidation and explanation of it is offered, and an example on how to apply it is outlined. Critiques of Voegelin's work are detailed to outline weaknesses in his theories and methods. This guide concludes by defining political reality, how to use Voegelinian techniques to analyze reality, and how to live a life that cultivates the pursuit of human knowledge in keeping with Western philosophic traditions. Book jacket. (shrink)

The Cold War has affected the communities around the world. Malaysia was no exception in being affected by the turmoil the international world, particularly after the World War 2, due to ideological conflicts. Based on the domino theory, the ups and downs of particular country in terms of its, strong ideology, brings about network impacts to each country in the world. Thus, a freedom of Malaya and the establishment of Malaysia came from the history of Cold War which influenced the (...) international scene. The establishment of Malaysia is seen as a mechanism to stop the influence of communism. The involvement leaders from Malaya, Singapore, Sabah and Sarawak as well as Brunei Darussalam in the agenda to ‘build’ Malaysia with the approval from democratic countries showed a very strong cooperation that communism was a threat. This contributed to the creation of a new and bigger country. The wise Malaysian leaders in negotiating and being united in facing the global threats at that time, has shown that Malaysia’s ‘project’ in stopping the communist theory which is also known domino theory, was successfully carried out and maintained till today. Therefore, Malaysia as a case study, on how a country was ‘built’ on the basis of stopping the spread of communism in saving the Southeast Asia from falling into the hands of communists, is unique and its effectiveness should be studied. (shrink)

Why does sub-Saharan Africa exhibit the highest rates of gender inequality in the world? This article evaluates the contributions of Christian missionary societies in German East Africa to current socioeconomic gender inequalities in Tanzania. Previous studies ascribe a comparatively benign long-term effect of missionary societies, in particular of the Protestant denomination, on economic, developmental, and political outcomes. This article contrasts that perception by focusing on the wider cultural impact of the civilizing mission in colonial Africa. The analysis rests on a (...) novel georeferenced dataset on German East Africa—based on digitized colonial maps and extensive historical records available in the German colonial archives—and the most recently available DHS-surveys. The results highlight the formative role of Catholic missionary societies in German East Africa in shaping gender inequalities currently witnessed in Tanzania. (shrink)

The impact of culture and religion on sexual and reproductive health and behavior has been a developing area of study in contemporary time. Therefore, it is crucial for people using reproductive procedures to understand the religious and theological perspectives on issues relating to reproductive health. This paper compares different perspectives of three Abrahamic faiths, i.e., Judaism, Christianity, and Islam on ARTs. Procreation, family formation, and childbirth within the context of marriage have all been advocated by these three major religions of (...) the world. Judaism permits the use of all assisted reproductive technologies when the oocyte and sperm come from the husband and wife, respectively. The different denominations of Christianity have diverse views on reproductive practices. Although the Vatican does not approve of assisted reproduction, Protestant, Anglican, and other religious groups are free to use it. ARTs are acceptable in Sunni Islam, although they can only be carried out if the couples are married. Shia Islam, however, permits third-party donations to married couples under specific restrictions. This comparison reveals that while the three major world religions utilize assisted reproduction in distinct ways, there are also many comparable aspects of each religion. (shrink)