The promise of genomic medicine lies in the opportunity to improve health outcomes via a personalized approach to management, grounded in genetic and genomic variation unique to an individual. However, disparities and inequities mar this remarkable landscape of genomic innovation. Prior efforts to understand these inequities have focused on populations for which genetic testing is relatively protocolized or where test utility varies greatly by ancestry groups, where equitable outcomes are more clearly defined. We therefore consider the current landscape of rare (...) disease genomics, in which diagnostic approaches vary widely and utility remains to be fully understood, and suggest a path forward: how ecosocial theory may be used to guide novel equity‐focused initiatives that incorporate illness narratives to improve population health. We present examples of narrative medicine in rare disease and reimagine the role this discipline may play in genomic sequencing studies, toward incorporation of the unique illness narrative into clinical genetics and genomics practice. Approaches that broaden the definitions of disease and of outcomes of interest will force the field to grapple with its racist history and begin to advance health equity and promote justice so that genomic medicine may truly deliver on its promise. (shrink)

Real kinds or categories, according to conventional wisdom, enter into lawlike generalizations, while nominal kinds do not. Thus, gold but not jewelry is a real kind. However, by such a criterion, few if any kinds or systems of classification employed in the social science are real, for the social sciences offer, at best, only restricted generalizations. Thus, according to conventional wisdom, race and class are on a par with telephone area codes and postal zones; all are nominal rather than real. (...) I propose an account of real kinds that recognizes the current reality of race but not zip codes and shows how a kind can be both constructed and real. One virtue of such an understanding of realism is the light shed on our current practice of racial classification. Race is not a real biological kind but neither is race a myth or illusion. However, the question of whether a social kind is real is separate from whether the category is legitimate. W. E. B. Du Bois maintained that while there are no biological races, race is real and should be conserved. My aim, in this paper, is not to argue for the legitimacy or conservation of race but to defend Du Bois's idea that kinds of people can be both made up and real and provide an understanding of realism that does justice to the social sciences. (shrink)

Implementing equity principles in resource allocation is challenging. In one approach, some US states implemented race-based prioritisation of COVID-19 vaccines in response to vast racial inequities in COVID-19 outcomes, while others used place-based allocation. In a nationally representative survey of n=2067 US residents, fielded in mid-April 2021, we explored the public acceptability of race-based prioritisation compared with place-based prioritisation, by offering vaccines to harder hit zip codes before residents of other zip codes. We found that in general, a majority of (...) respondents supported the place-based approach, and a substantial proportion supported the race-based plan. Support was higher among Democrats compared with Republicans. All US residents became eligible for vaccines on 19 April 2021 but as of this writing, equitable uptake of vaccines remains urgent not only for first doses for adults but also for boosters and for children. Our findings also provide a benchmark for future pandemic planning that racial and social justice in vaccine allocation are salient considerations for the public. The findings may furthermore be of interest to policy makers designing vaccine allocation frameworks in countries with comparable health disparities across social, ethnic and racial groups, and more broadly, for those exploring ways of promoting equity in resource allocation outside of a pandemic setting. (shrink)

Income is a primary determinant of social mobility, career progression, and personal happiness. It has been shown to vary with demographic variables like age and education, with more oblique variables such as height, and with behaviors such as delay discounting, i.e., the propensity to devalue future rewards. However, the relative contribution of each these salary-linked variables to income is not known. Further, much of past research has often been underpowered, drawn from populations of convenience, and produced findings that have not (...) always been replicated. Here we tested a large (n = 2,564), heterogeneous sample, and employed a novel analytic approach: using three machine learning algorithms to model the relationship between income and age, gender, height, race, zip code, education, occupation, and discounting. We found that delay discounting is more predictive of income than age, ethnicity, or height. We then used a holdout data set to test the robustness of our findings. We discuss the benefits of our methodological approach, as well as possible explanations and implications for the prominent relationship between delay discounting and income. (shrink)

Are wealthy neighborhoods visually more attractive than poorer neighborhoods? Past studies provided a positive answer to this question for characteristics such as green space and visible pollution. The condition of streets is one of the characteristics that can not only contribute to neighborhoods’ aesthetics, but can also affect residents’ health and mobility. In this study, we investigate whether street condition of wealthy neighborhoods is different from poorer neighborhoods. We resolved the difficulty of data collection using a dataset that utilized artificial (...) intelligence and laser imaging techniques to collect the data of street condition from 98 zip codes in Los Angeles, CA, and later, we conducted correlations between the metrics of neighborhood affluence and their street condition. Our results showed no positive correlation between neighborhood affluence and the condition of streets. On the contrary, the results favored a negative correlation, indicating that poorer neighborhoods had better streets than wealthy neighborhoods. By discussing possible reasons for these results, we call for future research that would show the direction and the extent of correlation between neighborhood affluence and street condition for other cities and in larger scales. Additionally, we discuss how artificial intelligence and automatic data collection techniques enable us to gather data of street condition for urban planning and management. (shrink)

Teachers are brain changers. Thus it would seem obvious that an understanding of the brain – the organ of learning – would be critical to a teacher’s readiness to work with students. Unfortunately, in traditional public, public-charter, private, parochial, and home schools across the country, most teachers lack an understanding of how the brain receives, filters, consolidates, and applies learning for both the short and long term. Neuroteach was therefore written to help solve the problem teachers and school leaders have (...) in knowing how to bring the growing body of educational neuroscience research into the design of their schools, classrooms, and work with each individual student. It is our hope, that Neuroteach will help ensure that one day, every student –regardless of zip code or school type—will learn and develop with the guidance of a teacher who knows the research behind how his or her brain works and learns. (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)

Aiming to further explore possible underlying causes of the recent remarkable stagnation and relative decline in American heights, this paper describes the result of analysis of the commercial US Sizing Survey (2002). Heights are correlated positively with income and education among both white males and females while Body Mass Index (BMI) is correlated negatively among females, as in other samples. In contrast to much of the literature, this paper considers geographic correlates of height such as local poverty rate, median income (...) and population density at the zip code level of resolution. After adjusting for confounding factors that influence height such as income and education, population density is found to be strongly and negatively correlated with height among white men, but less so among white women. The effect on BMIs less convincing. Other ethnic groups are not analysed in detail because of the small number of observations available. Local economic conditions as measured by median income, unemployment and poverty rate do not have a strong correlation with height or BMI after adjusting for individual income and education. (shrink)

Mrs. Vogul wore the same zip‐up white fleece and leather sandals for thirty‐one days of her husband's hospitalization. She slept in the empty bed in his two‐person room or in a chair. When she couldn't sleep, she stood motionless in the hallway like a gargoyle protecting his room. During each crisis, Mrs. Vogul frowned in the doorway, telling us which tests to order and which interventions we were allowed to try. When we supported his breathing with an oxygen mask, she (...) took it off. “Don't try to put that mask back on him again!” she warned as he gasped for air. Despite this, Mr. Vogul was “full code.” If he were to stop breathing on his own, she wanted us to intubate him. If his heart were to stop, she wanted us to try to restart it. With no advance directive to guide us, we deferred these decisions to Mrs. Vogul, despite what sometimes seemed like contradictions in what she wanted for her husband. (shrink)

"Rastafari practitioners have continually resisted social sciences definition of what outsiders called a millenarian movement. They maintained against these efforts of categorization that Rastafari as a lived and living philosophy combines ancient roots with ever emerging routes. These historical, dynamic and creative dimensions challenge any homogenizing attempts to freeze the 'movement' in time and space. African origins are as important as Diasporean experiences for Rastafari in the manifold struggles to downstroy slavery and oppression. But the strong universal appeal towards the (...) realization of equal rights and justice implodes analytical and practical limitations of a Black Atlantic culture. This volume brings together contributions from well-known Rastafari practitioners and social scientists as a counter to the unilateral politics of outside definition, identification, and misrepresentation. They discuss Rastafari as an experimental philosophy; its historical and contemporary global culture dimensions and its contribution to issues such as decolonization, reparation and repatriation. ". (shrink)

Fifteen essays examine the work of German philosopher Hans Georg Gadamer to provide feminist interpretations of his views on science, language, history, ...

In this lively and accessible book Lorraine Code addresses one of the most controversial questions in contemporary theory of knowledge, a question of fundamental concern for feminist theory as well: Is the sex of the knower epistemologically significant? Responding in the affirmative, Code offers a radical alterantive to mainstream philosophy's terms for what counts as knowledge and how it is to be evaluated. Code first reviews the literature of established epistemologies and unmasks the prevailing assumption in Anglo-American (...) philosophy that "the knower" is a value-free and ideologically neutral abstraction. Approaching knowledge as a social construct produced and validated through critical dialogue, she defines the knower in light of a conception of subjectivity based on a personal relational model. Code maps out the relevance of the particular people involved in knowing: their historical specificity, the kinds of relationships they have, the effects of social position and power on those relationships, and the ways in which knowledge can change both knower and known. In an exploration of the politics of knowledge that mainstream epistemologies sustain, she examines such issues as the function of knowledge in shaping institutions and the unequal distribution of cognitive resources. What Can She Know? will raise the level of debate concerning epistemological issues among philosophers, political and social scientists, and anyone interested in feminist theory. (shrink)

Arguing that ecological thinking can animate an epistemology capable of addressing feminist, multicultural, and other post-colonial concerns, this book critiques the instrumental rationality, hyperbolized autonomy, abstract individualism, and exploitation of people and places that western epistemologies of mastery have legitimated. It proposes a politics of epistemic location, sensitive to the interplay of particularity and diversity, and focused on responsible epistemic practices. Starting from an epistemological approach implicit in Rachel Carson’s scientific projects, the book draws, constructively and critically, on ecological theory (...) and practice, on (post-Quinean) naturalized epistemology, and on feminist and post-colonial theory. Analyzing extended examples from developmental psychology, from medicine and law, and from circumstances where vulnerability, credibility, and public trust are at issue, the argument addresses the constitutive part played by an instituted social imaginary in shaping and regulating human lives. The practices and examples discussed invoke the responsibility requirements central to this text’s larger purpose of imagining, crafting, articulating a creative, innovative, instituting social imaginary, committed to interrogating entrenched hierarchical social structures, en route to enacting principles of ideal cohabitation. (shrink)

Having adequate knowledge of the world is not just a matter of survival but also one of obligation. This obligation to "know well" is what philosophers have termed "epistemic responsibility." In this innovative and eclectic study, Lorraine Code explores the possibilities inherent in this concept as a basis for understanding human attempts to know and understand the world and for discerning the nature of intellectual virtue. By focusing on the idea that knowing is a creative process guided by imperatives (...) of epistemic responsibility, Code provides a fresh perspective on the theory of knowledge. From this new perspective, Code poses questions about knowledge that have a different focus from those traditionally raised in the two leading epistemological theories, foundationalism and coherentism. While not rejecting these approaches, this new position moves away from a primary concentration on determinate products and towards an examination of ever-changing processes. Arguing that knowledge never exists as an ungrounded abstraction but rather emerges through dialogue between variously authoritative "knowers" situated within particular social and historical contexts, she draws extensively on examples from lived social experience to illustrate the ways in which human beings have long tried to recognize and meet their epistemic responsibilities. This edition of Epistemic Responsibility includes a new preface from Lorraine Code"--Provided by the publisher. (shrink)

In a remarkable development, I have constructed a new definition for a self-delimiting universal Turing machine (UTM) that is easy to program and runs very quickly. This provides a new foundation for algorithmic information theory (AIT), which is the theory of the size in bits of programs for selfdelimiting UTM's. Previously, AIT had an abstract mathematical quality. Now it is possible to write down executable programs that embody the constructions in the proofs of theorems. So AIT goes from dealing with (...) remote idealized mythical objects to being a theory about practical down-to-earth gadgets that one can actually play with and use. (shrink)

Abstract Taking my point of entry from George Eliot's reference to ?the power of Ignorance?, I analyse some manifestations of that power as she portrays it in the life of a young woman of affluence, in her novel Daniel Deronda. Comparing and contrasting this kind of ignorance with James Mill's avowed ignorance of local tradition and custom in his History of British India, I consider how ignorance can foster immoral beliefs which, in turn, contribute to social-political arrangements of dominance and (...) subordination. Yet I ask, too, how judgements of culpability can be sustained when ignorance is culturally induced. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Commentary on “Loopholes, Gaps, and What Is Held Fast”Lorraine Code (bio)Keywordsepistemology, incredulity, knowing other people, memory, testimonyNancy Potter’s compelling essay points to some of the limitations of the theoretical apparatus that the post-positivist empiricist epistemologies of the Anglo-American mainstream make available for evaluating experiential memory claims in general, and “false memory syndrome” in particular. The loopholes and gaps in these theories of knowledge push urgent questions about testimony, (...) trust, and the politics of knowledge into a prominent place on the agendas of successor epistemology projects. These politics are enacted in societies whose dominant rhetoric privileges eye-witness evidence and “knowledge by acquaintance” as sources of objective knowledge, yet whose practices of incredulity—of granting and withholding acknowledgement to testimonial knowledge claims—expose power-saturated structures of dominance and subordination and of arbitrarily uneven distributions of epistemic authority. 1For classical empiricists and their successors, perception, memory and testimony, hierarchically ordered with perception on top, count as the principal sources of empirical knowledge. This ordering maps the relative reliability of the processes, with perception ranking as most stable, reliable and secure, memory coming second on all of these scores, and testimony ranking a poor third, closer to opinion, hearsay and rumor than to the other more respectable sources. Perception, for these theories, is “immediate” in that it is direct, bare, uncontaminated either by the particularities of the perceiving subject or of the perceptual event: from its presumed (but contestable) immediacy, all the rest follows. Memory counts as perception at one remove, its reliability a function of the relative “vividness” of the perceptions it commemorates. The esteem commonly claimed for eye-witness testimony derives from this conception of memory, which is believed to ground the testimony because of its presumed proximity to “immediate” perception. Yet testimony, even in its restricted “knowledge by description” form, tends by contrast with perception and memory to be a shaky affair; and as the temporal distance between event and testimony increases, so knowledge of matters unavailable to direct observation fares less and less well in classical and post-positivist epistemologies. A distrust of testimony is at once understandable and odd, because so small a proportion both of communal and of “individual” knowledge indeed derives from first-hand observations and experiences: most of it comes from testimony in an extended sense that encompasses books, teachings, media reports, all of the sources and resources on which both secular and scholarly knowledge relies for much of its substance. This expanded construction of the term runs alongside [End Page 255] the first-personal “testimonial” sense that is more plainly operative in discussions of false memory syndrome which, despite its experiential source, is often likewise contested on grounds that discredit the “privileged access” status that these same epistemologies claim for experience at first hand.Epistemologists commonly assimilate testimony to monologic, observational knowledge, deriving its constitutive features from instances where a testimonial utterance can pose as another perception—this time an auditory one—in a personal set of knowledge-producing observations (e.g., Fricker 1987). Because the speaker may be lying or mistaken, the process may fail to transmit knowledge; but this failure can be read as a simple perceptual error or a misremembering. Such approaches ignore the constitutive function of an interpreter/listener in fostering or thwarting testimonial knowledge to subsume it, too, much under an observational model. Indeed, not only do they separate the knower from the known and the process of knowing, as Potter observes, they also separate the knower from other knowers to guard against their influencing (= contaminating) the knowledge-production process. Experiences where an interlocutor actually enables the production of knowledge do not figure in such analyses, 2 whose effect is to suggest that giving or hearing testimony invokes no more significant moral-political issues than do acts of perceiving tables and chairs: that hearing, like seeing, is believing. (Norman Malcolm’s analysis of memory, which Potter cites, would also underwrite such a view of testimony.) Yet standard empiricist and post-positivist epistemologies generate an inquisitorial model of eliciting testimony in which the more generalized “testimony” in the knowledge that people acquire from books, media reports, conversation, reference sources recedes from... (shrink)

To ask this famous question in 2017 under the threat of an imminent global catastrophe is to invite a host of very tricky interlocking questions, not the least of which is whether a rescue could be effected in the short time that we seem to have available. This is apart from the worry whether a sufficiently determined collective will would be able to effect the changes in thinking that are needed. Then again, the impending environmental crisis, which is generally referred (...) to as anthropogenic `climate change,' may be but one of many symptoms of a civilization that is passing through the last stages of its finite time on Earth. (shrink)

A consumer society that has embraced global capitalism while striving to preserve all the comforts and conveniences provided by technoscience is arguably fatally ill. Much support for this gloomy diagnosis is provided by, among others, Hannah Arendt, Northrop Frye, and Friedrich Nietzsche. Their reflections on the health of a human culture point up the urgency of the need to rethink the idea of good reasoning that predominates in the West. However, they also indicate that a healthier, more life-enhancing conception of (...) good reasoning will arise only when a concern for justice and wisdom displaces the traditional ideals of pure and certain knowledge or eternal truths. To this end, Nietzsche recommends that philosophy ought now to concentrate on producing `cultural physicians' who would strive to fashion a philosophy of concern. This type of philosophical therapist requires a radically nonmodern approach to philosophy that must pivot on a vitalistic metaphysics capable of overcoming pervasive nihilistic ideologies which illustrate a globally spreading mythology of unconcern. Hence an effective and lasting cultural therapy will depend on the emergence of a general will/desire to broaden the conception of good reasoning beyond the narrow perspectives established by modern science. And this will depend in turn on the education of future educators who stress above all the importance of cultivating the mythopoeic imaginations of the young. (shrink)

Aristotle shares with Plato the attitude that the world, ‘the all,’ is a kosmos, a well-ordered and beautiful whole which, as such, can be rendered intelligible, or understood, by the intellect. One understands things, generally speaking, by tracing them back to their sources, origins or principles and causes or explanatory factors, and seeing in what manner they are related to these principles. We know, or understand, a thing when we grasp ‘the why’ or cause. Consequently, understanding is systematic. Some things (...) we understand through themselves - these are the first principles and as such are not understood by tracing them back to causes. We understand other things by systematically relating them in appropriate ways to what is known through itself. These other things are known through, or by means of, their causes and principles. (shrink)

Samuel Butler, a contemporary critic of Charles Darwin, proffered an alternative, vitalistic account of evolution. At the same time, he put into question all modern naturalistic treatments of this fundamental idea which presuppose that evolution is mainly a scientific problem. On the contrary, Butler in effect insists, this extremely vague idea calls for not an `explanation' but rather a fairly comprehensive, plausible story that helps elucidate an inherently complex idea. Butler can thus be read as outlining an anthropomorphic metaphorics that (...) evokes a living Cosmos wherein it might be possible to do justice to the problem which Darwin left unresolved---the problem of heredity. In this picture of the Cosmos Butler links the fundamental notion of organization not to the allegedly universal and immutable `laws of nature,' as the moderns would have it, but rather to dynamically evolving relationships between only more or less stable habits. The variations in extant habits that emergence elicits are moreover the products of quasi-intelligent responses to new challenges from the environment. For Butler follows Lamarck in holding that all organisms possess powers capable of responding to felt needs and/or desires to make alterations in the habits (or instincts) that characterize their modes of existence. He thus in the end effectively bequeaths to his readers a challenge to extend and amplify, if possible, his outline of a promising metaphysical imaginary that can take into account some highly unorthodox conjectures. Normal 0 false false false EN-AU X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman","serif";}. (shrink)

Feminist epistemologists who attempt to refigure epistemology must wrestle with a number of dualisms. This essay examines the ways Lorraine Code, Sandra Harding, and Susan Hekman reconceptualize the relationship between self/other, nature/culture, and subject/object as they struggle to reformulate objectivity and knowledge.

The arguments in this book are informed at once by the moral-political implications of how knowledge is produced and circulated and by issues of gendered subjectivity. In their critical dimension, these lucid essays engage with the incapacity of the philosophical mainstream's dominant epistemologies to offer regulative principles that guide people in the epistemic projects that figure centrally in their lives. In its constructive dimension, ____Rhetorical__ ____Spaces__ focuses on developing productive, case-by-case analyses of knowing other people in situations where social-political inequalities (...) create asymmetrical patterns of epistemic power and privilege. (shrink)

Who is the autonomous moral agent? The individual? The exemplary/typical knowing, acting, suffering, or thriving human being? Such questions in diverse modalities, originating in multiple circumsta...

Here I discuss some epistemological questions posed by projects of attempting to think globally, in light of the impossibility of affirming universal sameness. I illustrate one strategy for embarking on such a project, ecologically, in a reading of an essay by Chandra Talpade Mohanty. And I conclude by suggesting that the North/South border between Canada and the U.S.A. generates underacknowledged issues of cultural alterity.

Assumptions about what it is to be human are implicit in most philosophical reflections upon ethical and epistemological issues. Although such assumptions are not usually elaborated into a comprehensive theory of human nature, they are nonetheless influential in beliefs about what kinds of problem are worthy of consideration, and in judgments about the adequacy of proposed solutions. Claims to the effect that one should not be swayed by feelings and loyalties in the making of moral decisions, for example, presuppose that (...) human beings are creatures whose nature is amenable to guidance by reason rather than emotion and are creatures capable of living well when they act as impartially as possible. Analogously, claims to the effect that knowledge, to merit that title, should be acquired out of independent cognitive endeavour uncluttered by opinion and hearsay, suggest that human beings are creatures who can come to know their environment through their own unaided efforts. And claims to the effect that knowledge, once acquired, is timelessly and universally true depend upon assumptions about the constancy and uniformity of human nature across historical and cultural boundaries. (shrink)

I evaluate post-Quinean naturalized epistemology as a resource for postcolonial and feminist epistemology. I argue that naturalistic inquiry into material conditions and institutions of knowledge production has most to offer epistemologists committed to maintaining continuity with the knowledge production of specifically located knowers. Yet naturalistic denigrations of folk epistemic practices and stereotyped, hence often oppressive, readings of human nature challenge the naturalness of the nature they claim to study. I outline an ecologically modelled epistemology that focuses on questions of epistemic (...) responsibility and community, while refusing the reductivism of totalizing theory, and producing realistic moral-epistemic analyses of specific, local epistemic resources to ground its normative injunctions. (shrink)

In this final paper in the invited collection, Lorraine Code responds to panelists and provides background and reflections on her work.