In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known (...) as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known (...) as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do. (shrink)

The legal requirements and justifications for collecting patient-identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population-based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient-identifiable data without patient consent for research purposes. This is (...) largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient-identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient-identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support. (shrink)

Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their health data for healthcare and research. Few studies have addressed consumers’ views on electronic data sharing and fewer still have explored the dual purposes of healthcare and research together. The objective of the study is to explore factors that affect consumers’ willingness to share electronic health information for healthcare and research. (...) This study involved a random-digit dial telephone survey of 800 adult Californians conducted in English and Spanish. Logistic regression was performed using backward selection to test for significant associations of each explanatory variable with the outcome variable. The odds of consent for electronic data sharing for healthcare decreased as Likert scale ratings for EHR impact on privacy worsened, odds ratio = 0.74, 95% CI [0.60, 0.90]; security, OR = 0.80, 95% CI [0.66, 0.98]; and quality, OR = 0.59, 95% CI [0.46–0.75]. The odds of consent for sharing for research was greater for those who think EHR will improve research quality, OR = 11.26, 95% CI [4.13, 30.73]; those who value research benefit over privacy OR = 2.72, 95% CI [1.55, 4.78]; and those who value control over research benefit OR = 0.49, 95% CI [0.26, 0.94]. Consumers’ choices about electronically sharing health information are affected by their attitudes toward EHRs as well as beliefs about research benefit and individual control. Design of person-centered interventions utilizing electronically collected health information, and policies regarding data sharing should address these values of importance to people. Understanding of these perspectives is critical for leveraging health data to support learning health care systems. (shrink)

Michael A. PetersBeijing Normal UniversityMy deepest condolences to Pepe, Dom and Marcus and to Jim’s grandchildren. Tina and I spent a lot of time at the Marshall family home, often attending dinn...

It is immensely difficult to give a philosophically adequate account of mental imagery. Peter F.R. Haynes, pp. 709–19) objects to the standard accounts, and offers one of his own which avoids the standard difficulties. Unfortunately it in turn seems to lapse into incoherence.Haynes rejects Cartesian accounts which would make images private objects in non-physical space. He also rejects current alternative views: both Rylean or behaviourist ones; and also intentionally complex ones, which assert that the relevant terms change their (...) meaning. He thinks that J. J. C. Smart's “topic neutral” approach may supply “the basis for a correct, intentionally simple, intuitively satisfying account of mental imagery”. But an adequate account must also be neutral, as Smart's is not, between different theories of mind. In addition to avoiding these difficulties an adequate theory has certain other desiderata; in particular Haynes places valuable emphasis on the need to explain the fact that we can sometimes mistake images for real perceptions or, more real perceptions for images. (shrink)

Archon or the Future of Government Hamilton Fyfe Originally published in 1927 "This is a good essay on the nature of government, or politics." Economic Review "Writes with a wide experience and an intimate knowledge". Daily Herald. This volume surveys the methods of government in the past and considers the conditions of government in the world of the early twentieth century. It predicts a system under which the affairs of communities will be managed by people specially trained for the job. (...) 90pp Cain, or the Future of Crime George Godwin Originally published in 1928. "Compels the reader to think…" Saturday Review "…makes out a strong case against the stupidity and cruelty of our present dealings with crime." Evening Standard In this volume the criminal is considered as curable and incurable; and the duty of Society to cure, in the one case and its right to destroy in the other, is discussed. Arguing that psychology is the rational instrument in the treatment of delinquency the volume then envisages criminal courts divested of power of punishment. 102pp. Solon or the Price of Justice C P Harvey Originally published in 1931. This volume calls attention to the exorbitant expense of civil actions. A scholarly review of the historical causes of this is followed by examination of the various solutions that have been proposed. 100pp Lycurgus or the Future of Law E S P Haynes Originally published in 1925 "A thoughtful book – deserves careful reading…" Law Times "A humane and conscientious investigation." T P’s Weekly This volume provides an analysis of the Law in England of the 1920s?? and deals with legislation, the law courts, criminal law, family law, land-laws, costs, international law, and individual liberty. 80pp. Fortuna Or Chance and Design Norwood Young Originally published in 1929 "Ingenious. His study of the "laws of chance" are not meant for those who wish to acquire sudden fortunes." T P’s Weekly. A philosophical essay on the subject of chance which is illustrated with examples from evolution, religion, economics and gambling. (shrink)

The philosophical theory of scientific explanation proposed here involves a radically new treatment of causality that accords with the pervasively statistical character of contemporary science. Wesley C. Salmon describes three fundamental conceptions of scientific explanation--the epistemic, modal, and ontic. He argues that the prevailing view is untenable and that the modal conception is scientifically out-dated. Significantly revising aspects of his earlier work, he defends a causal/mechanical theory that is a version of the ontic conception. Professor Salmon's theory furnishes a robust (...) argument for scientific realism akin to the argument that convinced twentieth-century physical scientists of the existence of atoms and molecules. To do justice to such notions as irreducibly statistical laws and statistical explanation, he offers a novel account of physical randomness. The transition from the "reviewed view" of scientific explanation to the causal/mechanical model requires fundamental rethinking of basic explanatory concepts. (shrink)

In this article I try to refute the so-called "libertarian" theory of free will, and to examine how our conclusion ought to modify our common attitudes of praise and blame. In attacking the libertarian view, I shall try to show that it cannot be consistently stated. That is, my dscussion will be an "analytic-philosophic" one. I shall neglect what I think is in practice an equally powerful method of attack on the libertarian: a challenge to state his theory in such (...) a way that it will fit in the modern biology and psychology, which are becoming increasingly physicalistic. (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)

_Rhetoric_ is the sixth volume in The New Hackett Aristotle series, a series featuring translations, with Introductions and Notes, by C. D. C. Reeve, Delta Kappa Epsilon Distinguished Professor of Philosophy at The University of North Carolina at Chapel Hill. The series will eventually include all of Aristotle's works.

In our papers on the rationality of magic, we distinghuished, for purposes of analysis, three levels of rationality. First and lowest (rationalitYl) the goal directed action of an agent with given aims and circumstances, where among his circumstances we included his knowledge and opinions. On this level the magician's treatment of illness by incantation is as rational as any traditional doctor's blood-letting or any modern one's use of anti-biotics. At the second level (rationalitY2) we add the element of rational thinking (...) or thinking which obeys some set of explicit rules, a level which is not found in magic in general, though it is sometimes given to specific details of magical thinking within the magical thought-system. It was the late Sir Edward E. Evans-Pritchard who observed that when considering magic in detail the magician may be as consistent or critical as anyone else; but when considering magic in general, or any system of thought in general, the magician could not be critical or even comprehend the criticism. Evans-Pritchard went even further: he was sceptical as to whether it could be done in a truly consistent manner: one cannot be critical of one's own system, he thought. On this level (rationalitY2) of discussion we have explained (earlier) why we prefer to wed Evans Pritchard's view of the magician's capacity for piece-meal rationality to Sir James Frazer's view that magic in general is pseudo-rational because it lacks standards of rational thinking. (shrink)

It is immensely difficult to give a philosophically adequate account of mental imagery. Peter F.R. Haynes, pp. 709–19) objects to the standard accounts, and offers one of his own which avoids the standard difficulties. Unfortunately it in turn seems to lapse into incoherence.Haynes rejects Cartesian accounts which would make images private objects in non-physical space. He also rejects current alternative views: both Rylean or behaviourist ones; and also intentionally complex ones, which assert that the relevant terms change their (...) meaning. He thinks that J. J. C. Smart's “topic neutral” approach may supply “the basis for a correct, intentionally simple, intuitively satisfying account of mental imagery”. But an adequate account must also be neutral, as Smart's is not, between different theories of mind. In addition to avoiding these difficulties an adequate theory has certain other desiderata; in particular Haynes places valuable emphasis on the need to explain the fact that we can sometimes mistake images for real perceptions or, more real perceptions for images. (shrink)

The flowering of creative and speculative philosophy that emerged in modern Europe--particularly in Germany--is a thrilling adventure story as well as an essential chapter in the history of philosophy. In this integrative narrative, Solomon provides an accessible introduction to the major authors and movements of modern European philosophy, including the Enlightenment and Romanticism, Rousseau, German Idealism, Kant, Fichte, Schelling and the Romantics, Hegel, Schopenhauer, Kierkegaard, Feuerbach, Max Brentano, Meinong, Frege, Dilthey, Bergson, Nietzsche, Husserl, Freud, Wittgenstein, Heidegger, hermeneutics, Sartre, Postmodernism, Structuralism, (...) Foucault, and Derrida. (shrink)

Investigates the resolution of contradictions and ambiguous derogations in a code, by means of the imposition of partial orderings. Although formulated as a study in the logic of norms, it provided the initial ideas for work on the logic of theory (or belief) change, developed by the authors in a series of papers by the authors and Peter Gardenfors beginning in 1985.

The Phenomenology of Spirit was Hegel's grandest experiement, changing our vision of the world and the very nature of philosophical enterprise. In this book, Solomon captures the bold and exhilarating spirit, presenting the Phenomenology as a thoroughly personal as well as philosophical work. He begins with a historical introduction, which lays the groundwork for a section-by-section analysis of the Phenomenology. Both the initiated as well as readers unacquainted with the intricacies of German idealism will find this to be an accessible (...) and exciting introduction to this great philosopher's monumental work. (shrink)

Aristotle's treatise De Interpretatione is one of his central works; it continues to be the focus of much attention and debate. C. W. A. Whitaker presents the first systematic study of this work, and offers a radical new view of its aims, its structure, and its place in Aristotle's system, basing this view upon a detailed chapter-by-chapter analysis.By treating the work systematically, rather than concentrating on certain selected passages, Whitaker is able to show that, contrary to traditional opinion, it forms (...) an organized and coherent whole. He argues that the De Interpretatione is intended to provide the underpinning for dialectic, the system of argument by question and answer set out in Aristotle's Topics; and he rejects the traditional view that the De Interpretatione concerns the assertion and is oriented towards the formal logic of the Prior Analytics. In doing so, he sheds valuable new light on some of Aristotle's most famous texts. (shrink)

'Original and provocative . . . engagingly written. (C Fred Alford) counters Levinas's notorious obscurity with a goodly dose of transparency' - John Lechte, Macquarrie University Abstract and evocative, writing in what can only be ...

Expounds on the relationship between theory and practice as applied, adjusted, and inaugurated in health care.

C. Stephen Evans explains and defends Kierkegaard's account of moral obligations as rooted in God's commands, the fundamental command being `You shall love your neighbour as yourself'. The work will be of interest not only to those interested in Kierkegaard, but also to those interested in the relation between ethics and religion, especially questions about whether morality can or must have a religious foundation. As well as providing a comprehensive reading of Kierkegaard as an ethical thinker, Evans puts him into (...) conversation with contemporary moral theorists. Kierkegaard's divine command theory is shown to be an account that safeguards human flourishing, as well as protecting the proper relations between religion and state in a pluralistic society. (shrink)

Is there such a thing as natural knowledge of God? C. Stephen Evans presents the case for understanding theistic arguments as expressions of natural signs in order to gain a new perspective both on their strengths and weaknesses. Three classical, much-discussed theistic arguments - cosmological, teleological, and moral - are examined for the natural signs they embody. At the heart of this book lie several relatively simple ideas. One is that if there is a God of the kind accepted by (...) Christians, Jews, and Muslims, then it is likely that a 'natural' knowledge of God is possible. Another is that this knowledge will have two characteristics: it will be both widely available to humans and yet easy to resist. If these principles are right, a new perspective on many of the classical arguments for God's existence becomes possible. We understand why these arguments have for many people a continued appeal but also why they do not constitute conclusive 'proofs' that settle the debate once and for all. Touching on the interplay between these ideas and contemporary scientific theories about the origins of religious belief, particularly the role of natural selection in predisposing humans to form beliefs in God or gods, Evans concludes that these scientific accounts of religious belief are fully consistent, even supportive, of the truth of religious convictions. (shrink)

C. Fred Alford interviewed working people, prisoners, and college students in order to discover how people experience evil -- in themselves, in others, and in ...

_Verificationism_ is the first comprehensive history of a concept that dominated philosophy and scientific methodology between the 1930s and the 1960s. The verificationist principle - the concept that a belief with no connection to experience is spurious - is the most sophisticated version of empiricism. More flexible ideas of verification are now being rehabilitated by a number of philosophers. C.J. Misak surveys the precursors, the main proponents and the rehabilitators. Unlike traditional studies, she follows verificationist theory beyond the demise of (...) positivism to examine its reappearance in the work of modern philosophers. Most interestingly, she argues that despite feminism's strenuous opposition to positivism, verificationist thought is at the heart of much of contemporary feminist philosophy. _Verificationism_ is an excellent assessment of a major and influential system of thought. (shrink)

Although sports and athletics provide a nearly universal social context for the learning of such cherished values as courage, honesty, discipline, communal efforts, and the pursuit of excellence, little attention has been devoted to the philosophy of this important element in human life. In a fascinating survey of the philosophic dimensions of sports and athletics, the author delves into a variety of topics, including game and play theory, play-forms and game principles in history, existentialism and sports, the popularity of sports, (...) its educational values, the function of ethics and moral values, and the role of competition, violence and aggression, self discovery, spirituality, and joy. He also considers recurrent problems such as corruption, the excessive emphasis on winning, and the exploitation of student athletes and suggests specific ways of preserving perspective and integrity. -- From publisher's description. (shrink)

"A rich collection. Since it holds a number of introductory pieces along with advanced essays and review articles, the volume will be accessible to a broad audience and will work well in philosophy of science courses....Essential."--Lawrence Sklar, University of Michigan.

A critical and detailed introduction to Kant's philosophy, with particular reference to the Critique of Pure Reason. Since Broad's death there have been many publications on Kant but Broad's 1978 book still finds a definite place between the very general surveys and the more specialised commentaries. He offers a characteristically clear, judicious and direct account of Kant's work; his criticisms are acute and sympathetic, reminding us forcefully that 'Kant's mistakes are usually more important than other people's correctitudes'. C.D. Broad was (...) Knightsbridge Professor of Moral Philosophy at Cambridge from 1933 to 1953, and this book is based on his undergraduate lectures on Kant. Broad died in 1971 and Dr Lewy has since edited the book for publication. (shrink)

In this investigation of the contemporary notion of evil, C. Fred Alford asks what we can learn about this concept, and about ourselves, by examining a society where it is unknown--where language contains no word that equates to the English term "evil." Does such a society look upon human nature more benignly? Do its members view the world through rose-colored glasses? Korea offers a fascinating starting point, and Alford begins his search for answers there.In conversations with hundreds of Koreans from (...) diverse religions and walks of life--students, politicians, teachers, Buddhist monks, Confucian scholars, Catholic priests, housewives, psychiatrists, and farmers--Alford found remarkable agreement about the nonexistence of evil. Koreans regard evil not as a moral category but as an intellectual one, the result of erroneous Western thinking. For them, evil results from the creation of dualisms, oppositions between people and ideas.Alford's interviews often led to discussions about imported ways of thinking and the impact of globalization upon society at large. In particular, he was struck by how Koreans' responses to globalization matched Westerners' views about evil. In much of the world, he argues, globalization is the ultimate dualism--attractive for the enlightenment and freedom it brings, terrifying for the great social and personal upheaval it can cause. (shrink)

The self is a topic that crosses a great many disciplinary boundaries; concepts of the self are central to political science, psychoanalysis, philosophy, sociology, and classical studies. In this book, C.Fred Alford sets forth a psychoanalytic account of the self and applies it to texts by Plato, Hobbes, Locke, Rawis, and Rouseau in order to draw out their implicit, often inchoate, assumptions about the self.

The Holocaust marks a decisive moment in modern suffering in which it becomes almost impossible to find meaning or redemption in the experience. In this study, C. Fred Alford offers a new and thoughtful examination of the experience of suffering. Moving from the Book of Job, an account of meaningful suffering in a God-drenched world, to the work of Primo Levi, who attempted to find meaning in the Holocaust through absolute clarity of insight, he concludes that neither strategy works well (...) in today's world. More effective are the day-to-day coping practices of some survivors. Drawing on testimonies of survivors from the Fortunoff Video Archives, Alford also applies the work of Julia Kristeva and the psychoanalyst Donald Winnicot to his examination of a topic that has been and continues to be central to human experience. (shrink)

Most whistleblowers talk as if they never had a choice about whether to blow the whistle. This doesn't mean they acted suddenly, or impulsively, only that they believe they could not have done otherwise. Trying to make sense of this near universal answer to the question "Why did you do it?" the essay draws on narrative theory. Narrative theory distinguishes between actant and sender—that is, between actor and his or her values. This distinction helps to explain what it means to (...) face a difficult choice over something about which one feels one never had a choice. (shrink)