RULE or restricted utilitarianism is frequently propounded and just as frequently criticized in the literature. Its various refinements initially involve conceptual adjustments such as clarifying the logical relations between some stateable rule of utility and other moral rules or the specification of a criterion for ranking rules in case of conflict and so forth. It soon becomes clear, comparatively speaking, that a cluster of problems involving justice, personal rights and the denotation of ‘intrinsic good’ cannot be resolved without extending rule (...) utilitarianism as a theory of right conduct and justification; thus the origin of the appellation ‘extended’ rule utilitarianism. In this paper I shall: render an interpreted model of rule utilitarianism that possesses all the logical features of alternative interpretations. Describe a style of argument for extending rule utilitarianism to incorporate a rule of distribution. Such an extension preserves the consistency of rule utilitarianism. Describe a second style of argument for extending rule utilitarianism to incorporate a rule of distribution. Such an extension does not preserve the consistency of rule utilitarianism. (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)

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others (...) can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)

I explore gender messages in Boy Scout and Girl Scout handbooks through an analysis of how gender is infused in the context and content of Scout activities as well as in instructions about how the Scouts are to approach these activities. I find that girls are offered more activities intended to be performed in group contexts than are boys. Boys are offered proportionately more activities with scientific content and proportionately fewer artistic activities than are girls. The girls’ handbook conveys messages (...) about approaching activities with autonomous and critical thinking, whereas the boys’ handbook facilitates intellectual passivity through a reliance on organizational scripts. Taken together, girls’ messages promote an “up-to-date traditional woman” consistent with the Girl Scouts’ organizational roots; boys’ messages promote an assertive heteronormative masculinity that is offset by facilitating boys’ intellectual passivity. (shrink)

Since the Supreme Court upheld the partial birth abortion ban in 2007, more U.S. abortion providers have begun performing intraamniotic digoxin injections prior to uterine dilation and evacuations. These injections can cause medical harm to abortion patients. Our objective is to perform an in-depth bioethical analysis of this procedure, which is performed mainly for the provider’s legal benefit despite potential medical consequences for the patient.

An effective restructuring of the social sciences around the evolutionary model requires that evolutionary theory has explanatory power with respect to the spread of cultural traits: The causal mechanisms involved should be structurally analogous to those of biological evolution. I argue that this is implausible because phenotypical consequences of cultural traits are not causally relevant to their chances of “survival.” (Published Online November 9 2006).

In the last few decades of the twentieth century there was a revolution in metaphysics: the intensional revolution. Many metaphysicians rejected the doctrine, associated with Quine and Davidson, that extensional analyses and theoretical resources were the only acceptable ones. Metaphysicians embraced tools like modal and counterfactual analyses, claims of modal and counterfactual dependence, and entities such as possible worlds and intensionally individuated properties and relations. The twenty-first century is seeing a hypterintensional revolution. Theoretical tools in common use carve more finely (...) than by necessary equivalence: two pieces of language can apply to the same entities across all possible worlds but not be equivalent; thoughts can be necessarily equivalent in truth value but not synonymous. This paper argues that hyperintensional resources are valuable in metaphysics outside theories of representation, and discusses some promising areas of hyperintensional metaphysics. (shrink)

Jones & Love (J&L) suggest that Bayesian approaches to the explanation of human behavior should be constrained by mechanistic theories. We argue that their proposal misconstrues the relation between process models, such as the Bayesian model, and mechanisms. While mechanistic theories can answer specific issues that arise from the study of processes, one cannot expect them to provide constraints in general.

Abstract There are at least eight good reasons practicing historians should concern themselves with counterfactual claims. Furthermore, four of these reasons do not even require that we are able to tell which historical counterfactuals are true and which are false. This paper defends the claim that these reasons to be concerned with counterfactuals are good ones, and discusses how each can contribute to the practice of history. Content Type Journal Article Pages 1-19 DOI 10.1007/s11098-011-9817-z Authors Daniel Nolan, School of (...) Philosophy, Australian National University, 0200 Canberra, Australia Journal Philosophical Studies Online ISSN 1573-0883 Print ISSN 0031-8116. (shrink)

In this paper, I motivate the view that quantitative parsimony is a theoretical virtue: that is, we should be concerned not only to minimize the number of kinds of entities postulated by our theories (i. e. maximize qualitative parsimony), but we should also minimize the number of entities postulated which fall under those kinds. In order to motivate this view, I consider two cases from the history of science: the postulation of the neutrino and the proposal of Avogadro's hypothesis. I (...) also consider two issues concerning how a principle of quantitative parsimony should be framed. (shrink)

Asay (2018) criticizes our contention that psychologists do best to adhere to a substantive theory of correspondence truth. He argues that deflationary theory can serve the same purposes as correspondence theory. In the present article we argue that (a) scientific realism, broadly construed, requires a version of correspondence theory and (b) contrary to Asay’s suggestion, correspondence theory does have important additional resources over deflationary accounts in its ability to support generalizations over classes of true sentences.

Philosophers have found postulating possible worlds to be very useful in a number of areas, including philosophy of language and mind, logic, and metaphysics. Impossible worlds are a natural extension to this use of possible worlds, and can help resolve a number of difficulties thrown up by possible‐worlds frameworks.

David Lewis's work is of fundamental importance in many areas of philosophical inquiry and there are few areas of Anglo-American philosophy where his impact has not been felt. Lewis's philosophy also has a rare unity: his views form a comprehensive philosophical system, answering a broad range of questions in metaphysics, philosophy of mind, philosophy of language, philosophy of action and many other areas. This breadth of Lewis's work, however, has meant that it is difficult to know where to start in (...) Lewis's work and a casual reader may often miss some of the illuminating connections between apparently quite disparate pieces of Lewis's work. This book aims to make this body of work more accessible to a general philosophical readership, while also providing a unified overview of the many contributions Lewis has made to contemporary Anglo-American philosophy. The book can be divided into four parts. The first part examines Lewis's metaphysical picture - one of the areas where he has had the greatest impact and also the framework for the rest of his theories. The second section discusses Lewis's important contributions in the philosophy of mind, language and meaning. The third part explores some of Lewis's work in decision theory, metaethics and applied ethics, areas where his work in not necessarily as widely appreciated, but in which he has done a range of work that is both accessible and important. The final section focuses on Lewis's distinctive philosophical method, perhaps one of his most significant legacies, which combines naturalism with "common-sense" theorizing. (shrink)

The central aim of this article is to specify the ontological nature of constitutive mechanistic phenomena. After identifying three criteria of adequacy that any plausible approach to constitutive mechanistic phenomena must satisfy, we present four different suggestions, found in the mechanistic literature, of what mechanistic phenomena might be. We argue that none of these suggestions meets the criteria of adequacy. According to our analysis, constitutive mechanistic phenomena are best understood as what we will call ‘object-involving occurrents’. Furthermore, on the basis (...) of this notion, we will clarify what distinguishes constitutive mechanistic explanations from etiological ones. 1 Introduction 2 Criteria of Adequacy 2.1 Descriptive adequacy 2.2 Constitutive–etiological distinction 2.3 Constitution 3 The Ontological Nature of Constitutive Mechanistic Phenomena 3.1 Phenomena as input–output relations 3.2 Phenomena as end states 3.3 Phenomena as dispositions 3.4 Phenomena as behaviours 4 Phenomena as Object-Involving Occurrents 4.1 What object-involving occurrents are and why we need them 4.2 The object in the phenomenon 4.3 The adequacy of option 5 Conclusion. (shrink)

Curry's paradox for "if.. then.." concerns the paradoxical features of sentences of the form "If this very sentence is true, then 2+2=5". Standard inference principles lead us to the conclusion that such conditionals have true consequents: so, for example, 2+2=5 after all. There has been a lot of technical work done on formal options for blocking Curry paradoxes while only compromising a little on the various central principles of logic and meaning that are under threat. -/- Once we have a (...) sense of the technical options, though, a philosophical choice remains. When dealing with puzzles in the logic of conditionals, a natural place to turn is independently motivated semantic theories of the behaviour of "if... then...". This paper argues that the closest-worlds approach outlined in Nolan 1997 offers a philosophically satisfying reason to deny conditional proof and so block the paradoxical Curry reasoning, and can give the verdict that standard Curry conditionals are false, along with related "contraction conditionals". (shrink)

This book discusses a range of important issues in current philosophical work on the nature of possible worlds. Areas investigated include the theories of the nature of possible worlds, general questions about metaphysical analysis and questions about the direction of dependence between what is necessary or possible and what could be.

In this paper we introduce a distinct metaethical position, fictionalism about morality. We clarify and defend the position, showing that it is a way to save the 'moral phenomena' while agreeing that there is no genuine objective prescriptivity to be described by moral terms. In particular, we distinguish moral fictionalism from moral quasi-realism, and we show that fictionalism possesses the virtues of quasi-realism about morality, but avoids its vices.

Angeregt von Freunden und Kollegen, hat Ernst Cassirer im amerikanischen Exil mit diesem Werk eine Summe seines Denkens vorgelegt, in der seine Philosophie der symbolischen Formen in ihren Hauptgedanken fortgeführt wird, und zwar in einer Weise, die auch einem breiteren Kreis interessierter Leser zugänglich ist. Cassirer stellt die alte Frage nach dem Wesen des Menschen neu und beantwortet sie, indem er die klassische Antwort mit weitreichenden Folgen abwandelt: Er bestimmt den Menschen als ein Wesen, das Symbole schafft und sich durch (...) Symbole mit seinesgleichen und der Welt verständigt. "Der Begriff der Vernunft ist höchst ungeeignet, die Formen menschlicher Kultur in ihrer Fülle und Mannigfaltigkeit zu erfassen [...]. Alle diese Formen sind symbolische Formen. Deshalb sollten wir den Menschen nicht als animal rationale, sondern als animal symbolicum definieren.". (shrink)

This paper explores a special kind of loop of grounding: cosmic loops. A cosmic loop is a loop that intuitively requires us to go "around" the entire universe to come back to the original ground. After describing several kinds of cosmic loop scenarios, I will discuss what we can learn from these scenarios about constraints on grounding; the conceivability of cosmic loops; the possibility of cosmic loops; and the prospects for salvaging local reflexivity, asymmetry and transitivity of grounding in a (...) world containing a cosmic loop of ground. The considerations raised in this paper also bear on what we should think about relations that are meant to support grounding relations: in particular, revisions to theories of the part-whole relation are discussed. (shrink)

Marriages come in a very wide variety: if the reports of anthropologists and historians are to be believed, an extraordinarily wide variety. This includes some of the more unusual forms, including marriage to the dead; to the gods; and even to plants. This does suggest that few proposed marriage relationships would require 'redefining marriage': but on the other hand, it makes giving a general theory of marriage challenging. So one issue we should face is how accepting we should be of (...) the reports: to what extent reported 'marriages' really are marriages. This paper defends the view that almost all of these reported marriages are in fact marriages, and suggests some theoretical approaches that may be generous enough to account for this. (shrink)

A lot of good philosophy is done in the armchair, but is nevertheless a posteriori. This paper clarifies and then defends that claim. Among the a posteriori activities done in the armchair are assembling and evaluating commonplaces; formulating theoretical alternatives; and integrating well-known past a posteriori discoveries. The activity that receives the most discussion, however, is the application of theoretical virtues to choose philosophical theories: the paper argues that much of this is properly seen as a posteriori.

David Lewis’s arguments against magical ersatzism are notoriously puzzling. Untangling different strands in those arguments is useful for bringing out what he thought was wrong with not just one style of theory about possible worlds, but with much of the contemporary metaphysics of abstract objects. After setting out what I take Lewis’s arguments to be and how best to resist them, I consider the application of those arguments to general theories of properties and relations. The constraints Lewis motivates turn out (...) to yield an argument for concretism about possible individuals that is quite different from the better-known Lewisian arguments for that position. The discussion also touches on the puzzling question of whether things are the way they are because of the properties they have, or are the properties and relations the way they are because of the things that have them. (shrink)

Are there dispositions which not only do not manifest, but which could not manifest? We argue that there are dispositions to Ф in circumstances C where C is impossible, and some where Ф is impossible. Furthermore, postulating these dispositions does useful theoretical work. This paper describes a number of cases of dispositions had by objects even though those dispositions are not possibly manifest, and argues for the importance of these dispositions.

A lot of philosophers engage in debates about what claims are “metaphysically necessary”, and a lot more assume with little argument that some classes of claims have the status of “metaphysical necessity”. I think we can usefully replace questions about metaphysical necessity with five other questions which each capture some of what people may have had in mind when talking about metaphysical necessity. This paper explains these five other questions, and then discusses the question “how much of metaphysics is metaphysically (...) necessary?”, and each of its five replacements. (shrink)

When it originated in the late 19th century, psychometrics was a field with both a scientific and a social mission: psychometrics provided new methods for research into individual differences, and at the same time, these psychometric instruments were considered a means to create a new social order. In contrast, contemporary psychometrics - due to its highly technical nature and its limited involvement in substantive psychological research - has created the impression of being a value-free discipline. In this article, we develop (...) a contrasting characterization of contemporary psychometrics as a value-laden discipline. We expose four such values: that individual differences are quantitative (rather than qualitative), that measurement should be objective in a specific sense, that test items should be fair, and that utility of a model is more important than its truth. Our goal is not to criticize psychometrics for employing these values, but rather to bring them into the open and to show that these values are not inevitable and are in need of systematic evaluation. (shrink)

As is well known, Aristotelian natural philosophy, and many other systems of natural philosophy since, have relied heavily on teleology and teleological causation. Somehow, the purpose or end of an obj ect can be used to predict and explain what that object does: once you know that the end of an acorn is to become an oak, and a few things about what sorts of circumstances are conducive to the attainment of this end, you can predict a lot about the (...) sprouting of the acorn and the subsequent behaviour of the piece of vegetation that results. Once you know that a rock seeks to move towards the centre of the Earth, you gain some insight into why it falls when released, and why it deforms the carpet or foot that it lands on. Once you know that the rabbit seeks to preserve itself, you can predict it will run from the fox. And so on. There are at least three features of Aristotle’s teleology, and more generally of an Aristotelian frame of mind about teleology, that may induce suspicion. One is that an end can serve as a "cause": as well as the sort of causation we all recognize, efficient causation, there are other forms, one of which is teleological causation. However, this can look less odd if we think of causes as things that figure in "because" answers to "why" questions. Whether or not self-preservation, or the rabbit’s continued existence, or something similar, causes the rabbit to run, the reply "because it seeks to continue in existence" certainly makes sense as an answer, or part of an answer, to a question about why it ran from the fox. (At present we are only. (shrink)

One very popular kind of semantics for subjunctive conditionals is aclosest-worlds account along the lines of theories given by David Lewisand Robert Stalnaker. If we could give the same sort of semantics forindicative conditionals, we would have a more unified account of themeaning of ``if ... then ...'' statements, one with manyadvantages for explaining the behaviour of conditional sentences. Such atreatment of indicative conditionals, however, has faced a battery ofobjections. This paper outlines a closest-worlds account of indicativeconditionals that does better (...) than some of its cousins in explaining thebehaviour of such conditionals. The paper then discusses objectionsoffered by Dorothy Edgington and Frank Jackson to closest-worldsaccounts of indicative conditionals, and shows that these objections canbe met by the account outlined. (shrink)

One of the standard approaches to the metaphysics of personal identity has some counter-intuitive ethical consequences when combined with maximising consequentialism and a plausible doctrine about aggregation of consequences. This metaphysical doctrine is the so-called ‘multiple occupancy’ approach to puzzles about fission and fusion. It gives rise to a new version of the ‘utility monster’ problem, particularly difficult problems about infinite utility, and a new version of a Parfit-style ‘repugnant conclusion’. While the article focuses on maximising consequentialism for simplicity, the (...) problems demonstrated apply more widely to a range of ethical views, especially flavours of consequentialism. This article demonstrates how these problems arise, and discusses a number of options available in the light of these problems for a consequentialist tempted by a multiple occupancy metaphysics. (shrink)

Biological individuality is a notoriously thorny topic for biologists and philosophers of biology. In this paper we argue that biological individuality presents multiple, interconnected questions for biologists and philosophers that together form a problem agenda. Using a case study of an interdisciplinary research group in ecology, behavioral and evolutionary biology, we claim that a debate on biological individuality that seeks to account for diverse practices in the biological sciences should be broadened to include and give prominence to questions about uniqueness (...) and temporality. We show that broadening the problem agenda of biological individuality draws attention to underrecognized philosophical issues and discussions and thereby organizes and enriches the existing debate. (shrink)

The philosophy of necessity and possibility has flourished in the last half-century, but much less attention has been paid to the question of how we know what can be the case and what must be the case. Many friends of modal metaphysics and many enemies of modal metaphysics have agreed that while empirical discoveries can tell us what is the case, they cannot shed much light on what must be the case or on what non-actual possibilities there are. In this (...) paper, in contrast, I discuss and defend naturalistic approaches to discovering the facts about necessity and possibility. After some remarks about what methodological naturalism in philosophy might amount to, I argue that naturalistic method in modal investigations may not need to be particularly revisionary of much of what is currently being done in modal investigation. I then discuss a number of respects in which a naturalistic orientation in modal investigation may improve on our current epistemic situation. (shrink)

There’s an argument around from so-called “linguistic theories of vagueness”, plus some relatively uncontroversial considerations, to powerful metaphysical conclusions. David Lewis employs this argument to support the mereological principle of unrestricted composition, and Theodore Sider employs a similar argument not just for unrestricted composition but also for the doctrine of temporal parts. This sort of argument could be generalised, to produce a lot of other less palatable metaphysical conclusions. However, arguments to Lewis’s and Sider’s conclusions on the basis of considerations (...) about vagueness are uncompelling, even if we accept the crucial premises about vagueness. And a good thing too, since the generalised form of the argument would prove far too much. (shrink)

This paper examines both creepiness and the distinctive reaction had to creepiness, being “creeped out.” The paper defends a response-dependent account of creepiness in terms of this distinctive reaction, contrasting our preferred account to others that might be offered. The paper concludes with a discussion of the value of detecting creepiness.