REMARKS ON EVOLUTION AND TIME-SCALES, Graham Cairns-Smith; HODGSON'S BLACK BOX, Thomas Clark; DO HODGSON'S PROPOSITIONS UNIQUELY CHARACTERIZE FREE WILL?, Ravi Gomatam; WHAT SHOULD WE RETAIN FROM A PLAIN PERSON'S CONCEPT OF FREE WILL?, Gilberto Gomes; ISOLATING DISPARATE CHALLENGES TO HODGSON'S ACCOUNT OF FREE WILL, Liberty Jaswal; FREE AGENCY AND LAWS OF NATURE, Robert Kane; SCIENCE VERSUS REALIZATION OF VALUE, NOT DETERMINISM VERSUS CHOICE, Nicholas Maxwell; COMMENTS ON HODGSON, J.J.C. Smart; THE VIEW FROM WITHIN, Sean Spence; COMMENTARY ON HODGSON, Henry (...) Stapp. (shrink)

As one of the most important ethicists to emerge since the Second World War, Alan Gewirth continues to influence philosophical debates concerning morality. In this ground-breaking book, Gewirth's neo-Kantianism, and the communitarian problems discussed, form a dialogue on the foundation of moral theory. Themes of agent-centered constraints, the formal structure of theories, and the relationship between freedom and duty are examined along with such new perspectives as feminism, the Stoics, and Sartre. Gewirth offers a picture of the philosopher's theory and (...) its applications, providing a richer, more complete critical assessement than any which has occurred to date. (shrink)

The last decade has seen great progress in the study of the nature of crossmodal links in exogenous and endogenous spatial attention . Exogenous spatial cuing studies of human crossmodal attention and multisensory integration. In C. Spence, & J. Driver , Crossmodal space and crossmodal attention . Oxford, UK: Oxford University Press.], for a recent review). A growing body of research now highlights the existence of robust crossmodal links between auditory, visual, and tactile spatial attention. However, until recently, studies (...) of exogenous and endogenous attention have proceeded relatively independently. In daily life, however, these two forms of attentional orienting continuously compete for the control of our attentional resources, and ultimately, our awareness. It is therefore critical to try and understand how exogenous and endogenous attention interact in both the unimodal context of the laboratory and the multisensory contexts that are more representative of everyday life. To date, progress in understanding the interaction between these two forms of orienting has primarily come from unimodal studies of visual attention. We therefore start by summarizing what has been learned from this large body of empirical research, before going on to review more recent studies that have started to investigate the interaction between endogenous and exogenous orienting in a multisensory setting. We also discuss the evidence suggesting that exogenous spatial orienting is not truly automatic, at least when assessed in a crossmodal context. Several possible models describing the interaction between endogenous and exogenous orienting are outlined and then evaluated in terms of the extant data. (shrink)

BackgroundECMO is a particularly scarce resource during the COVID-19 pandemic. Its allocation involves ethical considerations that may be different to usual times. There is limited pre-pandemic literature on the ethical factors that ECMO physicians consider during ECMO allocation. During the pandemic, there has been relatively little professional guidance specifically relating to ethics and ECMO allocation; although there has been active ethical debate about allocation of other critical care resources. We report the results of a small international exploratory survey of ECMO (...) clinicians’ views on different patient factors in ECMO decision-making prior to and during the COVID-19 pandemic. We then outline current ethical decision procedures and recommendations for rationing life-sustaining treatment during the COVID-19 pandemic, and examine the extent to which current guidelines for ECMO allocation (and reported practice) adhere to these ethical guidelines and recommendations.MethodsAn online survey was performed with responses recorded between mid May and mid August 2020. Participants (n = 48) were sourced from the ECMOCard study group—an international group of experts (n = 120) taking part in a prospective international study of ECMO and intensive care for patients during the COVID-19 pandemic. The survey compared the extent to which certain ethical factors involved in ECMO resource allocation were considered prior to and during the pandemic.ResultsWhen initiating ECMO during the pandemic, compared to usual times, participants reported giving more ethical weight to the benefit of ECMO to other patients not yet admitted as opposed to those already receiving ECMO, (p < 0.001). If a full unit were referred a good candidate for ECMO, participants were more likely during the pandemic to consider discontinuing ECMO from a current patient with low chance of survival (53% during pandemic vs. 33% prior p = 0.002). If the clinical team recommends that ECMO should cease, but family do not agree, the majority of participants indicated that they would continue treatment, both in usual circumstances (67%) and during the pandemic (56%).ConclusionsWe found differences during the COVID-19 pandemic in prioritisation of several ethical factors in the context of ECMO allocation. The ethical principles prioritised by survey participants were largely consistent with ECMO allocation guidelines, current ethical decision procedures and recommendations for allocation of life-sustaining treatment during the COVID-19 pandemic. (shrink)

The two purposes of this essay. The general philosophical problem with most versions of social libertarianism and how this essay will proceed. The specific problem with liberty explained by a thought-experiment. The positive and abstract theory of interpersonal liberty-in-itself as ‘the absence of interpersonal initiated constraints on want-satisfaction’, for short ‘no initiated impositions’. The individualistic liberty-maximisation theory solves the problems of clashes, defences, and rectifications without entailing interpersonal utility comparisons or libertarian consequentialism. The practical implications of instantiating liberty: three rules (...) of liberty-in-practice, 1) initial ultimate control of one’s body, 2) initial ultimate control of one’s used resources, 3) consensual interpersonal interactions and resource transfers. These rules are economically efficient and maximise general want-satisfaction. Private property and legal remedies are additional practical institutional aspects, but to which ‘initiated impositions’ then apply prima facie. Libertarian law is often mistaken for complete libertarianism. Moral explanations are a separate issue. The three main moral theories imply libertarianism, but it can be morally posited independently of them. Critical rationalism and its application. No empirical or argumentative support for theories. An important ambiguity with ‘justification’. How the epistemology applies to the theory of liberty and its application but remains separable in principle. Conclusion: there are further published explanations but this should be enough to generate useful criticism. Appendix replying to some typical comments. (shrink)

Reproduced from Robert J.C. Young, Torn Halves. Pages: 256. ISBN: 0-7190-477-3 ; 0-7190-4776-5. Price: 14.99 ; 40.00.

This is a response to Macleod 2012's argument that the history of unjust property acquisitions requires rich libertarians to give away everything in excess of equality. At first, problematic questions are raised. How much property is usually inherited or illegitimate? Why should legitimate inheritance be affected? What of the burden of proof and court cases? A counterfactual problem is addressed. Three important cases are considered: great earned wealth; American slavery; land usurpation. All are argued to be problematic for Macleod 2012's (...) thesis. Various problems are explained concerning using the Nozickian argument to decide the alleged excess that rich libertarians own. The essay's main error is the presupposition that free markets do not help the worst-off. The majority of unjust holdings today are not the result of historical injustices but arise through continuing transfers enabled by taxation and state-regulation. More study of libertarian contributions to the social sciences and philosophy would appear to be desirable "personal behavior" among socialists. (shrink)

“Critical-Rationalist Libertarianism” (CRL) was replied to in “Libertarianism Without Argument” (the reply). Various points in that text are here given responses. Both critical rationalism and how it applies to libertarianism are elucidated and elaborated. This response will proceed by quoting the reply where relevant (virtually all of it) and then responding immediately after the quotations, following the order of the reply’s very brief “critique” (605 words).

I do not approach the question of free will as a scientist, like Colin Blakemore, or a lawyer, like David Hodgson, or philosopher, like Daniel Dennett, but as a priest -- someone who feels responsible for my own actions and who is called upon to counsel and absolve such as come to me with their shame and their guilt. Should I say that their sense of responsibility is illusory? Or should I encourage them to accept responsibility, and then to deal (...) with it in the various ways -- religious, psychological and practical -- that are open to them? (shrink)

In this essay I contrast Freud’s account of mourning in Mourning and Melancholia to that of Merleau-Ponty in Phenomenology of Perception. In suggesting a somatic as well as a psychic response, Merleau-Ponty, I argue, more accurately accounts for the ways in which we experience loss and why, contrary to Freud’s suggestion, mourning’s work is never completed.

This essay is part of an attempt to reconcile two extreme views in economics: the (neglected) subjective, apriorist approach and the (standard) objective, scientific (i.e., falsifiable) approach. The Austrian subjective view of value, building on Carl Menger’s theory of value, was developed into a theory of economics as being entirely an a priori theory of action. This probably finds its most extreme statement in Ludwig von Mises’ Human Action (1949). In contrast, the standard economic view has developed into making falsifiable (...) predictions about economic phenomena whereby the truth of the assumptions, especially about economic agents, is relatively unimportant: predictive fecundity is all. This finds an extreme statement in Milton Friedman’s introductory essay in his Essays in Positive Economics (1953). However, many economists fall somewhere between the two extremes, such as McKenzie and Tullock (1978). (shrink)

This essay goes through Frederick 2015 (the critique) in some detail, responding to the various paraphrases and criticisms therein. It is argued that in each case the critique is mistaken about what Lester 2012 (Escape from Leviathan: EfL) says, or about what the critique presents as a sound criticism, or both. Introduction: the three problems with the critique and the philosophical problem that EfL is attempting to solve. “Abstract”: the critique’s confusion about EfL’s aprioristic theory of instrumental rationality. There are (...) then detailed replies (too many and too diverse to summarise) to quotations from the critique’s confused interpretations and criticisms under the following headings (quoted from the critique): “2. Instrumental Rationality”; 3. Weakness of Will”; “4. Desires and Values”; “5. Free Will”; “6. Self-Interest”; “7. Maximisation”; “8. Morals”. Finally, in “9. Conclusion”, the philosophical problem for economics is briefly restated. The philosophical interpretation of homo economicus in EfL (as with its overall philosophical theory of libertarianism) has yet to be given adequate critical consideration. (shrink)

What is my thesis? It is not that radical experimentation by the state, rather than liberal democracy, is more in accord with the spirit and logic of Popper’s ‘revolutionary’ epistemology. It is the opposite criticism, that full anarchic libertarianism (individual liberty and the free market without any state interference) better fits Popper’s epistemology and scientific method.

Frederick 2013 (the critique) offers criticisms of the Escape from Leviathan (EfL) theory of libertarian liberty and also of its compatibility with preference-utilitarian welfare and private-property anarchy. This reply to the critique first explains the underlying philosophical problem with libertarian liberty and EfL’s proposed solution. It then goes through the critique in detail showing that it does not grasp the problem or the solution and offers only misrepresentations and unsound criticisms.

Andy Curzon replied (often quoting from the opening sections of Lester 2014, chapter 10) in an ongoing debate with Lee Waaks, which Mr Waaks forwarded (with approval) to the Libertarian Alliance Forum (27 February 2015). This response replies to the criticisms after directly quoting them (the indented text; except where Lester is occasionally quoted, as indicated). A few cuts have been made to avoid some repetition and irrelevance. However, just as Mr Curzon sometimes repeats his main points in slightly different (...) ways and contexts in the hope that some of them might prove cogent, so this reply does the same. The dialogue-like result seems to engage more directly and completely than producing a new stand-alone exposition. And some new arguments are even developed in the process. But the full nature of many of the criticisms and replies often only becomes clear as the “dialogue” proceeds. An addendum then rebuts two further brief critical responses in the same manner. (shrink)

Lester‘s reply to the review by Gordon and Modugno of Escape from Leviathan was due to appear in a later edition of the same periodical, but it was eventually dropped without notice or a reason being given. Subsequently, their review has occasionally been cited in isolation as a refutation of that book‘s theory of liberty, the compatibility of such liberty with welfare maximisation, and the use of "Popperian views" as though a complete reply did not exist and were not freely (...) available and easily found online. To make it harder to avoid the reply, whether by accident or design, it is reproduced here (but with sundry small emendations for greater clarity). (shrink)

This essay is intended to be a refutation of the main thesis in Against Intellectual Property, Kinsella 2008 (hereafter, K8). Points of agreement, relatively trivial disagreement, and irrelevant issues will largely be ignored, as will much repetition of errors in K8. Otherwise, the procedure is to go through K8 quoting various significantly erroneous parts as they arise and explaining the errors involved. It will not be necessary to respond at the same length as K8 itself.

(Revised 31-10-17) This is only one view on the topic; other views may be rather different. It starts at the more philosophical end and then becomes more empirical, and possibly easier to understand, as it proceeds.

This essay explains Jeffrey Friedman's two fundamental and persistent philosophical errors concerning the libertarian conception of liberty and the lack of a "justification‟ of libertarianism. It is ironic that Friedman himself is thereby revealed to be guilty of both an “a priori” anti-libertarianism and an anti-libertarian “straddle.” Critical-rationalist, proactive-imposition-minimising libertarianism remains completely unchallenged by him.

This brief monograph was written in an attempt to discover the general situation of Disability Studies, given that this appears to have become a growth area in academia with various typically illiberal aspects. The findings bear out the initial impression. There is a style of argument, even propaganda (for there is usually little genuine engagement with opposing liberal views), that can be seen in many other areas of academia. It amounts to a relatively new ‘progressive’ industry with various fashionable keywords, (...) phrases and ideologies—often not obviously related to disabilities in any serious way—indicating the nature of the beast: ‘progressive’, ‘radical’, ‘oppression’, ‘bourgeois’, ‘empowerment’, ‘rights’, ‘equal opportunities’, ‘discrimination’, ‘prejudice’, ‘citizenship’, ‘social justice’, ‘socially constructed’, ‘Marxism’, ‘Post Modernism’ and ‘Feminism’. The overall picture is that disability has become increasingly politicised along politically correct lines to the detriment of society as a whole and, eventually, even to the disabled themselves. This is largely caused by the endemic trahison des clercs in our tax-consuming and coercively monopolised university system. (shrink)

Most self-identified libertarians unwittingly have a moral muddle without a central factual theory of liberty. They cannot yet see that they first need to sort out what liberty is, and therefore entails if instantiated, and only after that can moral questions about it be coherently raised and tackled.

This essay explains various significant errors, imprecisions, and omissions concerning libertarianism in Long 2013. The “right not to be aggressed against” is not, as such, the libertarian right because the ‘right to liberty’ must be that right (although not being aggressed against can charitably be interpreted as equivalent). There are non-libertarian rights, but they don’t override the right to liberty. Unsupported assumptions are inevitable because justifications are impossible. Rights should not be “defined” but, rather, morally and metaphysically theorised—with criticism permanently (...) invited. Moral and legal permissibility need to be clearly distinguished. The conceptions of “aggression” and “force” are normative and confused. It is possible to advocate the right to liberty on no grounds whatsoever and also to conjecture that liberty (deontologically) and welfare (consequentially) are systematically compatible in practice for theoretical and causal reasons. The rejection of positive rights is “privileging” and not “conceptual”. Libertarian property needs to be derived from an explicit, non-normative, theory of libertarian liberty. Long 2013’s overall account is “mysterious” and “one-sided”. (shrink)

Charles Murray describes himself as a libertarian, most notably in his short book, What it Means to be a Libertarian. He might more accurately have described himself as having libertarian tendencies. My reading of Simple Justice is that the views it espouses are far more traditionalist than libertarian. Neither traditionalist state-retribution nor modernist state-leniency is libertarian. Nor does either provide as just or efficient a response to crime as does libertarian restitution, including restitutive retribution. Here, I shall respond directly only (...) to Murray's views, rather than also deal with state-leniency. This is because I accept Murray's thesis, without endorsing his specific arguments for it, that state-leniency is disastrous as a response to crimes against persons and their justly acquired property. (shrink)

Vallentyne 2010 and Zwolinski 2008 are internet encyclopaedia articles on “libertarianism” which include various serious faults. Vallentyne 2010 has the following ones. It does not properly explain mainstream libertarianism or consider criticisms of it. Instead, it mainly discusses self-ownership and natural-resource egalitarianism. Every aspect of the alleged “strict sense” of “libertarianism” is dubi ous, at best. So- called “left - libertarianism” is not made sense of as any kind of liberty-based libertarianism. Problems arise because self-ownership is assumed to be libertarian (...) without an explicit theory of libertarian liberty. The replies to “five impor tant objections to full self- ownership” are confused and mistaken; both as regards philosophical analysis and as regards empirical assumptions. The long discussion about various ways to “Appropriate Natural Resources” is rendered muddled and barren by the lack of a clear libertarian theory of liberty, the mere presumption of some form of egalitarianism, and the inclusion of various non-libertarian criteria. The remaining sections are largely uninformed by any relevant libertarian literature. It reaches a justificationist conclusion that cites mistaken welfare concerns and ignores the productivity of free markets. Zwolinski 2008 shares some errors with Vallentyne 2010, but also includes the following ones. It is even less clear about what libertarian liberty is. It fails to understand that libertarianism (private-property anarchy and, possibly, minarchy) is a subset of classical liberalism. It asserts that libertarianism is about “the proper role of government.” It assumes (illogical) justificationist/foundationalist epistemology and does not mention critical-rationalist libertarianism. It eventually faults justificationism and unwittingly assumes something approaching critical rationalism. Finally, it embraces John Rawls’s “overlapping consensus” as a “justification” (i.e., defence) of libertarianism oblivious to the similar position in Lester 1996 and 2000. (shrink)

Itis a strange chance that our whole conception of that scene of the Persae in which Atossa and the Chorus evoke from the lower world the spirit of Darius should be dependent largely on the interpretation or the restoration of a single line. πιστ πιστν λικς θ' βης μς Πρσαι γεραιο, τνα πλις πονε πνονον; στνει, κκοπται, κα χαρσσεται πδον. λεσσων δ' κοιτιν τν μν τφου πλας ταρβ, χος δ πρευμνς δεξμην. μες δ θρηνετ' γγς σττες τφου κα ψυχαγωγος ρθιζοντες (...) γοις οκτρς καλεσθ μ' …. (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)

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