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)

In a single volume intended for philosophy students of all levels as well as their teachers, this reader provides modern, accurate translations of the texts necessary for a careful study of most aspects of Aristotle's philosophy. Professor Ackrill has drawn on his broad experience of teaching graduate classes in selecting the texts, and his choice reflects issues of current philosophical interest as well as the perennial themes. Only recent translations which achieve a high level of accuracy have been chosen: the (...) aim is to place the reader without Greek, as nearly as possible, in the position of a reader of Greek. As an aid to study, a valuable guide to the key topics covered is also suppied, giving references to works or passages contained in the reader, an indication of their interrelation, and a currnet bibliography. (shrink)

Mareschal and his colleagues argue that cognition consists of partial representations emerging from organismic constraints placed on information processing through development. However, any notion of constraints must consider multiple sensory modalities, and their gradual integration across development. Multisensory integration constitutes one important way in which developmental constraints may lead to enriched representations that serve more than immediate behavioural goals.

In Wrong Medicine, Lawrence J. Schneiderman, M.D., and Nancy S. Jecker, Ph.D., address issues that have occupied the media and the courts since the time of Karen Ann Quinlan. The authors examine the ethics of cases in which medical treatment is offered--or mandated--even if a patient lacks the capacity to appreciate its benefit or if the treatment will still leave a patient totally dependent on intensive medical care. In exploring these timely issues Schneiderman and Jecker reexamine the doctor-patient relationship and (...) call for a restoration of common sense and reality to what we expect from medicine. They discuss economic, historical, and demographic factors that affect medical care and offer clear definitions of what constitutes futile medical treatment. And they address such topics as the limits on unwanted treatment, the shift from the "Age of Physician Paternalism" to the "Age of Patient Autonomy," health care rationing, and the adoption of new ethical standards. (shrink)

J. L. Ackrill; VIII*—Aristotle's Definitions of Psuche, Proceedings of the Aristotelian Society, Volume 73, Issue 1, 1 June 1973, Pages 119–134, https://doi.org.

Aristotle is widely regarded as the greatest of all philosophers; indeed, he is traditionally referred to simply as `the philosopher'. Today, after more than two millennia, his arguments and ideas continue to stimulate philosophers and provoke them to controversy. In this book J.L. Ackrill conveys the force and excitement of Aristotle's philosophical investigations, thereby showing why contemporary philosophers still draw from him and return to him. He quotes extensively from Aristotle's works in his own notably clear English translation, and a (...) picture emerges of a lucid, lively, subtle and tough-minded thinker of astonishing range and penetration. Professor Ackrill identifies many striking connections between Aristotle's ideas and ideas in recent philosophy; he also raises philosophical questions of his own, and exemplifies the way in which Aristotle can still be argued with and learned from. (shrink)

Examining those risk and benefit perceptions utilised in the formation of attitudes and opinions about emerging technologies such as nanotechnology can be useful for both industry and policy makers involved in their development, implementation and regulation. A broad range of different socio-psychological and affective factors may influence consumer responses to different applications of nanotechnology, including ethical concerns. A useful approach to identifying relevant consumer concerns and innovation priorities is to develop predictive constructs which can be used to differentiate applications of (...) nanotechnology in a way which is meaningful to consumers. This requires elicitation of attitudinal constructs from consumers, rather than measuring attitudes assumed to be important by the researcher. Psychological factors influencing societal responses to 15 applications of nanotechnology drawn from different application areas were identified using repertory grid method in conjunction with generalised Procrustes analysis. The results suggested that people differentiate nanotechnology applications based on the extent to which they perceive them to be beneficial, useful, necessary and important. The benefits may be offset by perceived risks focusing on fear and ethical concerns. Compared to an earlier expert study on societal acceptance of nanotechnology, consumers emphasised ethical issues compared to experts but had less concern regarding potential physical contact with the product and time to market introduction. Consumers envisaged fewer issues with several applications compared to experts, in particular food applications. (shrink)

ABSTRACT:The notion of stakeholder salience based on attributes (e.g., power, legitimacy, urgency) is applied in the family business setting. We argue that where principal institutions intersect (i.e., family and business); managerial perceptions of stakeholder salience will be different and more complex than where institutions are based on a single dominant logic. We propose that (1) whereas utilitarian power is more likely in the general business case, normative power is more typical in family business stakeholder salience; (2) whereas in a general (...) business context legitimacy is socially constructed; for family stakeholders, legitimacy is based on heredity; and (3) whereas temporality and criticality are somewhat independent in general-business urgency, they are linked in the family business case because of family ties and family-centered non-economic goals. We apply this theoretical framework to position and integrate the contributions to this special section ofBusiness Ethics Quarterlyon “Stakeholder Theory, Ethics, Corporate Social Responsibility, and Family Enterprise.”. (shrink)

Social capital has as its key element the value of social relationships to generate positive outcomes, both for the key parties involved and for wider society. Some authors have noted that social capital nevertheless has a dark side. There is a moral element to such a conceptualisation, yet there is scarce discussion of ethics within the social capital literature. In this paper ethical theory is applied to four traditions or approaches to economic social capital: neo-capitalism; network/reputation; neo-Tocquevellian; and development. Each (...) is considered in detail and subject to ethical analysis by the application of utilitarianism, Kantianism, justice and rights, and ethic of care. Accordingly, the assumption that social capital is either value-neutral or a force for good is critiqued, and a framework for understanding social capital from an ethics perspective is presented. (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the (...) informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

Recent policy developments in the area of livestock husbandry have suggested that, from the perspective of optimizing animal welfare, new animal husbandry systems should be developed that provide opportunities for livestock animals to be raised in environments where they are permitted to engage in “natural behavior.” It is not known whether consumers regard animal husbandry issues as important, and whether they differentiate between animal husbandry and other animal welfare issues. The responsibility for the development of such systems is allocated jointly (...) between farmers, regulators, different actors in the food chain, and consumers. This research focuses on understanding consumer attitudes and preferences regarding the development and introduction of such systems, to ensure that they are acceptable to consumers as well as producers, regulators, and scientists. Consumer perceptions of animal welfare and animal husbandry practices were evaluated using quantitative consumer survey, which focused on two animal husbandry issues – farmed pigs and farmed fish. Following pilot work, 1000 representative Dutch consumers were sampled about their attitudes to either pig or fish husbandry. The results indicated that consumers think about animal welfare in terms of two broad categories related to their health and living environment, but do not think about welfare issues at a more detailed level. Greater concern was expressed about the welfare of pigs compared to fish. Consumer trust in labeling also emerged as an important issue, since consumers need to trust different food chain actors with responsibility for promoting animal welfare, and are reluctant to consider the details of animal husbandry systems. As a consequence, a transparent, enforceable, and traceable monitoring system for animal welfare friendly products is likely to be important for consumers. (shrink)

This paper investigates the efficiency of application of medical ethics principles in the practice of artificial insemination by donors in China, in a culture characterised by traditional ethical values and disapproval of AID. The paper presents the ethical approach to AID treatment as established by the Reproduction and Genetics Hospital of CITIC-Xiangya in the central southern area of China against the social ethical background of China and describes its general features. The CITIC-Xiangya Approach facilitates the implementation of ethical relations between (...) clinicians and patients participating in AID treatment procedures in Hunan-Yale. (shrink)