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 paper argues that the value of genetic-relative family health history information and the notion that lack of this information is a disadvantage can be established through its role as a nested goal in comprehensive life projects independent of documentation of particular health outcomes. Health information often plays a significant role in a person's formulation of life goals and projects, as well as in identification of plausible effective means to realize these goals. If health outcomes are valuable in part because (...) of the nested role these play in the successful realization of a person's life projects and goals, then other, similarly nested contributors to such success must also be valued on a similar scale. Some of these other contributors to a successful life may themselves be nested with health considerations, as illustrated in the relationship that will be the focus of this paper. Health information --independent of outcomes per se – influences relationships, reproduction, and the formulation of plausible comprehensive life goals in intricate and very influential ways. Although such information may be valued in part because it is predictive of health outcomes, this relationship does not reduce such information, nor the comprehensive life goals and projects such information promotes, to health outcomes. That is, while health status can both enhance and detract from the autonomous pursuit of life projects formulated in the context of health information, the value and weight of these projects is independent of particular health status or outcomes, even while in part shaped by them. (shrink)

It is quite likely that parents will soon be able to use genetic engineering to select the sex of their child by directly manipulating the sex of an embryo. Some might think that this method would be a more ethical method of sex selection than present technologies such as preimplantation genetic diagnosis (PGD) because, unlike PGD, it does not need to create and destroy “wrong gendered” embryos. This paper argues that those who object to present technologies on the grounds that (...) the embryo is a person are unlikely to be persuaded by this proposal, though for different reasons. (shrink)

Patients belonging to ethnic, racial, and religious minorities have been all but excluded from the legal academy’s ongoing conversation about informed consent. Perhaps this is just as well, since the conversation appears to have concluded that the doctrine has failed to serve as a meaningful regulation of clinical relationships. Informed consent does not operate in practice the way it was intended in theory. More than a decade ago, Peter Schuck noted the “informed consent gap” that distinguishes the “proper” law of (...) informed consent “on the books” from the actual consent law in action, and called for a more contextualized approach to informed consent. Susan Wolf later called for a systemic approach to informed consent in order to accommodate multiple decision points in the managed care setting. Some reformers have sought enhancements to expand the doctrine. (shrink)

The increased competition for a share of the market of insured patients, which arose in the wake of failed comprehensive health care reform, has provoked questions about what, if any, standards will govern new “competitive” health care organizations. Managed care arrangements, which typically shift to providers and patients some or all of the financial risk for patient care, are of special concern because they can create incentives to withhold beneficial care from patients. Of course, fee-for-service medical practice creates incentives to (...) provide unnecessary services, and managed care can avoid that type of harm. Still, as Edmund Pellegrino has noted, “managed care, by its nature, places the good of the patient into conflict with … the good of all the other patients served by the plan; the good of the plan and the organization, themselves…; and the self-interest of the physician. (shrink)

The increased competition for a share of the market of insured patients, which arose in the wake of failed comprehensive health care reform, has provoked questions about what, if any, standards will govern new “competitive” health care organizations. Managed care arrangements, which typically shift to providers and patients some or all of the financial risk for patient care, are of special concern because they can create incentives to withhold beneficial care from patients. Of course, fee-for-service medical practice creates incentives to (...) provide unnecessary services, and managed care can avoid that type of harm. Still, as Edmund Pellegrino has noted, “managed care, by its nature, places the good of the patient into conflict with … the good of all the other patients served by the plan; the good of the plan and the organization, themselves…; and the self-interest of the physician. (shrink)

Human papillomavirus (HPV) infection is the world’s most common sexually transmitted infection. It is a prerequisite for cervical cancer, the second most common cause of death in cancer among women worldwide, and is also believed to cause other anogenital and head and neck cancers. Vaccines that protect against the most common cancer-causing HPV types have recently become available, and different countries have taken different approaches to implementing vaccination. This paper examines the ethics of alternative HPV vaccination strategies. It devotes particular (...) attention to the major arguments for and against one strategy: voluntary, publicly funded vaccination for all adolescent boys and girls. This approach seems attractive because it would protect more people against cervical cancer and other HPV-related cancers than less inclusive alternatives, without the sacrifice of autonomy that a comparably broad compulsory programme would require. Also, the herd immunity that it would likely generate would protect those who remain unvaccinated, a major advantage from a justice perspective. However, there is a possibility that a HPV vaccination programme targeting all adolescents of both sexes is not considered sufficiently cost-effective. Also, it might pose more difficulties for achieving informed consent than comparable vaccination programmes against other diseases. Ultimately, society’s choice of HPV vaccination strategy requires careful consideration not only of the values at stake but also of available and emerging scientific evidence. (shrink)

Actually possible and conceivable future uses of preimplantation genetic diagnosis (PGD) and germ-line genetic intervention in assisted reproduction seem to offer increasing possibilities of choosing the kind of persons that will be brought to existence. Many are troubled by the idea of these technologies being used for enhancement purposes. How can we make sense of this worry? Why are our thoughts about therapeutic genetic interventions and non-genetic enhancement (for instance education) not accompanied by the same intuitive uneasiness? I argue that (...) the concepts of autonomy and freedom of choice, typically invoked to delimit the morally acceptable uses of reproductive technologies, cannot fully answer these questions. Instead, I suggest that an alternative answer might begin with reflections on the notion of interfering with nature. Drawing on Martin Heidegger’s critique of modern technology and Hans Jonas’s moral philosophy, I outline an argument that attempts to capture what might be particularly troubling about the idea of “designing” future persons. At the core of the argument is the suggestion that enhancing selections and modifications on embryos might be bound up with an instrumentalising, non-responsive perspective on the future persons into which they are intended to grow. (shrink)

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge (...) the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice. (shrink)

The right to health implies, among other things, that individuals and communities must be allowed to have a voice in decisions concerning the definition of their well-being. The article argues for a more active participation of ethnocultural minorities in healthcare decisions and highlights the relevance of strategies aimed at creating a bottom-up engagement of people and groups, as well as of measures aimed at a broader organizational flexibility, in order to meet migrants’ and minorities’ needs. Finally, the article clarifies that (...) these strategies are not simply the outcome of a welcoming attitude of the Western healthcare system but may be interpreted as a specific duty resulting from the notion of “particularly vulnerable groups,” as formulated by the ECtHR in its case law: when vulnerable groups are at stake, every decision about state actions and rules regarding healthcare should start from an a consideration of the specific conditions and needs of people belonging to vulnerable minority groups. (shrink)

Governments must determine the legal procedures by which their residents are registered, or can register, as organ donors. Provided that governments recognize that people have a right to determine what happens to their organs after they die, there are four feasible options to choose from: opt-in, opt-out, mandated active choice, and voluntary active choice. We investigate the ethics of these policies' use of nudges to affect organ donor registration rates. We argue that the use of nudges in this context is (...) morally problematic. It is disrespectful of people's autonomy to take advantage of their cognitive biases since doing so involves bypassing, not engaging, their rational capacities. We conclude that while mandated active choice policies are not problem free—they are coercive, after all—voluntary active choice, opt-in, and opt-out policies are potentially less respectful of people's autonomy since their use of nudges could significantly affect people's decision making. (shrink)

There are positive views towards use of science and technology in all Asian countries, and positive views towards use of enhancement in China, India and Thailand. After considering of the widespread use of cosmetic surgery and other body enhancements in Asian countries, and the generally positive views towards letting individuals make choices about improvement of themselves, the paper concludes that we can expect other enhancements to also be adopted rapidly in Asia. There will be future ethical dilemmas emerging from this (...) with concepts of preservation of nature, flow with nature, and definitions of human-ness, along with concepts of harmony and social justice. Japan is less willing to engage in genetic enhancement compared to China, India and Thailand, despite widespread cosmetic surgery across Asia. (shrink)

Over the past thirty years, the doctrine of informed consent has become a focal point in discussions of medical ethics. The literature of informed consent explores the evolution of the principle of autonomy, purportedly emerging from the mists of 19th Century medical practice, and finding its earliest articulation in legal cases where wronged citizens asserted their rights against medical authority. A commonplace, if not obligatory, feature of that literature is a reference to the case of Mary Schloendorff and the opinion (...) written by Judge Benjamin Cardozo by which the case is remembered. Commentators today applaud the prescience of Cardozo for an early articulation of what eventually would become bioethical orthodoxy concerning informed consent and its place as a bulwark of patient autonomy. They inevitably quote Cardozo's famous statement, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”. (shrink)

Over the past thirty years, the doctrine of informed consent has become a focal point in discussions of medical ethics. The literature of informed consent explores the evolution of the principle of autonomy, purportedly emerging from the mists of 19th Century medical practice, and finding its earliest articulation in legal cases where wronged citizens asserted their rights against medical authority. A commonplace, if not obligatory, feature of that literature is a reference to the case of Mary Schloendorff and the opinion (...) written by Judge Benjamin Cardozo by which the case is remembered. Commentators today applaud the prescience of Cardozo for an early articulation of what eventually would become bioethical orthodoxy concerning informed consent and its place as a bulwark of patient autonomy. They inevitably quote Cardozo's famous statement, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”. (shrink)

Purpose Cybersecurity in healthcare has become an urgent matter in recent years due to various malicious attacks on hospitals and other parts of the healthcare infrastructure. The purpose of this paper is to provide an outline of how core values of the health systems, such as the principles of biomedical ethics, are in a supportive or conflicting relation to cybersecurity. Design/methodology/approach This paper claims that it is possible to map the desiderata relevant to cybersecurity onto the four principles of medical (...) ethics, i.e. beneficence, non-maleficence, autonomy and justice, and explore value conflicts in that way. Findings With respect to the question of how these principles should be balanced, there are reasons to think that the priority of autonomy relative to beneficence and non-maleficence in contemporary medical ethics could be extended to value conflicts in health-related cybersecurity. Research limitations/implications However, the tension between autonomy and justice, which relates to the desideratum of usability of information and communication technology systems, cannot be ignored even if one assumes that respect for autonomy should take priority over other moral concerns. Originality/value In terms of value conflicts, most discussions in healthcare deal with the conflict of balancing efficiency and privacy given the sensible nature of health information. In this paper, the authors provide a broader and more detailed outline. (shrink)

ZusammenfassungDieser Artikel beschreibt die ethischen Herausforderungen, die sich durch das Problem der Antibiotikaresistenz ergeben. Wir legen die Ursachen für ABR dar und argumentieren, dass eine effektive Bekämpfung der ABR es erforderlich macht, den derzeitigen Antibiotikagebrauch drastisch zu reduzieren. Allerdings müssen hierbei auch die ethischen Probleme, die durch ABR entstehen, berücksichtigt werden. ABR führt zum einen zur Verstärkung bereits bestehender Herausforderungen im Infektionsschutz, zum anderen wirft sie neue ethische Probleme auf. Wir argumentieren, dass sich diese Probleme vor allem in Bezug auf (...) kollektive Handlungsentscheidungen und gerechte Ressourcenverteilung ergeben. Um den Konsum von Antibiotika fair zu reduzieren, entwickeln wir anschließend sowohl ein kontraktualistisches Prinzip für die Rationierung, als auch erste Vorschläge zu dessen Implementierung. Hierbei skizzieren wir Risikogrenzen für die Patienten, bei denen ein Verzicht auf Antibiotikatherapie gerechtfertigt werden kann. (shrink)

Obtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients. We conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed that had experimental or observational study design and involved adult trauma patients. Studies involving (...) informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach. A total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information. Many articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients. (shrink)

We investigated whether, in the emergency department, educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care. We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video (...) illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups. A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention ) than in the control group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores. Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients’ perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction. Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast (...) outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Background Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. Methods A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items (...) to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. Results The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Conclusions Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. Trial registration The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

Taking up the notion of engineering as social experimentation, this paper argues that engineering research laboratory directors have a responsibility to inform graduate engineering students who participate in their research projects of the potential broader social dimensions of those projects. Informing engineers-in-the-making of the broader social dimensions of the research they are learning to conduct would help ensure their future capacity to act as ethically responsible social experimenters. The paper also argues that graduate engineers have a right to be informed (...) participants in activities that may have broader social dimensions than are recognized by formal research evaluation or educational processes. The process of obtaining the informed consent of graduate engineering students, if implemented effectively, would thus help ensure both their capacity to act as moral agents and their own moral integrity. Since the eventual outcomes of research can be uncertain, complex, and contested, most traditional institutional frameworks—such as principle-based codes of conduct and risk-benefit frameworks—provide an insufficient basis to inform engineers and citizens. Rather, we recommend an ongoing discursive process that explores a number of different actors, contexts, and scenarios, and that evolves with the social context of the engineering research in question. While this may seem burdensome to the engineering research process, it can be integrated directly into the group research meetings and mentorship activities that typically already go on. Moreover, it can actually be seen to benefit engineering practices. (shrink)

Advances in immunotherapy pave the way for vaccines that target not only infections, but also unhealthy behaviors such as smoking. A nicotine vaccine that eliminates the pleasure associated with smoking could potentially be used to prevent children from adopting this addictive and dangerous behavior. This paper offers an ethical analysis of such vaccines. We argue that it would be permissible for parents to give their child a nicotine vaccine if the following conditions are met: (1) the vaccine is expected to (...) result in a net benefit to each individual vaccinated, (2) the expected harms from the side effects of the vaccine are lower than the non-voluntary harms of smoking, and (3) there are no less manipulative methods available that are as effective at preventing smoking initiation. Finally, we show how the framework developed here could be used to analyze the ethics of other chemical interventions designed to modify children’s behavior. (shrink)

Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in considerations (...) of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. (shrink)

Several ethicists have argued that research trials and treatment programs that involve the provision of drugs to addicts are prima facie unethical, because addicts can’t refuse the offer of drugs and therefore can’t give informed consent to participation. In response, several people have pointed out that addiction does not cause a compulsion to use drugs. However, since we know that addiction impairs autonomy, this response is inadequate. In this paper, I advance a stronger defense of the capacity of addicts to (...) participate in the programs envisaged. I argue that it is only in certain circumstances that addicts find themselves choosing in ways that conflict with their genuine preferences. Research and treatment programs have none of the features that characterize choices in these autonomy-undermining circumstances, and there is therefore no reason to think that addicts lack the capacity to give informed consent to these programs. (shrink)

Feminist health activists and medical researchers frequently disagree on the adequacy of the informed consent processes in clinical trials. I argue for an informed consent process that reflects the central importance of patient-participant autonomy. Such a standard may raise concerns for medical researchers about their capacity to control the quantity and quality of the information they disclose to potential participants. These difficulties might be addressed by presenting potential participants with differently sized disclosure packages.

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in (...) large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights, Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”. (shrink)

Drugs developed to treat cognitive impairments are proving popular with healthy college students seeking to boost their focus and productivity. Concerned observers have called these practices a form of cheating akin to athletes’ use of steroids, with some proposing testing students’ urine to deter “academic doping.” The ease with which critics analogize the academic enterprise to competitive sport, and the impulse to crack down on students using study drugs, reflect the same social influences and trends that spur demand for these (...) interventions—our hyper-competitive culture, the commodification of education, and our attraction to technological quick-fixes. Rather than focusing on the technologies that are being put to troubling uses, we would be better served reforming the culture that makes these practices attractive. (shrink)

Over the past decade, the ideal model of shared decision-making has been increasingly promoted as the preferred standard of doctor-patient communication in medical consultation. The model advocates a treatment decision-making process in which the doctor and his patient are considered coequal partners that carefully negotiate the treatment options available in order to ultimately reach a treatment decision that is mutually shared. Thereby, the model notably leaves room for—and stimulates—argumentative discussions to arise in the context of medical consultation. A paradigm example (...) of a discussion that often emerges between doctors and their patients concerns antibiotics as a method of treatment for what is presumed to be a viral infection. Whereas the doctor will generally not encourage treatment with antibiotics, patients oftentimes prefer the medicine to other methods of treatment. In this paper, two cases of such antibiotic-related discussions in consultation are studied using insights gained in the extended pragma-dialectical theory to argumentation. It is examined how patient and physician maneuver strategically in order to maintain a balance between dialectical reasonableness and rhetorical effectiveness, as well as an equilibrium between patient participation and evidence-based medication, while arguing a case for and against antibiotics respectively. (shrink)

The speed and degree to which e- commerce is infiltrating the very fabric of our society, faster and more pervasively than any other entity in history, makes an examination of its ethical dimensions critical. Though ethical lag has heretofore hindered ourexplorations of e- commerce ethics, it is now time to identify and confront them. In this paper we define e- commerce and describe thecharacteristics that set it apart from traditional brick and-mortar business. We then examine the ethical foundation of e- (...) commerce, focusing on the question, “Is there a special e- commerce ethics?” Our answer is “no.” We support our answer by showing that the current issues in e- commerce ethics and brick-and-mortar business are fundamentally the same, but that e- commerce issues have different manifestations and scope. We then demonstrate that ethical principles and rules in e- commerce and brick-and-mortar business are fundamentally the same, but have different manifestations at the most specific level. We elucidate this point by discussing the use of personal information and the opt-in, opt-out debate. We conclude with a call for research on trust, a key value in the success of e- commerce. (shrink)

Two incompatible policies exist for guiding medical decisions for extremely premature, sick, or terminally ill infants, the Best Interests Standard and the newer, 20-year old "Baby Doe" Rules. The background, including why there were two sets of Baby Doe Rules, and their differences with the Best Interests Standard, are illustrated. Two defenses of the Baby Doe Rules are considered and rejected. The first, held by Reagan, Koop, and others, is a "right-to-life" defense. The second, held by some leaders of the (...) American Academy of Pediatrics, is that the Baby Doe Rules are benign and misunderstood. The Baby Doe Rules should be rejected since they can thwart compassionate and individualized decision-making, undercut duties to minimize unnecessary suffering, and single out one group for treatment adults would not want for themselves. In these ways, they are inferior to the older Best Interests Standard. A "negative" analysis of the Best Interests Standard is articulated and defended for decision-making for all incompetent individuals. (shrink)

Our cultural disagreements can often be anticipated, negotiated and resolved using shared methods of moral reasoning. This claim is incompatible with any extreme version of communitarianism or strong ethical relativism, which hold that one's culture is the final arbiter of good, bad, right and wrong, or that the rights of the community should trump individual rights within that community. This view is discussed and found to be implausible using the example of common grounds for responding to different cultural views about (...) being truthful in medical practice. Its implausibility stems from difficulties individuating cultures, and accounting for intercultural goals, values and methods. Given our increasingly diverse populations, problems arise as clinicians from one culture try to care respectfully and compassionately for people from other groups. Yet working from shared values and goals, we can use some bridging methods such as discussing grim news in the third person. Claims that something is a cultural belief or attitude, moreover, cannot always be taken at face value. Various meanings of ‘multiculturalism’ are distinguished. (shrink)

A dispute exists about whether bioethics should become a new discipline with its own methods, competency standards, duties, honored texts, and core curriculum. Unique expertise is a necessary condition for disciplines. Using the current literature, different views about the sort of expertise that might be unique to bioethicists are critically examined to determine if there is an expertise that might meet this requirement. Candidates include analyses of expertise based in "philosophical ethics," "casuistry," "atheoretical or situation ethics," "conventionalist relativism," "institutional guidance," (...) "regulatory guidance and compliance," "political advocacy," "functionalism," and "principlism." None succeed in identifying a unique area of expertise for successful bioethicists that could serve as a basis for making it a new discipline. Rather expertise in bioethics is rooted in many professions, disciplines and fields and best understood as a second-order discipline. (shrink)

There has long been tension between bioethicists whose work focuses on classical philosophical inquiry and those who perform empirical studies on bioethical issues. While many have argued that empirical research merely illuminates current practices and cannot inform normative ethics, others assert that research-based work has significant implications for refining our ethical norms. In this essay, I present a novel construct for classifying empirical research in bioethics into four hierarchical categories: Lay of the Land, Ideal Versus Reality, Improving Care, and Changing (...) Ethical Norms. Through explaining these four categories and providing examples of publications in each stratum, I define how empirical research informs normative ethics. I conclude by demonstrating how philosophical inquiry and empirical research can work cooperatively to further normative ethics. (shrink)

MacKay and Robinson (2016) provide a critical analysis of four organ donation registration options using an expanded conception of manipulation introduced by Jennifer Blumenthal-Barby (Blumenthal-B...

Gamification is the use of elements and techniques from video game design in non-game contexts. Amid the rapid growth of this practice, normative questions have been under-explored. The primary goal of this article is to develop a normatively sophisticated and descriptively rich account for appropriately addressing major ethical considerations associated with gamification. The framework suggests that practitioners and designers should be precautious about, primarily, but not limited to, whether or not their use of gamification practices: takes unfair advantage of workers (...) ; infringes any involved workers’ or customers’ autonomy ; intentionally or unintentionally harms workers and other involved parties; or has a negative effect on the moral character of involved parties. (shrink)

This essay considers implications of formal mereologies and ontologies for medical metaphysics. Edward Fried’s extensional mereological account of the human body is taken as representative of a prominent strand in analytic metaphysics that has close affinities with medical positivism. I show why such accounts fail. First, I consider how Fried attempts to make sense of the medical case of Barney Clark, the first recipient of an artificial heart, and show that his analytic metaphysical categories do not have the right kind (...) of fit with the case. A proper medical metaphysic should involve a richer two way dialogue with medicine, and it should not just “apply” formal accounts worked out in other settings. Second, I argue that any effort to account for real wholes with extensional mereological sums requires all sorts of ad hoc, supplementary mechanisms that do the real work, and the full repertoire of these mechanisms involves inconsistencies and semantic shifts. Finally, I consider an alternative strand of work on non-extensional whole/part relations that is closer to medicine and that can deepen reflection on some core problems in bioethics, for example, associated with the determination of death when an organism ceases to function as a whole. In addition to the utility such formal ontologies have for addressing traditional problems such as the determination of death, philosophers of medicine should appreciate the increasingly influential role such formal tools are playing in the development of data system ontologies. Assumptions integral to these ontologies have far reaching implications for the way future research and practice in medicine will be conducted, and much greater critical reflection is needed on the full range of issues associated with the development and use of such medical ontologies. (shrink)

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general (...) attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants. (shrink)

What must laypersons understand about science to allow them to make sound decisions on science-related issues? Relying on recent developments in social epistemology, this paper argues that scientific education should have the goal not of bringing laypersons' understanding of science closer to that of expert insiders, but rather of cultivating the kind of competence characteristic of “competent outsiders” (Feinstein 2011). Moreover, it argues that philosophers of science have an important role to play in attempts to promote this kind of understanding, (...) but that to successfully fulfill this role, they will have to approach central questions in the field differently. (shrink)

Objectives: To determine the effects of risk and payment on subjects’ willingness to participate, and to examine how payment influences subjects’ potential behaviours and risk evaluations.Methods: A 3 × 3 , between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects. Payment (...) levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating.Results: Monetary payment had positive effects on respondents’ willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents’ potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents’ propensity to neglect to tell researchers about negative effects.Conclusions: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns—notably the potential for payments to diminish the integrity of a study’s findings. Future research is critical to make sound decisions about the payment of research subjects. (shrink)

Purpose: Explore public attitudes towards the trade-offs between justice and medical outcome inherent in organ allocation decisions.Background: The US Task Force on Organ Transplantation recommended that considerations of justice, autonomy and medical outcome be part of all organ allocation decisions. Justice in this context may be modeled as a function of three types of need, related to age, clinical urgency, and quality of life.Methods: A web-based survey was conducted in which respondents were asked to choose between two hypothetical patients who (...) differed in clinical urgency , age, pretransplant and post-transplant quality of life, and life expectancy.Results: A pool of 1600 people were notified via email about the survey; 623 responded. Respondents preferred giving organs to younger people up to an age difference of <15.4 years and more clinically urgent people up to a difference in urgency of <2.54 months . Priority varied with the quality of life of the worst-off patient and the relative status of the patients. If both had worse than average quality of life, respondents preferred the better-off patient. When both had better than average quality of life, they preferred the worse-off patient. In analysis according to age versus clinical urgency, the older the patient, the more urgency needed to receive priority. In quality of life versus clinical urgency, the better the control’s quality of life, the more urgency the competing patient required. The worse the patient’s post-transplant outcome, the more urgency needed to receive priority.Conclusions: It appears that clinical urgency is only one of many factors influencing attitudes about allocation decisions and that respondents may invoke different principles of fairness depending the relative clinical status of patients. (shrink)