Search results for 'Research Subjects' (try it on Scholar)

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  1. Stefan Eriksson (2012). On the Need for Improved Protections of Incapacitated and Non-Benefiting Research Subjects. Bioethics 26 (1):15-21.score: 162.0
    In this article, it is claimed that the protective provisions for adults with impaired decision-making capacity are misguided, insofar as they do not conclusively state whether research on this group should be permitted only as an exception, and as they arbitrarily allow for some groups to benefit from such research while others will not. Moreover, the presumed or former will of the subject is given insufficient weight, and the minimal risk standard does not make sense in this context. (...)
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  2. Gideon Koren (2003). Healthy Children as Subjects in Pharmaceutical Research. Theoretical Medicine and Bioethics 24 (2):149-159.score: 156.0
    Recruitment of healthy children for drugresearch has emerged due in part to several newAmerican laws and policies that have led to asurge in pharmaceutical research involvingchildren-subjects. In this paper, I review theethical and scientific issues and the argumentsin favor and against this new practice.
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  3. E. Bjorn, P. Rossel & S. Holm (1999). Can the Written Information to Research Subjects Be Improved?--An Empirical Study. Journal of Medical Ethics 25 (3):263-267.score: 150.0
    OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with (...)
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  4. Lawrence Burns (2008). What is the Scope for the Interpretation of Dignity in Research Involving Human Subjects? Medicine, Health Care and Philosophy 11 (2):191-208.score: 150.0
    Drawing on Lennart Nordenfelt’s distinction between the four distinct senses of dignity, I elucidate the meaning of dignity in the context of research involving human subjects. I acknowledge that different interpretations of the personal senses of dignity may be acceptable in human subject research, but that inherent dignity (Menschenwürde) is not open to interpretation in the same way. In order to map out the grounds for interpreting dignity, I examine the unique application of the principle of respect (...)
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  5. R. Macklin (1981). On Paying Money to Research Subjects: 'Due' and 'Undue' Inducements. Irb 3 (5):1-6.score: 150.0
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  6. Sami Alsmadi (2008). Marketing Research Ethics: Researcher's Obligations Toward Human Subjects. Journal of Academic Ethics 6 (2):153-160.score: 144.0
    This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on (...)
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  7. Rebecca L. Walker (2006). Human and Animal Subjects of Research: The Moral Significance of Respect Versus Welfare. Theoretical Medicine and Bioethics 27 (4):305-331.score: 144.0
    Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is (...)
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  8. Elizabeth H. Bassett & Kate O'Riordan (2002). Ethics of Internet Research: Contesting the Human Subjects Research Model. Ethics and Information Technology 4 (3):233-247.score: 144.0
    The human subjects researchmodel is increasingly invoked in discussions ofethics for Internet research. Here we seek toquestion the widespread application of thismodel, critiquing it through the two themes ofspace and textual form. Drawing on ourexperience of a previous piece ofresearch, we highlightthe implications of re-considering thetextuality of the Internet in addition to thespatial metaphors that are more commonlydeployed to describe Internet activity. Weargue that the use of spatial metaphors indescriptions of the Internet has shaped theadoption of the human (...)
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  9. Joseph B. Walther (2002). Research Ethics in Internet-Enabled Research: Human Subjects Issues and Methodological Myopia. [REVIEW] Ethics and Information Technology 4 (3):205-216.score: 144.0
    As Internet resources are usedmore frequently for research on social andpsychological behavior, concerns grow aboutwhether characteristics of such research affecthuman subjects protections. Early efforts toaddress such concerns have done more toidentify potential problems than to evaluatethem or to seek solutions, leaving bodiescharged with human subjects oversight in aquagmire. This article critiques some of theseissues in light of the US Code of FederalRegulations' policies for the Protection ofHuman Subjects, and argues that some of theissues have no (...)
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  10. Amy Bruckman (2002). Studying the Amateur Artist: A Perspective on Disguising Data Collected in Human Subjects Research on the Internet. Ethics and Information Technology 4 (3):217-231.score: 144.0
    In the mid-1990s, the Internet rapidly changedfrom a venue used by a small number ofscientists to a popular phenomena affecting allaspects of life in industrialized nations. Scholars from diverse disciplines have taken aninterest in trying to understand the Internetand Internet users. However, as a variety ofresearchers have noted, guidelines for ethicalresearch on human subjects written before theInternet's growth can be difficult to extend toresearch on Internet users.In this paper, I focus on one ethicalissue: whether and to what extent to (...)
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  11. Angela Ballantyne (2008). Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement? Developing World Bioethics 8 (3):178-191.score: 132.0
    There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence (...)
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  12. Trisha Phillips (2011). Exploitation in Payments to Research Subjects. Bioethics 25 (4):209-219.score: 132.0
    Offering cash payments to research subjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower (...)
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  13. Professor John R. Williams (2006). The Physician's Role in the Protection of Human Research Subjects. Science and Engineering Ethics 12 (1):5-12.score: 132.0
    Responsibility for the protection of human research subjects is shared by investigators, research ethics committees, sponsors/funders, research institutions, governments and, the focus of this article, physicians who enrol patients in clinical trials. The article describes the general principles of the patient-physician relationship that should regulate the participation of physicians in clinical trials and proposes guidelines for determining when and how such participation should proceed. The guidelines deal with the following stages of the trial: when first considering (...)
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  14. B. Brown & M. W. Merritt (2012). A Global Public Incentive Database for Human Subjects Research. Irb 35 (2):14-17.score: 132.0
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  15. M. Groman & J. Sugarman (2012). The Presidential Bioethics Commission's Database of Human Subjects Research. Irb 35 (2):18-19.score: 132.0
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  16. Hans-Peter Graf (2011). Protecting Research Subjects From Prohibited Multi-Participation in Clinical Trials. Research Ethics 7 (4):136-147.score: 126.0
    The protection of human research subjects in clinical studies is regulated by international guidelines and national laws. Research Ethics Committees play an important role here, as they review the documentation for clinical studies under consideration of ethical aspects. This documentation includes an exclusion or wash-out period which designates when study subjects may not have participated in another study or be allowed to take part in a future one within a specified time period. However not all (...) subjects comply with their applicable exclusion period. This prohibited multi-participation in clinical studies is known as ‘research subject tourism,’ ‘clinical study overlapping’, or ‘guinea-pigging’. This practice brings with it additional risks for the research subject and the integrity of the research being conducted. No comprehensive data are available to demonstrate exactly how many research subjects participate in overlapping multiple studies. However, the number of them who ‘travel’ from one study to another seems to be significant. Preventing this practice is a matter of concern for ethics committees, but the responsibility for protecting research subjects in this respect apart from approving the ethics of a wash-out period and recruiting from a specific pool or database of patients is solely that of the investigating physician. But how can the investigating physician be certain that a research subject complies with their exclusion period? An international data bank for research subjects who have participated, or are participating, in clinical studies, is a measure that would serve to prevent prohibited multi-participation in clinical studies and thereby protect the research subject, the investigating physician and their institution. VIP Check, International, which was founded by the author in 1990, is an example of such a data bank. This article examines the existence of prohibited multi-participation in clinical studies, the additional risk this practice of itself poses to the research subjects and the integrity of clinical studies, and how this practice might best be reduce or even eliminated through use of an international data bank of research subjects such as that of VIP Check. (shrink)
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  17. Dianne Quigley (forthcoming). Promoting Human Subjects Training for Place-Based Communities and Cultural Groups in Environmental Research: Curriculum Approaches for Graduate Student/Faculty Training. Science and Engineering Ethics:1-18.score: 126.0
    A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details (...)
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  18. Leslie Meltzer Henry (2013). Moral Gridlock: Conceptual Barriers to No‐Fault Compensation for Injured Research Subjects. Journal of Law, Medicine and Ethics 41 (2):411-423.score: 120.0
    The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. (...)
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  19. Timothy F. Murphy (2010). Sex, Romance, and Research Subjects: An Ethical Exploration. American Journal of Bioethics 10 (7):30-38.score: 120.0
    Professional standards in medicine and psychology treat concurrent sexual relationships with patients as violations of fiduciary trust, and they sometimes rule out sexual relationships even after a clinical relationship is over. These standards also rule out sex with research subjects who are also patients, but what about nonclinical relationships where there are not always parallels to the standards of clinical medicine? One way to treat sex in nonclinical research relationships is to treat it as sex is treated (...)
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  20. Trisha B. Phillips (2011). A Living Wage for Research Subjects. Journal of Law, Medicine and Ethics 39 (2):243-253.score: 120.0
    Offering cash payments to research subjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Federal regulations and guidelines currently allow researchers to pay subjects for participation, but they say very little about how much researchers can pay their subjects. This paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, (...)
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  21. Nancy E. Kass & Jeremy Sugarman (1996). Are Research Subjects Adequately Protected? A Review and Discussion of Studies Conducted by the Advisory Committee on Human Radiation Experiments. Kennedy Institute of Ethics Journal 6 (3):271-282.score: 120.0
    : In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human research subjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of research subjects. The Committee's examination of current protections revealed great improvement over those from (...)
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  22. C. Paradis, M. P. Phelan & M. Brinich (2010). A Pilot Study to Examine Research Subjects' Perception of Participating in Research in the Emergency Department. Journal of Medical Ethics 36 (10):580-587.score: 120.0
    Study objectives The emergency department (ED) provides an arena for patient enrolment into a variety of research studies even for non-critically ill patients. Given the types of illness, time constraints and sense of urgency that exists in the ED environment, concern exists about whether research subjects in the ED can provide full consent for participation. We sought to identify enrolled research subjects' perspectives on the informed consent process for research conducted in the ED. Methods (...)
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  23. Janet Borgerson (2005). Addressing the 'Global Basic Structure' in the Ethics of International Health Research Involving Human Subjects. Journal of Philosophical Research 30:235-249.score: 114.0
    The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...)
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  24. David Wendler & Emily Abdoler (2011). Does It Matter Whether Investigators Intend to Benefit Research Subjects? Kennedy Institute of Ethics Journal 20 (4):353-370.score: 114.0
    It is widely agreed that clinical research should satisfy a number of ethical requirements. These include requirements to address a valuable question, to select subjects fairly, and to pose appropriate risks. In contrast, there remains considerable debate over the ethical relevance of investigator intentions: Does it matter ethically whether investigators intend to collect generalizable knowledge or to benefit subjects, or both? Some commentators do not mention investigator intentions when evaluating what makes clinical research ethical (Emanuel, Wendler, (...)
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  25. Stephen Napier (2013). Challenging Research on Human Subjects: Justice and Uncompensated Harms. Theoretical Medicine and Bioethics 34 (1):29-51.score: 110.0
    Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research (...)
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  26. Toby Schonfeld (2013). The Perils of Protection: Vulnerability and Women in Clinical Research. Theoretical Medicine and Bioethics 34 (3):189-206.score: 108.0
    Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In (...)
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  27. Mark Sheehan, Vernon Marti & Tony Roberts (2014). Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance. Bioethics 28 (6):284-292.score: 108.0
    This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.
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  28. Jane Johnson & Neal D. Barnard (2014). Chimpanzees as Vulnerable Subjects in Research. Theoretical Medicine and Bioethics 35 (2):133-141.score: 108.0
    Using an approach developed in the context of human bioethics, we argue that chimpanzees in research can be regarded as vulnerable subjects. This vulnerability is primarily due to communication barriers and situational factors—confinement and dependency—that make chimpanzees particularly susceptible to risks of harm and exploitation in experimental settings. In human research, individuals who are deemed vulnerable are accorded special protections. Using conceptual and moral resources developed in the context of research with vulnerable humans, we show how (...)
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  29. Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.score: 102.0
    Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous (...)
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  30. Ruth W. Grant & Jeremy Sugarman (2004). Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy 29 (6):717 – 738.score: 102.0
    There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But (...)
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  31. Ari VanderWalde & Seth Kurzban (2011). Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What? Journal of Law, Medicine and Ethics 39 (3):543-558.score: 102.0
    Both international and federal regulations exist to ensure that scientists perform research on human subjects in an environment free of coercion and in which the benefits of the research are commensurate with the risks involved. Ensuring that these conditions hold is difficult, and perhaps even more so when protocols include the issue of monetary compensation of research subjects. The morality of paying human research subjects has been hotly debated for over 40 years, and (...)
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  32. N. Ondrusek, R. Abramovitch, P. Pencharz & G. Koren (1998). Empirical Examination of the Ability of Children to Consent to Clinical Research. Journal of Medical Ethics 24 (3):158-165.score: 102.0
    This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to (...)
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  33. Anna Eva Westra & Inez de Beaufort (forthcoming). Improving the Helsinki Declaration's Guidance on Research in Incompetent Subjects. Journal of Medical Ethics:2013-101496.score: 102.0
    Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that (...)
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  34. Ezekiel J. Emanuel (ed.) (2003). Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Johns Hopkins University Press.score: 102.0
    All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical (...)
     
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  35. S. Guest (1997). Compensation for Subjects of Medical Research: The Moral Rights of Patients and the Power of Research Ethics Committees. Journal of Medical Ethics 23 (3):181-185.score: 98.0
    Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there (...)
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  36. Julie M. Aultman (2013). Abuses and Apologies: Irresponsible Conduct of Human Subjects Research in Latin America. Journal of Law, Medicine and Ethics 41 (1):353-368.score: 96.0
    This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses.
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  37. T. Phillips (2011). From the Ideal Market to the Ideal Clinic: Constructing a Normative Standard of Fairness for Human Subjects Research. Journal of Medicine and Philosophy 36 (1):79-106.score: 96.0
    Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to (...)
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  38. Charles Weijer, The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation.score: 96.0
    This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?
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  39. Dave Wendler (2000). Informed Consent, Exploitation and Whether It is Possible to Conduct Human Subjects Research Without Either One. Bioethics 14 (4):310–339.score: 96.0
    Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devasting conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider (...)
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  40. Czesław Radzikowski (2006). Protection of Animal Research Subjects. Science and Engineering Ethics 12 (1):103-110.score: 96.0
    The use of experimental animals, mostly rodents, in biomedical research and especially in oncology and immunology should be acknowledged with respect, recognizing the contribution of animal experimentation in the fascinating scientific progress in these disciplines of research. It is an obligation of the investigator to justify the scientific and ethical aspects of each study requiring the use of animals. The international guiding principles for using animals in biomedical research are well defined and have been distributed worldwide by (...)
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  41. W. Jianping, L. Li, D. Xue, Z. Tang, X. Jia, R. Wu, Y. Xi, T. Wang & P. Zhou (2010). Analysis of the Status of Informed Consent in Medical Research Involving Human Subjects in Public Hospitals in Shanghai. Journal of Medical Ethics 36 (7):415-419.score: 96.0
    Objectives The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. Methods In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug (...)
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  42. Ken Kirkwood (2012). On the Exploitation of Research Subjects. Journal of Clinical Research and Bioethics 3 (3).score: 96.0
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  43. J. P. de Jong, M. C. B. van Zwieten & D. L. Willems (2013). Research Monitoring by US Medical Institutions to Protect Human Subjects: Compliance or Quality Improvement? Journal of Medical Ethics 39 (4):236-241.score: 96.0
    In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews (...)
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  44. Steven Joffe (2012). Revolution or Reform in Human Subjects Research Oversight. Journal of Law, Medicine and Ethics 40 (4):922-929.score: 96.0
    The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
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  45. Lynn Pasquerella (2002). Confining Choices: Should Inmates' Participation in Research Be Limited? Theoretical Medicine and Bioethics 23 (6):519-536.score: 96.0
    Historically, prisoners in the United Stateshave served as an inexpensive and readilyavailable source of human subjects forresearch. Coinciding with the civil rightsmovement, however, was an emerging conceptionof prisoners'' rights that led to the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research beingcharged with investigating the use of prisonersas research subjects. The recommendations thatevolved and the subsequent guidelines that havebeen implemented by the Department of Healthand Human Services significantly curtail theuse of prisoners as (...) subjects. Whilethese measures are designed to protect inmatesfrom the abuses of the past, of particularconcern to many health care officials isexclusion of inmates from experimental HIV/AIDSand hepatitis treatments. This paper addresseswhether the vulnerability of prisoners in theUnited States due to their incarceration issufficient to prohibit them from participationin clinical trials that offer the possibilityof life-saving treatment. It first outlinesthe evolution in moral thinking that has led tolaws broadly prohibiting prisoners frombiomedical research studies and then analyzescases in the law to develop ethical argumentsin support of the view that prisoners should beallowed to participate in clinical trials. Theconclusion is that prisoners should be allowedto participate in such trials. (shrink)
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  46. Lisa Eckenwiler (2001). Moral Reasoning and the Review of Research Involving Human Subjects. Kennedy Institute of Ethics Journal 11 (1):37-69.score: 96.0
    : The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions (...)
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  47. Brandon Brown, Janni Kinsler, Morenike O. Folayan, Karen Allen & Carlos F. Cáceres (2014). Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries. Journal of Bioethical Inquiry 11 (2):119-123.score: 96.0
    The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of (...)
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  48. Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline (2012). Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field. Journal of Law, Medicine and Ethics 40 (4):716-750.score: 96.0
    The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR (...)
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  49. Cathal T. Gallagher, Lisa J. McDonald & Niamh P. McCormack (2014). Undergraduate Research Involving Human Subjects Should Not Be Granted Ethical Approval Unless It is Likely to Be of Publishable Quality. HEC Forum 26 (2):169-180.score: 96.0
    Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare (...)
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  50. Aamir M. Jafarey (2002). Conflict of Interest Issues in Informed Consent for Research on Human Subjects: A South Asian Perspective. Science and Engineering Ethics 8 (3):353-362.score: 96.0
    Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to (...)
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