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

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  1.  16
    Stefan Eriksson (2012). On the Need for Improved Protections of Incapacitated and Non-Benefiting Research Subjects. Bioethics 26 (1):15-21.
    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.  7
    R. Macklin (1981). On Paying Money to Research Subjects: 'Due' and 'Undue' Inducements. IRB: Ethics & Human Research 3 (5):1-6.
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  3.  21
    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.
    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.  13
    Gideon Koren (2003). Healthy Children as Subjects in Pharmaceutical Research. Theoretical Medicine and Bioethics 24 (2):149-159.
    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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  5.  3
    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.
    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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  6.  53
    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.
    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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  7.  33
    Trisha Phillips (2011). Exploitation in Payments to Research Subjects. Bioethics 25 (4):209-219.
    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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  8.  71
    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.
    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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  9.  97
    Sami Alsmadi (2008). Marketing Research Ethics: Researcher's Obligations Toward Human Subjects. Journal of Academic Ethics 6 (2):153-160.
    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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  10.  40
    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.
    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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  11.  16
    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.
    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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  12.  12
    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.
    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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  13.  7
    Professor John R. Williams (2006). The Physician's Role in the Protection of Human Research Subjects. Science and Engineering Ethics 12 (1):5-12.
    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.  3
    M. Groman & J. Sugarman (2012). The Presidential Bioethics Commission's Database of Human Subjects Research. IRB: Ethics & Human Research 35 (2):18-19.
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  15.  6
    Hans-Peter Graf (2011). Protecting Research Subjects From Prohibited Multi-Participation in Clinical Trials. Research Ethics 7 (4):136-147.
    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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  16.  1
    Karin Jongsma, Wendy Bos & Suzanne Vathorst (2015). Morally Relevant Similarities and Differences Between Children and Dementia Patients as Research Subjects: Representation in Legal Documents and Ethical Guidelines. Bioethics 29 (9):662-670.
    Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire life ahead of (...)
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  17.  5
    B. Brown & M. W. Merritt (2012). A Global Public Incentive Database for Human Subjects Research. IRB: Ethics & Human Research 35 (2):14-17.
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  18.  10
    Timothy F. Murphy (2010). Sex, Romance, and Research Subjects: An Ethical Exploration. American Journal of Bioethics 10 (7):30-38.
    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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  19.  11
    M. L. Russell (2000). Paying Research Subjects: Participants' Perspectives. Journal of Medical Ethics 26 (2):126-130.
    Objective—To explore the opinions of unpaid healthy volunteers on the payment of research subjects.Design—Prospective cohort.Setting—Southern Alberta, Canada.Participants—Medically eligible persons responding to recruiting advertisements for a randomised vaccine trial were invited to take part in a study of informed consent at the point at which they formally consented or refused trial participation. Of 72 invited, 67 returned questionnaires at baseline and 54 at follow-up.Outcome measures—Proportions of persons who agreed or disagreed with three close-ended statements on the payment of (...) subjects; themes and categories identified by content analysis of responses to an open-ended question.Results—A minority agreed with paying either patient or healthy volunteer participants. Opinions did not change over time. Participants' comments addressed: benefits and drawbacks to research participation; benefits and drawbacks to paying research participants; conditions under which payment of research subjects would be acceptable, and the nature of acceptable recognition. Acceptable conditions were to improve problematic recruitment, to reimburse costs, and to recognise participants, particularly for their time investment. Both non-monetary and monetary recognition of volunteers were thought to be appropriate.Conclusions—Most unpaid volunteers disagreed with paying research participants. The themes arising from their comments are similar to those that have been raised by ethicists and suggest that recognising the time and effort of participants should receive greater emphasis than presently occurs. (shrink)
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  20.  27
    Leslie Meltzer Henry (2013). Moral Gridlock: Conceptual Barriers to No‐Fault Compensation for Injured Research Subjects. Journal of Law, Medicine & Ethics 41 (2):411-423.
    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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  21.  17
    D. B. Resnick (2008). Increasing the Amount of Payment to Research Subjects. Journal of Medical Ethics 34 (9):e14-e14.
    This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers (...)
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  22.  5
    John R. Williams (2006). The Physician's Role in the Protection of Human Research Subjects. Science and Engineering Ethics 12 (1):5-12.
    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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  23.  1
    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.
    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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  24.  17
    Trisha B. Phillips (2011). A Living Wage for Research Subjects. Journal of Law, Medicine & Ethics 39 (2):243-253.
    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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  25. S. B. Kennedy (2006). Developing Capacity to Protect Human Research Subjects in a Post-Conflict, Resource-Constrained Setting: Procedures and Prospects. Journal of Medical Ethics 32 (10):592-595.
    The capacity-building strategy used by a US-based research organisation, the Pacific Institute for Research and Evaluation , to strengthen the system for the protection of human research subjects and the infrastructure of its international collaborating partner, the University of Liberia, are discussed. To conduct the much-needed biomedical and social science-based research-related activities in the future, this partnership is expected by PIRE to gradually evolve over time to strengthen the capacity of the local investigators and administrators (...)
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  26.  5
    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.
    : 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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  27.  2
    D. B. Resnick (2008). Increasing the Amount of Payment to Research Subjects. Journal of Medical Ethics 34 (9):e14-e14.
    This article discusses some ethical issues that can arise when researchers decide to increase the amount of payment offered to research subjects to boost enrollment. Would increasing the amount of payment be unfair to subjects who have already consented to participate in the study? This article considers how five different models of payment—the free market model, the wage payment model, the reimbursement model, the appreciation model, and the fair benefits model—would approach this issue. The article also considers (...)
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  28. David Wendler & Emily Abdoler (2011). Does It Matter Whether Investigators Intend to Benefit Research Subjects? Kennedy Institute of Ethics Journal 20 (4):353-370.
    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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  29.  7
    Kathleen Cranley Glass & Marc Speyer-Ofenberg (1996). Incompetent Persons as Research Subjects and the Ethics of Minimal Risk. Cambridge Quarterly of Healthcare Ethics 5 (3):362.
    The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the (...)
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  30.  8
    Dianne Quigley (2015). 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 21 (1):209-226.
    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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  31.  8
    Evan DeRenzo (1994). Surrogate Decision Making for Severely Cognitively Impaired Research Subjects: The Continuing Debate. Cambridge Quarterly of Healthcare Ethics 3 (4):539.
    As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in (...)
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  32. S. Curry (2006). Living Patients in a Permanent Vegetative State as Legitimate Research Subjects. Journal of Medical Ethics 32 (10):606-607.
    Ravelingien et al1 argue that we should recategorise people in a permanent vegetative state as dead. Although the dilemma they describe is very real, their solution will not work. Other respondents to this paper have advanced several powerful arguments against the attempt to describe patients in a PVS as dead. Fortunately, the original argument contains sufficient resources for developing an alternative solution to this dilemma without having to radically change the current legal or social status of patients in a PVS. (...)
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  33.  71
    David L. Evers, Carol B. Fowler, Jeffrey T. Mason & Rebecca K. Mimnall (2015). Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects. Science and Engineering Ethics 21 (4):1049-1064.
    Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. (...)
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  34.  75
    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.
    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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  35.  26
    Ruth Macklin (forthcoming). The Paradoxical Case of Payment as Benefit to Research Subjects. IRB: Ethics & Human Research.
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  36.  21
    Evan G. DeRenzo (forthcoming). Coercion in the Recruitment and Retention of Human Research Subjects, Pharmaceutical Industry Payments to Physician-Investigators and the Moral Courage of the IRB. IRB: Ethics & Human Research.
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  37.  14
    Jane Johnson & Neal D. Barnard (2014). Chimpanzees as Vulnerable Subjects in Research. Theoretical Medicine and Bioethics 35 (2):133-141.
    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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  38.  28
    Nicholas Christakis (forthcoming). Do Medical Student Research Subjects Need Special Protection? IRB: Ethics & Human Research.
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  39.  29
    Philip J. Candilis, Robert W. Wesley & Alison Wichman (1993). A Survey of Researchers Using a Consent Policy for Cognitively Impaired Human Research Subjects. IRB: Ethics & Human Research 15 (6):1.
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  40.  22
    Terrence F. Ackerman (1988). An Ethical Framework for the Practice of Paying Research Subjects. IRB: Ethics & Human Research 11 (4):1-4.
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  41.  27
    Maurie Markman (forthcoming). What Must Research Subjects Be Told Regarding the Results of Completed Randomized Trials? IRB: Ethics & Human Research.
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  42.  22
    Nancy Neveloff Dubler (forthcoming). Treating Research Subjects Fairly. IRB: Ethics & Human Research.
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  43.  23
    Alvin Novick, Nancy Neveloff Dubler & Sheldon H. Landesman (1986). Do Research Subjects Have the Right Not to Know Their HIV Antibody Test Results? IRB: Ethics & Human Research 8 (5):6.
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  44.  29
    Stephen Napier (2013). Challenging Research on Human Subjects: Justice and Uncompensated Harms. Theoretical Medicine and Bioethics 34 (1):29-51.
    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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  45.  18
    Joyce G. Reed (forthcoming). Regulatory Orphans: Juvenile Prisoners as Transvulnerable Research Subjects. IRB: Ethics & Human Research.
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  46.  24
    Mark Sheehan, Vernon Marti & Tony Roberts (2014). Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance. Bioethics 28 (6):284-292.
    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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  47.  18
    David C. Flagel (forthcoming). Children as Research Subjects: New Guidelines for Canadian IRBs. IRB: Ethics & Human Research.
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  48.  16
    Ruth Dreyfus (1998). A Collaborative Conference on Women as Research Subjects. IRB: Ethics & Human Research 20 (6):12.
  49.  23
    Czesław Radzikowski (2006). Protection of Animal Research Subjects. Science and Engineering Ethics 12 (1):103-110.
    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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  50.  12
    Ken Kirkwood (2012). On the Exploitation of Research Subjects. Journal of Clinical Research and Bioethics 3 (3).
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