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Medical Research Ethics

Edited by Ruchika Mishra (Program in Medicine and Human Values, California Pacific Medical Center)
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  1. Rona Abramovitch, Jonathan L. Freedman, Kate Henry & Michelle Van Brunschot (1995). Children's Capacity to Agree to Psychological Research: Knowledge of Risks and Benefits and Voluntariness. Ethics and Behavior 5 (1):25 – 48.
    A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would not be upset (...)
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  2. Mathieu Albert, Suzanne Laberge & Brian Hodges (2009). Boundary-Work in the Health Research Field: Biomedical and Clinician Scientists' Perceptions of Social Science Research. [REVIEW] Minerva 47 (2):171-194.
    Funding agencies in Canada are attempting to break down the organizational boundaries between disciplines to promote interdisciplinary research and foster the integration of the social sciences into the health research field. This paper explores the extent to which biomedical and clinician scientists’ perceptions of social science research operate as a cultural boundary to the inclusion of social scientists into this field. Results indicated that cultural boundaries may impede social scientists’ entry into the health research field through three modalities: (1) biomedical (...)
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  3. Emily E. Anderson & James M. DuBois (2012). IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review. Journal of Law, Medicine and Ethics 40 (4):951-969.
    Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.
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  4. James A. Anderson & Jonathan Kimmelman (2014). Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor. Bioethics 28 (3):138-146.
    Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, (...)
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  5. James R. Anderson & Mark Krailo (2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. American Journal of Bioethics 11 (3):18-19.
    (2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. The American Journal of Bioethics: Vol. 11, No. 3, pp. 18-19.
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  6. Misha Angrist (2010). Urge Overkill: Protecting Deidentified Human Subjects at What Price? American Journal of Bioethics 10 (9):17-18.
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  7. Vibian Angwenyi, Dorcas Kamuya, Dorothy Mwachiro, Vicki Marsh, Patricia Njuguna & Sassy Molyneux (2013). Working with Community Health Workers as 'Volunteers' in a Vaccine Trial: Practical and Ethical Experiences and Implications. Developing World Bioethics 13 (1):38-47.
    Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information (...)
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  8. George J. Annas (1980). Report on the National Commission: Good as Gold. [REVIEW] Journal of Law, Medicine and Ethics 8 (6):4-4.
    The National Commission for the Protection of Human Subjects of Bio-medical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the commission's researcher-dominated composition which permitted it to assume that(1) research is good;(2) experimentation is almost never harmful to subjects; and (3) researcher-dominated IRBs can adequately protect the interests of human subjects. The successor Presidential Commission can learn much by reexamining (...)
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  9. George J. Annas (1980). The Goals of Informed Consent. Journal of Law, Medicine and Ethics 8 (3):13-13.
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  10. Marco Annoni, Virginia Sanchini & Cecilia Nardini (2013). The Ethics of Non-Inferiority Trials: A Consequentialist Analysis. Research Ethics 9 (3):109-120.
    Discussions about the merits and shortcomings of non-inferiority trials are becoming increasingly common in the medical community and among regulatory agencies. However, criticisms targeting the ethical standing of non-inferiority trials have often been mistargeted. In this article we review the ethical standing of trials of non-inferiority. In the first part of the article, we outline a consequentialist position according to which clinical trials are best conceived as epistemic tools aimed at fostering the proper ends of medicine. According to this view, (...)
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  11. Jacob M. Appel (2001). Research Guidelines: Changes Urged. Journal of Law, Medicine and Ethics 28 (s4):103-104.
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  12. John Appiah-Poku, Sam Newton & Nancy Kass (2011). Participants' Perceptions of Research Benefits in an African Genetic Epidemiology Study. Developing World Bioethics 11 (3):128-135.
    Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment.Methods: In-depth (...)
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  13. Patricia A. Areán & Jennifer Alvidrez (2002). Ethical Considerations in Psychotherapy Effectiveness Research: Choosing the Comparison Group. Ethics and Behavior 12 (1):63 – 73.
    The primary purpose behind effectiveness research is to determine whether a treatment with demonstrated efficacy has utility when administered to the general population. The main questions these studies are meant to answer are these: Can the typical patient respond to treatment? Is the treatment acceptable to the typical patient? Can the treatment be administered safely and in its entirety in the typical treatment setting? Is the treatment under study significantly better than the community standard of care both from a cost (...)
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  14. Robert Arzbaecher (1995). Ethics and Relationships in Laboratories and Research Communities. Professional Ethics 4 (3/4):83-125.
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  15. Atsushi Asai & Yasuhiro Kadooka (2013). Reexamination of the Ethics of Placebo Use in Clinical Practice. Bioethics 27 (4):186-193.
    A placebo is a substance or intervention believed to be inactive, but is administered by the healthcare professional as if it was an active medication. Unlike standard treatments, clinical use of placebo usually involves deception and is therefore ethically problematic. Our attitudes toward the clinical use of placebo, which inevitably includes deception or withholding information, have a tremendous effect on our practice regarding truth-telling and informed consent. A casual attitude towards it weakens the current practice based on shared decision-making and (...)
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  16. 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.
    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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  17. Christiane Auray-Blais & Johane Patenaude (2006). A Biobank Management Model Applicable to Biomedical Research. BMC Medical Ethics 7 (1):1-9.
    Background The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light (...)
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  18. Denise Avard, Karine Sénécal, Parvaz Madadi & Daniel Sinnett (2011). Pediatric Research and the Return of Individual Research Results. Journal of Law, Medicine and Ethics 39 (4):593-604.
    The return of individual research results to participants raises many socio-ethical issues and is even more challenging when the participant is a child. The objective of this article is to present an overview of the few ethical guidelines and relevant literature addressing the return of individual results in pediatric research. By reviewing policies and the literature, we present some overarching considerations and delineate contextual issues in order to propose a framework.
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  19. Jon S. Bailey (2005). Ethics for Behavior Analysts: A Practical Guide to the Behavior Analyst Certification Board Guidelines for Responsible Conduct. Lawrence Erlbaum Associates, Publishers.
    Behavior analysis, a rapidly growing profession, began with the use and application of conditioning and learning techniques to modify the behavior of children or adults presenting severe management problems, often because of developmental disabilities. Now behavior analysts work in a variety of settings, from clinics and schools to workplaces. Especially since their practice often involves aversive stimuli or punishment, they confront many special ethical challenges. Recently, the Behavior Analysis Certification Board codified a set of ten fundamental ethical guidelines to be (...)
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  20. Michael Bamberg & Nancy Budwig (1992). Therapeutic Misconceptions: When the Voices of Caring and Research Are Misconstrued as the Voice of Curing. Ethics and Behavior 2 (3):165 – 184.
    Research on doctor-patient communication has characterized such interactions as being asymmetrical. The present article tries to shift emphasis away from the different orientations individuals bring to the communicative setting and attempts to highlight the different orientations ("voices") within a given individual. We draw on an in-depth analysis of discourse between a 2 l-year-old man who can be ascribed the roles of both patient and potential research subject and an interviewer who acts in both the role of medical staff and researcher. (...)
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  21. Rebecca Bamford (2011). Cultural Diversity, Families, and Research Subjects. American Journal of Bioethics 11 (5):33-34.
  22. Zbigniew Bańkowski & Norman Howard-Jones (eds.) (1982). Human Experimentation and Medical Ethics: Proceedings of the Xvth Cioms Round Table Conference, Manila, 13-16 September 1981. [REVIEW] Who Publications Centre Usa [Distributor].
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  23. Zbigniew Bańkowski & Robert J. Levine (eds.) (1993). Ethics and Research on Human Subjects: International Guidelines: Proceedings of the Xxvith Cioms Conference, Geneva, Switzerland, 5-7 February 1992. [REVIEW] Cioms.
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  24. Mark Barnes & Patrik S. Florencio (2002). Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts. Journal of Law, Medicine and Ethics 30 (3):390-402.
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  25. Anne Barnhill (2011). What It Takes to Defend Deceptive Placebo Use. Kennedy Institute of Ethics Journal 21 (3):219-250.
    The American Medical Association prohibits physicians from giving placebos to their patients unless the patients are informed of and agree to the use of placebos.1 This prohibition, and the ethics of placebo treatment more generally, have been discussed in numerous recent papers (Finniss, Kaptchuk, Miller, et al. 2010; Shaw 2009; Foddy 2009; Miller and Colloca 2009; Kolber 2007; Blease 2010). Though some bioethicists support the AMA prohibition, others challenge it, arguing that using placebos without patients’ knowledge and consent—that is, using (...)
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  26. Till Bärnighausen (2006). Barbaric Research, Japanese Human Experiments in Occupied China : Relevance, Alternatives, Ethics. In Wolfgang Uwe Eckart (ed.), Man, Medicine, and the State: The Human Body As an Object of Government Sponsored Medical Research in the 20th Century. Steiner.
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  27. Jane Barrett (2006). Ethics in Clinical Research. Icr Pub..
    Chapter One: Introduction “The ethical basis of all [medical] research is that information gained from one patient's experience should, where feasible, ...
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  28. Françoise Baylis & Carolyn McLeod (2007). The Stem Cell Debate Continues: The Buying and Selling of Eggs for Research. Journal of Medical Ethics 33 (12):726-731.
    Now that stem cell scientists are clamouring for human eggs for cloning-based stem cell research, there is vigorous debate about the ethics of paying women for their eggs. Generally speaking, some claim that women should be paid a fair wage for their reproductive labour or tissues, while others argue against the further commodification of reproductive labour or tissues and worry about voluntariness among potential egg providers. Siding mainly with those who believe that women should be financially compensated for providing eggs (...)
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  29. Tom L. Beauchamp (1992). The Moral Standing of Animals in Medical Research. Journal of Law, Medicine and Ethics 20 (1-2):7-16.
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  30. Tom L. Beauchamp & Yashar Saghai (2012). The Historical Foundations of the Research-Practice Distinction in Bioethics. Heoretical Medicine and Bioethics 33 (1):45-56.
    The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and interventions. This (...)
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  31. Henry K. Beecher (1970). Research and the Individual. Boston,Little, Brown.
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  32. Derek R. Bell (2003). Rawls and Research on Cognitively Impaired Patients: A Reply to Maio. Theoretical Medicine and Bioethics 24 (5):381-393.
    In his paper, “The Relevance of Rawls’ Principle of Justice for Research on Cognitively Impaired Patients” (Theoretical Medicine and Bioethics 23 (2002):45–53), Giovanni Maio has developed a thought-provoking argument for the permissibility of non-therapeutic research on cognitively impaired patients. Maio argues that his conclusion follows from the acceptance of John Rawls’s principles of justice, specifically, Rawls’s “liberty principle” Maio has misinterpreted Rawls’s “libertyprinciple” – correctly interpreted it does notsupport non-therapeutic research on cognitivelyimpaired patients. Three other ‘Rawlsian’ arguments are suggested by (...)
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  33. Jennifer Bell & Anita Ho (2011). Authenticity as a Necessary Condition for Voluntary Choice: A Case Study in Cancer Clinical Trial Participation. American Journal of Bioethics 11 (8):33-35.
    The American Journal of Bioethics, Volume 11, Issue 8, Page 33-35, August 2011.
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  34. Solomon R. Benatar (2004). Towards Progress in Resolving Dilemmas in International Research Ethics. Journal of Law, Medicine and Ethics 32 (4):574-582.
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  35. Frazier Benya (2011). The Need for Topically Focused Efforts to Deal with the Long-Term Social Implications of Research. American Journal of Bioethics 11 (5):19-20.
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  36. Jessica Berg & Nicole Deming (2011). New Rules for Research with Human Participants? Hastings Center Report 41 (6):10-11.
    In July, the Department of Health and Human Services and the Office of Science and Technology Policy published an advance notice of proposed rulemaking proposing sweeping changes to the rules governing oversight of research on human subjects—changes aimed at “better protect[ing] human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”1 The process is likely to amend not only the core regulation on human-subjects research , but also regulations governing vulnerable subjects, (...)
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  37. Ivan Berlin & David A. Gorelick (2003). The French Law on "Protection of Persons Undergoing Biomedical Research": Implications for the U.S. Journal of Law, Medicine and Ethics 31 (3):434-441.
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  38. Claudia Bernard (2012). Ethical Issues in Researching Black Teenage Mothers with Harmful Childhood Histories: Marginal Voices. Ethics and Social Welfare 7 (1):54-73.
    This paper highlights a number of ethical dilemmas encountered in a pilot study with a hard-to-reach group of research participants with harmful childhood histories. Drawing on a project exploring black teenage mothers' understandings of their own childhood experiences of abuse, it is argued that in asking young mothers to talk about such an emotionally sensitive topic as their own harmful childhood, a number of challenges are posed about how to deal with number of key ethical principles. The paper begins by (...)
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  39. Stephanie J. Bird (2010). Responsible Research: What is Expected? Commentary On: “Statistical Power, the Belmont Report, and the Ethics of Clinical Trials”. Science and Engineering Ethics 16 (4):693-696.
    “Responsible research” and “good science” are concepts with various meanings depending on one’s perspective and assumptions. Fellow researchers, research participants, policy makers and the general public also have differing expectations of the benefits of research ranging from accurate and reliable data that extend the body of knowledge, to solutions to societal concerns. Unless these differing constituencies articulate their differing views they may fail to communicate and undermine the value of research to society.
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  40. Jeff Blackmer (2003). The Unique Ethical Challenges of Conducting Research in the Rehabilitation Medicine Population. BMC Medical Ethics 4 (1):1-6.
    Background The broad topic of research ethics is one which has been relatively well-investigated and discussed. Unique ethical issues have been identified for such populations as pediatrics, where the issues of consent and assent have received much attention, and obstetrics, with concerns such as the potential for research to cause harm to the fetus. However, little has been written about ethical concerns which are relatively unique to the population of patients seen by the practitioner of rehabilitation medicine. Discussion This paper (...)
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  41. Robyn Bluhm (2007). Clinical Trials as Nomological Machines: Implications for Evidence-Based Medicine. In Harold Kincaid Jennifer McKitrick (ed.), Establishing Medical Reality: Essays In The Metaphysics And Epistemology Of Biomedical Science. Springer.
  42. J. Blustein, W. Robinson, G. S. Loeben & B. S. Wilfond (1997). Case Vignette: Placebos and Informed Consent. Ethics and Behavior 8 (1):89-98.
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  43. John R. Boatright (2010). Conflict of Interest in Financial Services : A Contractual Risk-Management Analysis. In Thomas H. Murray & Josephine Johnston (eds.), Trust and Integrity in Biomedical Research: The Case of Financial Conflicts of Interest. Johns Hopkins University Press.
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  44. Christian Bonah (2006). You Should Not Use Our Senegalese Infantrymen as Guinea Pigs" : Human Vaccination Experiments in the French Army, 1916-1933. In Wolfgang Uwe Eckart (ed.), Man, Medicine, and the State: The Human Body As an Object of Government Sponsored Medical Research in the 20th Century. Steiner.
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  45. Jürgen Boomgaarden, Pekka Louhiala & Urban Wiesing (eds.) (2003). Issues in Medical Research Ethics. Berghahn Books.
    Introduction TEMPE (Teaching Ethics: Material for Practitioner Education) is a two-year research project (2000-2002) funded by the European Commission ...
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  46. 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 biomedical research (...)
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  47. Kirstin Borgerson (2013). Are Explanatory Trials Ethical? Shifting the Burden of Justification in Clinical Trial Design. Theoretical Medicine and Bioethics 34 (4):293-308.
    Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some (...)
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  48. Lisa Bortolotti & John Harris (2005). Stem Cell Research, Personhood and Sentience. Reproductive Biomedicine Online 10:68-75.
    In this paper the permissibility of stem cell research on early human embryos is defended. It is argued that, in order to have moral status, an individual must have an interest in its own wellbeing. Sentience is a prerequisite for having an interest in avoiding pain, and personhood is a prerequisite for having an interest in the continuation of one's own existence. Early human embryos are not sentient and therefore they are not recipients of direct moral consideration. Early human embryos (...)
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  49. Annelien L. Bredenoord & Johannes Jm van Delden (2012). Disclosing Individual Genetic Research Results to Deceased Participants' Relatives by Means of a Qualified Disclosure Policy. American Journal of Bioethics 12 (10):10-12.
    The American Journal of Bioethics, Volume 12, Issue 10, Page 10-12, October 2012.
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  50. Frederic Bretzner, Frederic Gilbert, Françoise Baylis & Robert M. Brownstone (2011). Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury. Cell Stem Cell 8 (5):468-475.
    Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute (...)
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