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David Wendler [67]D. Wendler [8]Dave Wendler [6]David S. Wendler [2]
D. S. Wendler [1]
  1.  7
    Broad Consent for Research With Biological Samples: Workshop Conclusions.Christine Grady, Lisa Eckstein, Ben Berkman, Dan Brock, Robert Cook-Deegan, Stephanie M. Fullerton, Hank Greely, Mats G. Hansson, Sara Hull, Scott Kim, Bernie Lo, Rebecca Pentz, Laura Rodriguez, Carol Weil, Benjamin S. Wilfond & David Wendler - 2015 - American Journal of Bioethics 15 (9):34-42.
    Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...)
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  2.  4
    What Should Be Disclosed to Research Participants?David Wendler - 2013 - American Journal of Bioethics 13 (12):3-8.
    Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose only the information that is disclosed in the clinical care setting. To resolve this debate, it is important to identify the ethical concerns raised by clinical research and determine (...)
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  3.  1
    Moral Standards for Research in Developing Countries From "Reasonable Availability" to "Fair Benefits".Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu, Newton Kumwenda, Joseph Mfutso-Bengu, Malcolm Molyneux, Terrie Taylor, Doumbia Aissata Diarra, Saibou Maiga, Mamadou Sylla, Dione Youssouf, Catherine Olufunke Falade, Segun Gbadegesin, Reidar Lie, Ferdinand Mugusi, David Ngassapa, Julius Ecuru, Ambrose Talisuna, Ezekiel Emanuel, Christine Grady, Elizabeth Higgs, Christopher Plowe, Jeremy Sugarman & David Wendler - 2004 - Hastings Center Report 34 (3):17.
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  4.  29
    A New Justification for Pediatric Research Without the Potential for Clinical Benefit.David Wendler - 2012 - American Journal of Bioethics 12 (1):23 - 31.
    Pediatric research without the potential for clinical benefit is vital to improving pediatric medical care. This research also raises ethical concern and is regarded by courts and commentators as unethical. While at least 10 justifications have been proposed in response, all have fundamental limitations. This article describes and defends a new justification based on the fact that enrollment in clinical research offers children the opportunity to contribute to a valuable project. Contributing as children to valuable projects can benefit individuals in (...)
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  5.  23
    Protecting Communities in Health Research From Exploitation.Segun Gbadegesin & David Wendler - 2006 - Bioethics 20 (5):248-253.
    Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).
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  6.  22
    The Duty to Rescue and Randomized Controlled Trials Involving Serious Diseases.Joseph Millum & David Wendler - 2018 - Journal of Moral Philosophy 15 (3):298-323.
    During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patient-participants with serious diseases (...)
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  7. Philosophical Justifications of Informed Consent in Research.D. Brock, E. J. Emanuel, C. Grady, R. Lie, F. Miller & D. Wendler - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press.
     
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  8. Empirical Issues in Informed Consent for Research.James Flory, David Wendler & Ezekiel Emanuel - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 645--60.
     
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  9.  21
    Must Research Participants Understand Randomization?David Wendler - 2009 - American Journal of Bioethics 9 (2):3 – 8.
    In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that (...)
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  10.  7
    Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic.Seema K. Shah, David Wendler & Marion Danis - 2015 - American Journal of Bioethics 15 (4):11-16.
    The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease , debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth (...)
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  11.  8
    Are Physicians Obligated Always to Act in the Patient's Best Interests?D. Wendler - 2010 - Journal of Medical Ethics 36 (2):66-70.
    The principle that physicians should always act in the best interests of the present patient is widely endorsed. At the same time, and often within the same document, it is recognised that there are appropriate exceptions to this principle. Unfortunately, little, if any, guidance is provided regarding which exceptions are appropriate and how they should be handled. These circumstances might be tenable if the appropriate exceptions were rare. Yet, evaluation of the literature reveals that there are numerous exceptions, several of (...)
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  12.  22
    Risk Standards for Pediatric Research: Rethinking the Grimes Ruling.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
  13.  27
    Risk Standards for Pediatric Research: Rethinking The.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
    : In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective (...)
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  14.  39
    Should Protections for Research with Humans Who Cannot Consent Apply to Research with Nonhuman Primates?David Wendler - 2014 - Theoretical Medicine and Bioethics 35 (2):157-173.
    Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to address this concern (...)
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  15.  4
    Assessing Research Risks Systematically: The Net Risks Test.D. Wendler & F. G. Miller - 2007 - Journal of Medical Ethics 33 (8):481-486.
    Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...)
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  16.  14
    Treatment Decision Making for Incapacitated Patients: Is Development and Use of a Patient Preference Predictor Feasible?Annette Rid & David Wendler - 2014 - Journal of Medicine and Philosophy 39 (2):130-152.
    It has recently been proposed to incorporate the use of a “Patient Preference Predictor” (PPP) into the process of making treatment decisions for incapacitated patients. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Including a PPP in the shared decision-making process between clinicians and surrogates has the potential to better realize important ethical goals for making treatment decisions (...)
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  17.  3
    The Ethics of Peer Review in Bioethics.D. Wendler & F. Miller - 2014 - Journal of Medical Ethics 40 (10):697-701.
    A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit from the peer (...)
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  18.  8
    Involving Communities in Deciding What Benefits They Receive in Multinational Research.David Wendler & Seema Shah - 2015 - Journal of Medicine and Philosophy 40 (5):584-600.
    There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, (...)
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  19.  17
    Should Children Decide Whether They Are Enrolled in Nonbeneficial Research?David Wendler & Seema Shah - 2003 - American Journal of Bioethics 3 (4):1 – 7.
    The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...)
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  20.  7
    When Research Regulations and Ethics Conflict.Haley K. Sullivan, Derek W. Braverman & David Wendler - 2018 - American Journal of Bioethics 18 (4):96-97.
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  21.  29
    Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks.David Wendler - 2005 - Hastings Center Report 35 (5):37-43.
    : When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than "minimal" risks, according to guidelines accepted around the world. We need a new standard for what "minimal" risks are, howeve--one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.
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  22.  48
    Clinical Research: Should Patients Pay to Play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  23.  4
    Broad Versus Blanket Consent for Research with Human Biological Samples.David Wendler - 2013 - Hastings Center Report 43 (5):3-4.
    The first of two commentaries on "Respecting Donors to Biobank Research," from the January-February 2013 issue. © 2013 by The Hasti.
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  24.  8
    Assent in Paediatric Research: Theoretical and Practical Considerations.D. S. Wendler - 2006 - Journal of Medical Ethics 32 (4):229-234.
    Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable (...)
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  25.  2
    In Defense of a Social Value Requirement for Clinical Research.David Wendler & Annette Rid - 2017 - Bioethics 31 (2):77-86.
    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this (...)
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  26. The Duty to Take Rescue Precautions.Tina Rulli & David Wendler - 2016 - Journal of Applied Philosophy 33 (3):240-258.
    There is much philosophical literature on the duty to rescue. Individuals who encounter and could save, at relatively little cost to themselves, a person at risk of losing life or limb are morally obligated to do so. Yet little has been said about the other side of the issue. There are cases in which the need for rescue could have been reasonably avoided by the rescuee. We argue for a duty to take rescue precautions, providing an account of the circumstances (...)
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  27.  34
    What Should Research Participants Understand to Understand They Are Participants in Research?David Wendler & Christine Grady - 2008 - Bioethics 22 (4):203–208.
    To give valid informed consent to participate in clinical research, potential participants should understand the risks, potential benefits, procedures, and alternatives. Potential participants also should understand that they are being invited to participate in research. Yet it is unclear what potential participants need to understand to satisfy this particular requirement. As a result, it is unclear what additional information investigators should disclose about the research; and it is also unclear when failures of understanding in this respect undermine the validity of (...)
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  28.  13
    Use of a Patient Preference Predictor to Help Make Medical Decisions for Incapacitated Patients.A. Rid & D. Wendler - 2014 - Journal of Medicine and Philosophy 39 (2):104-129.
    The standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decision making leaves families with the stressful challenge of identifying the patient’s preferred treatment (...)
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  29.  25
    Which Benefits of Research Participation Count as 'Direct'?Alexander Friedman, Emily Robbins & David Wendler - 2012 - Bioethics 26 (2):60-67.
    It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial (...)
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  30.  22
    Can We Improve Treatment Decision-Making for Incapacitated Patients?Annette Rid & David Wendler - 2010 - Hastings Center Report 40 (5):36-45.
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  31.  10
    When Clinical Care is Like Research: The Need for Review and Consent.David Wendler & Rebecca Johnson - 2016 - Theoretical Medicine and Bioethics 37 (3):193-209.
    The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review (...)
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  32.  12
    What Research with Stored Samples Teaches Us About Research with Human Subjects.David Wendler - 2002 - Bioethics 16 (1):33–54.
  33. The Moral Duty to Buy Health Insurance.Tina Rulli, Ezekiel Emanuel & David Wendler - 2012 - Journal of the American Medical Association 308 (2):137-138.
    The 2010 Patient Protection and Affordable Care Act was designed to increase health insurance coverage in the United States. Its most controversial feature is the requirement that US residents purchase health insurance. Opponents of the mandate argue that requiring people to contribute to the collective good is inconsistent with respect for individual liberty. Rather than appeal to the collective good, this Viewpoint argues for a duty to buy health insurance based on the moral duty individuals have to reduce certain burdens (...)
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  34.  9
    An Ethical Framework for Biomedical Research.Ezekiel J. Emanuel, David Wendler & C. Grady - 2008 - In The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 123--135.
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  35.  39
    Debriefing and Accountability in Deceptive Research.G. Miller Franklin, P. GluckJohn & Wendler David - 2008 - Kennedy Institute of Ethics Journal 18 (3):235-251.
    Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology (...)
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  36.  5
    Time to Stop Worrying About the Therapeutic Misconception.David S. Wendler - 2012 - Journal of Clinical Ethics 23 (3):272-287.
    Work on the therapeutic misconception suggests that investigators should ensure that potential research subjects understand the fundamental differences between clinical research and clinical care. Yet, what potential research subjects should understand depends on their circumstances and the study in question. This analysis implies that researchers and review committees should stop attempting to define, measure, and dispel the therapeutic misconception, and instead should focus on what potential subjects should understand to participate in individual studies.
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  37. Does It Matter Whether Investigators Intend to Benefit Research Subjects?David Wendler & Emily Abdoler - 2010 - 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, and Grady 2000). Others (...)
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  38.  2
    Clarifying Substituted Judgement: The Endorsed Life Approach: Table 1.John Phillips & David Wendler - 2015 - Journal of Medical Ethics 41 (9):723-730.
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  39.  1
    Challenging the Sanctity of Donorism: Patient Tissue Providers as Payment-Worthy Contributors.Rebecca A. Johnson & David Wendler - 2015 - Kennedy Institute of Ethics Journal 25 (3):291-333.
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  40.  74
    Innateness as an Explanatory Concept.David Wendler - 1996 - Biology and Philosophy 11 (1):89-116.
    Although many of the issues surrounding innateness have received a good deal of attention lately, the basic concept of token innateness has been largely ignored. In the present paper, I try to correct this imbalance by offering an account of the innateness of token traits. I begin by explaining Stephen Stich's account of token innateness and offering a counterexample to that account. I then clarify why the contemporary biological approaches to innateness will not be able to resolve the problems that (...)
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  41.  2
    Making Treatment Decisions for Oneself:Weighing the Value.Dan W. Brock, John K. Park & David Wendler - 2014 - Hastings Center Report 44 (2):22-25.
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  42.  9
    Is It Ethical to Keep Interim Findings of Randomised Controlled Trials Confidential?F. G. Miller & D. Wendler - 2008 - Journal of Medical Ethics 34 (3):198-201.
    Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that withholding interim findings from (...)
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  43.  38
    What We Worry About When We Worry About the Ethics of Clinical Research.David Wendler - 2011 - Theoretical Medicine and Bioethics 32 (3):161-180.
    Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research is ethically problematic because it exposes some individuals (...)
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  44. Research with Biological Samples.David Wendler - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 290--297.
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  45. The Assent Requirement in Pediatric Research.D. Wendler - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press. pp. 661--671.
  46.  10
    Research on Stored Biological Samples: The Views of Ugandans.David Wendler, Christine Pace, Ambrose O. Talisuna, Faustine Maiso, Christine Grady & Ezekiel Emanuel - 2005 - IRB: Ethics & Human Research 27 (2).
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  47.  11
    Understanding the 'Conservative' View on Abortion.Dave Wendler - 1999 - Bioethics 13 (1):32–56.
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  48.  64
    Response to the Requirement to Purchase Health Insurance.Tina Rulli & David Wendler - 2012 - Journal of the American Medical Association 308 (16):1629.
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  49.  14
    Informed Consent to Future Research on Stored Tissue Samples: The Views of Researchers, Ethics Review Committee Members and Policy Makers in Five Non-Western Countries.Kenji Matsui, Alaa Abou Zeid, Zhang Xinqing, Benjamin Krohmal, Vasantha Muthuswamy, Young Mo Koo, David Wendler, Jesse Chao, Yoshikuni Kita & Reidar Lie - 2009 - Asian Bioethics Review 1 (4):401-416.
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  50.  24
    Informed Consent, Exploitation and Whether It is Possible to Conduct Human Subjects Research Without Either One.Dave Wendler - 2000 - Bioethics 14 (4):310–339.
    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 to what extent (...)
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