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David Wendler [87]Dave Wendler [7]D. Wendler [7]David S. Wendler [3]
D. S. Wendler [1]
  1.  58
    Reframing Consent for Clinical Research: A Function-Based Approach.Scott Y. H. Kim, David Wendler, Kevin P. Weinfurt, Robert Silbergleit, Rebecca D. Pentz, Franklin G. Miller, Bernard Lo, Steven Joffe, Christine Grady, Sara F. Goldkind, Nir Eyal & Neal W. Dickert - 2017 - American Journal of Bioethics 17 (12):3-11.
    Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...)
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  2.  55
    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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  3.  5
    A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials: Response to Commentaries.Saskia Hendriks, Christine Grady, David Wasserman, David Wendler, Diana W. Bianchi & Benjamin Berkman - 2022 - American Journal of Bioethics 22 (3):45-61.
    New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...)
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  4.  22
    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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  5. 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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  6. Avoiding Exploitation in Multinational Covid-19 Vaccine Trials.Alexander A. Iyer, Joseph Millum, Christine Grady & David Wendler - 2021 - The BMJ 372:n541.
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  7.  22
    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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  8.  46
    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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  9.  29
    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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  10.  37
    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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  11. 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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  12.  54
    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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  13.  32
    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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  14.  22
    Is There a Role for Assent or Dissent in Animal Research?Holly Kantin & David Wendler - 2015 - Cambridge Quarterly of Healthcare Ethics 24 (4):459-472.
  15.  31
    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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  16.  8
    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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  17.  29
    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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  18.  48
    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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  19.  11
    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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  20.  59
    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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  21. 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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  22.  30
    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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  23.  46
    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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  24.  17
    A New Method for Making Treatment Decisions for Incapacitated Patients: What Do Patients Think About the Use of a Patient Preference Predictor?David Wendler, Bob Wesley, Mark Pavlick & Annette Rid - 2016 - Journal of Medical Ethics 42 (4):235-241.
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  25.  17
    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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  26. 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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  27.  56
    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.  33
    Risk Standards for Pediatric Research: Rethinking the Grimes Ruling.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.
  29.  28
    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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  30.  25
    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):1.
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  31.  2
    Autonomy-Based Criticisms of the Patient Preference Predictor.E. J. Jardas, David Wasserman & David Wendler - 2022 - Journal of Medical Ethics 48 (5):304-310.
    The patient preference predictor is a proposed computer-based algorithm that would predict the treatment preferences of decisionally incapacitated patients. Incorporation of a PPP into the decision-making process has the potential to improve implementation of the substituted judgement standard by providing more accurate predictions of patients’ treatment preferences than reliance on surrogates alone. Yet, critics argue that methods for making treatment decisions for incapacitated patients should be judged on a number of factors beyond simply providing them with the treatments they would (...)
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  32.  33
    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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  33.  21
    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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  34.  16
    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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  35.  27
    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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  36.  26
    The Theory and Practice of Surrogate Decision‐Making.David Wendler - 2017 - Hastings Center Report 47 (1):29-31.
    When a patient lacks decision-making capacity and has not left a clear advance directive, there is now widespread agreement that patient-designated and next-of-kin surrogates should implement substituted judgment within a process of shared decision-making. Specifically, after discussing the “best scientific evidence available, as well as the patient's values, goals, and preferences” with the patient's clinicians, the patient-designated or next-of-kin surrogate should attempt to determine what decision the patient would have made in the circumstances. To the extent that this approach works, (...)
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  37.  6
    Conducting Human Challenge Studies in LMICs: A Survey of Researchers and Ethics Committee Members in Thailand.Jaranit Kaewkungwal, Pornpimon Adams, Jetsumon Sattabongkot, Reidar K. Lie & David Wendler - 2019 - PLoS ONE 14 (10).
    Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries. Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who (...)
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  38. 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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  39.  36
    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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  40.  35
    What Research with Stored Samples Teaches Us About Research with Human Subjects.David Wendler - 2002 - Bioethics 16 (1):33–54.
  41.  65
    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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  42.  13
    Do Patients Want Their Families or Their Doctors to Make Treatment Decisions in the Event of Incapacity, and Why?David Wendler, Robert Wesley, Mark Pavlick & Annette Rid - 2016 - AJOB Empirical Bioethics 7 (4):251-259.
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  43.  6
    Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks.David Wendler - 2005 - Hastings Center Report 35 (5):37.
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  44.  4
    Minimizing Risks Is Not Enough: The Relevance of Benefits to Protecting Research Participants.David Wendler - 2020 - Perspectives in Biology and Medicine 63 (2):346-358.
    Martin Luther King, Jr., quoting the 19th-century clergyman Theodore Parker, claimed that the arc of the moral universe “bends toward justice.” One hopes he is right, perhaps especially at times when history appears to have taken something of a detour. The 40th anniversary of the Belmont Report offers the opportunity to evaluate the arc of research ethics, to assess where it is going and whether it too is bending toward justice.The Belmont Report is the work of the National Commission, which (...)
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  45.  24
    The Quality of Informed Consent in a Clinical Research Study in Thailand.Christine Pace, Ezekiel J. Emanuel, Theshinee Chuenyam, Chris Duncombe, Judith D. Bebchuk, David Wendler, Jorge A. Tavel, Laura A. McNay, Praphan Phanuphak & Heidi P. Forster - 2004 - IRB: Ethics & Human Research 27 (1):9-17.
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  46.  14
    A Proposed Process for Reliably Updating the Common Rule.Benjamin E. Berkman, David Wendler, Haley K. Sullivan & Christine Grady - 2017 - American Journal of Bioethics 17 (7):8-14.
    The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given (...)
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  47.  8
    The Ethics of Peer Review in Bioethics.David Wendler & Franklin 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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  48.  82
    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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  49.  37
    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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  50.  24
    Adolescent Research Participants' Descriptions of Medical Research.Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond & David Wendler - 2016 - AJOB Empirical Bioethics 7 (1):1-7.
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