Dave Wendler

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. ncbi request reprint Protecting subjects who cannot give consent: toward a better standard for "minimal" risks
    David Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institute of Health, USA
    Hastings Cent Rep 35:37-43. 2005
  2. ncbi request reprint The consent process for cadaveric organ procurement: how does it work? How can it be improved?
    D Wendler
    Department of Clinical Bioethics, Bldg 10, Room 1C118, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 285:329-33. 2001
  3. ncbi request reprint Does the current consent process minimize the risks of genetics research?
    Dave Wendler
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892 1156, USA
    Am J Med Genet 113:258-62. 2002
  4. ncbi request reprint What research with stored samples teaches us about research with human subjects
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD, USA 20892
    Bioethics 16:33-54. 2002
  5. ncbi request reprint Views of potential subjects toward proposed regulations for clinical research with adults unable to consent
    Dave Wendler
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892 1156, USA
    Am J Psychiatry 159:585-91. 2002
  6. ncbi request reprint The debate over research on stored biological samples: what do sources think?
    Dave Wendler
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 162:1457-62. 2002
  7. ncbi request reprint Consent for continuing research participation: what is it and when should it be obtained?
    Dave Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
    IRB 24:1-6. 2002
  8. ncbi request reprint One-time general consent for research on biological samples: is it compatible with the health insurance portability and accountability act?
    David Wendler
    Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 166:1449-52. 2006
  9. ncbi request reprint Hematopoietic stem cell transplant research with pediatric donors: when can institutional review boards approve it?
    Jehanna M Peerzada
    National Institutes of Health, Department of Clinical Bioethics, Bethesda, MD 20892, USA
    Transplantation 81:1616-20. 2006
  10. pmc Does random treatment assignment cause harm to research participants?
    Cary P Gross
    Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
    PLoS Med 3:e188. 2006

Collaborators

Detail Information

Publications61

  1. ncbi request reprint Protecting subjects who cannot give consent: toward a better standard for "minimal" risks
    David Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institute of Health, USA
    Hastings Cent Rep 35:37-43. 2005
    ..Such a standard appears likely to provide more stringent protections for these vulnerable populations...
  2. ncbi request reprint The consent process for cadaveric organ procurement: how does it work? How can it be improved?
    D Wendler
    Department of Clinical Bioethics, Bldg 10, Room 1C118, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 285:329-33. 2001
    ..However, no data exist on OPOs' current consent practices...
  3. ncbi request reprint Does the current consent process minimize the risks of genetics research?
    Dave Wendler
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892 1156, USA
    Am J Med Genet 113:258-62. 2002
    ....
  4. ncbi request reprint What research with stored samples teaches us about research with human subjects
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD, USA 20892
    Bioethics 16:33-54. 2002
    ..Based on this analysis, this paper describes a new model of research participation that is emerging, and considers its implications for clinical research...
  5. ncbi request reprint Views of potential subjects toward proposed regulations for clinical research with adults unable to consent
    Dave Wendler
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892 1156, USA
    Am J Psychiatry 159:585-91. 2002
    ..The authors' goal was to assess healthy individuals' attitudes toward five of the most prominent proposed safeguards regarding the consent process for research with adults unable to consent...
  6. ncbi request reprint The debate over research on stored biological samples: what do sources think?
    Dave Wendler
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 162:1457-62. 2002
    ..The debate over informed consent for research on stored biological samples has enormous scientific implications. Unfortunately, there are no data on individuals' attitudes regarding when their consent should be obtained for such research...
  7. ncbi request reprint Consent for continuing research participation: what is it and when should it be obtained?
    Dave Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
    IRB 24:1-6. 2002
  8. ncbi request reprint One-time general consent for research on biological samples: is it compatible with the health insurance portability and accountability act?
    David Wendler
    Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 166:1449-52. 2006
  9. ncbi request reprint Hematopoietic stem cell transplant research with pediatric donors: when can institutional review boards approve it?
    Jehanna M Peerzada
    National Institutes of Health, Department of Clinical Bioethics, Bethesda, MD 20892, USA
    Transplantation 81:1616-20. 2006
    ..Transplant protocols that expose pediatric donors to more than minimal risk can be approved by the Secretary of U.S. Department of Health and Human Services in a special category of pediatric research...
  10. pmc Does random treatment assignment cause harm to research participants?
    Cary P Gross
    Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
    PLoS Med 3:e188. 2006
    ..We therefore performed a systematic review to quantify the differences in health outcomes between randomized trial participants and eligible non-participants...
  11. ncbi request reprint Informed consent for research and authorization under the Health Insurance Portability and Accountability Act Privacy Rule: an integrated approach
    David Shalowitz
    NIH Clinical Center, Bethesda, Maryland 20892, USA
    Ann Intern Med 144:685-8. 2006
    ..Hence, consent forms that satisfy the U.S. federal regulations for human subjects research need only minimal additional text to also satisfy the authorization requirements under the HIPAA Privacy Rule...
  12. ncbi request reprint Overcoming language barriers in medical care
    David Wendler
    Department of Clinical Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
    Pediatr Blood Cancer 47:747. 2006
  13. ncbi request reprint Research on stored biological samples: views of African American and White American cancer patients
    Rebecca D Pentz
    Winship Cancer Institute, Emory University, Atlanta, Georgia 30322, USA
    Am J Med Genet A 140:733-9. 2006
    ..These findings support the recommendation to offer individuals a simplified consent with a one-time binary choice whether to provide biological samples for future research...
  14. pmc One-time general consent for research on biological samples
    David Wendler
    Department of Clinical Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
    BMJ 332:544-7. 2006
  15. ncbi request reprint Informed consent: practices and views of investigators in a multinational clinical trial
    Lindsay Sabik
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
    IRB 27:13-8. 2005
  16. ncbi request reprint Research advance directives: protection or obstacle?
    Palaniappan Muthappan
    Department of Clinical Bioethics, NIH, Bldg 10, Rm 1C118, Bethesda, MD 20892, USA
    Am J Psychiatry 162:2389-91. 2005
    ..This study assessed how many adults completed a research advance directive and the preferences indicated on the completed forms...
  17. pmc Are racial and ethnic minorities less willing to participate in health research?
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
    PLoS Med 3:e19. 2006
    ..It is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim...
  18. ncbi request reprint Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study
    Christine Pace
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, Mayland 20892, USA
    AIDS Res Hum Retroviruses 22:837-41. 2006
    ..IRB/REC chairs and researchers were less expansive both in who and how they thought a drug should be guaranteed...
  19. ncbi request reprint Protecting communities in health research from exploitation
    Segun Gbadegesin
    Department of Philosophy, Howard University, Washington, DC, USA
    Bioethics 20:248-53. 2006
    ..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...
  20. ncbi request reprint Minimal risk in pediatric research
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA
    J Pediatr 149:855-61. 2006
  21. ncbi request reprint Debriefing and accountability in deceptive research
    Franklin G Miller
    Department of Bioethics, National Institutes of Health, Bethesda, MD, USA
    Kennedy Inst Ethics J 18:235-51. 2008
    ..We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception...
  22. doi request reprint Why patients continue to participate in clinical research
    David Wendler
    Department of Bioethics, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892, USA
    Arch Intern Med 168:1294-9. 2008
    ..While some commentators argue that this process inappropriately exploits patient participants, there are few data available to evaluate this claim...
  23. doi request reprint The ethics of phase 0 oncology trials
    Emily Abdoler
    Department of Bioethics, NIH Clinical Center, Bethesda Maryland, USA
    Clin Cancer Res 14:3692-7. 2008
    ..To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology...
  24. ncbi request reprint Research benefits for hypothetical HIV vaccine trials: The views of Ugandans in the Rakai District
    Christine Grady
    Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA
    IRB 30:1-7. 2008
  25. doi request reprint What should research participants understand to understand they are participants in research?
    David Wendler
    NIH Clinical Center, Bethesda, MD 20892, USA
    Bioethics 22:203-8. 2008
    ....
  26. pmc Is it possible to protect pediatric research subjects without blocking appropriate research?
    David Wendler
    Department of Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    J Pediatr 152:467-70. 2008
  27. doi request reprint Children's and their parents' views on facing research risks for the benefit of others
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bldg 10, Room 1C118, Bethesda, MD 20892, USA
    Arch Pediatr Adolesc Med 162:9-14. 2008
    ..To assess children's and parents' attitudes regarding pediatric research that poses minimal risk or a minor increase over minimal risk and does not offer the potential to benefit the child clinically...
  28. pmc Research involving wards of the state: protecting particularly vulnerable children
    Sumeeta Varma
    Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland 20892, USA
    J Pediatr 152:9-14. 2008
  29. ncbi request reprint How does the collection of genetic test results affect research participants?
    David Wendler
    Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
    Am J Med Genet A 143:1733-8. 2007
    ..Investigators and IRBs should recognize these phenomena and address them in the design and conduct of studies which collect genetic information...
  30. pmc A standard for assessing the risks of pediatric research: pro and con
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
    J Pediatr 150:579-82. 2007
  31. pmc How should treatment decisions be made for incapacitated patients, and why?
    David I Shalowitz
    National Institutes of Health Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, United States of America
    PLoS Med 4:e35. 2007
  32. ncbi request reprint What is a "minor" increase over minimal risk?
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
    J Pediatr 147:575-8. 2005
  33. pmc The relevance of empirical research in bioethics
    Franklin G Miller
    Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892 1156, USA
    Schizophr Bull 32:37-41. 2006
    ..In order to examine the value and limitations of ethics-related empirical research, we discuss 3 case studies involving research with stored biological samples, placebo-controlled trials, and the idea of the therapeutic misconception...
  34. ncbi request reprint Institutional review board practices regarding assent in pediatric research
    Amy Whittle
    Department of Clinical Bioethics National Institutes of Health, Bethesda, Maryland 20892 1156, USA
    Pediatrics 113:1747-52. 2004
    ..To assess how Institutional Review Boards (IRBs) implement the assent requirement for research with children...
  35. ncbi request reprint Assessing the ethics of ethics research: a case study
    Franklin G Miller
    Unit on Clinical Research, Department of Clinical Bioethics, National Institutes of Health, USA
    IRB 26:9-12. 2004
  36. ncbi request reprint Deception in the pursuit of science
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892, USA
    Arch Intern Med 164:597-600. 2004
  37. ncbi request reprint What makes clinical research in developing countries ethical? The benchmarks of ethical research
    Ezekiel J Emanuel
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
    J Infect Dis 189:930-7. 2004
  38. ncbi request reprint Assessing the ethical and practical wisdom of surrogate consent for living organ donation
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 291:732-5. 2004
  39. ncbi request reprint Why we need legal standards for pediatric research
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland 20892, USA
    J Pediatr 144:150-3. 2004
  40. ncbi request reprint How do institutional review boards apply the federal risk and benefit standards for pediatric research?
    Seema Shah
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 291:476-82. 2004
    ..Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benefit categories for pediatric research...
  41. ncbi request reprint A response to commentators on "Should children decide whether they are enrolled in nonbeneficial research?"
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health
    Am J Bioeth 3:W37-W38. 2003
  42. ncbi request reprint Should children decide whether they are enrolled in nonbeneficial research?
    David Wendler
    National Institutes of Health
    Am J Bioeth 3:1-7. 2003
    ..These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research...
  43. ncbi request reprint Nonbeneficial research with individuals who cannot consent: is it ethically better to enroll healthy or affected individuals?
    David Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD, USA
    IRB 25:1-4. 2003
  44. ncbi request reprint When do the federal regulations allow placebo-controlled trials in children?
    Franklin G Miller
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, USA
    J Pediatr 142:102-7. 2003
  45. pmc The standard of care debate: can research in developing countries be both ethical and responsive to those countries' health needs?
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892
    Am J Public Health 94:923-8. 2004
    ....
  46. ncbi request reprint Risk standards for pediatric research: rethinking the Grimes ruling
    David Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
    Kennedy Inst Ethics J 14:187-98. 2004
    ....
  47. ncbi request reprint Palliative care: a supportive adjunct to pediatric phase I clinical trials for anticancer agents?
    Connie M Ulrich
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center National Institutes of Health Bethesda, MD 20892, USA
    Pediatrics 114:852-5. 2004
  48. ncbi request reprint Research on stored biological samples: the views of Ugandans
    David Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD, USA
    IRB 27:1-5. 2005
  49. ncbi request reprint Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit
    David Wendler
    Department of Clinical Bioethics, NIH Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA
    JAMA 294:826-32. 2005
    ..These data also raise the question of whether the federal minimal risk standard may sometimes fail to provide sufficient protection for children, prompting the need to consider alternative standards...
  50. pmc Deception in research on the placebo effect
    Franklin G Miller
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, USA
    PLoS Med 2:e262. 2005
  51. ncbi request reprint The quality of informed consent in a clinical research study in Thailand
    Christine Pace
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, MD, USA
    IRB 27:9-17. 2005
  52. ncbi request reprint Research with stored biological samples: what do research participants want?
    Donna T Chen
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, and National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 165:652-5. 2005
    ..Many believe consent for each future use is required to respect individuals. Others worry this approach may block important research...
  53. ncbi request reprint Can we ensure that all research subjects give valid consent?
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 164:2201-4. 2004
    ..Future research should focus on developing a postdecision questionnaire that can be adapted to individual studies and used to assess the voluntariness and understanding of all research subjects...
  54. ncbi request reprint Placebo research and the spirit of informed consent
    Franklin G Miller
    Psychosom Med 67:678; author reply 678. 2005
  55. ncbi request reprint Direct-to-consumer advertising and physician prescribing
    Franklin G Miller
    JAMA 294:678; author reply 678-9. 2005
  56. pmc A family's request for complementary medicine after patient brain death
    Arthur Isak Applbaum
    John F Kennedy School of Government and Edmond J Safra Foundation Center for Ethics, Harvard University, Cambridge, Massachusetts, USA
    JAMA 299:2188-93. 2008
    ..The present article reviews this case and discusses other cases that share key features to determine whether and when it is appropriate to accommodate requests for interventions on patients who have been declared dead...
  57. pmc Quality of parental consent in a Ugandan malaria study
    Christine Pace
    Section on Human Subjects, Department of Clinical Bioethics, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892 1156, USA
    Am J Public Health 95:1184-9. 2005
    ....
  58. ncbi request reprint The accuracy of surrogate decision makers: a systematic review
    David I Shalowitz
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Intern Med 166:493-7. 2006
    ..However, commentators have questioned the accuracy with which surrogates predict patients' treatment preferences...
  59. ncbi request reprint Medical decision making for patients without surrogates
    Sumeeta Varma
    Department of Bioethics, NIH Clinical Center, 10 Center Dr, Building 10, Room 1C118, Bethesda, MD 20892, USA
    Arch Intern Med 167:1711-5. 2007
    ....
  60. ncbi request reprint Dissolving the dilemma over forced treatment
    Vardit Ravitsky
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    Lancet 365:1525-6. 2005
  61. ncbi request reprint The ethics of paying for children's participation in research
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, 20892, USA
    J Pediatr 141:166-71. 2002