David S Wendler

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. doi request reprint Should protections for research with humans who cannot consent apply to research with nonhuman primates?
    David Wendler
    Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD, 20892 1156, USA
    Theor Med Bioeth 35:157-73. 2014
  2. ncbi request reprint Problems with the consensus definition of the therapeutic misconception
    David S Wendler
    Department of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA
    J Clin Ethics 24:387-94. 2013
  3. pmc Views of adolescents and parents on pediatric research without the potential for clinical benefit
    David Wendler
    Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA
    Pediatrics 130:692-9. 2012
  4. doi request reprint Consent for research with biological samples: one-time general consent versus a gift model
    David Wendler
    National Institutes of Health Clinical Center, Bethesda, Maryland 20892 1156, USA
    Ann Intern Med 156:596-8. 2012
  5. doi request reprint A new justification for pediatric research without the potential for clinical benefit
    David Wendler
    NIH Clinical Center, Bethesda, MD 20892 1156, USA
    Am J Bioeth 12:23-31. 2012
  6. doi request reprint Are physicians obligated always to act in the patient's best interests?
    David Wendler
    Department of Bioethics, NIH Clinical Center, Bethesda, MD 20892 1156, USA
    J Med Ethics 36:66-70. 2010
  7. doi request reprint Minimal risk in pediatric research as a function of age
    David Wendler
    Department of Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Pediatr Adolesc Med 163:115-8. 2009
  8. 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
  9. 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
  10. ncbi request reprint How can medical training and informed consent be reconciled with volume-outcome data?
    David S Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, USA
    J Clin Ethics 17:149-57. 2006

Collaborators

Detail Information

Publications70

  1. doi request reprint Should protections for research with humans who cannot consent apply to research with nonhuman primates?
    David Wendler
    Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD, 20892 1156, USA
    Theor Med Bioeth 35:157-73. 2014
    ..the principle of fairness-treat like cases alike-imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? ..
  2. ncbi request reprint Problems with the consensus definition of the therapeutic misconception
    David S Wendler
    Department of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA
    J Clin Ethics 24:387-94. 2013
    ....
  3. pmc Views of adolescents and parents on pediatric research without the potential for clinical benefit
    David Wendler
    Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA
    Pediatrics 130:692-9. 2012
    ..The present survey was designed to assess whether this claim is consistent with the views of adolescents who actually participate in research, or their parents...
  4. doi request reprint Consent for research with biological samples: one-time general consent versus a gift model
    David Wendler
    National Institutes of Health Clinical Center, Bethesda, Maryland 20892 1156, USA
    Ann Intern Med 156:596-8. 2012
    ..This conclusion supports the suggestion made in a recent Advance Notice of Proposed Rulemaking to incorporate one-time general consent for research with human biological samples into any revisions of the federal regulations...
  5. doi request reprint A new justification for pediatric research without the potential for clinical benefit
    David Wendler
    NIH Clinical Center, Bethesda, MD 20892 1156, USA
    Am J Bioeth 12:23-31. 2012
    ....
  6. doi request reprint Are physicians obligated always to act in the patient's best interests?
    David Wendler
    Department of Bioethics, NIH Clinical Center, Bethesda, MD 20892 1156, USA
    J Med Ethics 36:66-70. 2010
    ..The present article considers the range of exceptions, illustrates how the lack of guidance poses ethical concern and describes an alternative account of physician obligations to address this concern...
  7. doi request reprint Minimal risk in pediatric research as a function of age
    David Wendler
    Department of Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
    Arch Pediatr Adolesc Med 163:115-8. 2009
    ..This analysis supports 2 thresholds for minimal risk in pediatric research: one for research with younger children and a distinct standard for older children who can understand and who agree to participate...
  8. 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...
  9. 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
    ....
  10. ncbi request reprint How can medical training and informed consent be reconciled with volume-outcome data?
    David S Wendler
    Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, USA
    J Clin Ethics 17:149-57. 2006
  11. 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
  12. 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
  13. 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...
  14. 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...
  15. 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
  16. 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
  17. 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
  18. 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
  19. 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...
  20. doi request reprint Must research participants understand randomization?
    David Wendler
    National Institutes of Health Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA
    Am J Bioeth 9:3-8. 2009
    ....
  21. 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
  22. 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
  23. pmc Assessing research risks systematically: the net risks test
    D Wendler
    Department of Clinical Bioethics, The NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA
    J Med Ethics 33:481-6. 2007
    ....
  24. 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
  25. 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...
  26. doi request reprint What we worry about when we worry about the ethics of clinical research
    David Wendler
    Department of Bioethics, NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA
    Theor Med Bioeth 32:161-80. 2011
    ..I end by considering the normative significance of this feature and the implications it has for how clinical research should be regulated and conducted...
  27. 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
    ....
  28. 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
  29. doi request reprint Systematic review: the effect on surrogates of making treatment decisions for others
    David Wendler
    National Institutes of Health, Bethesda, Maryland 20892, USA
    Ann Intern Med 154:336-46. 2011
    ..Clinical practice relies on surrogates to make or help to make treatment decisions for incapacitated adults; however, the effect of this practice on surrogates has not been evaluated...
  30. 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...
  31. pmc Assent in paediatric research: theoretical and practical considerations
    D S Wendler
    Department of Clinical Bioethics, The NIH Clinical Center, Building 10, Room 1C118, Bethesda, MD 20892, USA
    J Med Ethics 32:229-34. 2006
    ....
  32. 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
  33. 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
  34. 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
    ....
  35. ncbi request reprint Time to stop worrying about the therapeutic misconception
    David S Wendler
    Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA
    J Clin Ethics 23:272-87. 2012
    ....
  36. 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...
  37. doi request reprint How do children and parents make decisions about pediatric clinical research?
    Sumeeta Varma
    Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
    J Pediatr Hematol Oncol 30:823-8. 2008
    ..Investigators should be aware of and find ways to address these disagreements when soliciting assent from children...
  38. 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...
  39. 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...
  40. 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...
  41. 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
  42. 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...
  43. doi request reprint Interpretation of the subjects' condition requirement: a legal perspective
    Seema Shah
    Department of Bioethics, National Institutes of Health, USA
    J Law Med Ethics 38:365-73. 2010
    ..Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should be understood...
  44. doi request reprint Ancillary care obligations of medical researchers
    Neal Dickert
    Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    JAMA 302:424-8. 2009
    ..That responsibility, however, is significantly limited by the depth of the investigator's relationship with participants and the resource demands of providing such care...
  45. 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
  46. 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...
  47. 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...
  48. 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
  49. 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
  50. 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
  51. 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
  52. 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
  53. 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...
  54. 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
  55. 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...
  56. 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...
  57. 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...
  58. doi request reprint Is emergency research without initial consent justified?: the consent substitute model
    Emily A Largent
    National Institutes of Health, 10 Center Dr, Bldg 10, Room 1C118, Bethesda, MD 20892 1156, USA
    Arch Intern Med 170:668-74. 2010
    ..Together, these conditions constitute an ethical substitute for informed consent in emergency research-forming the consent substitute model...
  59. 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...
  60. 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
  61. 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
  62. pmc Performing nondiagnostic research biopsies in irradiated tissue: a review of scientific, clinical, and ethical considerations
    Aaron P Brown
    Radiation Oncology Branch, National Cancer Institute, 10 CRC, B2 3500, Bethesda, MD 20892, USA
    J Clin Oncol 26:3987-94. 2008
    ....
  63. 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
  64. 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
    ....
  65. doi request reprint Evaluating the risks of clinical research
    Annette Rid
    Department of Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
    JAMA 304:1472-9. 2010
    ....
  66. 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
  67. 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
    ....
  68. 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
  69. 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...
  70. ncbi request reprint Can we improve treatment decision-making for incapacitated patients?
    Annette Rid
    Department of Bioethics, National Institutes of Health Clinical Center, USA
    Hastings Cent Rep 40:36-45. 2010
    ..One way to improve it would be to arm surrogates with information about what patients in similar circumstances tend to prefer, allowing them to make empirically grounded predictions about what their patient would want...