Research Topics
| David S WendlerSummaryAffiliation: National Institutes of Health Country: USA Publications
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Publications
Views of adolescents and parents on pediatric research without the potential for clinical benefitDavid 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...
Consent for research with biological samples: one-time general consent versus a gift modelDavid 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...- A new justification for pediatric research without the potential for clinical benefitDavid Wendler
NIH Clinical Center, Bethesda, MD 20892 1156, USA
Am J Bioeth 12:23-31. 2012.... 
Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefitDavid 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...- 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.... - 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 - 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 
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...- Children's and their parents' views on facing research risks for the benefit of othersDavid 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... - One-time general consent for research on biological samplesDavid Wendler
Department of Clinical Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
BMJ 332:544-7. 2006 - Assent in paediatric research: theoretical and practical considerationsD 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.... - Overcoming language barriers in medical careDavid Wendler
Department of Clinical Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
Pediatr Blood Cancer 47:747. 2006 - 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... - A standard for assessing the risks of pediatric research: pro and conDavid Wendler
Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
J Pediatr 150:579-82. 2007 - 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 - 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 - Why patients continue to participate in clinical researchDavid 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... - Minimal risk in pediatric researchDavid Wendler
Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA
J Pediatr 149:855-61. 2006 - Assessing research risks systematically: the net risks testD Wendler
Department of Clinical Bioethics, The NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA
J Med Ethics 33:481-6. 2007.... - Minimal risk in pediatric research as a function of ageDavid 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... - Assessing the ethical and practical wisdom of surrogate consent for living organ donationDavid Wendler
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
JAMA 291:732-5. 2004 - 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.... - Why we need legal standards for pediatric researchDavid Wendler
Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland 20892, USA
J Pediatr 144:150-3. 2004 - 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.... - 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... - 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... - Systematic review: the effect on surrogates of making treatment decisions for othersDavid 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... - What we worry about when we worry about the ethics of clinical researchDavid 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... - Deception in the pursuit of scienceDavid Wendler
Department of Clinical Bioethics, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892, USA
Arch Intern Med 164:597-600. 2004 - Informed consent: practices and views of investigators in a multinational clinical trialLindsay Sabik
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
IRB 27:13-8. 2005 - Assessing the ethics of ethics research: a case studyFranklin G Miller
Unit on Clinical Research, Department of Clinical Bioethics, National Institutes of Health, USA
IRB 26:9-12. 2004 - Risk standards for pediatric research: rethinking the Grimes rulingDavid Wendler
Unit on Vulnerable Populations, Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD, USA
Kennedy Inst Ethics J 14:187-98. 2004.... - Time to stop worrying about the therapeutic misconceptionDavid S Wendler
Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland, USA
J Clin Ethics 23:272-87. 2012.... - 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... - Debriefing and accountability in deceptive researchFranklin 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... - Protecting subjects who cannot give consent: toward a better standard for "minimal" risksDavid 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... - Research involving wards of the state: protecting particularly vulnerable childrenSumeeta Varma
Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, Maryland 20892, USA
J Pediatr 152:9-14. 2008 - The ethics of phase 0 oncology trialsEmily 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... - Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS studyChristine 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... - 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... - Interpretation of the subjects' condition requirement: a legal perspectiveSeema 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... - What research with stored samples teaches us about research with human subjectsDavid 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... - Institutional review board practices regarding assent in pediatric researchAmy Whittle
Department of Clinical Bioethics National Institutes of Health, Bethesda, Maryland 20892-1156, USA
Pediatrics 113:1747-52. 2004..These data suggest that IRBs need guidance on how to implement the assent requirement in a way that provides appropriate protections for pediatric research subjects... - Ancillary care obligations of medical researchersNeal 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... - What makes clinical research in developing countries ethical? The benchmarks of ethical researchEzekiel 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 - 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 - 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 - 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 - The quality of informed consent in a clinical research study in ThailandChristine Pace
Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD, USA
IRB 27:9-17. 2005 - Research on stored biological samples: the views of UgandansDavid 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 - 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... - Informed consent for research and authorization under the Health Insurance Portability and Accountability Act Privacy Rule: an integrated approachDavid 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... - Deception in research on the placebo effectFranklin G Miller
Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, USA
PLoS Med 2:e262. 2005 - The relevance of empirical research in bioethicsFranklin 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... - Is emergency research without initial consent justified?: the consent substitute modelEmily 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... - 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... - 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... - 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 - Research benefits for hypothetical HIV vaccine trials: The views of Ugandans in the Rakai DistrictChristine Grady
Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA
IRB 30:1-7. 2008 - Performing nondiagnostic research biopsies in irradiated tissue: a review of scientific, clinical, and ethical considerationsAaron P Brown
Radiation Oncology Branch, National Cancer Institute, 10 CRC, B2 3500, Bethesda, MD 20892, USA
J Clin Oncol 26:3987-94. 2008.... - The ethics of paying for children's participation in researchDavid Wendler
Department of Clinical Bioethics, National Institutes of Health, Bethesda, Maryland, 20892, USA
J Pediatr 141:166-71. 2002 - 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 - Medical decision making for patients without surrogatesSumeeta 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.... - Evaluating the risks of clinical researchAnnette Rid
Department of Bioethics, NIH Clinical Center, Bethesda, MD 20892, USA
JAMA 304:1472-9. 2010.... - Quality of parental consent in a Ugandan malaria studyChristine 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..Our results indicate that further debate is needed about informed consent in treatment studies of emergent illnesses in children... - Dissolving the dilemma over forced treatmentVardit Ravitsky
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
Lancet 365:1525-6. 2005 - 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... - The accuracy of surrogate decision makers: a systematic reviewDavid I Shalowitz
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892, USA
Arch Intern Med 166:493-7. 2006..Also, they should assess whether reliance on patient-designated and next-of-kin surrogates offers patients and/or their families benefits that are independent of the accuracy of surrogates' decisions...