Robert M Nelson
Affiliation: The Children's Hospital of Philadelphia
- Appropriate risk exposure in environmental health research. The Kennedy-Krieger lead abatement studyRobert M Nelson
Department of Anesthesiology and Critical Care Medicine, 9th Floor, The Children s Hospital of Philadelphia, Philadelphia, PA 19104 4399, USA
Neurotoxicol Teratol 24:445-9. 2002
- Food and Drug Administration public hearing on the conduct of emergency clinical research: testimony of Dr. NelsonRobert M Nelson
Department of Anesthesiology, Critical Care, The Children s Hospital of Philadelphia, Philadelphia, PA
Acad Emerg Med 14:e43-4. 2007
- Voluntariness of consent for research: an empirical and conceptual reviewRobert M Nelson
Department of Anesthesiology and Critical Care Medicine, The Children s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania 19104 4399, USA
Med Care 40:V69-80. 2002..Policy responses may be appropriate where the probability of control is too high...
- Imagining the developmentally disabled and mentally retarded: an introductionRobert M Nelson
Department of Anesthesiology and Critical Care Medicine, The Children s Hospital of Philadelphia, Pennsylvania 19104, USA
Ment Retard Dev Disabil Res Rev 9:1-2. 2003
- Assessment of parental decision-making in neonatal cardiac research: a pilot studyAruna T Nathan
Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Pennsylvania, USA
J Med Ethics 36:106-10. 2010..To assess parental permission for a neonate's research participation using the MacArthur competence assessment tool for clinical research (MacCAT-CR), specifically testing the components of understanding, appreciation, reasoning and choice...
- The decision making control instrument to assess voluntary consentVictoria A Miller
Department of Anesthesiology and Critical Care Medicine, Children s Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA
Med Decis Making 31:730-41. 2011..The decision to participate in a research intervention or to undergo medical treatment should be both informed and voluntary...
- Risk perception and decision processes underlying informed consent to research participationWilliam W Reynolds
Department of Anesthesiology and Critical Care Medicine, The Children s Hospital of Philadelphia, Center for Research Integrity, CHOP North Room 1511, 3405 Civic Center Boulevard, Philadelphia, PA 19104, USA
Soc Sci Med 65:2105-15. 2007..We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers...
- Factors related to voluntary parental decision-making in pediatric oncologyVictoria A Miller
Department of Anesthesiology and Critical Care Medicine, The Children s Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, USA
Pediatrics 129:903-9. 2012..The aim of the current study was to examine demographic and contextual correlates of voluntariness in parents making research or treatment decisions for their children with cancer...
- Challenges in measuring a new construct: perception of voluntariness for research and treatment decision makingVictoria A Miller
The Children s Hospital of Philadelphia, Civic Center, Philadelphia, PA 19104, USA
J Empir Res Hum Res Ethics 4:21-31. 2009..The strategies discussed here can be adapted by other researchers who are considering a scale development study related to the empirical study of ethics...
- Relationship of external influence to parental distress in decision making regarding children with a life-threatening illnessVictoria A Miller
Department of Anesthesiology and Critical Care Medicine, The Children s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA
J Pediatr Psychol 36:1102-12. 2011..To examine the relationship of external influence to parental distress when making a decision about research or treatment for a child with a life-threatening illness and to test potential moderators of this relationship...
- Challenges in the conduct of emergency research in children: a workshop reportRobert M Nelson
The Children s Hospital of Philadelphia, Philadelphia, PA
Am J Bioeth 6:W1-9. 2006
- Is a "wage-payment" model for research participation appropriate for children?Stephen J Bagley
College of Arts and Sciences, University of Pennsylvania, Philadelphia, PA, USA
Pediatrics 119:46-51. 2007..Our goal was to evaluate the applicability of a "wage-payment" model to inducements for children to participate in research...
- Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trialsMichael B Kimberly
Pediatric Generalist Research Group, Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
Pediatrics 117:1706-11. 2006....
- A developmental approach to child assent for nontherapeutic researchVictoria A Miller
Center for Research Integrity, The Children s Hospital of Philadelphia, PA 19104, USA
J Pediatr 149:S25-30. 2006....
- Advising parents about children's participation in clinical researchK Sarah Hoehn
Department of Anesthesiology and Critical Care Medicine, Children s Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA 19104, USA
Pediatr Ann 33:778-81. 2004..If there are unanswered questions, the pediatrician should encourage a parent to contact the researcher, or offer (with the parent's permission) to contact the researchers on the parent's behalf...
- Is there an objective way to compare research risks?John Rossi
Community Health and Prevention, Drexel University School of Public Health, 1505 Race Street, Bellet Building, 11th Floor, Philadelphia, PA 19102, USA
J Med Ethics 38:423-7. 2012..Instead, the authors suggest that a deliberative approach may be a more viable candidate for future development. Such an approach could be informed by methods such as SERR without being rigidly bound to them...
- The Children's Hospital of Philadelphia's experience with donation after cardiac deathMaryam Y Naim
The Children s Hospital of Philadelphia, Department of Anesthesiology and Critical Care Medicine, Philadelphia, PA, USA
Crit Care Med 36:1729-33. 2008..To describe our experience with pediatric donation after cardiac death...
- Parental decision-making in congenital heart diseaseK Sarah Hoehn
Division of Critical Care Medicine, Children s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA
Cardiol Young 14:309-14. 2004..To explore whether prenatal diagnosis of congenital heart disease is associated with lower levels of parental distress and greater satisfaction with decisions about cardiothoracic surgery when compared to postnatal diagnosis...
- Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrestMarilyn C Morris
Department of Anesthesia and Critical Care Medicine, Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
Pediatrics 114:776-81. 2004....
- Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiativeGerri R Baer
Department of Pediatrics, Children s Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA
Clin Ther 28:1399-407. 2006..The Newborn Drug Development Initiative (NDDI) was established to address the lack of substantive data supporting efficacy and safety of drugs in the neonate...
- Child assent and parental permission in pediatric researchWilma C Rossi
Department of Pediatrics, The Children s Hospital of Philadelphia, PA 19104, USA
Theor Med Bioeth 24:131-48. 2003..We suggest a developmental approach, viewing assent as a continuum ranging from mere affirmation in the youngest children to the equivalent of the informed consent process in the mature adolescent...
- Self-determination is not an appropriate model for understanding parental permission and child assentE Joseph Denham
Anesth Analg 94:1049-51. 2002
- Empirical data and the acceptability of research risk: a commentary on the charitable participation standardWilliam W Reynolds
Arch Pediatr Adolesc Med 162:88-90. 2008
- Institutional review boards lack the moral legitimacy to reinterpret subpart DRobert M Nelson
United States Food and Drug Administration, Rockville, MD 20057, USA
Am J Bioeth 8:37-9. 2008
- We should reject passive resignation in favor of requiring the assent of younger children for participation in nonbeneficial researchRobert M Nelson
University of Pennsylvania and The Children s Hospital of Philadelphia
Am J Bioeth 3:11-3. 2003
- Minimal risk, yet againRobert M Nelson
J Pediatr 150:570-2. 2007
- Certificates of confidentiality in research: rationale and usageZachary N Cooper
The College, University of Chicago, Chicago, IL 60637, USA
Genet Test 8:214-20. 2004..These findings show that COCs are often congregated within institutions and by particular individuals. This may be because others are unaware of COCs or because others do not believe they are necessary or useful...
- An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trialKen Kipnis
University of Hawaii, Manoa, USA
Am J Bioeth 6:18-21. 2006..Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards...
- In defense of a single standard of research risk for all childrenRobert M Nelson
J Pediatr 147:565-6. 2005
- Pediatric research and the federal minimal risk standardLainie Friedman Ross
JAMA 295:759; author reply 759-60. 2006
- Are research ethics standards satisfied in pediatric journal publications?Eric Weil
MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois 60637, USA
Pediatrics 110:364-70. 2002..Although many studies document them poorly, most published research undergoes IRB review and has IC procedures. Less is known about research published in pediatric journals, and how child health research is determined to be exempt...
- Child assent and parental permission: a comment on Tait's "Do they understand?"Robert M Nelson
Anesthesiology 98:597-8. 2003
- Randomized, controlled trials as minimal risk: an ethical analysisMarilyn C Morris
Department of Pediatrics, Division of Pediatric Critical Care, The Children s Hospital of New York Presbyterian, Columbia University, New York, NY, USA
Crit Care Med 35:940-4. 2007....
- Trials and errors: barriers to oversight of research conducted under the emergency research consent waiverKen Kipnis
Department of Philosophy, University of Hawaii at Manoa, Hawaii, USA
IRB 28:16-9. 2006
- Moving beyond the consent document in research on informed consentVictoria A Miller
Arch Pediatr Adolesc Med 159:396-7. 2005
- A paradigm for inpatient resuscitation research with an exception from informed consentMarilyn C Morris
Department of Pediatrics, Children s Hospital of New York Presbyterian, Columbia University, New York, NY, USA
Crit Care Med 34:2567-75. 2006....
- Parental opinions about clinical researchMarilyn C Morris
Department of Pediatrics, Division of Critical Care Medicine, The Children s Hospital of New York Presbyterian, Columbia University, New York, New York 10032, USA
J Pediatr 151:532-7, 537.e1-5. 2007..To characterize parental perception of clinical research, particularly in emergency settings. To identify specific aspects of clinical research that concern parents and to discuss how these concerns can be addressed...
- Informed consent for genetic research involving pleiotropic genes: an empirical study of ApoE researchZachary N Cooper
London School of Economics, London, UK
IRB 28:1-11. 2006
- Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: ethical and safety considerations for normal pediatric hematopoietic cell donorsMichael A Pulsipher
Primary Children s Medical Center, Salt Lake City, Utah 84113, USA
Pediatr Blood Cancer 46:422-33. 2006..Short and long-term risks of G-CSF administration and leukopheresis are not well understood in the pediatric population...