Robert M Nelson

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint The concept of voluntary consent
    Robert M Nelson
    US Food and Drug Administration, Silver Spring, MD 20993, USA
    Am J Bioeth 11:6-16. 2011
  2. doi request reprint Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention research
    Robert M Nelson
    Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD 20993, USA
    J Acquir Immune Defic Syndr 54:S18-24. 2010
  3. doi request reprint Institutional review boards lack the moral legitimacy to reinterpret subpart D
    Robert M Nelson
    United States Food and Drug Administration, Rockville, MD 20057, USA
    Am J Bioeth 8:37-9. 2008
  4. doi request reprint Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials
    Haihao Sun
    Office of Pediatric Therapeutics, Office of the Commissioner Division of Gastroenterology and Inborn Errors Products Study Endpoint and Labeling Development SEALD Pediatrics and Maternal Health Staff, Office of New Drug, Center for Drug Research and Evaluation, Food and Drug Administration, Silver Spring, MD
    J Pediatr Gastroenterol Nutr 58:12-7. 2014
  5. pmc Parental permission and child assent in research on children
    Michelle Roth-Cline
    Office of Pediatric Therapeutics, Food and Drug Administration, Silver Spring, Maryland
    Yale J Biol Med 86:291-301. 2013
  6. doi request reprint A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings
    Patricia L Bright
    Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    J Med Ethics 38:672-6. 2012
  7. doi request reprint Ethical considerations in conducting pediatric research
    Michelle Roth-Cline
    U S Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics, Silver Spring, MD 2011, USA
    Handb Exp Pharmacol 205:219-44. 2011
  8. ncbi request reprint An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial
    Ken Kipnis
    University of Hawaii, Manoa, USA
    Am J Bioeth 6:18-21. 2006
  9. ncbi request reprint Parental opinions about clinical research
    Marilyn 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
  10. ncbi request reprint Risk perception and decision processes underlying informed consent to research participation
    William 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

Collaborators

Detail Information

Publications23

  1. doi request reprint The concept of voluntary consent
    Robert M Nelson
    US Food and Drug Administration, Silver Spring, MD 20993, USA
    Am J Bioeth 11:6-16. 2011
    ..We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research...
  2. doi request reprint Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention research
    Robert M Nelson
    Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, MD 20993, USA
    J Acquir Immune Defic Syndr 54:S18-24. 2010
    ....
  3. doi request reprint Institutional review boards lack the moral legitimacy to reinterpret subpart D
    Robert M Nelson
    United States Food and Drug Administration, Rockville, MD 20057, USA
    Am J Bioeth 8:37-9. 2008
  4. doi request reprint Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trials
    Haihao Sun
    Office of Pediatric Therapeutics, Office of the Commissioner Division of Gastroenterology and Inborn Errors Products Study Endpoint and Labeling Development SEALD Pediatrics and Maternal Health Staff, Office of New Drug, Center for Drug Research and Evaluation, Food and Drug Administration, Silver Spring, MD
    J Pediatr Gastroenterol Nutr 58:12-7. 2014
    ..Presently, there is no consensus on endpoint measures to assess clinical outcomes for pediatric ulcerative colitis (UC). This study reviewed the endpoints used in the registration trials of approved drugs for pediatric UC...
  5. pmc Parental permission and child assent in research on children
    Michelle Roth-Cline
    Office of Pediatric Therapeutics, Food and Drug Administration, Silver Spring, Maryland
    Yale J Biol Med 86:291-301. 2013
    ..Further research needs to be done on how best to obtain truly informed and voluntary parental permission and child assent for research participation. ..
  6. doi request reprint A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings
    Patricia L Bright
    Food and Drug Administration, Silver Spring, MD 20993 0002, USA
    J Med Ethics 38:672-6. 2012
    ..This approach can help in planning and establishing organisational policies that govern the provision of ancillary care...
  7. doi request reprint Ethical considerations in conducting pediatric research
    Michelle Roth-Cline
    U S Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Pediatric Therapeutics, Silver Spring, MD 2011, USA
    Handb Exp Pharmacol 205:219-44. 2011
    ..We incorporate selected national (USA) and international guidelines, as well as regulatory approaches to pediatric studies that have been adopted in the USA, Canada, and Europe...
  8. ncbi request reprint An open letter to institutional review boards considering Northfield Laboratories' PolyHeme trial
    Ken 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...
  9. ncbi request reprint Parental opinions about clinical research
    Marilyn 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...
  10. ncbi request reprint Risk perception and decision processes underlying informed consent to research participation
    William 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...
  11. ncbi request reprint Minimal risk, yet again
    Robert M Nelson
    J Pediatr 150:570-2. 2007
  12. ncbi request reprint Food and Drug Administration public hearing on the conduct of emergency clinical research: testimony of Dr. Nelson
    Robert M Nelson
    Department of Anesthesiology, Critical Care, The Children s Hospital of Philadelphia, Philadelphia, PA
    Acad Emerg Med 14:e43-4. 2007
  13. ncbi request reprint Randomized, controlled trials as minimal risk: an ethical analysis
    Marilyn 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
    ....
  14. ncbi request reprint Voluntariness of consent for research: an empirical and conceptual review
    Robert 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...
  15. ncbi request reprint Child assent and parental permission in pediatric research
    Wilma 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...
  16. ncbi request reprint Certificates of confidentiality in research: rationale and usage
    Zachary 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...
  17. ncbi request reprint In defense of a single standard of research risk for all children
    Robert M Nelson
    J Pediatr 147:565-6. 2005
  18. ncbi request reprint 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 trials
    Michael B Kimberly
    Pediatric Generalist Research Group, Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
    Pediatrics 117:1706-11. 2006
    ....
  19. ncbi request reprint Reforming the oversight of multi-site clinical research: a review of two possible solutions
    Kristin S Nowak
    Dartmouth College, Hanover, NH, USA
    Account Res 13:11-24. 2006
    ..However, IRBNet offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies...
  20. ncbi request reprint Trials and errors: barriers to oversight of research conducted under the emergency research consent waiver
    Ken Kipnis
    Department of Philosophy, University of Hawaii at Manoa, Hawaii, USA
    IRB 28:16-9. 2006
  21. ncbi request reprint Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative
    Gerri 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...
  22. ncbi request reprint Challenges in the conduct of emergency research in children: a workshop report
    Robert M Nelson
    The Children s Hospital of Philadelphia, Philadelphia, PA
    Am J Bioeth 6:W1-9. 2006
  23. ncbi request reprint 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...