Robert M Nelson
Affiliation: Food and Drug Administration
- 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
- The concept of voluntary consentRobert 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...
- Ethical and regulatory considerations for the inclusion of adolescents in HIV biomedical prevention researchRobert 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....
- Parental permission and child assent in research on childrenMichelle 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. ..
- Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokineticsHaihao Sun
US Food and Drug Administration, Silver Spring, MD European Medicines Agency, London, UK Health Canada, Ottawa, Ontario, Canada Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
J Pediatr Gastroenterol Nutr 58:684-8. 2014....
- Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical PharmacologyMichelle Roth-Cline
Pediatric Ethicist, Office of Pediatric Therapeutics, FDA, 10903 New Hampshire Ave, Bldg 32 Rm 5121 Silver Spring, MD 20993
Curr Pharm Des 21:5619-35. 2015..Topics examined include: the status of children as a vulnerable population; the appropriate balance of risk and potential benefit in research; and parental permission and child assent to participate in research. ..
- Ethical considerations in conducting pediatric researchMichelle 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...
- Alternate endpoints and clinical outcome assessments in pediatric ulcerative colitis registration trialsHaihao 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...
- A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settingsPatricia 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...
- 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...
- 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...
- 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...
- Minimal risk, yet againRobert M Nelson
J Pediatr 150:570-2. 2007
- 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...
- 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...
- 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...
- In defense of a single standard of research risk for all childrenRobert M Nelson
J Pediatr 147:565-6. 2005
- 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....
- Reforming the oversight of multi-site clinical research: a review of two possible solutionsKristin 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...
- 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
- 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...
- 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
- 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....
- 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...