TY - STD TI - (OHRP). Federal Policy for the Protection of Human Subjects (‘Common Rule’). http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html. Accessed 7 May 2016. UR - http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html ID - ref1 ER - TY - JOUR AU - Sachdeva, T. AU - Morris, M. C. PY - 2013 DA - 2013// TI - Higher-hazard, no benefit research involving children: parental perspectives JO - Pediatrics VL - 132 UR - https://doi.org/10.1542/peds.2013-1700 DO - 10.1542/peds.2013-1700 ID - Sachdeva2013 ER - TY - JOUR AU - Shah, S. AU - Whittle, A. AU - Wilfond, B. AU - Gensler, G. AU - Wendler, D. PY - 2004 DA - 2004// TI - How do institutional review boards apply the federal risk and benefit standards for pediatric research? JO - JAMA VL - 291 UR - https://doi.org/10.1001/jama.291.4.476 DO - 10.1001/jama.291.4.476 ID - Shah2004 ER - TY - JOUR AU - Wendler, D. AU - Abdoler, E. AU - Wiener, L. AU - Grady, C. PY - 2012 DA - 2012// TI - Views of Adolescents and Parents on Pediatric Research Without the Potential for Clinical Benefit JO - Pediatrics VL - 130 UR - https://doi.org/10.1542/peds.2012-0068 DO - 10.1542/peds.2012-0068 ID - Wendler2012 ER - TY - JOUR AU - Wendler, D. AU - Jenkins, T. PY - 2008 DA - 2008// TI - Children’s and their parents’ views on facing research risks for the benefit of others JO - Arch Pediatr Adolesc Med VL - 162 UR - https://doi.org/10.1001/archpediatrics.2007.3 DO - 10.1001/archpediatrics.2007.3 ID - Wendler2008 ER - TY - JOUR AU - Wendler, D. AU - Varma, S. PY - 2006 DA - 2006// TI - Minimal risk in pediatric research JO - J Pediatr VL - 149 UR - https://doi.org/10.1016/j.jpeds.2006.08.064 DO - 10.1016/j.jpeds.2006.08.064 ID - Wendler2006 ER - TY - JOUR AU - Weijer, C. AU - Miller, P. B. PY - 2007 DA - 2007// TI - Refuting the net risks test: a response to Wendler and Miller’s “Assessing research risks systematically” JO - J Med Ethics VL - 33 UR - https://doi.org/10.1136/jme.2006.016444 DO - 10.1136/jme.2006.016444 ID - Weijer2007 ER - TY - JOUR AU - Hirshon, J. M. AU - Krugman, S. D. AU - Witting, M. D. PY - 2002 DA - 2002// TI - Variability in institutional review board assessment of minimal-risk research JO - Acad Emerg Med VL - 9 UR - https://doi.org/10.1111/j.1553-2712.2002.tb01612.x DO - 10.1111/j.1553-2712.2002.tb01612.x ID - Hirshon2002 ER - TY - JOUR AU - Nelson, R. M. PY - 2007 DA - 2007// TI - Minimal Risk. Yet Again JO - J Pediatr VL - 150 UR - https://doi.org/10.1016/j.jpeds.2007.03.040 DO - 10.1016/j.jpeds.2007.03.040 ID - Nelson2007 ER - TY - JOUR AU - Resnik, D. B. PY - 2005 DA - 2005// TI - Eliminating the daily life risks standard from the definition of minimal risk JO - J Med Ethics VL - 31 UR - https://doi.org/10.1136/jme.2004.010470 DO - 10.1136/jme.2004.010470 ID - Resnik2005 ER - TY - JOUR AU - Varma, S. AU - Jenkins, T. AU - Wendler, D. PY - 2008 DA - 2008// TI - How do children and parents make decisions about pediatric clinical research? JO - J Pediatr Hematol VL - 30 UR - https://doi.org/10.1097/MPH.0b013e318180bc0d DO - 10.1097/MPH.0b013e318180bc0d ID - Varma2008 ER - TY - JOUR AU - Westra, A. E. AU - Wit, J. M. AU - Sukhai, R. N. AU - Beaufort, I. D. PY - 2011 DA - 2011// TI - How best to define the concept of minimal risk JO - J Pediatr VL - 159 UR - https://doi.org/10.1016/j.jpeds.2011.05.034 DO - 10.1016/j.jpeds.2011.05.034 ID - Westra2011 ER - TY - JOUR AU - Wendler, D. PY - 2012 DA - 2012// TI - A New Justification for Pediatric Research Without the Potential for Clinical Benefit JO - Am J Bioeth VL - 12 UR - https://doi.org/10.1080/15265161.2011.634482 DO - 10.1080/15265161.2011.634482 ID - Wendler2012 ER - TY - JOUR AU - Westra, A. E. AU - Sukhai, R. N. AU - Wit, J. M. AU - Beaufort, I. D. AU - Cohen, A. F. PY - 2010 DA - 2010// TI - Acceptable risks and burdens for children in research without direct benefit: a systematic analysis of the decisions made by the Dutch Central Committee JO - J Med Ethics VL - 36 UR - https://doi.org/10.1136/jme.2010.035550 DO - 10.1136/jme.2010.035550 ID - Westra2010 ER - TY - JOUR AU - Binik, A. AU - Weijer, C. PY - 2014 DA - 2014// TI - Why the debate over minimal risk needs to be reconsidered JO - J Med Philos (United Kingdom) VL - 39 UR - https://doi.org/10.1093/jmp/jhu020 DO - 10.1093/jmp/jhu020 ID - Binik2014 ER - TY - JOUR AU - Tait, A. R. AU - Zikmund-Fisher, B. J. AU - Fagerlin, A. AU - Voepel-Lewis, T. PY - 2010 DA - 2010// TI - Effect of various risk/benefit trade-offs on parents’ understanding of a pediatric research study JO - Pediatrics VL - 125 UR - https://doi.org/10.1542/peds.2009-1796 DO - 10.1542/peds.2009-1796 ID - Tait2010 ER - TY - JOUR AU - Tait, A. R. AU - Voepel-Lewis, T. AU - Malviya, S. PY - 2004 DA - 2004// TI - Factors that influence parents’ assessments of the risks and benefits of research involving their children JO - Pediatrics VL - 113 UR - https://doi.org/10.1542/peds.113.4.727 DO - 10.1542/peds.113.4.727 ID - Tait2004 ER - TY - JOUR AU - Brody, J. L. AU - Annett, R. D. AU - Scherer, D. G. AU - Perryman, M. L. AU - Cofrin, K. M. W. PY - 2005 DA - 2005// TI - Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols JO - J Adolesc Heal VL - 37 UR - https://doi.org/10.1016/j.jadohealth.2004.09.026 DO - 10.1016/j.jadohealth.2004.09.026 ID - Brody2005 ER - TY - JOUR AU - Ballard, H. O. AU - Shook, L. A. AU - Desai, N. S. AU - Anand, K. J. S. PY - 2004 DA - 2004// TI - Neonatal research and the validity of informed consent obtained in the perinatal period JO - J Perinatol VL - 24 UR - https://doi.org/10.1038/sj.jp.7211142 DO - 10.1038/sj.jp.7211142 ID - Ballard2004 ER - TY - JOUR AU - Caldwell, P. H. Y. AU - Dans, L. AU - Vries, M. C. PY - 2012 DA - 2012// TI - Standard 1: Consent and Recruitment JO - Pediatrics VL - 129 UR - https://doi.org/10.1542/peds.2012-0055D DO - 10.1542/peds.2012-0055D ID - Caldwell2012 ER - TY - JOUR AU - Cameron, M. A. AU - Marsillio, L. E. AU - Cushman, L. F. AU - Morris, M. C. PY - 2011 DA - 2011// TI - Parents’ perspectives on the consent approach for minimal- risk research involving children JO - IRB Ethics Hum Res VL - 33 ID - Cameron2011 ER - TY - JOUR AU - Fisher, H. R. AU - McKevitt, C. AU - Boaz, A. PY - 2011 DA - 2011// TI - Why do parents enrol their children in research: a narrative synthesis JO - J Med Ethics VL - 37 UR - https://doi.org/10.1136/jme.2010.040220 DO - 10.1136/jme.2010.040220 ID - Fisher2011 ER - TY - JOUR AU - Fogas, B. S. AU - Oesterheld, J. R. AU - Shader, R. I. PY - 2001 DA - 2001// TI - A retrospective study of children’s perceptions of participation as clinical research subjects in a minimal risk study JO - J Dev Behav Pediatr VL - 22 UR - https://doi.org/10.1097/00004703-200108000-00001 DO - 10.1097/00004703-200108000-00001 ID - Fogas2001 ER - TY - JOUR AU - Wendler, D. AU - Belsky, L. AU - Thompson, K. M. AU - Emanuel, E. J. PY - 2005 DA - 2005// TI - Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit JO - JAMA VL - 294 UR - https://doi.org/10.1001/jama.294.7.826 DO - 10.1001/jama.294.7.826 ID - Wendler2005 ER - TY - JOUR AU - Morris, M. C. PY - 2012 DA - 2012// TI - Pediatric Participation in Non-Therapeutic Research JO - J Law, Med Ethics VL - 40 UR - https://doi.org/10.1111/j.1748-720X.2012.00697.x DO - 10.1111/j.1748-720X.2012.00697.x ID - Morris2012 ER - TY - JOUR AU - Singhal, N. AU - Oberle, K. AU - Burgess, E. AU - Huber-Okrainec, J. PY - 2002 DA - 2002// TI - Parents’ perceptions of research with newborns JO - J Perinatol VL - 22 UR - https://doi.org/10.1038/sj.jp.7210608 DO - 10.1038/sj.jp.7210608 ID - Singhal2002 ER - TY - JOUR AU - Hoehn, K. S. AU - Nathan, A. AU - White, L. E. PY - 2009 DA - 2009// TI - Parental perception of time and decision-making in neonatal research JO - J Perinatol VL - 29 UR - https://doi.org/10.1038/jp.2009.5 DO - 10.1038/jp.2009.5 ID - Hoehn2009 ER - TY - JOUR AU - Ward, F. R. PY - 2009 DA - 2009// TI - Chaos, vulnerability and control: parental beliefs about neonatal clinical trials JO - J Perinatol VL - 29 UR - https://doi.org/10.1038/jp.2008.139 DO - 10.1038/jp.2008.139 ID - Ward2009 ER - TY - STD TI - Miller RB. Children, Ethics and Modern Medicine. Indiana University Press; 2003. ID - ref29 ER - TY - JOUR AU - Lantos, J. D. AU - Feudtner, C. PY - 2015 DA - 2015// TI - SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies JO - Hastings Cent Rep VL - 45 UR - https://doi.org/10.1002/hast.407 DO - 10.1002/hast.407 ID - Lantos2015 ER - TY - JOUR AU - Drazen, J. M. AU - Solomon, C. G. AU - Morrissey, S. AU - Greene, M. F. PY - 2015 DA - 2015// TI - Support for SUPPORT JO - N Engl J Med VL - 373 UR - https://doi.org/10.1056/NEJMe1511158 DO - 10.1056/NEJMe1511158 ID - Drazen2015 ER - TY - JOUR AU - Drazen, J. M. AU - Solomon, C. G. AU - Greene, M. F. PY - 2013 DA - 2013// TI - Informed Consent and SUPPORT JO - N Engl J Med VL - 368 UR - https://doi.org/10.1056/NEJMe1304996 DO - 10.1056/NEJMe1304996 ID - Drazen2013 ER -