TY - STD TI - Vukoja M, Riviello E, Gavrilovic S, Adhikari NK, Kashyap R, Bhagwanjee S, et al. A survey on critical care resources and practices in low- and middle-income countries. Glob Heart. 2014;9(3):337–42. e1-5. ID - ref1 ER - TY - JOUR AU - Bhagwanjee, S. AU - Scribante, J. PY - 2007 DA - 2007// TI - National audit of critical care resources in South Africa - unit and bed distribution JO - S Afr Med J VL - 97 ID - Bhagwanjee2007 ER - TY - STD TI - Luce JM, Cook DJ, Martin TR, Angus DC, Boushey HA, Curtis JR, et al. The ethical conduct of clinical research involving critically ill patients in the United States and Canada: principles and recommendations. Am J Respir Crit Care Med. 2004;170(12):1375–84. ID - ref3 ER - TY - STD TI - UK Medical Research Council: MRC Ethics Guide: Medical research involving children. 2004, [http://www.mrc.ac.uk/documents/pdf/medical-research-involving-children/] UR - http://www.mrc.ac.uk/documents/pdf/medical-research-involving-children/ ID - ref4 ER - TY - JOUR AU - Truog, R. D. PY - 2008 DA - 2008// TI - Ethical assessment of pediatric research protocols JO - Intensive Care Med VL - 34 UR - https://doi.org/10.1007/s00134-007-0917-3 DO - 10.1007/s00134-007-0917-3 ID - Truog2008 ER - TY - JOUR AU - Brierley, J. AU - Larcher, V. PY - 2011 DA - 2011// TI - Emergency research in children: options for ethical recruitment JO - J Med Ethics VL - 37 UR - https://doi.org/10.1136/jme.2010.040667 DO - 10.1136/jme.2010.040667 ID - Brierley2011 ER - TY - JOUR AU - Weijer, C. PY - 2004 DA - 2004// TI - The ethical analysis of risk in intensive care unit research JO - Crit Care VL - 8 UR - https://doi.org/10.1186/cc2822 DO - 10.1186/cc2822 ID - Weijer2004 ER - TY - JOUR AU - Brierley, J. AU - Larcher, V. PY - 2009 DA - 2009// TI - Compassionate and innovative treatments in children: a proposal for an ethical framework JO - Arch Dis Child VL - 94 UR - https://doi.org/10.1136/adc.2008.155317 DO - 10.1136/adc.2008.155317 ID - Brierley2009 ER - TY - STD TI - World Medical Association: WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2013, [www.wma.net/en/30publications/10policies/b3/] UR - http://www.wma.net/en/30publications/10policies/b3/ ID - ref9 ER - TY - STD TI - Argent AC, Ahrens J, Morrow BM, Reynolds LG, Hatherill M, Salie S, et al. Pediatric intensive care in South Africa: an account of making optimum use of limited resources at the Red Cross War Memorial Children’s Hospital*. Pediatr Crit Care Med. 2014;15(1):7–14. ID - ref10 ER - TY - JOUR AU - Kanthimathinathan, H. K. AU - Scholefield, B. R. PY - 2014 DA - 2014// TI - Dilemmas in undertaking research in paediatric intensive care JO - Arch Dis Child VL - 99 UR - https://doi.org/10.1136/archdischild-2013-304871 DO - 10.1136/archdischild-2013-304871 ID - Kanthimathinathan2014 ER - TY - JOUR AU - Knox, C. A. AU - Burkhart, P. V. PY - 2007 DA - 2007// TI - Issues related to children participating in clinical research JO - J Pediatr Nurs VL - 22 UR - https://doi.org/10.1016/j.pedn.2007.02.004 DO - 10.1016/j.pedn.2007.02.004 ID - Knox2007 ER - TY - JOUR AU - Eltorki, M. AU - Uleryk, E. AU - Freedman, S. B. PY - 2013 DA - 2013// TI - Waiver of informed consent in pediatric resuscitation research: a systematic review JO - Acad Emerg Med VL - 20 UR - https://doi.org/10.1111/acem.12180 DO - 10.1111/acem.12180 ID - Eltorki2013 ER - TY - JOUR AU - Halila, R. PY - 2007 DA - 2007// TI - Assessing the ethics of medical research in emergency settings: how do international regulations work in practice? JO - Sci Eng Ethics VL - 13 UR - https://doi.org/10.1007/s11948-007-9026-5 DO - 10.1007/s11948-007-9026-5 ID - Halila2007 ER - TY - JOUR AU - Brierley, J. AU - Larcher, V. PY - 2010 DA - 2010// TI - Lest we forget… research ethics in children: perhaps onerous, yet absolutely necessary JO - Arch Dis Child VL - 95 UR - https://doi.org/10.1136/adc.2009.179762 DO - 10.1136/adc.2009.179762 ID - Brierley2010 ER - TY - JOUR AU - Roberts, R. AU - Rodriguez, W. AU - Murphy, D. AU - Crescenzi, T. PY - 2003 DA - 2003// TI - Pediatric drug labeling: improving the safety and efficacy of pediatric therapies JO - JAMA VL - 290 UR - https://doi.org/10.1001/jama.290.7.905 DO - 10.1001/jama.290.7.905 ID - Roberts2003 ER - TY - JOUR AU - Caldwell, P. H. AU - Murphy, S. B. AU - Butow, P. N. AU - Craig, J. C. PY - 2004 DA - 2004// TI - Clinical trials in children JO - Lancet VL - 364 UR - https://doi.org/10.1016/S0140-6736(04)16942-0 DO - 10.1016/S0140-6736(04)16942-0 ID - Caldwell2004 ER - TY - JOUR AU - Baren, J. M. AU - Fish, S. S. PY - 2005 DA - 2005// TI - Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? JO - Acad Emerg Med VL - 12 UR - https://doi.org/10.1111/j.1553-2712.2005.tb00832.x DO - 10.1111/j.1553-2712.2005.tb00832.x ID - Baren2005 ER - TY - JOUR AU - Shaul, R. Z. PY - 2005 DA - 2005// TI - Potato, potato, proxy consent, permission -- just don’t call the a whole thing off JO - Crit Care VL - 9 UR - https://doi.org/10.1186/cc3037 DO - 10.1186/cc3037 ID - Shaul2005 ER - TY - STD TI - U.S. Department of Health and Human Services: Protection of Human Subjects.; Code of Federal Regulations; Code of Federal Regulations. 45 CFR 46: 2009, [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html] UR - http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html ID - ref20 ER - TY - STD TI - The National Commission for the protection of human subjects of biomedical and behavioural research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. 1979, U.S Government Printing Office, Washington DC, [http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html]. UR - http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html ID - ref21 ER - TY - JOUR AU - Zawistowski, C. A. AU - Frader, J. E. PY - 2003 DA - 2003// TI - Ethical problems in pediatric critical care: consent JO - Crit Care Med VL - 31 UR - https://doi.org/10.1097/01.CCM.0000065274.46402.DB DO - 10.1097/01.CCM.0000065274.46402.DB ID - Zawistowski2003 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 - STD TI - Shudy M, de Almeida ML, Ly S, Landon C, Groft S, Jenkins TL, et al. Impact of pediatric critical illness and injury on families: a systematic literature review. Pediatrics. 2006;118 Suppl 3:S203–18. ID - ref24 ER - TY - JOUR AU - Silverman, H. PY - 2011 DA - 2011// TI - Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards JO - Ann Intensive Care VL - 1 UR - https://doi.org/10.1186/2110-5820-1-8 DO - 10.1186/2110-5820-1-8 ID - Silverman2011 ER - TY - JOUR AU - Gefenas, E. PY - 2007 DA - 2007// TI - Balancing ethical principles in emergency medicine research JO - Sci Eng Ethics VL - 13 UR - https://doi.org/10.1007/s11948-007-9029-2 DO - 10.1007/s11948-007-9029-2 ID - Gefenas2007 ER - TY - JOUR AU - Joffe, S. AU - Wertheimer, A. PY - 2014 DA - 2014// TI - Determining minimal risk for comparative effectiveness research JO - IRB VL - 36 ID - Joffe2014 ER - TY - JOUR AU - Morris, M. C. AU - Nelson, R. M. PY - 2007 DA - 2007// TI - Randomized, controlled trials as minimal risk: an ethical analysis JO - Crit Care Med VL - 35 UR - https://doi.org/10.1097/01.CCM.0000257333.95528.B8 DO - 10.1097/01.CCM.0000257333.95528.B8 ID - Morris2007 ER - TY - JOUR AU - Miller, F. G. AU - Wertheimer, A. PY - 2007 DA - 2007// TI - Facing up to paternalism in research ethics JO - Hastings Cent Rep VL - 37 UR - https://doi.org/10.1353/hcr.2007.0044 DO - 10.1353/hcr.2007.0044 ID - Miller2007 ER - TY - JOUR AU - McRae, A. D. AU - Weijer, C. PY - 2002 DA - 2002// TI - Lessons from everyday lives: a moral justification for acute care research JO - Crit Care Med VL - 30 UR - https://doi.org/10.1097/00003246-200205000-00032 DO - 10.1097/00003246-200205000-00032 ID - McRae2002 ER - TY - JOUR AU - McRae, A. D. AU - Ackroyd-Stolarz, S. AU - Weijer, C. PY - 2005 DA - 2005// TI - Risk in emergency research using a waiver of/exception from consent: implications of a structured approach for institutional review board review JO - Acad Emerg Med VL - 12 UR - https://doi.org/10.1111/j.1553-2712.2005.tb00837.x DO - 10.1111/j.1553-2712.2005.tb00837.x ID - McRae2005 ER - TY - STD TI - Maitland K, Babiker A, Kiguli S, Molyneux E, FEAST Trial Group. The FEAST trial of fluid bolus in African children with severe infection. Lancet. 2012;379(9816):613. ID - ref32 ER - TY - JOUR AU - Maitland, K. AU - Kiguli, S. AU - Opoka, R. O. AU - Engoru, C. AU - Olupot-Olupot, P. AU - Akech, S. O. AU - Nyeko, R. AU - Mtove, G. AU - Reyburn, H. AU - Lang, T. AU - Brent, B. AU - Evans, J. A. AU - Tibenderana, J. K. AU - Crawley, J. AU - Russell, E. C. AU - Levin, M. AU - Babiker, A. G. AU - Gibb, D. M. PY - 2011 DA - 2011// TI - Mortality after fluid bolus in African children with severe infection JO - N Engl J Med VL - 364 UR - https://doi.org/10.1056/NEJMoa1101549 DO - 10.1056/NEJMoa1101549 ID - Maitland2011 ER - TY - JOUR AU - Nienaber, A. PY - 2013 DA - 2013// TI - Consent to research by mentally ill children and adolescents: the implications of chapter 9 of the national health Act JO - South African J Psychiatry VL - 19 UR - https://doi.org/10.7196/sajp.386 DO - 10.7196/sajp.386 ID - Nienaber2013 ER - TY - STD TI - South African Children’s Act 38 of 2005. 2005 :Section 129 (3):1-26, [http://www.plusto.com/uploads/5780/docs/Childrens-Act.pdf]. UR - http://www.plusto.com/uploads/5780/docs/Childrens-Act.pdf ID - ref35 ER - TY - JOUR AU - Strode, A. AU - Slack, C. AU - Essack, Z. PY - 2010 DA - 2010// TI - Child consent in South African law: implications for researchers, service providers and policy-makers JO - S Afr Med J VL - 100 UR - https://doi.org/10.7196/SAMJ.3609 DO - 10.7196/SAMJ.3609 ID - Strode2010 ER - TY - STD TI - South African National Health Act 61 of 2003 (Government Notice 869 in Government Gazette 26595 dated 23 July 2004. As amended by: National Health Amendment Act 12 of 2013). 2013, Pretoria, South Africa: 1-48. ID - ref37 ER - TY - STD TI - Price M: Statement from the Vice- Chancellor of the University of Cape Town about Research involving humans and S 71 of the National Health Act. 2012, [http://prepare.b.uib.no/files/2011/01/Statement-from-the-Vice-Chancellor-of-UCT-about-Research-invo_2.pdf].  UR - http://prepare.b.uib.no/files/2011/01/Statement-from-the-Vice-Chancellor-of-UCT-about-Research-invo_2.pdf ID - ref38 ER - TY - STD TI - National Department of Health: Ethics in Health Research: Principles, Structures and Processes. 2004, Department of Health, Pretoria, South Africa, [http://www.hsrc.ac.za/en/about/research-ethics#sthash.Quthxn4j.dpuf] UR - http://www.hsrc.ac.za/en/about/research-ethics#sthash.Quthxn4j.dpuf ID - ref39 ER - TY - STD TI - Motsoaledi A (letter): Delegation of powers to consent for research or experimentation to be conducted with a minor for a non-therapeutic purpose as desribed by Section 71 (3) (A) (II) of the National Health Act No. 61 of 2003 to Health Research Ethics Committees registered with the National Health Research Ethics Council. 2014. ID - ref40 ER - TY - STD TI - South African Department of Health. Guidelines for good practice in the conduct of clinical trials with human participants in South Africa (Second Edition). 2006, Department of Health: Pretoria, South Africa. ID - ref41 ER - TY - STD TI - Human Sciences Research Council: Guidelines for research with minors. 2012, [http://www.hsrc.ac.za/uploads/pageContent/5498/Guidelines%20for%20research%20with%20minors%202012.pdf]. UR - http://www.hsrc.ac.za/uploads/pageContent/5498/Guidelines%20for%20research%20with%20minors%202012.pdf. ID - ref42 ER - TY - JOUR AU - Miller, V. A. AU - Luce, M. F. AU - Nelson, R. M. PY - 2011 DA - 2011// TI - Relationship of external influence to parental distress in decision making regarding children with a life-threatening illness JO - J Pediatr Psychol VL - 36 UR - https://doi.org/10.1093/jpepsy/jsr033 DO - 10.1093/jpepsy/jsr033 ID - Miller2011 ER - TY - JOUR AU - Bull, S. AU - Lindegger, G. C. PY - 2011 DA - 2011// TI - Ensuring consent to research is voluntary: how far do we need to go? JO - Am J Bioeth VL - 11 UR - https://doi.org/10.1080/15265161.2011.585272 DO - 10.1080/15265161.2011.585272 ID - Bull2011 ER - TY - JOUR AU - Iserson, K. V. AU - Lindsey, D. PY - 1995 DA - 1995// TI - Research on critically ill and injured patients: rules, reality, and ethics JO - J Emerg Med VL - 13 UR - https://doi.org/10.1016/0736-4679(95)80021-2 DO - 10.1016/0736-4679(95)80021-2 ID - Iserson1995 ER - TY - JOUR AU - Nelson, R. M. AU - Beauchamp, T. AU - Miller, V. A. AU - Reynolds, W. AU - Ittenbach, R. F. AU - Luce, M. F. PY - 2011 DA - 2011// TI - The concept of voluntary consent JO - Am J Bioeth VL - 11 UR - https://doi.org/10.1080/15265161.2011.583318 DO - 10.1080/15265161.2011.583318 ID - Nelson2011 ER - TY - JOUR AU - Wertheimer, A. PY - 2012 DA - 2012// TI - Voluntary consent: why a value-neutral concept won’t work JO - J Med Philos VL - 37 UR - https://doi.org/10.1093/jmp/jhs016 DO - 10.1093/jmp/jhs016 ID - Wertheimer2012 ER - TY - JOUR AU - As, A. B. AU - Rode, H. PY - 2006 DA - 2006// TI - The history of paediatric trauma care in Cape Town JO - S Afr Med J VL - 96 ID - As2006 ER - TY - STD TI - Tindana P, Bull S, Amenga-Etego L, de Vries J, Aborigo R, Koram K, et al. Seeking consent to genetic and genomic research in a rural Ghanaian setting: a qualitative study of the MalariaGEN experience. BMC Med Ethics. 2012;13:15–6939. 13-15. ID - ref49 ER - TY - STD TI - Molyneux S, Njue M, Boga M, Akello L, Olupot-Olupot P, Engoru C, et al. ‘The words will pass with the blowing wind’: staff and parent views of the deferred consent process, with prior assent, used in an emergency fluids trial in two African hospitals. PLoS One. 2013;8(2):e54894. ID - ref50 ER - TY - JOUR AU - Huckabay, L. M. AU - Tilem-Kessler, D. PY - 1999 DA - 1999// TI - Patterns of parental stress in PICU emergency admission JO - Dimens Crit Care Nurs VL - 18 UR - https://doi.org/10.1097/00003465-199903000-00009 DO - 10.1097/00003465-199903000-00009 ID - Huckabay1999 ER - TY - JOUR AU - LaMontagne, L. L. AU - Hepworth, J. T. AU - Johnson, B. D. AU - Deshpande, J. K. PY - 1994 DA - 1994// TI - Psychophysiological responses of parents to pediatric critical care stress JO - Clin Nurs Res VL - 3 UR - https://doi.org/10.1177/105477389400300204 DO - 10.1177/105477389400300204 ID - LaMontagne1994 ER - TY - JOUR AU - Mason, S. PY - 1997 DA - 1997// TI - Obtaining informed consent for neonatal randomised controlled trials--an “elaborate ritual”? JO - Arch Dis Child Fetal Neonatal Ed VL - 76 UR - https://doi.org/10.1136/fn.76.3.F143 DO - 10.1136/fn.76.3.F143 ID - Mason1997 ER - TY - JOUR AU - Menon, K. AU - Ward, R. PY - 2014 DA - 2014// TI - A study of consent for participation in a non-therapeutic study in the pediatric intensive care population JO - J Med Ethics VL - 40 UR - https://doi.org/10.1136/medethics-2012-101075 DO - 10.1136/medethics-2012-101075 ID - Menon2014 ER - TY - JOUR AU - Board, R. AU - Ryan-Wenger, N. PY - 2000 DA - 2000// TI - State of the science on parental stress and family functioning in pediatric intensive care units JO - Am J Crit Care VL - 9 ID - Board2000 ER - TY - JOUR AU - Board, R. AU - Ryan-Wenger, N. PY - 2002 DA - 2002// TI - Long-term effects of pediatric intensive care unit hospitalization on families with young children JO - Heart Lung VL - 31 UR - https://doi.org/10.1067/mhl.2002.121246 DO - 10.1067/mhl.2002.121246 ID - Board2002 ER - TY - JOUR AU - Board, R. AU - Ryan-Wenger, N. PY - 2003 DA - 2003// TI - Stressors and stress symptoms of mothers with children in the PICU JO - J Pediatr Nurs VL - 18 UR - https://doi.org/10.1053/jpdn.2003.38 DO - 10.1053/jpdn.2003.38 ID - Board2003 ER - TY - JOUR AU - Natale, J. E. AU - Joseph, J. G. AU - Pretzlaff, R. K. AU - Silber, T. J. AU - Guerguerian, A. M. PY - 2006 DA - 2006// TI - Clinical trials in pediatric traumatic brain injury: unique challenges and potential responses JO - Dev Neurosci VL - 28 UR - https://doi.org/10.1159/000094154 DO - 10.1159/000094154 ID - Natale2006 ER - TY - JOUR AU - Sturdivant, L. AU - Warren, N. A. PY - 2009 DA - 2009// TI - Perceived met and unmet needs of family members of patients in the pediatric intensive care unit JO - Crit Care Nurs Q VL - 32 UR - https://doi.org/10.1097/CNQ.0b013e3181a27f6d DO - 10.1097/CNQ.0b013e3181a27f6d ID - Sturdivant2009 ER - TY - JOUR AU - Kasper, J. W. AU - Nyamathi, A. M. PY - 1988 DA - 1988// TI - Parents of children in the pediatric intensive care unit: what are their needs? JO - Heart Lung VL - 17 ID - Kasper1988 ER - TY - JOUR AU - Schultz, A. L. AU - Pardee, G. P. AU - Ensinck, J. W. PY - 1975 DA - 1975// TI - Are research subjects really informed? JO - West J Med VL - 123 ID - Schultz1975 ER - TY - STD TI - Yuval R, Halon DA, Merdler A, Khader N, Karkabi B, Uziel K, et al. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Arch Intern Med. 2000;160(8):1142–6. ID - ref62 ER - TY - JOUR AU - Yuval, R. AU - Halon, D. A. AU - Flugelman, M. Y. AU - Lewis, B. S. PY - 2003 DA - 2003// TI - Perceived patient comprehension in acute and chronic cardiovascular clinical trials JO - Cardiology VL - 99 UR - https://doi.org/10.1159/000069729 DO - 10.1159/000069729 ID - Yuval2003 ER - TY - JOUR AU - Menon, K. AU - Ward, R. E. AU - Gaboury, I. AU - Thomas, M. AU - Joffe, A. AU - Burns, K. AU - Cook, D. PY - 2012 DA - 2012// TI - Factors affecting consent in pediatric critical care research JO - Intensive Care Med VL - 38 UR - https://doi.org/10.1007/s00134-011-2412-0 DO - 10.1007/s00134-011-2412-0 ID - Menon2012 ER - TY - JOUR AU - Miles, M. S. AU - Carter, M. C. AU - Riddle, I. AU - Hennessey, J. AU - Eberly, T. W. PY - 1989 DA - 1989// TI - The pediatric intensive care unit environment as a source of stress for parents JO - Matern Child Nurs J VL - 18 ID - Miles1989 ER - TY - JOUR AU - Miles, M. S. AU - Carter, M. C. AU - Eberly, T. W. AU - Hennessey, J. AU - Riddle, I. I. PY - 1989 DA - 1989// TI - Toward an understanding of parent stress in the pediatric intensive care unit: overview of the program of research JO - Matern Child Nurs J VL - 18 ID - Miles1989 ER - TY - JOUR AU - Eberly, T. W. AU - Miles, M. S. AU - Carter, M. C. AU - Hennessey, J. AU - Riddle, I. PY - 1985 DA - 1985// TI - Parental stress after the unexpected admission of a child to the intensive care unit JO - CCQ VL - 8 ID - Eberly1985 ER - TY - STD TI - Maitland K, Molyneux S, Boga M, Kiguli S, Lang T. Use of deferred consent for severely ill children in a multi-centre phase III trial. Trials. 2011;12:90, [http://www.trialsjournal.com/content/12/1/90]. UR - http://www.trialsjournal.com/content/12/1/90 ID - ref68 ER - TY - JOUR AU - Silverman, H. J. AU - Lemaire, F. PY - 2006 DA - 2006// TI - Ethics and research in critical care JO - Intensive Care Med VL - 32 UR - https://doi.org/10.1007/s00134-006-0305-4 DO - 10.1007/s00134-006-0305-4 ID - Silverman2006 ER - TY - JOUR AU - Majdalani, M. N. AU - Doumit, M. A. AU - Rahi, A. C. PY - 2014 DA - 2014// TI - The lived experience of parents of children admitted to the pediatric intensive care unit in Lebanon JO - Int J Nurs Stud VL - 51 UR - https://doi.org/10.1016/j.ijnurstu.2013.06.001 DO - 10.1016/j.ijnurstu.2013.06.001 ID - Majdalani2014 ER - TY - JOUR AU - Hoffman, T. M. AU - Taeed, R. AU - Niles, J. P. AU - McMillin, M. A. AU - Perkins, L. A. AU - Feltes, T. F. PY - 2007 DA - 2007// TI - Parental factors impacting the enrollment of children in cardiac critical care clinical trials JO - Pediatr Cardiol VL - 28 UR - https://doi.org/10.1007/s00246-006-0020-5 DO - 10.1007/s00246-006-0020-5 ID - Hoffman2007 ER - TY - JOUR AU - Manning, D. J. PY - 2000 DA - 2000// TI - Presumed consent in emergency neonatal research JO - J Med Ethics VL - 26 UR - https://doi.org/10.1136/jme.26.4.249 DO - 10.1136/jme.26.4.249 ID - Manning2000 ER - TY - JOUR AU - Koogler, T. PY - 2012 DA - 2012// TI - Legal and ethical policies regarding research involving critically ill children JO - Virtual Mentor VL - 14 UR - https://doi.org/10.1001/virtualmentor.2012.14.10.pfor1-1210 DO - 10.1001/virtualmentor.2012.14.10.pfor1-1210 ID - Koogler2012 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 VL - 33 ID - Cameron2011 ER - TY - JOUR AU - Preziosi, M. P. AU - Yam, A. AU - Ndiaye, M. AU - Simaga, A. AU - Simondon, F. AU - Wassilak, S. G. PY - 1997 DA - 1997// TI - Practical experiences in obtaining informed consent for a vaccine trial in rural Africa JO - N Engl J Med VL - 336 UR - https://doi.org/10.1056/NEJM199701303360511 DO - 10.1056/NEJM199701303360511 ID - Preziosi1997 ER - TY - JOUR AU - IJsselmuiden, C. B. AU - Faden, R. R. PY - 1992 DA - 1992// TI - Research and informed consent in Africa--another look JO - N Engl J Med VL - 326 UR - https://doi.org/10.1056/NEJM199203193261212 DO - 10.1056/NEJM199203193261212 ID - IJsselmuiden1992 ER - TY - JOUR AU - Crow, K. AU - Matheson, L. AU - Steed, A. PY - 2000 DA - 2000// TI - Informed consent and truth-telling: cultural directions for healthcare providers JO - J Nurs Adm VL - 30 UR - https://doi.org/10.1097/00005110-200003000-00007 DO - 10.1097/00005110-200003000-00007 ID - Crow2000 ER - TY - CHAP AU - Desai, S. AU - Johnson, K. ED - Kishor, S. PY - 2005 DA - 2005// TI - Women’s decision making and child health: familial and social hierarchies BT - A focus on gender PB - ORC Macro CY - Calverton MD ID - Desai2005 ER - TY - STD TI - Silverman HJ, Luce JM, Lanken PN, Morris AH, Harabin AL, Oldmixon CF, et al. Recommendations for informed consent forms for critical care clinical trials. Crit Care Med. 2005;33(4):867–82. ID - ref79 ER - TY - JOUR AU - Appelbaum, P. S. PY - 2002 DA - 2002// TI - Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception JO - Am J Bioeth VL - 2 UR - https://doi.org/10.1162/152651602317533596 DO - 10.1162/152651602317533596 ID - Appelbaum2002 ER - TY - STD TI - Woolfall K, Shilling V, Hickey H, Smyth RL, Sowden E, Williamson PR, et al. Parents’ agendas in paediatric clinical trial recruitment are different from researchers’ and often remain unvoiced: a qualitative study. PLoS One. 2013;8(7):e67352. ID - ref81 ER - TY - STD TI - Oduro AR, Aborigo RA, Amugsi D, Anto F, Anyorigiya T, Atuguba F, et al. Understanding and retention of the informed consent process among parents in rural northern Ghana. BMC Med Ethics. 2008;9:12–6939. 9-12. ID - ref82 ER - TY - JOUR AU - Truog, R. D. PY - 1999 DA - 1999// TI - Informed consent and research design in critical care medicine JO - Crit Care VL - 3 UR - https://doi.org/10.1186/cc347 DO - 10.1186/cc347 ID - Truog1999 ER - TY - JOUR AU - Morris, A. D. AU - Zaritsky, A. L. AU - LeFever, G. PY - 2000 DA - 2000// TI - Evaluation of ethical conflicts associated with randomized, controlled trials in critically ill children JO - Crit Care Med VL - 28 UR - https://doi.org/10.1097/00003246-200004000-00039 DO - 10.1097/00003246-200004000-00039 ID - Morris2000 ER - TY - STD TI - Durand-Zaleski IS, Alberti C, Durieux P, Duval X, Gottot S, Ravaud P, et al. Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception. J Med Ethics. 2008;34(9):e16. ID - ref85 ER - TY - JOUR AU - Caldwell, P. H. AU - Butow, P. N. AU - Craig, J. C. PY - 2003 DA - 2003// TI - Parents’ attitudes to children’s participation in randomized controlled trials JO - J Pediatr VL - 142 UR - https://doi.org/10.1067/mpd.2003.192 DO - 10.1067/mpd.2003.192 ID - Caldwell2003 ER - TY - JOUR AU - Morris, M. C. AU - Fischbach, R. L. AU - Nelson, R. M. AU - Schleien, C. L. PY - 2006 DA - 2006// TI - A paradigm for inpatient resuscitation research with an exception from informed consent JO - Crit Care Med VL - 34 UR - https://doi.org/10.1097/01.CCM.0000239115.76603.55 DO - 10.1097/01.CCM.0000239115.76603.55 ID - Morris2006 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 - STD TI - Adde M, Magrath I, International Network for Cancer Research and Treatment, Brussells, Belgium: Overcoming challenges in conducting clinical trials in Africa. Cancer Control 2013:27–33, [http://cancercontrol.info/wp-content/uploads/2014/08/cc2013_27-33-Melissa-Adde-and-Ian-Magrath_2013.pdf]. UR - http://cancercontrol.info/wp-content/uploads/2014/08/cc2013_27-33-Melissa-Adde-and-Ian-Magrath_2013.pdf ID - ref89 ER - TY - JOUR AU - Lema, V. M. AU - Mbondo, M. AU - Kamau, E. M. PY - 2009 DA - 2009// TI - Informed consent for clinical trials: a review JO - East Afr Med J VL - 86 ID - Lema2009 ER - TY - JOUR AU - Lantos, J. D. PY - 1999 DA - 1999// TI - The “inclusion benefit” in clinical trials JO - J Pediatr VL - 134 UR - https://doi.org/10.1016/S0022-3476(99)70400-2 DO - 10.1016/S0022-3476(99)70400-2 ID - Lantos1999 ER - TY - JOUR AU - Bland, M. PY - 1997 DA - 1997// TI - Informed consent in medical research. Let readers judge for themselves JO - BMJ VL - 314 UR - https://doi.org/10.1136/bmj.314.7092.1477 DO - 10.1136/bmj.314.7092.1477 ID - Bland1997 ER - TY - JOUR AU - Baines, P. PY - 2008 DA - 2008// TI - Medical ethics for children: applying the four principles to paediatrics JO - J Med Ethics VL - 34 UR - https://doi.org/10.1136/jme.2006.018747 DO - 10.1136/jme.2006.018747 ID - Baines2008 ER - TY - STD TI - Nijhawan LP, Janodia MD, Muddukrishna BS, Bhat KM, Bairy KL, Udupa N, et al. Informed consent: Issues and challenges. J Adv Pharm Technol Res. 2013;4(3):134–40. ID - ref94 ER - TY - JOUR AU - Jansen, T. C. AU - Kompanje, E. J. AU - Bakker, J. PY - 2009 DA - 2009// TI - Deferred proxy consent in emergency critical care research: ethically valid and practically feasible JO - Crit Care Med VL - 37 UR - https://doi.org/10.1097/CCM.0b013e3181920851 DO - 10.1097/CCM.0b013e3181920851 ID - Jansen2009 ER - TY - STD TI - Constitution Of The Republic Of South Africa; No. 108 of 1996; amended 2003. 1996, Pretoria, South Africa, [http://www.gov.za/documents/constitution/1996/a108-96.pdf].  UR - http://www.gov.za/documents/constitution/1996/a108-96.pdf ID - ref96 ER - TY - JOUR AU - Freedman, B. AU - Fuks, A. AU - Weijer, C. PY - 1993 DA - 1993// TI - In loco parentis. Minimal risk as an ethical threshold for research upon children JO - Hastings Cent Rep VL - 23 UR - https://doi.org/10.2307/3562813 DO - 10.2307/3562813 ID - Freedman1993 ER - TY - STD TI - Nuffield Council on Bioethics: Children and clinical research: ethical issues. 2015, [http://nuffieldbioethics.org/project/children-research/] UR - http://nuffieldbioethics.org/project/children-research/ ID - ref98 ER - TY - JOUR AU - Woods, S. AU - McCormack, P. PY - 2013 DA - 2013// TI - Disputing the ethics of research: the challenge from bioethics and patient activism to the interpretation of the Declaration of Helsinki in clinical trials JO - Bioethics VL - 27 UR - https://doi.org/10.1111/j.1467-8519.2011.01945.x DO - 10.1111/j.1467-8519.2011.01945.x ID - Woods2013 ER - TY - CHAP AU - Childress, J. F. ED - Milunsky, A. ED - Annas, G. J. PY - 1985 DA - 1985// TI - Protecting handicapped newborns BT - Genetics and the Law: III PB - Plenum Press CY - New York ID - Childress1985 ER - TY - JOUR AU - Neill, S. J. PY - 2005 DA - 2005// TI - Research with children: a critical review of the guidelines JO - J Child Health Care VL - 9 UR - https://doi.org/10.1177/1367493505049646 DO - 10.1177/1367493505049646 ID - Neill2005 ER - TY - JOUR AU - Wendler, D. S. PY - 2006 DA - 2006// TI - Assent in paediatric research: theoretical and practical considerations JO - J Med Ethics VL - 32 UR - https://doi.org/10.1136/jme.2004.011114 DO - 10.1136/jme.2004.011114 ID - Wendler2006 ER - TY - JOUR AU - Sibley, A. AU - Sheehan, M. AU - Pollard, A. J. PY - 2012 DA - 2012// TI - Assent is not consent JO - J Med Ethics VL - 38 UR - https://doi.org/10.1136/medethics-2011-100317 DO - 10.1136/medethics-2011-100317 ID - Sibley2012 ER - TY - JOUR AU - Tankanow, R. M. AU - Sweet, B. V. AU - Weiskopf, J. A. PY - 1992 DA - 1992// TI - Patients’ perceived understanding of informed consent in investigational drug studies JO - Am J Hosp Pharm VL - 49 ID - Tankanow1992 ER - TY - JOUR AU - Young, D. R. AU - Hooker, D. T. AU - Freeberg, F. E. PY - 1990 DA - 1990// TI - Informed consent documents: increasing comprehension by reducing reading level JO - IRB VL - 12 UR - https://doi.org/10.2307/3564107 DO - 10.2307/3564107 ID - Young1990 ER - TY - JOUR AU - Freer, Y. AU - McIntosh, N. AU - Teunisse, S. AU - Anand, K. J. AU - Boyle, E. M. PY - 2009 DA - 2009// TI - More information, less understanding: a randomized study on consent issues in neonatal research JO - Pediatrics VL - 123 UR - https://doi.org/10.1542/peds.2007-3860 DO - 10.1542/peds.2007-3860 ID - Freer2009 ER - TY - JOUR AU - Johnson-Greene, D. PY - 2010 DA - 2010// TI - Informed consent issues in traumatic brain injury research: current status of capacity assessment and recommendations for safeguards JO - J Head Trauma Rehabil VL - 25 UR - https://doi.org/10.1097/HTR.0b013e3181d8287d DO - 10.1097/HTR.0b013e3181d8287d ID - Johnson-Greene2010 ER - TY - STD TI - Miller VA, Ittenbach RF, Harris D, Reynolds WW, Beauchamp TL, Luce MF, et al. The decision making control instrument to assess voluntary consent. Med Decis Making. 2011;31(5):730–41. ID - ref108 ER - TY - JOUR AU - Rischbieth, A. AU - Blythe, D. PY - 2005 DA - 2005// TI - Ethical intensive care research: development of an ethics handbook JO - Crit Care Resusc VL - 7 ID - Rischbieth2005 ER - TY - JOUR AU - Hayes, J. S. PY - 2000 DA - 2000// TI - Getting nurses involved: use of existing databases for pediatric trauma research JO - Int J Trauma Nurs VL - 6 UR - https://doi.org/10.1067/mtn.2000.107881 DO - 10.1067/mtn.2000.107881 ID - Hayes2000 ER - TY - JOUR AU - Morris, M. C. AU - Nadkarni, V. M. AU - Ward, F. R. AU - Nelson, R. M. PY - 2004 DA - 2004// TI - Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest JO - Pediatrics VL - 114 UR - https://doi.org/10.1542/peds.2004-0482 DO - 10.1542/peds.2004-0482 ID - Morris2004 ER - TY - JOUR AU - Raymond, T. T. AU - Carroll, T. G. AU - Sales, G. AU - Morris, M. C. PY - 2010 DA - 2010// TI - Effectiveness of the informed consent process for a pediatric resuscitation trial JO - Pediatrics VL - 125 UR - https://doi.org/10.1542/peds.2009-2427 DO - 10.1542/peds.2009-2427 ID - Raymond2010 ER - TY - JOUR AU - Brody, H. AU - Miller, F. G. PY - 2013 DA - 2013// TI - The research- clinical practice distinction, learning health systems and relationships JO - Hast Cent Rep VL - 43 UR - https://doi.org/10.1002/hast.199 DO - 10.1002/hast.199 ID - Brody2013 ER - TY - JOUR AU - Flory, J. AU - Emanuel, E. PY - 2004 DA - 2004// TI - Interventions to improve research participants’ understanding in informed consent for research: a systematic review JO - JAMA VL - 292 UR - https://doi.org/10.1001/jama.292.13.1593 DO - 10.1001/jama.292.13.1593 ID - Flory2004 ER - TY - JOUR AU - Gamble, C. AU - Nadel, S. AU - Snape, D. AU - McKay, A. AU - Hickey, H. AU - Williamson, P. AU - Glennie, L. AU - Snowdon, C. AU - Young, B. PY - 2012 DA - 2012// TI - What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey JO - PLoS One VL - 7 UR - https://doi.org/10.1371/journal.pone.0035982 DO - 10.1371/journal.pone.0035982 ID - Gamble2012 ER - TY - JOUR AU - Jansen, T. C. AU - Bakker, J. AU - Kompanje, E. J. PY - 2010 DA - 2010// TI - Inability to obtain deferred consent due to early death in emergency research: effect on validity of clinical trial results JO - Intensive Care Med VL - 36 UR - https://doi.org/10.1007/s00134-010-1988-0 DO - 10.1007/s00134-010-1988-0 ID - Jansen2010 ER - TY - STD TI - Nichol G, Powell J, van Ottingham L, Maier R, Rea T, Christenson J, et al. Consent in resuscitation trials: benefit or harm for patients and society? Resuscitation. 2006;70(3):360–8. ID - ref117 ER - TY - JOUR AU - Jansen, T. C. AU - Kompanje, E. J. AU - Druml, C. AU - Menon, D. K. AU - Wiedermann, C. J. AU - Bakker, J. PY - 2007 DA - 2007// TI - Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? JO - Intensive Care Med VL - 33 UR - https://doi.org/10.1007/s00134-007-0580-8 DO - 10.1007/s00134-007-0580-8 ID - Jansen2007 ER - TY - JOUR AU - Magnus, D. AU - Caplan, A. L. PY - 2013 DA - 2013// TI - Risk, consent, and SUPPORT JO - N Engl J Med VL - 368 UR - https://doi.org/10.1056/NEJMp1305086 DO - 10.1056/NEJMp1305086 ID - Magnus2013 ER - TY - JOUR AU - Strode, A. AU - Richter, M. AU - Wallace, M. AU - Technau, K. PY - 2014 DA - 2014// TI - Failing the vulnerable: Three new consent norms that will undermine health research with children JO - South African J HIV Med VL - 15 UR - https://doi.org/10.7196/sajhivmed.1014 DO - 10.7196/sajhivmed.1014 ID - Strode2014 ER -