Appropriately designed clinical trials to improve outcome from pediatric cardiac arrest are currently not being conducted because of the difficulty of obtaining informed consent for research participation from a parent during or soon after a child's cardiac arrest. The applicability of exception from informed consent to pediatric resuscitation research must be clarified to allow progress in caring for children who suffer a cardiac arrest. This is a proposal for a career development grant to provide the experience and formal education necessary for a young investigator to become a successful and productive clinical researcher in the field of pediatric cardiac arrest. The young investigator will earn a Masters in Public Health focused the practical kills necessary to propedy conduct clinical trials and on the policy and ethical issues at the interface between resuscitation research and bioethics. She will augment these skills by conducting a research plan under the experienced mentorship of a team of outstanding physicians and scientists. The goal of the research plan is to determine in what cases and through what mechanisms exception from informed consent should be applied to pediatric in-hospital resuscitation research. She will determine what categories of in hospital pediatric resuscitation research may appropriately be conducted with an exception from informed consent and what type of community consultation and public disclosure process is appropriate for trials of different levels of risk. She will make this determination through extensive consultation both with health care providers and with the lay community invested in the health of children. She will then develop a document categorizing types of pediatric in-hospital resuscitation research and delineating appropriate components of a community consultation and public disclosure process for each of these broad types of research. ? ?
| Raymond, Tia Tortoriello; Carroll, Timothy Glenn; Sales, Glenda et al. (2010) Effectiveness of the informed consent process for a pediatric resuscitation trial. Pediatrics 125:e866-75 |
| Morris, Marilyn C; Besner, Deborah; Vazquez, Hector et al. (2007) Parental opinions about clinical research. J Pediatr 151:532-7, 537.e1-5 |
| Morris, Marilyn C; Mechem, C Crawford; Berg, Robert A et al. (2007) Impact of the privacy rule on the study of out-of-hospital pediatric cardiac arrest. Prehosp Emerg Care 11:272-7 |
| Morris, Marilyn C; Nelson, Robert M (2007) Randomized, controlled trials as minimal risk: an ethical analysis. Crit Care Med 35:940-4 |
| Morris, Marilyn C; Fischbach, Ruth L; Nelson, Robert M et al. (2006) A paradigm for inpatient resuscitation research with an exception from informed consent. Crit Care Med 34:2567-75 |
