Background: In critical care and emergency medicine research, obtaining consent can be problematic when patients present with life-threatening conditions. This issue is further complicated in children, as even while coherent, they are often incapable of making decisions regarding their own care. To enable the ethical conduct of research in such situations, the Food and Drug Administration (FDA) of the United States has set recommendations for the conduct of research employing a waiver of consent. These regulations have been termed "exception from informed consent," or EFIC. As this is an evolving concept with limited pediatric experience, the authors conducted a review to examine the conduct of emergency research in the absence of prospectively obtained informed consent. Our review focused both on opinions and on the ability to conduct research without informed consent in life-threatening situations.
Methods: A systematic review of the literature was undertaken in accordance with the PRISMA guidelines. Medline, CINAHL, and EMBASE databases were searched on January 9, 2013. Eligibility criteria included: 1) examined a method of conducting research in a life-threatening situation, 2) involved a real or theoretical clinical situation, 3) involved patients less than 18 years of age or a substitute decision-maker, and 4) reported at least one quantifiable outcome. The findings were synthesized qualitatively with the pertinent results summarized and discussed.
Results: Eleven articles matched the eligibility criteria. Six focused on community consultation and public disclosure, three focused on the feasibility of employing a waiver of consent, and two examined attitudes toward emergency research. Of the studies focusing on community consultation, four defined the community as previous or current patients and health care providers and administrators in the study's home institution; the other two defined the community as the general population. Although there was heterogeneity in study designs, settings, and outcome measures, overall 68% (3,219 of 4,767) of subjects surveyed supported the use of EFIC under select circumstances (individual study range = 50% to 92%). Caregiver support increased among those in whom the situation was a more possible reality (e.g., critical care unit patients) and varied by the scenario and method of presentation (e.g., bulleted handout vs. preferred). Several studies revealed that patient accrual and time to intervention are impeded when prospective informed consent is required. Finally, deferred consent, although endorsed and used outside of the United States, continues to raise important ethical questions, particularly related to the need and timing of disclosure.
Conclusions: Limited data exist evaluating ethical issues in pediatric acute care resuscitation research. This review highlighted the fact that every proposal is unique and the method of obtaining consent (or waiver) requires careful consideration by local ethics committees. Particular attention must be paid to use of the population selected for community consultation. Several studies highlighted the need to consider the use of alternatives to prospective informed consent to enable the conduct of research in emergency departments (EDs) in life-threatening situations. Future research should evaluate children's opinions on this topic.
© 2013 by the Society for Academic Emergency Medicine.