The special challenges of emergency medicine and critical care research led to federal regulations that define very specific circumstances under which research can be ethically conducted without obtaining prospective informed consent from participants. These regulations require a number of special protections including """"""""community consultation"""""""" (CC) before the study is performed, a provision that has proven extremely problematic. In 2003, NHLBI funded R01HL073387: """"""""Research Without Consent: The Community Perspective"""""""", to explore community attitudes towards these regulations, their underlying ethical principles and preferred methods of """"""""community consultation"""""""". This application proposes to continue this work, using the data, methods and resources produced by the original study, to achieve three specific aims: 1) Identify and evaluate strategies for defining and engaging the community for purposes of adhering to the Exception from Informed Consent regulations;2) Develop a toolkit consisting of informational materials for community members, best practices and successful innovations for use by investigators and IRBs who are conducting community consultation regarding emergency research;and 3) Develop criteria for evaluating the adequacy and appropriateness of CC and to assess the usefulness of these criteria in evaluating community consultation processes. First, we will compare 4 recruitment methods to conduct """"""""mock"""""""" community consultations: Probability Sampling (random digit dialing);Convenience Sampling (polling in ED waiting rooms);Purposive Sampling (community leaders);and Quota Sampling (individuals who proportionately reflect race, age, gender of neighborhood);using two formats: individual queries (random digit dialing &in- person interviews) or group discussion. To assess these CC strategies, a structured evaluation instrument will be developed with measures in five domains: feasibility, composition of participants, quality of communication, community participant perceptions &IRB/investigator responses. Using a modified Delphi process, expert consultants will evaluate the various strategies for CC and the usefulness of evaluation measures. The resulting structured evaluation instrument will be used in years 4 &5 to compare the 2 most promising CC strategies using scripted research scenarios. Inter-rater reliability of the structured evaluation instrument will be assessed. Investigators will also develop a toolkit with a) compilation of best practices from a comprehensive review of all exception from consent studies;b) a series of culturally-appropriate informational modules designed to facilitate public participation in community consultation;and c) ratings of the 4 CC strategies in the five measurement domains from SA-1 activities;and the structured evaluation instrument for SA-3. The entire toolkit will be made publicly available on the Mount Sinai EM website and will be actively disseminated to medical societies, governmental agencies, bioethics organizations &others.
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