Exception from Informed Consent in Emergency Research Designed for implementation of research in emergency settings when exception from informed consent.

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Presentation transcript:

Exception from Informed Consent in Emergency Research Designed for implementation of research in emergency settings when exception from informed consent is requested under 21 CFR

Criteria The exception applies when: –Human subjects cannot give informed consent because of emerging, life- threatening medical condition –Available treatments for the condition are unproven or unsatisfactory –The intervention must be administered before informed consent from LAR is feasible

Benefits and Risks Participation must hold out prospect of direct benefit to the subject –If placebo design is used, standard care must be given to all subjects Risks of the study are reasonable in relation to: –What is known about the medical condition of the potential subjects –The risks and benefits of standard therapy –Any benefits of the proposed treatment

Study Design Design should be adequate to the task of evaluating whether the treatment provides the hypothesized effect The therapeutic window must be defined The amount of time spent in locating family members must be defined

Contact of Family Members Attempts to contact a legally authorized representative (LAR) or family member need not exhaust the entire therapeutic window The effect of delaying study treatment must be taken into account when determining the portion of the therapeutic window to be spent trying to locate family

Public Disclosure and Community Consultation Prior to start of the study -- public disclosure of sufficient information to describe : –the nature and purpose of the study –the fact that informed consent will not be obtained for most study subjects Following completion of the study information about the study results must be disclosed –to the community where the research was done –the research community should have access to comprehensive summary data

IRB Responsibilities Specific to Waiver of Consent Review/approve proposed plan and procedures for contacting LAR/family Review/approve community notification and consultation plan Attend/participate in community consultation activities