INFORMED CONSENT REGS NEED REWRITE TO CREATE ONE STANDARD OF INCREMENTAL RISK, NIH/FDA TOLD; IRBs SHOULD GET MORE LEEWAY TO WAIVE INFORMED CONSENT
Executive Summary
Informed consent documents should be rewritten by the federal government to create a uniform standard allowing Institutional Review Boards to assess risk-benefit using a standard of situational incremental risk, Carolinas Medical Center Research Services Director Beth Ribbeck asserted at a joint FDA/National Institutes of Health conference on informed consent in emergency research Jan. 9-10 in Bethesda, Md.
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