INFORMED CONSENT REGS NEED REWRITE TO CREATE ONE STANDARD OF INCREMENTAL RISK, NIH/FDA TOLD; IRBs SHOULD GET MORE LEEWAY TO WAIVE INFORMED CONSENT
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth