Working Through the Public Disclosure Process Mandated by Use of 21 CFR 50.24 (Exception to Informed Consent): Guidelines for Success
Santora, Thomas A.
Trooskin, Stanley Z.
Journal of Trauma: Injury, Infection, and Critical Care 1998 November; 45(5): 907-913
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Recommendations for Implementation of Community Consultation and Public Disclosure Under the Food and Drug Administration's "Exception From Informed Consent Requirements for Emergency Research": A Special Report From the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: Endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine Halperin, Henry; Paradis, Norman; Mosesso, Vincent Jr.; Nichol, Graham; Sayre, Michael; Ornato, Joseph P.; Gerardi, Michael; Nadkarni, Vinay M.; Berg, Robert; Becker, Lance; Siegler, Mark; Collins, Megan; Cairns, Charles B.; Biros, Michelle H.; Vanden Hoek, Terry; Peberdy, Mary Ann (2007-10-16)
Public Disclosure in Research With Exception From Informed Consent: The Use of Survey Methods to Assess Its Effectiveness Jacoby, Liva H.; Young, Barry; Watt, James (2008-03)IN CLINICAL TRIALS WITH EXCEPTION from informed consent, the Final Rule stipulates that investigators inform and consult with the community. A random-digit-dialing survey of 200 individuals assessed the effectiveness of ...
Implementing Emergency Research Requiring Exception From Informed Consent, Community Consultation, and Public Disclosure Salzman, Joshua G.; Frascone, Ralph J.; Godding, Bobette K.; Provo, Terry A.; Gertner, Elie (2007-10)