Public Disclosure in Research With Exception From Informed Consent: The Use of Survey Methods to Assess Its Effectiveness
Jacoby, Liva H.
Journal of Empirical Research on Human Research Ethics 2008 March; 3(1): 79-87
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 public disclosure via press releases, notices in local newspapers, local radio and television stations and the host hospital's website, as well as a series of community meetings regarding a pending clinical trial of this kind. Results showed a 10% awareness level of the public trial, which is higher than surveys using convenience samples. Understanding of the nature of the trial was generally poor, while opinions about participating in this type of research were more favorable among individuals aware of the trial. Our findings suggest that adherence to the intent of the Final Rule is dependent on uniform guidelines for what constitute effective public disclosure methods and adequate community awareness and understanding and the use of rigorous sampling methods for evaluation.
Showing items related by title, author, creator and subject.
Triner, Wayne; Jacoby,Liva; Shelton, Wayne; Burk,Mathew; Imarenakhue, Samual; Watt, James; Larkin, Gregory; McGee, Glenn (2007-02)
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)