Back to Annual Meeting

Back to Annual Meeting

APHA Scientific Session and Event Listing

Armida Ayala, MHA, PhD, Arthur Durazo, BA, and René Apel, BA. Institutional Review Board, Kaiser Permanente Southern California, 393 East Walnut St. , 2nd Floor, Pasadena, CA 91188, 626-405-3692, arthur.durazo@kp.org

Objectives: 1) To identify questions, complaints, and concerns from vulnerable populations who participate in research, 2) to improve human participant education to increase understanding of participation in the research process. Methods: Data from 84 human participants from 2004-2005 was gathered retrospectively from existing records of questions, complaints and concerns submitted to the Institutional Review Board at an HMO. Results: Most (80%) of the participants had questions regarding the informed consent process, recruitment letters and risks associated with their participation in clinical trials. Latinos who were Spanish speaking only and elderly participants (68%) were the most frequent callers with questions related to their understanding of the informed consent process. Although the IRB received significantly less concerns (6%) and complaints (14%), 100% of these questions, complaints and concerns were resolved with a positive outcome. Conclusion: The difficulties vulnerable human participants encounter during recruitment and the informed consent process implicate our understanding of bioethical issues and psychological principles. There are still ways to improve vulnerable populations' participation in research which require new strategies designed to protect their health, safety and welfare.

Learning Objectives: