Alternative consent models for comparative effectiveness studies: Views of patients from two institutions
| Autor: | Rachel Fabi, Sean Tunis, Rachael Moloney, Donna A. Messner, Danielle Whicher, Kristina Hallez, Nancy E. Kass, James M Pitcavage, Ruth R. Faden, Stephanie R. Morain |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Health (social science) business.industry Health Policy Comparative effectiveness research Alternative medicine 06 humanities and the arts 0603 philosophy ethics and religion 03 medical and health sciences Philosophy 0302 clinical medicine Clinical research Documentation Informed consent Family medicine medicine Observational study 060301 applied ethics 030212 general & internal medicine business Social psychology |
| Zdroj: | AJOB Empirical Bioethics. 7:92-105 |
| ISSN: | 2329-4523 2329-4515 |
| DOI: | 10.1080/23294515.2016.1156188 |
| Popis: | Background: Informed consent requirements generally require a lengthy process and signed documentation for patients to participate in clinical research. With growing interest in comparative effectiveness research (CER), whereby patients receive approved (nonexperimental) medicines for their medical condition, questions have been raised whether the same consent requirements should apply. Little input from patients has been part of these debates. Methods: We conducted two “deliberative engagement sessions” with patients from Johns Hopkins Community Physicians (JHCP) and Geisinger Health System (GHS). Full-day sessions introduced participants to two different CER designs (observational vs. randomized) comparing two antihypertensive medications and three disclosure or consent approaches: Opt-In, Opt-Out, and “General Approval.” Sessions consisted of presentations and extensive discussion at small group tables. Pre- and posttest surveys were completed by participants before and after all-day discussion... |
| Databáze: | OpenAIRE |
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