The goal of this training award is to allow Dr- Karlawish to gain the multidisciplinary skills required to become a national leader and resource in research ethics. To achieve this goal, he will: 1) complete tutorials and coursework structured to develop his theoretical and methodological skills; 2) work with a multi-disciplinary team of sponsors; and 3) perform a series of supervised research projects and outreach activities. The overall specific aim of this Award is to understand and compare the preferences of potential subjects, their representatives and investigators for the priorities of Alzheimers Disease clinical research in order to help build consensus on the appropriate design and conduct of Alzheimers Disease clinical research. The ethical paradigm that has governed research in this country is changing. Research is regarded more and more as an activity that requires subject representation in clinical trials. The term that describes the desire to give greater input to subjects and potential subjects is community equipoise. Equipoise is the condition of uncertainty that must exist to justify a clinical trial. Community equipoise redirects the focus from uncertainty to consensus among physicians and potential subjects upon what is the most credible of the possible valid trial designs. In the initial years of this Award, Dr. Karlawish and his sponsors will perform a series Of integrated research projects that will focus upon identifying community preferences for the design and conduct of research that involves persons with Alzheimers Disease. Resource activities include institutional review board consultation and membership, a community forum on Alzheimers Disease clinical research and teaching research ethics about vulnerable populations. By the final years of this Award, these interrelated research and resource activities will allow Dr. Karlawish to pursue independent research and scholarship that will achieve this Award's objective: to design principles and policies that guide community representation in the design and conduct of clinical research. The University of Pennsylvania has outstanding resources in empirical bioethics and clinical research. Dr. Karlawish's mentor, Arthur Caplan, Ph.D., is a nationally recognized expert in research ethics who will Provide Dr. Karlawish advanced training in bioethics scholarship. Other sponsors include experts in clinical trial design, Alzheimers Disease research and empirical research in research ethics.
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