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With funding from the National Institute of Allergy & Infectious Diseases (NIAID), Dr. Jill Fisher is conducting a research study on pediatric clinical trials for food allergies, focusing primarily on peanut allergy. Using ethnographic research methods, the project investigates the on-the-ground ethical challenges that emerge in these clinical trials. In particular, the project explores how stakeholders—investigators, caregivers, adolescents, patient advocates, FDA officers, and pharmaceutical company representatives—define and understand acceptable risks and benefits from food allergy treatments, both in terms of research protocols and the eventual products to be used in clinical practice. The empirical findings from the project will be mobilized to develop a framework for the ethical conduct of peanut allergy clinical trials that attends to the myriad interests that drive biomedical research, including the search for therapies that meaningfully improve the lives of children with food allergies, the need to design and conduct clinical trials to meet the regulatory standards required by the FDA for the approval of products, and the commercial context in which investigators and companies have financial conflicts of interest that motivate the successful development of new therapies. Collaborating with Dr. Fisher on the project are Drs. Anne Drapkin Lyerly and Edwin H. Kim.

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