BTRA 640 UMGC Preclinical and Clinical Research Questions

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There are three separate questions to this assignment. Please answer each separately.

1. This week as we begin discussing clinical trials, I’d like us to take a moment to look at the bioethical aspects of product development and human testing. The writing assignment this week will position you well for our larger writing assignment later this term, which will be squarely focused on bioethics. Please review the cases provided below and draft a 3-4 page summary (double spaced) of these critical bioethical issues and clinical trial “disasters” that have occurred, including your own perceptions of how these disasters should have been prevented. Uninformed Consent: Five-Part Series of Unethical Behavior at the Hutchinson Cancer Center

2. Discuss the importance of clinical trials in the development of medicinal products for human use. In your opinion, is there ever a set of circumstances that would warrant the administration of therapies to people/patients without prior approval from the Food and Drug Administration.

3. write a one to two page essay on the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Be sure to cover at least the following questions: ‘Who are the founding co-sponsors?’, ‘How is the ICH organized?’, ‘What types of work products does ICH produce?’ and ‘Are the any of the ICH work products legally binding?’.

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