Question Completion Status: Path: p Words:0 QUESTION 4 15 pol You are a member o

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Question Completion Status: Path: p Words:0 QUESTION 4 15 pol You are a member of an Institutional Review Board (IRB), focusing on the ethical implications of research proposals. A proposal is presented to the IRB that has the following descripton: The following proposal is a Phase I clinical trial designed to test the safety of Drug X, a potential influenza treatment. The study is designed to test the drug in 40 children between the ages of 3 and 5 years of age. The drug was tested in mice and was shown to be safe in 45% of the treated mice, with 80% of the mice that died dying of brain hemorrhage List all the ethical problems with this short description, and re-write a proposal description that will reflect common ethical practices for a Phase I clinical trial and justify the use of the drug in the clinical trial. Also list at least one limitation, delimitation, and assumption that you can make in the study. HTHL ES5 "> Mashups

Explanation / Answer

Ethical problems:

Proposal description:

The study is designed to test the efficiency of drug in 40 children between the ages of 3 and 5 years of age.

Phase 1 clinical trials studies assess the study of drug. This is initial phase of testing which can take several months to complete, usually includes a small number of health volunteers, who are generally paid for participating in the study. The study is designed to determine the effects of drug on humans and how it is absorbed, metabolized and absorbed. This phase also investigates the side effects that occurs as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.

Phase 1 clinical trials usually occur after pilot studies have beeen completed in animals to reduce the potential mechanisms of acting, pharmacology and toxicology of a drug. They are generally the first stage of drug testing in huamans. Phase 1 trials are required and designed to assess the safety, tolerability, pharmakokinetics and pharmacodynamics of a drug in humans.

Limitation:

The study will be limited to the children between the ages of 3 and 5 years of age.

Delimitation:

The study will be delimited to 40 children

Assumption:

The assumption of the study are,

The study assumes that the drug will be safe to treat influenza.

The study assumes that drug will be generalizable

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