• July 3rd, 2016

Protocol Approval Application

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In accordance with the U.S. Food and Drug Administration, an institutional review board (IRB) has the authority to approve or reject a biomedical research study that involves human subjects. The IRB is set up to protect the rights of participants in research, and to do this, IRB members use a group process to evaluate applications for research. You will go through the motions of constructing for a Protocol Approval Application to an IRB as if you are the principal investigator for a research project that involves humans as the research subjects. Find 1 medical study for IRB Approval of Human Subjects Research form (file uploaded) or already completed IRB Approval of Human Subjects Research form. In a Word document, address the following: 1. Write 1 introduction paragraph (4 sentences). 2. In 1 paragraph (5 sentences or more), summarize the Research Questions of the medical study as indicated on the IRB application form that you chose. 3. In 1 paragraph (5 sentences or more), summarize the Data Analysis of the medical study as indicated on the IRB application form that you chose. 4. In 1 paragraph (5 sentences or more), summarize the Brief Summary of the medical study as indicated on the IRB application form that you chose. 5. In 1 paragraph (5 sentences or more), summarize the Purpose of the medical study as indicated on the IRB application form that you chose. 6. In 1 paragraph (5 sentences or more), provide a descriptive summary of the study with particular focus on the results and discussion sections and cites the medical study chosen to use as the basis for the IRB application form. 7. In 1 paragraph (5 sentences or more), provide an evaluative summary of the study with particular focus on the results and discussion sections and cites the medical study chosen to use as the basis for the IRB application form. 8. Write 1 conclusion paragraph

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