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
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. In this Application, you will go through the motions of constructing a Summary 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.
To prepare for this Application, search the Internet and download an application form for IRB Approval of Human Subjects Research . Explore the Internet for more information on the application process as can be found at the following Web sites:
For this Application:
Find a published medical study published within the last 36 months of todays date to use as the basis for completing a sample IRB application. A scholarly journal should be used such as the American Medical Association Journal. Scholarly medical journals can be found in the Walden library.
Next, assume that you are the principal investigator.
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