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  • Protocol Approval Application

    Field: Information Systems
    Posted: 6 months ago

    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:

    https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm


    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.

    • Provide the Brief Summary, Purpose and the Research Questions from the study in your own words. It is not required for you to provide the Data Collection Tools, Data Points Yielded or the Data Source but the Data Analysis should be summarized for the study. A sample of what is asked regarding proposed procedures can be found at #11 on the Walden IRB Application from the sample IRB Application linked above.
    • Provide a descriptive and evaluative summary of the study with particular focus on the results and discussion sections.
    • Cite the medical study chosen to use as the basis for completing a sample IRB Application form.
    • The document should be 1-2 pages, written in APA style.

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