The purpose of this tool is to provide research staff throughout the WWAMI region with a framework to understand how federal U.S. regulations covered by the Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the Health Insurance Portability and Accountability Act (HIPAA) apply and impact an investigator-initiated research study. Use this tool with a specific research study. Input the title of the study and institution name below.

This tool does not address state or local laws or institutional policies. It is meant to address broad federal regulations. Use this tool with institution-specific policies and guidance for human subjects research. Results may be useful for planning purposes and to facilitate conversations with the study team and other stakeholders.

This tool consists of 3 pages for each set of regulations. To retain your results from each page:

  • Before you click “Submit” on each page, right click on the page and select "Print."

  • To save a PDF record of the completed page with the advice for your study, select the printer as “PDFWriter.”

  • If you do not have this functionality, you can request a PDF copy of your responses when you complete and submit all 3 pages.

If at the end of using this tool, you have questions about any of the OHRP, FDA, or HIPAA regulations, you can submit a question and an ITHS Regulatory Specialist will respond.

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