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HIPAA Authorization: International Language
The JHM standard practice is to require use of a HIPAA Authorization Form for International Research when data from a research protocol will be transmitted to the research team in the U.S. Research conducted in countries that do not have medical privacy laws and in remote populations that are of limited education may alter, with IRB permission, standard JHM privacy language used in consent documents. In such cases, the application submitted by the PI must present the rationale for alteration of HIPAA authorization language and propose substituting the language below:
Some of your health information collected in this study will be sent to the United States. We are asking you to let us use and send details about your health as part of this study. (Optional section: This study uses (a drug or drugs). The U.S. Food and Drug Administration may need to see your health information when it is sent to the U.S.) If you join the study, you can decide later that you do not want to have your health information sent to the U.S. Tell the principal investigator if you do not want any more of your health information to be sent.
The IRB may grant an alteration of the HIPAA language or determine that the standard Form must be used.