May 2025

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. 

The standard separate international HIPAA Authorization Form for International Research is found here: https://www.hopkinsmedicine.org/institutional_review_board/forms/HIPAA_statement_for_international_research_form.docx

Alternatively, the study can include the following standard language in the consent document where data from a research protocol is transmitted to the research team in the U.S.:

“As part of your participation in this research study, your personal information may be sent to the United States for analysis or storage.  There are laws in the U.S. to protect your personal information when in that country.  We may share your information with members of the study team and certain third-parties, such as contractors, government agencies, and the sponsor of the study.  We will try to make sure that everyone who receives your information will keep it confidential, but we cannot guarantee that your information will not be further disclosed by those third-parties.”

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 in the consent document to the following:

“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 or the standard language must be used.

Additional Resources:

Information about international research guidance: https://www.hopkinsmedicine.org/institutional-review-board/guidelines-policies/guidelines/international