Indiana Code Title 16. Health § 16-38-4-11

(1) the person conducting the research provides written information about the purpose of the research project, the nature of the data to be collected and how the researcher intends to analyze it, the records the researcher wishes to review, and the safeguards the researcher will take to protect the identity of the patients whose records the researcher will be reviewing;

(2) the proposed safeguards are adequate to protect the identity of each patient whose records will be reviewed;  and

(3) an agreement is executed between the state department and the researcher that specifies the terms of the researcher's use of the records and that prohibits the publication or release of the names of individual patients or any facts tending to lead to the identification of individual patients.