HIPAA And Human Subjects Research

If research will involve the use of Protected Health Information (PHI), criteria under the Health Insurance Portability and Accountability Act (HIPAA) may apply and the researcher will need to address how their research meets HIPAA requirements in the research submission.

For more information about HIPAA and research, please visit the NIH HIPAA information page.

When researchers are planning to conduct a study where HIPAA will apply, please include Appendix D in your study materials. See our Applications, Forms and Guidance webpage for the most up to date versions of all forms and appendices.