IRB Approval & HIPAA Regulations

Researchers who wish to use the SEER-Medicaid data are required to obtain IRB determination prior to SEER-Medicaid data being released to them. A full IRB review is not required. Many IRBs, including NIH's Office of Human Subjects Research, have determined that the SEER-Medicare data are exempt (CFR 46.104(4)).

Researchers who wish to use the SEER-Medicaid data may have concerns about complying with the Health Insurance Portability and Accountability Act (HIPAA)External Web Site Policy regulations. The SEER-Medicaid data contain information about geographic location at the county level; the SEER-Medicaid data are considered by HIPAA requirements as a limited data set, which requires that investigators sign a Data Use Agreement prior to receiving the data. This exception allows for the release of the SEER-Medicaid data without obtaining authorization from individual patients (see Federal Register, August 14, 2002, pg 53235). However, because the SEER-Medicaid data are a limited data set, investigators who have the data may not share these files with other investigators. Investigators who are contacted by colleagues who wish to use their data should submit a request to do so via the SEER-Medicaid request system.

Last Updated: 19 Jul, 2021