IRB and EDRC Release New Policy Governing Public Databases
Date: March 19, 2013
The Medical College of Wisconsin/Froedtert Hospital Institutional Review Board (IRB) and the Epidemiology Data Resource Center (EDRC) announce the release of a new IRB policy governing human subject review of research involving secondary analysis of publicly available databases.
“This policy reduces the burden on MCW researchers by identifying a list of publicly available databases for which the IRB has granted a human subjects research exemption, eliminating the need for making an IRB application,” said Dr. David Clark, IRB Director.
The new policy identifies several well-known databases as meeting the definition of publicly available including: American College of Surgeons National Trauma Data Bank (NTDB), and several of the Healthcare Cost and Utilization Project (H-CUP) healthcare databases such as NIS, KID, SID and SEDD. Investigators seeking to utilize NCI SEER and NIH dB GAP databases for their research will still need to submit an IRB application as these databases do not qualify as publicly available under this new policy.
The development of the new policy took place in a series of meetings organized by faculty and staff in the Division of Epidemiology in MCW’s Institute for Health and Society, with leadership from EDRC Director Kirsten Beyer. The EDRC is MCW’s centralized source for secondary health and demographic data and Geographic Information Systems support.
“Our goal in initiating this effort was to reduce the burden on IRB reviewers and MCW researchers regarding IRB review of research using publicly available data. The new policy developed by the IRB meets that goal, and governs a long list of databases used frequently by MCW investigators. Many of these databases are maintained by the EDRC. We thank our colleagues in the IRB office for their support in making this policy a reality,” said Dr. Beyer.
Laura Cassidy, Director of the Division of Epidemiology, noted, “We would like to recognize our colleagues from across the MCW campus for their participation in the process of reviewing candidate databases and supporting the IRB office as it developed this policy.”
Contributors to this effort included: David Clark (IRB), Kathryn Gaudreau (IRB), Laura Cassidy (Epidemiology/EDRC), Kirsten Beyer (Epidemiology/EDRC), Tom Chelius (Epidemiology/EDRC), Renee Hill (Epidemiology/EDRC), Emily McGinley (PCCOR, formerly of EDSC), Ann Nattinger (PCOR), David Brousseau (PCOR), Rodney Sparapani (PCOR), Tina Yen (PCOR), Julie Panepinto (CCER), Fouza Yusuf (CCER), Peter Layde (IRC), Amy Schlotthauer (IRC), Clare Guse (IRC), Ann Christensen (IRC), Aniko Szabo (Biostatistics), Ruta Brazauskas (Biostatistics), Glen Bushee (HMGC, Bioinformatics), Ray Hoffman (QHS), Pippa Simpson (QHS), Tifany Frazer (Global Health), Kaija Zusevics (Bioethics), Jennifer Yauck (WI Pediatric Cardiac Registry), and Mary Krolikowski (Herma Heart Center).
The IRB office has developed a website and new resources to support the implementation of the new policy. These resources, and the full text of the new policy, can be found at: MCW defined Public Data Sets.
“After careful review, the MCW IRB can confirm that this list of databases meet the Department of Health and Human Services definition of publicly available for exemption purposes. We are pleased to be able to release this policy, which makes it easier to do epidemiologic and health services research here on campus,” said Dr. Clark, “We thank the EDRC for their leadership in this process, and encourage others to partner with the IRB in implementing changes that uphold federal data confidentiality standards while meeting the needs of MCW researchers.”
For questions about the new policy, please contact Kate Gaudreau, Director of IRB Development.
A full list of all EDRC Data Sets available can be found in the: EDRC Data Catalog.