Abstract

In 2008, leadership from the Human Subjects Protections IRB departments of the HMORN responded to the need for more distributed and diversified methods of conducting research across multiple institutions by introducing a research approval process for use among its member organizations for minimal risk, data-only studies. This process allows the lead principal investigator (PI) to submit to their local IRB (“lead IRB”) using their local site’s IRB forms and processes. Participating sites’ IRBs then use the application from the lead site to facilitate research review at their institution. Each institution decides if they would like to review and oversee the protocol for their site or cede oversight authority to the lead IRB. Only one set of application materials is required for this facilitated review process plus this additional short form, the HMORN Multi-Site Research Application Cover Sheet that provides investigator and IRB contact information for each site.

Publication Date

7-21-2011

Type of Governance Resource

Sample Agreement/Contract

Other Data Type

Regulatory

Generalizability to Other Settings

The application cover sheet is a tool that can be used in other multi-institutional research initiatives to enable a research approval process for minimal risk, data-only studies.

Network Description

The HMO Research Network (HMORN) includes 18 integrated healthcare delivery systems that collaborate with each other on research. Our research findings can be put into clinical practice quickly and efficiently. We are the nation’s foremost source of health research based in “real-world” populations. Our sites and millions of patients are diverse. Information from our “living laboratories” is broad and deep. We have standardized this information, so we can collaborate successfully on innovative multi-site research, while our patients’ data stays safe at each site. Our world-class research scientists ask—and answer—critical questions about health and care. Our goal is to be the research consortium of choice for stakeholders seeking to measure and transform the quality and efficiency of healthcare locally, nationally and internationally. To learn more about our work or collaborate with us, please visit www.hmorn.org.

Geographic scope type

Multi-State

Acknowledgement of Funders

National Center for Research Resources, contract number HHSN-268-2004-25216-C

Additional Information

This is the HMORN’s approach to IRB review of multi-institutional research projects. It is based on a ceding structure in which the lead site’s IRB assumes study oversight for all participating institutions if requested.

Recommended articles include:

Greene SM, Braff J, Nelson AF, Reid RJ. The Process Is the Product: A New Model for Multisite IRB Review of Data-Only Studies. IRB: Ethics & Human Research, Vol 32(3), May-Jun 2010, 1-6. PMID: 20590050.

Greene,S.M.; Braff,J.; Nelson,A.F.; Reid,R.J. HMO group uses alternate IRB model to review low-risk studies. IRB Advisor. 11(3):30-31, March 2011 .

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 License.

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