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The tools and guidance documents on this website are provided to assist the caBIG® community in facilitating data sharing activities. They are not legal advice, nor does their distribution or use create an attorney-client relationship. Users should consult with their own legal advisers to assure compliance with all applicable federal and state laws and institutional policies.

Tool Overview

icon representing Human Research Decision Support

This decision support tool is intended to be used in conjunction with the Data Sharing and Security Framework and Data Sharing and Security Framework Tree. The purpose of this document is to provide navigation on the differences between federal, state and local policies about human subjects and IRB considerations. The document should help the user distinguish between human subjects research and unregulated research as well as determine whether the research is exempt or otherwise covered.

The intended audience for the Human Research Decision Support Tool is researchers, their study teams, and institutional subject matter experts such as human research protection program directors, IRB staff, IRB chairs, and legal counsel.

The most current version of the Human Research Decision Support Tool - Wiki Version is posted on a wiki page. A downloadable version is also available below.

At A Glance Details

  • Version Number: 3.0
  • caBIG Tool Bundle: DSIC

Presentations, Demos and Other Materials

Note: If you are having trouble viewing this presentation via Window Media Player, we suggest the following solutions: Install a new set of codecs Exit Disclaimer logo, Associate Windows Media Player player to .wmv file types Exit Disclaimer logo, or install a different media player such as VLC Media Player Exit Disclaimer logo.

Documentation and Knowledge Articles

  • Secondary Use Scenarios - This tool is designed to assist users in determining the extent of regulation under the Common Rule of secondary use of data or specimens for research purposes. It relies primarily on OHRP's August 2004 "Coded" guidance and 2006 draft "Engagement" guidance. The document also includes a simple agreement users may wish to consider adopting or adapting to facilitate internal or external data sharing consistent with that guidance.

Forum for Questions about This Tool

  • Human Research Decision Support Tool discussion forum.

Installation/Downloads

Other Links and Support

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