Hawk IRB Database System: Development & Implementation

Why Do We Need a New Database System?

  • Our researchers have to deal with an ever increasing amount of regulatory requirements and procedures that are implemented through a variety of administrative offices and oversight committees.
    • Federal Regulations (OHRP, FDA, HIPAA)
    • Sponsor Requirements (NIH, pharmaceutical companies, private funding organizations)
    • Institutional Requirements (Contracts, Education)
  • There may be multiple committees/offices/centers from which faculty must obtain approval before initiating one human subjects research protocol, and many require ongoing review throughout the study.
  • To contend with this increasing amount of data and documentation the national trend is towards “paperless” systems.

Development of HawkIRB:

  • 2002 & 2003: Received NIH one-year grants to support development of HRPP (Human Research Protection Program) infrastructure including support for development of a new database system.
  • Summer 2002 – January/February 2003
    • Comprehensive review of available “off-the-shelf” products
    • Discussions with multiple University and corporate database developers
  • February, 2003-present: University ITS group develops our own in-house system
  • February/March 2004: Staged rollout

Key Features of HawkIRB:

  • Web-based system
    • Researchers have access to all information about their projects
    • All review committees in the HRPP can access database system for their own use
  • On-line electronic applications which populate the system database
    • New Project Applications, Continuing Reviews and Project Closures
    • Modifications and Adverse Events
  •  “Smart” application forms
    • Questions change depending on type of study and associated procedures
    • Computer edits occur prior to submission
    • Live links to guidance documents and instructions
    • Attach electronic versions of consent documents, grants, supporting documentation, etc.
  • Automated administrative functions
    • E-mail reminders to researchers
    • Approval notices and stamped consents available in electronic format immediately upon approval (no waiting for campus mail deliveries)
  • History of processing workflow from submission to approval

How Do We Effect a Smooth Transition?

  • Recognize that this is a BIG change!
    • Prepare current researchers with pre-release information and notifications
    • Gradual integration of new system
    • Initial rollout will be with IRB-02 researchers (Behavioral/Social Science)
    • Phase rollout to IRB-02 researchers (Biomedical)
  • Provide readily accessible system support for new users
    • Hands-on training sessions
    • HSO staff available by phone, e-mail, and in person for those having problems/questions