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