What is HawkIRB?
The Human Subjects Office in collaboration with Information Technology Services developed a proprietary and licensed web-based IRB application and review system, called HawkIRB. This eResearch application has been in place since 2004.
HawkIRB is a confidential, fully integrated, web-based system for human subject researchers, the IRB, and the Human Research Protection Programs. HawkIRB is an eResearch application that is a paperless system that provides information to the investigator about the IRB review and approval process in real time, as it occurs. HawkIRB addresses
- Federal Regulatory (OHRP, FDA, Federalwide Assurances, HIPAA) requirements
- Sponsor Requirements (NIH, pharmaceutical companies, private funding organizations)
- Institutional Requirements (Contracts, Human Research Protection Program, Education)
- National Accreditation Requirements (AAHRPP)
Some major features of HawkIRB are:
- on-line submission of application forms and Consent Documents
- meets FDA 21 CFR 11 requirements
- an electronic workflow process through which you will communicate with the IRB regarding review and approval of human subjects research applications
- a "My Projects" home page through which you will be able to view detailed IRB workflow information about all of your projects
- IRB approval memos and stamped Consent Documents returned to you electronically
- Reminder notices for continuing review sent by e-mail to PIs and contact persons
- Integrates with HR and UI Registrar systems to verify UI faculty, staff, and students affiliation status
- Compliance monitoring tracking and documentation
- IRB member and meeting management
- Application programming interfaces with national and institutional electronic systems and universal workflow forms such as
HawkIRB Submissions
All applications for local University of Iowa IRB or an IRB outside of the University of Iowa review must be submitted through HawkIRB. The HawkIRB system includes:
- Human subjects research determination forms
- Applications for new projects, modifications, and continuing reviews
- Applications for the use of an IRB physically located outside the University of Iowa (otherwise referred to as “External or Commercial” IRBs.
- Applications and documentation for both lead and relying IRB relationships
- Forms for reporting unanticipated problems and adverse events (REFs)
- Informed consent templates (standard informed consent, VAMC informed consent, UIHC Record of Consent, Assent, Spanish "short form" consent, consent as a letter, consent summary)
- Project closure forms
Consent forms, scripts, advertisements and other materials can be uploaded to HawkIRB during your application.
Key Features of HawkIRB:
- Web-based system
- Researchers have access to all information about their projects
- All review committees in the HRPP can access HawkIRB as needed for their committee review.
- 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
- Collaborative edits occur between HSO/IRB and PI (or their designee) prior to submission
- Live links to guidance documents and instructions
- Consent, grant, and other supporting documents can be attached directly to the protocol.
- Automated administrative functions
- E-mail reminders to researchers
- Approval notices and stamped consents available in electronic format immediately upon approval. History of processing workflow from submission to approval
- Documentation of Human Research Protection Program reviews and approvals
- Documentation of External and Commercial IRB approvals and research related materials (protocol, informed consent, investigator’s brochure, recruitment information, reportable events, etc.)
- Reporting features for HRPP committees.
Tips for How to Use HawkIRB
The Human Subjects Office has a developed a Submit to IRB section of the HSO website to provide guidance for how to use HawkIRB. If you would like to submit a question for consideration as an addition to the content, please send an e-mail to irb@uiowa.edu.
HawkIRB Training
Groups or individuals who need HawkIRB training should contact the HSO at irb-outreach@uiowa.edu or call (319) 335-6564 and request to speak with Education and Outreach staff.