The Human Subjects Office offers a variety of resources for investigators/coordinators to get started in completing the HawkIRB application.   These include in person/online training sessions, the online Educational Tools on a variety of specific topics, in person/ online Office Hours (to speak with HSO staff), Presentations, and online training courses through ICON. These resources are listed below. 

Resources for researchers new to HawkIRB submissions

​Educational Resources

The Human Subjects Office offers a variety of educational sessions and resources for investigators.  Session information may be found on the HSO website.  Online courses are also available to researchers through ICON. UI faculty and staff may access ICON through the 'ICON Courses for Researchers' section on the Education & Training page.

HawkIRB Training Sessions

Both online and in person training sessions are available for new project submissions and post approval/after IRB approval (Continuing Reviews, Modifications, Reportable Events, and Project Closure Forms). There are also training sessions for Single IRB Model HawkIRB applications.  These are form submissions for when the investigator is proposing to be the Lead IRB with relying sites or Rely on another IRB for approval. Pre-registration is recommended for these training sessions.

Office Hours

The HSO also offers Office Hours- walk in/online assistance. These are usually held three times a week during the academic year and once a week during the summer. Individuals are able to speak to Human Subjects Office (HSO) staff to get assistance with questions about human subjects research, HawkIRB application submissions, Federal regulations, University of Iowa research policies, etc.

Presentations

Research-related topics

The IRB offers hour-long presentations on a variety of topics related to human subjects research. These presentations are designed to provide information on topics of interest to Principal Investigators, Study Coordinators, research team members, and members of the University of Iowa research community. 

Presentation topic suggestions are always welcome; email ideas to: IRB-Outreach@uiowa.edu

Classroom Presentations

The IRB Education and Compliance Program staff deliver classroom presentations on a variety of research-related topics.  We consult with course instructors to create presentations that meet the needs of the students, on topics such as:

  • Requirements for course-related student projects
  • When and why IRB approval is required
  • How to ask whether IRB approval is necessary using the Human Subjects Research Determination (HSRD)
  • What to expect from the IRB review process
  • Ethical conduct of human subjects research
  • Flexibility in the federal regulations regarding IRB review and informed consent
  • Ethical conduct of human subjects research

A recording of the general IRB overview presentation is available in the IRB ICON Course for Researchers. This presentation provides a good orientation to the UI IRB and the IRB approval requirements for human subjects research. It is an excellent supplemental lecture for any research methods or responsible conduct of research course. It is ideal for students/trainees doing research as a course requirement or as an honors, Master’s or doctoral dissertation.

This presentation covers the following:

  • Guidelines for human subjects research: why and when IRB approval is required
  • Basic ethical principles for the conduct of human subjects research
  • Student Principal Investigator (PI) training requirements
  • What to expect from the IRB review process
  • Research off campus or outside the United States
  • Course-related student projects

Contact IRB Education and Outreach Program staff(link sends e-mail) to schedule a classroom presentation. We will attend however the class is meeting, in-person or by Zoom.

ICON Courses

University of Iowa faculty, staff, trainees, and students can access:

  • Recordings of the HawkIRB trainings that are required for student Principal Investigators (but available to everyone in the UI research community)
  • Back issues of Medical Ethics Advisor Newsletter
  • HawkIRB Overview
  • Recordings on additional topics of interest to human subjects researchers

For additional information, see the ICON content outline for a comprehensive list of all available courses.

If you have questions or need any assistance with the recordings or materials in this ICON course, please contact IRB-Outreach@uiowa.edu(link sends e-mail).

Click here for the log-in screen.

UI Investigators Guide 

The UI Investigators Guide is also a helpful resource for conducting research at The University of Iowa.  This guidance document represents the Human Subjects Office/IRB’s current thinking on applying federal, state and local human subjects research policies to human subjects research conducted under the University of Iowa’s Federalwide Assurance.  Content can be found quickly by clicking on your topic of interest in the Table of Contents, or perform your own text search. 

HawkIRB Help Messages 

Finally, we  offer assistance while you complete the New Project Application.  Many application questions have blue circles with a white “i” in the middle.   These are called Help Messages.  Help Messages give additional information about what information should be provided in each question.

Creating a HawkIRB New Project Form

Note: The HawkIRB system considers the person who creates the new project form to be the Principal Investigator. If you are completing the application for someone else, the PI must name you as a HawkIRB Delegate and you MUST log in as a delegate of the PI.

All IRB applications are submitted through HawkIRB.  The HawkIRB system is accessible from the Human Subjects Office web site.  The link is one of the gold buttons at the top of the homepage. There is also a link halfway down the page.

The first time you log into the system, you will be prompted to review your user profile.  Make any necessary changes and click Save and Continue.  Once in your HawkIRB inbox, select New Project Application. Note that you cannot link to every part of the application initially - HawkIRB is a smart application, meaning certain sections of the application will open and close based on how you answer previous questions.

As you work through the application, be sure to click on "Back/Save", "Index/Save", or "Continue/Save" at the top and bottom of the HawkIRB screen to save your answers.  DO NOT navigate through the application using your web browser buttons.  You can access your application at any time under "Draft Forms" in your HawkIRB inbox prior to submission. “Draft Forms’ allows a PI/delegate to work through the application and can be saved throughout the process.  The HawkIRB application does not need to be completed all at once.

The HSO/IRB will not see your application until you submit it.  Feel free to start an application to get a feel for the form and the questions; it does not have to be submitted to the IRB.

Reviewing applications prior to submission

You can view an application that is in draft form in HawkIRB.  Under Draft Forms in your Inbox, click on “review” (at the far right) for the appropriate application.  In the upper right corner, click on “View a printer friendly version of this form”.  This will open the entire application in a new window.

Keep in mind that HawkIRB is a “smart” application - the way you answer certain questions will open and close different questions.  The application has very complicated skip patterns built into the forms.  It is not possible to view all of the questions at one time.

Viewing a consent form template

The consent template is only available from the attachment page within a HawkIRB application.  The system inserts specific template language into the consent template based on the description of the study in the HawkIRB application.  Investigators are strongly encouraged to complete the entire HawkIRB application BEFORE generating the consent template on the form attachments page.

There are different consent templates available in HawkIRB.  Each of these templates include the IRB stamp in the upper right hand corner and is required on all consent documents and recruiting material.  The consent templates include:

  • Informed consent for adults/teenagers
  • Assent for minors or cognitively impaired adults 
  • Consent letter 
  • Exempt information sheet
  • Multiple consent summary templates
  • Blank document with IRB stamp

 If you would like to see a general template before you are ready to complete the application, follow these steps:

  • Log into HawkIRB.
  • Click on "New Project ".  (You don't have to submit this project and can delete it at any time.)
  • Click on “Project Introduction” to access the application - a few questions must be completed in the application for the consent template to be accessible: 
    • I.1-  Select the IRB
    • I.2-  Fill in a project title
    • IV.1-  Choose Regular review
  • Be sure to click "Back/Save", "Index/Save", or "Continue/Save" to save your answers.  After completing IV.1, click "Index/Save", then "Consent Forms & Other Attachments."  
  • Scroll to the attachment category titled ”Consent & Assent Document Types”.  In the drop-down menu, select Informed consent (for teenagers and older). 
  • NOTE: Downloading the Informed Consent template before completion of your application will result in missing sections.  This should be done only to ascertain a general idea of the Informed Consent format.  After completion of the application, download another Informed Consent template, and make your edits on this document