Education and Training

 

The Human Subjects Office is offering virtual HawkIRB Trainings, IRB Presentations, and IRB Office Hours (via Zoom). You may also access recorded HawkIRB trainings in the IRB ICON Course for Researchers.

 

Click on the links, or see below, for information about:

HawkIRB Training Sessions

HawkIRB is the web-based IRB application and review system.  Training sessions provide basic information about technical aspects of the HawkIRB system and guidance about content for specific sections and questions in the HawkIRB application.  These sessions are for anyone preparing to submit a HawkIRB application for the first time and for those who would like guidance about completing HawkIRB forms.

These sessions are intended to teach investigators, delegates, and research team members how to prepare HawkIRB applications to facilitate the IRB review process.  This is a four-part HawkIRB Training series. It is best to attend the two New Project sessions before attending the third training on Investigator Responsibilities after IRB Approval.

Student Principal Investigators: Attending the two New Project trainings satisfies the student PI training requirement.

See the Summer 2022 schedule of HawkIRB Trainings.

 

IRB Educational Tools

The Human Subjects Office issues guidance on a variety of topics to assist UI and VA researchers.

View the IRB Educational Tools

 

Office Hours

IRB Office Hours are for all UI faculty, staff, and Investigators, HawkIRB delegates, and research team members involved with Human Subjects research.  

No appointment necessary.  First come, first served; computers are available. HSO Staff will be available to:

  • Answer questions about conducting human subjects research.
  • Provide guidance and answer questions about the electronic application forms in the HawkIRB system.
  • Provide suggestions and guidance about study procedures that are in compliance with federal regulations and the UI IRB policies.
  • Provide guidance and answer questions about the submission of industry-initiated and industry-sponsored research projects to Western IRB (WIRB).

Summer 2022 Office Hours run June 1 through August 31.

Wednesdays, 2 - 4 pm (via Zoom)

Summer 2022 IRB Office Hours will be via Zoom: https://uiowa.zoom.us/j/97485975934

When you follow the link to the Zoom session:

  • Select “Sign In” (NOT “Join a Meeting”)
  • Choose “Sign in with SSO” (the UI Single Sign On) option
  • Enter “uiowa” as the domain
  • Sign in with your HawkID and password.

Use the Zoom link to access IRB Office Hours at the scheduled time. It is not an option to dial in. Please call the Human Subjects Office (319-335-6564) for assistance if you are unable to use Zoom for IRB Office Hours.

Please see the HSO Calendar for the dates of the Spring 2022 IRB Office Hours.

If you need assistance outside of Office Hours, call the Human Subjects Office (319-335-6564) or send an email to irb@uiowa.edu.

 

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

See the schedule for the Summer 2022 IRB presentations.

Please register to receive the Zoom link. You will receive an email confirmation message with the Zoom link. Use the SSO (UI Single Sign On) option to sign in with your HawkID and password.

A Deeper Dive into the Research Process

The Institute for Clinical and Translational Science and the Human Subjects Office are offering a five-part lecture series:

Registration is not necessary. Request the Zoom link from Dori Hinson (dori-hinson@uiowa.edu or 319-384-5282) or the IRB Education & Outreach Program (irb-outreach@uiowa.edu).

 

Lecture 1: May 5, 12-1 pm (regular Clinical Lecture Series)

Use a Sample Protocol to Create a HawkIRB Application

Prior to the lecture, attendees can use a sample protocol (PDF iconSnapeacillium for Quidmort Sample Protocol.April 2022.pdf) to draft an application in the HawkIRB Training platform. All are welcome to attend even if you are not able to prepare a draft HawkIRB application in advance. Attendees will learn:

  • How to collect everything you need to prepare a draft HawkIRB application
  • Where to put elements in the protocol in the HawkIRB application
  • Aspects of the HawkIRB application that are study-specific (not specified in a protocol)
  • When and how to request additional information from the Principal Investigator (PI), sponsor, coordinating center, or Other UI Committees involved in the review process.

Join Zoom Meeting
https://uiowa.zoom.us/j/95487581660
Meeting ID: 954 8758 1660
Find your local number: https://uiowa.zoom.us/u/aADqUK1Vl

 

Lecture 2: June 2, 12-1 pm (regular Clinical Lecture Series)

The Recruitment Process: Plan, Describe, Implement

This lecture will provide best practices for this often overlooked, yet essential, aspect of a research study. A study is doomed to fail without effective recruitment and retention of subjects. We will answer the following questions, and more!

  • Why should I plan multiple recruitment methods?
  • What should I include (or not include) in the recruitment message?
  • Do I need IRB approval for a “Dear Doctor” letter requesting referrals?
  • How do I send a UI mass email?
  • When does the IRB grant a partial waiver of HIPAA authorization?
  • What is ResearchMatch.org?
  • What support does the UI offer for study recruitment?
  • Do I need an IRB-approval stamp on recruitment materials?
  • Where do I attach recruitment materials?

Join Zoom Meeting
https://uiowa.zoom.us/j/96549440614
Meeting ID: 965 4944 0614
Find your local number: https://uiowa.zoom.us/u/adWenTI7YH

 

Lecture 3: June 9, 12-1 pm

The Informed Consent Process: An effective and ethical description of the study

Technically, the consent process begins with the recruitment message. In this lecture, we will start after a potential subject has agreed to learn more about the study. We will discuss how to use the Informed Consent Document to conduct the consent process with a “real” subject.

  • Using the IRB-approved Consent Summary and Informed Consent Document as a guide to conduct the consent process - best practices for the verbal description
  • The Gold Standard Consent Process: Read the Document, Verbal Description, Ask Questions, Think about it/Discuss with Family, Sign, Receive a Copy
  • Consent process with a Parent/Legal Guardian or Legally Authorized Representative (LAR)
  • Proper documentation on the Informed Consent Document and of the consent process
  • Record storage requirements for signed Informed Consent Documents

Join Zoom Meeting
https://uiowa.zoom.us/j/92755160106
Meeting ID: 927 5516 0106
Find your local number: 
https://uiowa.zoom.us/u/adMuM4ZU8L

 

Lecture 4: July 14, 12-1 pm

Reportable Events: Being Clear About What, When and How to Report

During this panel discussion, representatives from the Human Subjects Office, Institutional Review Board and the UI research community, will share best practices for submitting reportable events:

  • Recognizing the five types of events
  • Identifying these events during the course of a study
  • Reportable Event Forms (REFs) in HawkIRB
  • IRB review process for REFs

Pre-requisite: The Reportable Event Forms (REFs) portion of the Part 3 HawkIRB Training: Forms Submitted After IRB Approval (Modifications, Continuing Reviews, Reportable Events Forms and Project Close Forms). This HawkIRB Training is offered monthly. A recording is available in the IRB ICON Course for Researchers (in the module “HawkIRB Trainings Part 3, Part 4 and Part 5”).

Join Zoom Meeting:
https://uiowa.zoom.us/j/94861017966
Meeting ID: 948 6101 7966
Find your local number: https://uiowa.zoom.us/u/aeFNuKzxkG

 

Lecture 5: August 4, 12-1 pm (Rescheduled from May 19, 2022)

Use a Sample Protocol to create an Informed Consent Document (ICD) and Consent Summary

Attendees will use the same sample protocol (PDF iconSnapeacillium for Quidmort Sample Protocol.April 2022.pdf) and the UI IRB templates in the HawkIRB Training platform to create an Informed Consent Document and Consent Summary. During the lecture we will discuss:

  • The process of translating the protocol into lay language
  • Where to include elements of the protocol in the Informed Consent Document and Consent Summary
  • Best practices for creating a clear, concise Informed Consent Document and Consent Summary

Join Zoom Meeting:
https://uiowa.zoom.us/j/92760166468
Meeting ID: 927 6016 6468
Find your local number: https://uiowa.zoom.us/u/adiH8Nzbhf

 

 

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

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

 

IRB ICON Course for Researchers

All University of Iowa faculty, staff, trainees, and students with an active HawkID can access:

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

For additional information, see the Filecontent outline.

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

Click here for the log-in screen.

 

IRB Display and Education Materials

IRB Display

The Education and Outreach Program has a table top display about the Institutional Review Board (IRB) and the Human Subjects Office.  We welcome opportunities to set up this display and hand out educational materials at research-oriented events such as conferences and workshops, poster sessions, training events for new faculty, staff or students, etc.

Education Materials

The schedules are available to post on bulletin boards or distribute electronically to researchers at the University of Iowa (UI) and at the Veterans Affairs Health Care System (VAHCS). The Human Subjects Research Overview and HSO/IRB Overview handouts would be useful for anyone involved with conducting research at the UI or the VAHCS; including faculty, staff, trainees and student researchers.

Contact the IRB Education and Outreach Program staff regarding opportunities to set up the IRB display or distribute IRB educational materials or to receive slides for video boards.