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Institutional Review Board (IRB) ICON Classes ICON logo

To access the content covered in the How to Complete a New Project Application training session, complete the following:

HawkIRB Inbox
HawkIRB Project Summary Page
HawkIRB New Application, Index and Help Msg
HawkIRB Sections I-XII
HawkIRB Attachments Page
HawkIRB Workflow System
Creating an Informed Consent Document

To access the content covered in Investigator Responsibilities After IRB Approval: Continuing Reviews, Modifications, Reportable Event Forms (REFs), and Closing a Project training session, complete the following:

HawkIRB Project Summary Page
HawkIRB Modifications
HawkIRB Continuing Review
HawkIRB Reportable Event Form
HawkIRB Project Closure Form
HawkIRB Workflow System

IRB Core Courses
Course # WIRBCC

Advertising Description: These courses will provide an overview of many important aspects researchers should know when conducting research at The University of Iowa. There are two units of the IRB Core Courses for UI employees. The units are identical except for the last module. Unit 2 includes the module entitled UI Human Research Protections – An Overview and provides more general information geared toward any student audience. Unit 3 includes the module entitled Unit Regulations, Policies and Best Practices and is more 'practical' and specific to university practices for the graduate student group that requested it. Therefore, the unit selected will depend on the objective for taking the course, the requirement of your department and/or the desired length of the presentation.

Key Topics: Human Subjects Research Protections, Regulations, UI Policies and Best Practices, UI researchers

Objectives: (At the end of this course participants will be able to…) Understand human subjects research protections, University of Iowa regulations, policies and best practices when conducting human subjects and implications of non-compliance with federal regulations and University of Iowa policies.

These courses are designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB

University of Iowa Human Research Protections - An Overview
Course # WHSRP1

Advertising Description: This course will provide an overview of human subjects research protections at The University of Iowa.

Key Topics: Human Subjects Research, Overview of Research Protections

Objectives: (At the end of this course participants will be able to…) Have a basic understanding of human subjects research protections at The University of Iowa.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

Creating an Informed Consent Document
Course # WHSRP2

Advertising Description: This course will assist researchers in creating an Informed Consent Document in HawkIRB.

Key Topics: Human Subjects Research, Creating an Informed Consent Document

Objectives: (At the end of this course participants will be able to…) Create an Informed Consent Document, including the required elements of consent by using the HawkIRB consent template.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

Informed Consent and Assent - An Overview
Course # WHSRP4

Advertising Description: This course will provide researchers with the best practices for obtaining and documenting informed consent and assent in human research studies.

Key Topics: Human Subjects Research, Informed Consent and Assent Process

Objectives: (At the end of this course participants will be able to…) Understand the ethical foundation, federal regulations and UI policies for Informed Consent Documents and the process of obtaining consent and or assent.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

Subject Privacy and Data Confidentiality
Course # WHSRP5

Advertising Description: This course will present researchers with important privacy and confidentiality issues to consider when designing and conducting human subjects research.

Key Topics: Human Subjects Research, Privacy and Confidentiality

Objectives: (At the end of this course participants will be able to…) Have a solid understanding of privacy and confidentiality issues to consider when designing and conducting human subjects research.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

Managing Risk in Research
Course # WHSRP6

Advertising Description: This course will provide information on managing risk, including identifying various types of risk, minimizing risks and disclosing risks to participants.

Key Topics: Human Subjects Research, Managing Risks in Research

Objectives: (At the end of this course participants will be able to…) Evaluate various types of risks, measures to minimize these risks and understand the requirement for disclosing risks to participants.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

Do I Need IRB Review
Course # WHSRD1

Advertising Description: This course will provide guidance to University of Iowa researchers who may be uncertain if their study meets the definition of human subjects research as defined in federal regulations and provide instructions on the proper means to determine if the project will need IRB review.

Key Topics: Human Subjects Research, HawkIRB Research Determinations Form

Objectives: (At the end of this course participants will be able to…) Submit a Human Subjects Research Determination form to HawkIRB.

This course is designed for: Investigators and researchers involved in human subjects research and who submit projects for IRB review and approval.

HawkIRB Inbox
Course # WIRB0A

Advertising Description: This course will assist researchers in understanding the HawkIRB Inbox.

Key Topics: Human Subjects Research, HawkIRB Inbox

Objectives: (At the end of this course participants will be able to…) Understand the Inbox as the dashboard to the HawkIRB system, identify the four sections and be able to navigate to and from the Inbox.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB New Application
Course # WIRB0B

Advertising Description: This course will assist researchers in creating a new project application; using the new project index, and the help messages that provide guidance for required content in the new project application.

Key Topics: Human Subjects Research, New Project Application, Help Messages

Objectives: (At the end of this course participants will be able to…) Create a new project application, using the project index and help messages.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 01 Project Introduction
Course # WIRB01

Advertising Description: This course will assist researchers in completing HawkIRB Section 1 Project Introduction.

Key Topics: Human Subjects Research, Section I Project Introduction

Objectives: (At the end of this course participants will be able to…) Correctly complete Section I of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 02 Research Team
Course # WIRB02

Advertising Description: This course will assist researchers in completing Section 2 of the HawkIRB application.

Key Topics: Human Subjects Research, Section II Research Team

Objectives: (At the end of this course participants will be able to…) Correctly complete Section II-Research Team of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 03 Funding Other Support
Course # WIRB03

Advertising Description: This course will assist researchers in completing Section 3 of the HawkIRB application.

Key Topics: Human Subjects Research, Section III Funding

Objectives: (At the end of this course participants will be able to…) Correctly complete Section III-Funding of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 04 Project Type
Course # WIRB04

Advertising Description: This course will assist researchers in completing Section 4 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section IV

Objectives: (At the end of this course participants will be able to…) Correctly complete Section IV-Project Type of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 05 Other Committee Review
Course # WIRB05

Advertising Description: This course will assist researchers in completing Section 5 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section V

Objectives: (At the end of this course participants will be able to…) Correctly complete Section V-Other Committee Review of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 06 Subjects
Course # WIRB06

Advertising Description: This course will assist researchers in completing Section 6 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VI

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VI-Subjects of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 07A Project Description
Course # WIRB7A

Advertising Description: This course will assist researchers in completing Section 7A of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VII.A

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VII.A-Project Description of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 07B Project Description
Course # WIRB7B

Advertising Description: This course will assist researchers in completing Section 7B of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VII.B

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VII.B-Project Description of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 07C Project Description
Course # WIRB7C

Advertising Description: This course will assist researchers in completing Section 7C of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VII.C

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VII.C-Project Description of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 07D Project Description
Course # WIRB7D

Advertising Description: This course will assist researchers in completing Section 7D of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VII.D

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VII.D-Project Description of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 07E Project Description
Course # WIRB7E

Advertising Description: This course will assist researchers in completing Section 7E of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VII.E

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VII.E-Project Description of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 08 Risks
Course # WIRB08

Advertising Description: This course will assist researchers in completing Section 8 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section VIII

Objectives: (At the end of this course participants will be able to…) Correctly complete Section VIII-Risks of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 09 Benefits
Course # WIRB09

Advertising Description: This course will assist researchers in completing Section 9 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section IX

Objectives: (At the end of this course participants will be able to…) Correctly complete Section IX-Benefits of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 10 Privacy and Confidentiality
Course # WIRB10

Advertising Description: This course will assist researchers in completing Section 10 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section X

Objectives: (At the end of this course participants will be able to…) Correctly complete Section X-Privacy and Confidentiality of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 11 Data Analysis
Course # WIRB11

Advertising Description: This course will assist researchers in completing Section 11 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section XI

Objectives: (At the end of this course participants will be able to…) Correctly complete Section XI-Data Analysis of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Section 12 Future Research
Course # WIRB12

Advertising Description: This course will assist researchers in completing Section 12 of the HawkIRB application.

Key Topics: Human Subjects Research, HawkIRB Section XII

Objectives: (At the end of this course participants will be able to…) Correctly complete Section XII-Future Research of the HawkIRB application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Attachments Page
Course # WIRB14

Advertising Description: This course will assist researchers in attaching items in the proper categories, uploading revised attachments and deleting attachments that are no longer in use.

Key Topics: Human Subjects Research, HawkIRB Attachments

Objectives: (At the end of this course participants will be able to…) Attach items in the proper categories, uploading revised attachments and deleting attachments that are no longer in use.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Workflow System
Course # WIRB15

Advertising Description: This course will assist researchers in understanding the workflow system that documents communication between the IRB and the researcher.

Key Topics: Human Subjects Research, HawkIRB Workflow System

Objectives: (At the end of this course participants will be able to…) Understand the Workflow System that documents communication between the IRB and researcher.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Project Summary
Course # WIRB16

Advertising Description: This course will assist researchers in understanding the project summary page that is created with every project submitted to HawkIRB and its contents.

Key Topics: Human Subjects Research, HawkIRB Project Summary Page

Objectives: (At the end of this course participants will be able to…) Understand the HawkIRB project summary page, its location and contents.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Modifications
Course # WIRB17

Advertising Description: This course will assist researchers in completing modifications to existing projects in HawkIRB.

Key Topics: Human Subjects Research, Modification Forms

Objectives: (At the end of this course participants will be able to…) Correctly complete modification forms to existing projects in HawkIRB.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Continuing Review
Course # WIRB18

Advertising Description: This course will assist researchers in completing a continuing review application.

Key Topics: Human Subjects Research, Continuing Review Application

Objectives: (At the end of this course participants will be able to…) Correctly complete a HawkIRB continuing review application.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Reportable Event Form
Course # WIRB19

Advertising Description: This course will assist researchers in understanding how to complete and submit a reportable event form in HawkIRB.

Key Topics: Human Subjects Research, HawkIRB Reportable Event Form

Objectives: (At the end of this course participants will be able to…) Navigate to, complete and submit a reportable event form in HawkIRB.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

HawkIRB Project Closure Form
Course # WIRB20

Advertising Description: This course will assist researchers in completing a HawkIRB Project Closure Form.

Key Topics: Human Subjects Research, HawkIRB Project Closure Form

Objectives: (At the end of this course participants will be able to…) Correctly complete the HawkIRB Project Closure Form.

This course is designed for: Investigators and researchers involved in human subjects research and who submit applications to HawkIRB.

Off Campus Research IRB01
Course # WOCR01

Advertising Description: This course will assist biomedical researchers that plan to conduct research off-campus, either in the US or abroad.

Key Topics: Human Subjects Research, Off-Campus Research – IRB-01

Objectives: (At the end of this course participants will be able to…) Address the additional steps and requirements for conducting research off-campus, as well as specific issues to consider.

This course is designed for: Investigators and researchers who will conduct biomedical human subjects research off-campus.

Off Campus Research IRB02
Course # WOCR02

Advertising Description: This course will assist behavioral and social science researchers who plan to conduct research off-campus, either in the US or abroad.

Key Topics: Human Subjects Research, Off-Campus Research – IRB-02

Objectives: (At the end of this course participants will be able to…) Address the additional steps and requirements for conducting behavioral & social science research off-campus, as well as specific issues to consider.

This course is designed for: Investigators and researchers who will conduct behavioral & social science human subjects research off-campus.

Regulations Policies and Best Practices
Course # WREG00

Advertising Description: This course will provide an overview of many important aspects researchers should know when conducting research at the University of Iowa.

Key Topics: Human Subjects Research, Regulations, UI Policies and Best Practices

Objectives: (At the end of this course participants will be able to…) Understand the University of Iowa regulations, policies and best practices when conducting human subjects and implications of non-compliance with federal regulations and University of Iowa policies.

This course is designed for: Investigators and researchers involved in human subjects research at The University of Iowa and who submit applications to HawkIRB.

IRB01 Member Training Part 1
Course # WMT011

Advertising Description: This course will educate IRB members on the roles and responsibilities of all IRB members, including the primary review role, the use of the primary reviewer checklist and criteria for approval in the review of HawkIRB applications.

Key Topics: Human Subjects Research, IRB-01 Member Training

Objectives: (At the end of this course participants will be able to …) Understand the roles and responsibilities of all IRB members, the use of the primary reviewer checklist and the criteria for approval in the review of HawkIRB applications.

This course is designed for: IRB-01 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB01 Member Training Part 2
Course # WMT012

Advertising Description: This course will educate IRB members on the Human Subjects Office (HSO) staff application pre-screen process, post-approval IRB oversight responsibilities and will present a case of IRB noncompliance with federal regulations as reported in a FDA warning letter.

Key Topics: Human Subjects Research, IRB-01 Member Training

Objectives: (At the end of this course participants will be able to …) Understand the HSO application pre-screen process, post-approval IRB oversight responsibilities, and recognize instances of IRB noncompliance as presented in a FDA Warning Letter.

This course is designed for: IRB-01 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB01 Member Training Part 3
Course # WMT013

Advertising Description: This course will review contemporary cases of ethical issues in biomedical research to assist IRB members in practically applying the ethical principles outlined in the Belmont Report to the review of research applications.

Key Topics: Human Subjects Research, IRB-01 Member Training

Objectives: (At the end of this course participants will be able to …) Apply ethical principles outlined in the Belmont Report to the review of research applications after a review of contemporary cases of ethical issues in biomedical research.

This course is designed for: IRB-01 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB02 Member Training Part 1
Course # WMT021

Advertising Description: This course will educate IRB-02 members on the roles and responsibilities of all IRB members, including the primary review role, the use of the primary reviewer checklist and criteria for approval in the review of HawkIRB applications.

Key Topics: Human Subjects Research, IRB-02 Member Training

Objectives: (At the end of this course participants will be able to …) Understand the roles and responsibilities of all IRB members, the use of the primary reviewer checklist and the criteria for approval in the review of HawkIRB applications.

This course is designed for: IRB-02 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB02 Member Training Part 2
Course # WMT022

Advertising Description: This course will educate IRB-02 members on the Human Subjects Office (HSO) staff application pre-screen process, post-approval IRB oversight responsibilities and will present a case of IRB noncompliance with federal regulations as reported in a FDA warning letter.

Key Topics: Human Subjects Research, IRB-02 Member Training

Objectives: (At the end of this course participants will be able to …) Understand the HSO application pre-screen process, post-approval IRB oversight responsibilities, and recognize instances of IRB noncompliance as presented in a FDA Warning Letter.

This course is designed for: IRB-02 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB02 Member Training Part 3
Course # WMT023

Advertising Description: This course will review contemporary cases of ethical issues in behavioral and social science research to assist IRB members in practically applying the ethical principles outlined in the Belmont Report to the review of research applications.

Key Topics: Human Subjects Research, IRB-02 Member Training

Objectives: (At the end of this course participants will be able to …) Apply ethical principles outlined in the Belmont Report to the review of behavioral and social science research applications after a review of contemporary cases of ethical issues in human subjects research.

This course is designed for: IRB-02 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB03 Member Training Part 1
Course # WMT031

Advertising Description: This course will educate IRB members on the roles and responsibilities of all IRB members, including the primary review role, the use of the primary reviewer checklist and criteria for approval in the review of HawkIRB applications.

Key Topics: Human Subjects Research, IRB-03 Member Training

Objectives: (At the end of this course participants will be able to …) Understand the roles and responsibilities of all IRB members, the use of the primary reviewer checklist and the criteria for approval in the review of HawkIRB applications.

This course is designed for: IRB-03 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB03 Member Training Part 2
Course # WMT032

Advertising Description: This course will educate IRB members on the Human Subjects Office (HSO) staff application pre-screen process, post-approval IRB oversight responsibilities and will present a case of IRB noncompliance with federal regulations as reported in a FDA warning letter.

Key Topics: Human Subjects Research, IRB-03 Member Training

Objectives: (At the end of this course participants will be able to …) Understand the HSO application pre-screen process, post-approval IRB oversight responsibilities, and recognize instances of IRB noncompliance as presented in a FDA Warning Letter.

This course is designed for: IRB-03 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB03 Member Training Part 3
Course # WMT033

Advertising Description: This course will review contemporary cases of ethical issues in biomedical research to assist IRB members in practically applying the ethical principles outlined in the Belmont Report to the review of research applications.

Key Topics: Human Subjects Research, IRB-03 Member Training

Objectives: (At the end of this course participants will be able to …) Apply ethical principles outlined in the Belmont Report to the review of research applications after a review of contemporary cases of ethical issues in biomedical research.

This course is designed for: IRB-03 members involved in the review and approval of human subjects research proposals at The University of Iowa.

IRB International Research and Collaboration with
Non-UI or Non-VA Researchers

Course # WINTNR

Advertising Description: This course will cover the additional responsibilities and approvals required for investigators who plan to conduct research outside the U.S. or in collaboration with non-UI researchers.

Key Topics: International Research; Collaborating with non-UI researchers

Objectives: (At the end of this course participants will be able to…) Understand and comply with the additional investigator responsibilities required when undertaking research outside the U.S. or in collaboration with non-UI researchers.

This course is designed for: Researchers conducting research outside the U.S. or in collaboration with non-UI researchers.

IRB Research Subject Compensation Policy
Course # WCHP00

Advertising Description: This course will address the UI policy requirements that apply when compensating research subjects.

Key Topics: Research Subject Compensation, UI Cash Handling Policy

Objectives: (At the end of this course participants will be able to…) Comply with the requirements of the UI Cash Handling policy when compensating research subjects.

This course is designed for: Researchers who will compensate subjects for participation in research.

IRB UIHC Research Record of Consent HIPAA and HITECH
Course # WROC00

Advertising Description: The UIHC Privacy Officer, presents the UIHC policy for documenting patient's participation in research studies using the Record of Informed Consent and addresses the privacy concerns associated with electronic transmission of protected health information as defined under HIPAA and HITECH.

Key Topics: UIHC Record of Consent, HIPAA and HITECH

Objectives: (At the end of this course participants will be able to…) Understand when a Record of Consent is required, and the privacy concerns associated with electronic transmission of protected health information under HIPAA and HITECH.

This course is designed for: Researchers conducting research in UIHC that access or use Protected Health Information.

Updated: January 2012