IRB Courses

1. Introduction: A brief introduction to the Navigating Human Research Ethics & Regulatory Review with the IRB Office course is provided.
2. Human Research Foundations: A survey of human research ethics violations and key milestones throughout the United States and global history. This module contains a video on The Good, The Bad, and The Ugly of Human Experimentation and information on historical events that inform human research protection policy and guidance today, including the Tuskegee Syphilis Project and The Belmont Report.
3. Key Concepts: This short module establishes a groundwork for conducting human research by defining concepts critical to know when working with institutional review boards whose primary function is protecting participants' rights and welfare in human research protocols. Human research, the Human Research Protection Program (HRPP), institutional review,  Institutional Review Board (IRB) office, and IRB are all covered herein.
4. Understanding Review & Approval: This module offers learners insight into working with institutional review boards by outlining relevant human research regulations. Learners will gain insight into the criteria that must be met for reviewing board/members to grant approval, including general standards for exempt, expedited, and convened board reviews.
5. Vulnerable Populations: The United States Department of Health and Human Services' (DHHS) Office for Human Research Protection (OHRP) and the Food and Drug and Administration (FDA) policies on human research protections of special and vulnerable populations include that on pregnant persons, fetuses, neonates, prisoners, children. This section overviews of such policies and touches on undue influence, coercion, and research with students, employees, and other persons in subordinate positions.
6. Informed Consent: This module provides learners with the basics of the informed consent process, including the elements of informed consent that must be present in an informed consent document and the various types of waivers and alterations of informed consent that can be applied under special circumstances.
7. HIPAA & Biomedical Research: This module will be of most value to researchers working in clinical settings or with individually identifiable, private medical data. The Health Insurance Portability & Accountability Act (HIPAA) Privacy and Security Rules establish conditions under which Protected Health Information (PHI) can be used or disclosed by Covered Entities for research purposes. Biomedical research topics spanning emergency use of a test article, drug/biologic studies, device studies, and chart reviews are addressed in this module.
8. Northwestern Human Research Timeline: Every institution approaches human research and the work of institutional review boards differently. This module outlines the process researchers must follow when using Northwestern University's IRB Office services. This module is a "must-take" for anyone new to or needing of a refresher on human research at Northwestern.
9. Compliance & Education: This short module includes tips for maintaining compliance after the IRB grants initial approval, education resources, and guidance.
10. Reliance: This module differentiates local IRB review from IRB reliance and touches on single IRB review to outline the principles of collaborative research agreements for learners.
11. Resources: A brief conclusion to the Navigating Human Research Ethics & Regulatory Review with the IRB Office course is provided with resources for learners' further edification.

Quiz questions throughout the course are designed solely to inform IRB Office educational programming, The IRB Office, will not share individually identifiable results outside of the IRB Office. 

• If you are unaffiliated with Northwestern University and NOT an IRB Member please email irbtraining@northwestern.edu to inquire about access.

This module, and the course it is a part of, is a supplemental resource and not a substitute for departmental training requirements. Learners may choose modules catering to their onboarding needs, including those from Animal Use and Care (IACUC), Clinical and Translational Sciences, Libraries, Research Development, and more. A Northwestern NetID is required to access MyHR Learn, and, individual departments may post their onboarding modules on their websites.

The IRB Researcher Onboarding module addresses the following:

• IRB Office Investigator Manual
• eIRB+: IRB Office Submission and Review System
• Determining if a Study is Human Research
• Human Research Protections Training Requirements
• Principal Investigator Eligibility
• Preparing & Submitting a Human Research Study
• Reliance Planning: Required vs Optional
• Reliance Submissions in eIRB+
• Educational Tools & Events
• Resources

• Option 1: You can access this module at any time using this link: https://360.articulate.com/review/content/539cab85-326e-4e81-acef-95f789869893/review 
• Option 2: IRB members unaffiliated with Northwestern University may email irbtraining@northwestern.edu to obtain a POI account to gain access to MyHR Learn to take assigned modules for IRB service orientation.  

This module, which is part of a larger course, is a supplemental resource not a substitute for departmental training requirements. A comprehensive researcher offboarding course containing several modules from various departments across Northwestern University is available on MyHR Learn. Learners may choose from modules catering to their specific offboarding needs. A Northwestern NetID is required to access MyHR Learn, and individual departments may post their offboarding modules on their websites.

The IRB Researcher Offboarding module is brief but helpful and addresses the following:

• Closing a Study
• Transferring Principal Investigator Responsibility
• Transferring IRB Oversight
• Requesting Permission to Remain Principal Investigator
• Resources

• Option 1: You can access this module at any time using this link: https://360.articulate.com/review/content/33520a22-b4a8-4283-aa8b-4e98c9ad8028/review 
• Option 2: IRB members unaffiliated with Northwestern University may email irbtraining@northwestern.edu to obtain a POI account to gain access to MyHR Learn to take assigned modules for IRB service orientation.