Education

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 United States and global history, this module contains a video on The Good, The Bad, and The Ugly of Human Experimentation as well as information on events throughout history that inform the nature of human research protections 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 to protect the rights and welfare of participants in human research protocols. Human research, 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 provides an overview of such policies and touches on undue influence, coercion, and researching 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 using Northwestern University's IRB Office services must follow. This is a "must-take" for anyone new to or in need of a refresher of human research at Northwestern.
9. Compliance & Education: This short module includes tips for maintaining compliance after initial protocol approval is granted by the IRB Office along with office education resources and training 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, and results will not be utilized for any other purpose or shared with individuals outside the office. 

A certificate may be issued upon full completion of this course. Those utilizing this course as an instructional tool are free to accept the certificate as it meets their needs.  

IRB members unaffiliated with Northwestern University will need to email irbtraining@northwestern.edu to obtain a POI account to gain access to MyHR Learn to take assigned modules for IRB service orientation.