IRBMED Education
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IRBMED’s Education Program was designed and developed through collaboration with members of the research community. It is our goal to make sure this program is tailored to meet the ongoing educational needs of the research community.

Current Course Offerings
IRBMED Seminar Series
U-MIC
Other Human Research Education and/or Training (including PEERRS)
Current Course Offerings

Until further notice, all IRBMED courses and presentations will be held online via Zoom meetings.

IRBMED offers a range of courses to provide the research community with education to improve understanding of regulatory requirements, eResearch application completion, and special topics related to human subjects research.  Below is IRBMED’s Course Offering grid, outlining the different categories each course is a part of and the level of experience each course was designed for. Additionally, the Course Description document specifically explains the intent of each course.

Upcoming IRBMED Courses All IRBMED Courses
Introduction to sIRBs
This course will identify the Single IRB model for Multi-Site research, show the regulatory requirements of sIRB review and the exceptions to sIRB requirements, and explain sIRB requests of IRBMED as sIRB (accepting oversight), External IRB as sIRB (ceding oversight), and UofM as the Coordinating Center.
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FDA Research Involving Drugs and Devices
This course will review what research is subject to FDA oversight, highlight the differences between OHRP and FDA regulations, learn the responsibilities of sponsors, investigators, and the IRB when conducting and reviewing research involving drugs and devices, and examine the requirements for conducting research with a drug or biologic/medical device.
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Subparts B, C, and D - Special Populations
This course will examine the additional regulatory requirements for conducting research involving pregnant women, fetuses, neonates, children, and prisoners, including the requirements for these populations in a research project and obtaining informed consent.
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Federal and Institutional Requirements for Human Subject Research
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
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Elements of Informed Consent
This course offers an overview of informed consent in human subject research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal requirements.
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Introduction to eResearch
This course is intended for those unfamiliar with eResearch, the university’s electronic research administration site. This course will provide a basic knowledge of working in and using eResearch while examining the process for creating and submitting an initial project application.
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Waivers, Alterations, and Alternative Forms of Informed Consent
This course offers an overview of some special situations relating to informed consent. Specifically, waivers and alterations of informed consent, waivers of documentation of informed consent, and obtaining consent from non-English speakers.
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Reporting AEs, ORIOs, and UaPs
This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and how such events impact risk to subjects. Additionally, the course will review the requirements of reporting such events to the IRB and other entities.
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Amendments and Continuing Reviews
This course is a follow-up to Initial Project Applications and will examine the process for submitting amendments and scheduled continuing reviews to IRBMED using eResearch once a project’s initial application has been approved.
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Consultations

The University of Michigan IRBMED offers consults on various topics related to the protection of human participants in research. These educational consults are designed for small groups (typically less than 10 people).  We can attend research team or divisional meetings and present on the following topics:

Compliance

This is an informal overview of the process that is followed should a subject file a complaint about your project, including information about what is Serious or Continuing Non-Compliance. You’ll also be provided with tips and examples regarding how to avoid non-compliance issues.  To request this session, please contact IRBMED at 734-763-4768.

General Education

General education sessions can be required to provide information regarding the IRBMED structure and processes, information on policies and regulations, and adverse events (AEs), and Other Reportable Information or Occurrences (ORIOs). Help with using eResearch—the university’s electronic research administration site—is also available. Continuing education credits are not offered for IRBMED education sessions, however, a record of attendance will be provided opon request. Tailored informational sessions for study teams or departments are also possible. To request such a session, please contact IRBMED Education coordinator by emailing [email protected].

HIPAA/Privacy Board

This is a brief overview of HIPAA regulations as they relate to research, with a focus on how and when to request a Waiver of HIPAA Authorization.  This session also includes information regarding exempt and not-regulated application types and the functions of the Privacy Board. To request this session, please contact Privacy Board coordinator, Lark Speyer, by emailing [email protected].

Informed Consent

IRBMED’s senior technical writer can offer basic suggestions to help you write informed consent documents that are clear to subjects and compliant with federal and IRBMED requirements. For more information, please contact Technical Writer Senior, Brian Seabolt, by emailing [email protected].

Other Human Subjects Education & Training

In addition to the IRBMED offerings, UM offers other research education opportunities. There are non-UM education/training available as well.

University of Michigan

HIPAA Training for UM Researchers

Michigan Medicine requires a web-based HIPAA training module for the entire workforce, including faculty, staff, students, volunteers, contract employees, and others. Identify the module most appropriate to your role at the HIPAA Training Website. To enter a module in Cornerstone Learning:

  1. Log in to the portal through https://michmed.csod.com/samldefault.aspx
  2. Click the magnifying glass to “Search” on the upper right-hand side
  3. Enter “priv” (the beginning of the ‘code’ for the HIPAA modules) or HIPAA

PEERRS

UM requires this web-based Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS) be completed by anyone engaged in or associated with human subjects research. Key personnel--principal investigators, co-investigators, faculty advisors, study coordinators, and project managers--must complete PEERRs before the IRB can approve a study. Responsibility for assuring all others complete PEERRS falls to the principal investigator. For more information, visit the PEERRS Website.

HRPP Education Resources

U-M Human Research Protections Program (HRPP) hosts links to other education modules available, including good clinical practice (GCP) training for study team members on NIH-funded clinical trials. For more information, visit the HRPP Education Resources site.

Michigan Institute of Clinical and Health Research (MICHR)

The Michigan Institute of Clinical and Health Research Education Program offers clinical research educational opportunities and resources to faculty and staff within UM. For more information, visit the MICHR Website.

Statistics

The Center for Statistical Consultation and Research (CSCAR) is a service and research unit of UM, administratively located in the Office of the Vice President for Research. Its staff provides statistical services to faculty, primary researchers, graduate students and staff of the University. To learn more about educational opportunities about statistical analysis in biomedical and behavioral research, visit the CSCAR Website.

Investigator 101

This two-part program provides basic information on the topics of ethics in research and investigator compliance with federal regulations. Part 1 presents the history of research ethics and key ethical issues are explored in terms of application to research design and study execution. Regulatory compliance topics as they apply to investigators are presented in Part 2. Examined is the IRB approval process, obtaining informed consent, continuing review and proper study documentation and record retention practices. It can be viewed online. You can also sign out a copy of the computer CD "Investigator 101" by emailing the IRBMED office.

OHRP Educational Activities & Materials

OHRP provide educational videos on a variety of topics regarding the Department of Health and Human Services (DHHS) regulations for the protection of human subjects of research described at 45 CFR 46. Each video is approximately 20-25 minutes in length.

If you have technical difficulties with viewing the videos, please see: https://videocast.nih.gov/faq/. For more information, please see: https://www.hhs.gov/ohrp/education-and-outreach/index.html.

Collaborative IRB Training Initiative (CITI)

This nationally recognized web course provides advanced educational modules that supplement those in PEERRS. A certificate issued upon completion of each module. The courses are free, but there is a charge to obtain Continuing Education Credits if you want/need them. For more information, visit the CITI Website.

Contact Us
Institutional Review Boards (IRBMED)
Room 3214
North Campus Research Complex, Building 520
2800 Plymouth Road
Ann Arbor, MI 48109-2800
Phone: 734-763-4768
About Us
Institutional Review Boards (IRBMED) is a unit of the Medical School Office of Research, where our mission is to foster an environment of innovation and efficiency that serves the Michigan Medicine research community and supports biomedical science from insight to impact.
We're Accredited

IRBMED has full accreditation by they Association for the Accreditation of Human Research Protection Programs, Inc.

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