IRBMED Course Schedule: July - October 2023
July 2023
IRBMED courses will be online via Zoom. Select the name of the course to register your planned attendance.
Registration requires that you log in to the U-M instance of Zoom and register with an umich.edu account (without the med domain).
July 11 (Tuesday), 11:00 am - 12:00 pm
Writing Informed Consent Documents
This course offers guidance on writing informed consent documents. The discussion will explore strategies for creating documents that are easy to read, easy to understand, and compliant with federal and IRBMED requirements.
July 11 (Tuesday), 2:00 pm - 3:00 pm
Federal and Institutional Requirements for Human Subjects Research
This course presentation will focus on the basics of conducting human research in compliance with federal regulations and institutional practices. We will examine the history of medical experimentation in humans and reflect on the development of the ethical principles upon which federal human research requirements are based. This course will also discuss some of the ethical and regulatory requirements that study teams must adhere to throughout the conduct of a research project to protect the rights and welfare of human participants and comply with Federal and Institutional Requirements for human research. In particular, this course will focus on the requirements at Subpart A of 45 CFR Part 46: Basic HHS Policy for Protection of Human Subjects, also known as the "Common Rule".
July 12 (Wednesday), 10:00 am - 11:00 am
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.
July 18 (Tuesday), 1:00 pm - 2:30 pm
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.
July 20 (Thursday), 2:00 pm - 3:00 pm
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.
July 27 (Thursday), 1:00 pm - 2:30 pm
Reporting Adverse Events, ORIOs, and Unanticipated Problems
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.
July 28 (Friday), 1:00 pm - 2:30 pm
Amendments and Scheduled 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.
August 2023
IRBMED courses will be online via Zoom. Select the name of the course to register your planned attendance.
Registration requires that you log in to the U-M instance of Zoom and register with an umich.edu account (without the med domain).
August 3 (Thursday), 10:00 am - 11:00 am
Data Safety Monitoring Boards (DSMB) and Data Safety Monitor Plans (DSMP)
A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data. This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP.
August 4 (Friday), 10:00 am - 11:00 am
This course will review the fundamentals of maintaining confidentiality of subject data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and deidentified datasets.
August 10 (Thursday), 10:00 am - 11:00 am
Not Regulated/Secondary Use/Umbrella
This course will review Exempt, Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
August 17 (Thursday), 10:00 am - 11:00 am
Subparts B, C, D - Special Populations
This course will examine the additional requirements for conducting research involving special populations. Special populations include: Lactating Women, Women of Child Bearing Potential, Cognitively Impaired Adults, College Students, Economically or Educationally Disadvantaged Persons, Patients of the Study Team, Employees, Students, or Trainees of the Study Team, and Family Members of the Study Team.
August 22 (Tuesday), 10:00 am - 11:00 am
Federal and Institutional Requirements for Human Subjects Research
This course presentation will focus on the basics of conducting human research in compliance with federal regulations and institutional practices. We will examine the history of medical experimentation in humans and reflect on the development of the ethical principles upon which federal human research requirements are based. This course will also discuss some of the ethical and regulatory requirements that study teams must adhere to throughout the conduct of a research project to protect the rights and welfare of human participants and comply with Federal and Institutional Requirements for human research. In particular, this course will focus on the requirements at Subpart A of 45 CFR Part 46: Basic HHS Policy for Protection of Human Subjects, also known as the "Common Rule".
August 23 (Wednesday), 10:00 am - 11:30 am
Amendments and Scheduled 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.
August 24 (Thursday), 10:00 am - 11:00 am
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.
August 29 (Tuesday), 1:00 pm - 2:30 pm
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.
October 2023
October 6 (Friday), 1:00 pm - 2:30 pm
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.
October 10 (Tuesday) 2:00 pm - 3:00 pm
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.
October 12 (Thursday) 1:00 pm - 2:30 pm
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.
October 13 (Friday) 1:00 pm - 2:00 pm
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.
October 17 (Tuesday) 1:00 pm - 2:00 pm
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.
October 19 (Thursday) 10:00 - 11:00 am
Not Regulated/Secondary Use/Umbrella Applications
This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
October 25 (Wednesday) 10:00 am - 11:00 am
Data and Safety Monitoring Boards and Data Safety Monitoring Plans
A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data. This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP.
October 26 (Thursday) 1:00 pm - 2:00 pm
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.
October 30 (Monday) 10:00 am - 11:00 am
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.
November 2023
November 1 (Wednesday) 3-4 pm
Federal and Institutional Requirements for Human Subject Research (Level I)
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
November 2 (Thursday) 10 - 11 am
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.
November 3 (Friday) 2-3:30 pm
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.
November 6 (Monday) 3 – 4 pm
Waivers, Alterations, and Alternative Forms of Informed Consent (Level II)
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.
November 7 (Tuesday) 10 – 11:30 am
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.
November 9 (Thursday), 2:30 - 4 pm
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.
November 14 (Tuesday) 11 am - 12 pm
Data and Safety Monitoring Boards and Data Safety Monitoring Plans
A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data. This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP.
November 15 (Wednesday) 10 – 11 am
Storage and Retention (Level 1)
This course will review the fundamentals of maintaining confidentiality of subject data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de-identified datasets.
November 16 (Thursday) 2:30 – 3:30 pm
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.
November 17 (Friday) 1 – 2:30 pm
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.
November 20 (Monday) 3 – 4 pm
Not Regulated/Secondary Use/Umbrella Applications
This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
November 28 (Tuesday) 2 – 3:30 pm
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.
November 30 (Thursday) 10 – 11 am
Federal and Institutional Requirements for Human Subject Research (Level I)
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
December 2023
December 5 (Tuesday) 1-2:30 pm
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.
December 6 (Wednesday) 9 - 10 am
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.
December 7 (Thursday), 2:30 - 4 pm
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.
December 12 (Tuesday) 2:30 – 4 pm
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.
December 14 (Thursday) 10 – 11:30 am
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.
December 15 (Friday) 1 – 2 pm
Not Regulated/Secondary Use/Umbrella Applications
This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
December 18 (Monday) 11 am - 12 pm
Data and Safety Monitoring Boards and Data Safety Monitoring Plans
A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data. This course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP.
December 21 (Thursday) 2:30 – 3:30 pm
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.