Education

OVERVIEW

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.

IRBMED offers a variety of educational opportunities, both in-person and online.  To get started, please select one of the following options:

COURSE OFFERINGS

Until further notice, all IRBMED courses and presentations will be held online to minimize person-to-person contact during the COVID-19 outbreak. 

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 as 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.

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. Tailored informational sessions for study teams or departments are also possible. To request such a session, please contact IRBMED Education coordinator, Ray-Nitra Reynolds.

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.

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.

IRBMED Events

Button links to all Events and workshops

To register for an IRBMED event or course, select the name of the course you’d like to attend. 

 

IRBMED Monthly Course Schedule: February-April 2021

February 2021

IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance. 

 

February 10 (Wednesday), 10-11 am

Federal and Institutional Requirements for Human Research (Level I)

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 in order 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".

 

February 16 (Tuesday), 10-11:30 am

Regulatory Requirements for Research with Children, Pregnant Women, Fetuses, Neonates and Prisoners (Level II)

This course will examine the regulatory requirements for conducting research involving children, pregnant women, fetuses, neonates, and prisoners. These requirements, at 45 CFR 46 Subparts B, C and D are in addition to the basic requirements required at 45 CFR 46 Subpart A. The course will include the requirements for enrolling these populations in a research project, obtaining informed consent, assent, and obtaining parental permission, and the required procedures when an already enrolled participant becomes incarcerated.

 

February 23 (Tuesday), 10-11:30 am

Completing eResearch Applications for IRBMED Review (Level 1)

This course is intended familiarize attendees with eResearch, the university’s electronic research administration site. This course will provide a basic knowledge of working in and using eResearch. The course will examine the process for creating and submitting initial project applications, amendments and scheduled continuing reviews to IRBMED. 

 

March 2021

IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance. 

 

March 02 (Tuesday), 10-11 am

Single IRB Requirements for Multi-Site Research Involving Human Participants (Level III)

NIH policy and HHS federal regulations require certain types of federally-funded research projects involving multi-site research using the same research protocol to use a Single IRB (sIRB) model to accomplish IRB review for all participating institutions. This IRBMED course will provide an in-depth overview of sIRB requirements for multi-site research involving human subjects. In this course, you will learn the requirements for requesting IRBMED to serve as the sIRB of record for external sites (accepting oversight) and for requesting IRBMED to approve the use of an external IRB to be the sIRB of record for U-M (ceding oversight).

 

March 5 (Friday), 10-11:30 am

The Elements of Informed Consent and HIPAA Requirements (Level 1)

This course offers an overview of informed consent requirements in human research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal and institutional requirements. This course also includes a discussion of the basic requirements for HIPAA Authorization as part of the consent document and process. 

 

March 16 (Tuesday), 10-11 am

Writing Research Informed Consent Documents (Level I): 

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.

 

March 19 (Friday), 10-11:30 am

Waivers, Alterations, and Alternatives for Research Informed Consent and HIPAA Authorization (Level II)

This course offers an overview of exceptions to the requirement for informed consent in human research. Specifically, the regulations allow an IRB to grant waivers and alterations of informed consent, and waivers of documentation of informed consent, when specified criteria have been met. Additionally, Waivers and other exceptions for the requirements of HIPAA Authorization will also be discussed. 

 

March 31 (Wednesday), 10-11 am

Secondary Use and "Umbrella Project "Applications for IRBMED Review

This course will review non-standard applications for 'Not Regulated" research, secondary use projects and for projects lacking immediate plans for involvement of human participants, their data, and/or their specimens. These latter projects are sometimes referred to as "umbrella projects". The course will examine the appropriate application types for these types of projects and an overview of the submission process. "Secondary research" includes studies that involve only the re-use of private information and/or biospecimens that are collected for some other primary or initial activity. The application for projects lacking immediate plans for involvement of human participants, their data, and/or their specimens include activities such as training grants, program projects, center grants, or multi-phase studies not involving human participants until later years. 

April 2021

IRBMED courses will be online via Zoom. Select the name of a course to register your planned attendance. 

 

April 14 (Wednesday), 10-11:30 am

Reporting Requirements for Human Research: Adverse Events, ORIOs, and Unanticipated Problems (Level I)

This course will identify what constitutes an Adverse Event, ORIO, and Unanticipated Problem and review the requirements of reporting such events to the IRB in eResearch. This session will also include a discussion on when it may be appropriate to use a study specific AE reporting plan instead of the U-M standard time table for reporting adverse events to the IRB.

 

April 16 (Friday), 10-11:30 am

Basics of FDA Regulated Research: Human Research Involving Drugs and Devices (Level III)

This course will provide and introduction to the FDA requirements for conducting research with a drug or medical device, including conducting research under an IND (Investigational New Drug Application) and an IDE (Investigational Device Exemption). This course will also include an introductory discussion on the FDA's Expanded Access Program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. 

 

April 27 (Tuesday), 10-11 am

Data Safety Monitoring Boards (DSMB) and Data Safety Monitor Plans (DSMP) (Level II)

This course will review when studies are required to have a DSMP, who should implement or oversee the DSMP, and offer suggestions for developing an appropriate DSMP. In addition, the course will examine when a study is required to establish a DSMB.

 

April 30 (Tuesday), 10-11 am

Storage and Retention of Human Research Data (Level 1)

This course will review the fundamentals of maintaining confidentiality of human research data, including data encryption and protection, using secure environments and external websites, and distinguishing among anonymized, coded, and de-identified datasets. General best practices for protecting privacy and confidentially will also be discussed.

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.