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

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 human subjects’ research protection topics.  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

The education group is available to provide information regarding the IRBMED structure and processes, information on policies and regulations, and adverse events (AEs) and ORIOs. Help with using eResearch—IRBMED’s electronic application system—is also available. The education group is available to provide tailored informational sessions for study teams or departments. To request such a session, please contact 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 Privacy Board. To request this session, please contact Privacy Board coordinator, Lark Speyer.

Informed Consent

IRBMED’s 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, Brian Seabolt.

SCHEDULE

Button links to all Events and workshops

To register, click on the name of the course you’d like to attend.

All classes will start promptly.

 

January 2020

January 7 (Tuesday) 9:00 am-10:30 am 

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

2C224 – University Hospital

 

January 14 (Tuesday) 9:00 am-10:00 am 

Federal and Institutional Requirements for Human Subject Research (Level I)

F4834 – University Hospital South

 

January 21 (Tuesday) 9:00 am-10:30 am 

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

F4361 – University Hospital South

 

January 28 (Tuesday) 9:00 am-10:30 am 

Completing eResearch Applications for IRBMED Review (Level 1)

F4834 – University Hospital South

February 2020

February 11 (Tuesday) 9:00 am-10:30 am 

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

2C224 – University Hospital

March 2020

March 17 (Tuesday) 9:00 am-10:30 am 

Waivers, Alterations, and Alternative Forms of Informed Consent and Waivers and Exceptions to HIPPA Authorization (Level II)

2C224 – University Hospital

 

March 24 (Tuesday) 10:00 am-11:00 am 

Writing Informed Consent Documents (Level I)

2C224 – University Hospital

 

March 31 (Tuesday) 9:00 am-10:30 am 

Secondary Use and “Umbrella” Project Applications for IRBMED Review (Level I)

F4834 – University Hospital South

April 2020

 

April 7 (Tuesday) 9:00 am-10:00 am 

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

5340 – Taubman Health Sciences Library

 

April 14 (Tuesday) 9:00 am-10:00 am 

Storage and Retention of Human Subjects Research Data (Level 1)

3755 – Medical Sciences Building 2

 

April 21 (Tuesday) 9:00 am-10:00 am 

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

F4367 – University Hospital South

 

April 28 (Tuesday) 9:00 am-10:30 am 

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

2C224 – University Hospital

 

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.