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 2019

February 2019

March 2019

3/1 (Friday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Federal and Institutional Requirements for Human Subject Research (Level 1)

 

3/13 (Wednesday)

B1C111-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Completing eResearch Applications for Human Subjects Research (Level 1)

 

3/19 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: The Elements of Informed Consent and HIPAA Authorization for Research (Level 1)
10:00 am – 11:00 am: Waivers, Alterations, and Alternative Forms of Informed Consent & Waivers of HIPAA Authorization (Level II)

 

3/22 (Friday)

2C108-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

3:00 pm-4:00 pm: Writing Informed Consent (Level 1)

 

3/26 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Not Regulated, Secondary Use, and “Umbrella” eResearch Applications (Level I)

April 2019

4/2 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Research Involving Drugs and Devices (Level III)

 

4/12 (Friday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Regulatory Requirements for Research with Children, Pregnant Women, Fetuses, Neonates and Prisoners (Level II)

 

4/19 (Thursday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Reporting Adverse Events, ORIOs, and Unanticipated Problems (Level 1)

 

4/30 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Data and Safety Monitoring Plans and Data and Safety Monitoring Boards (Level II)

May 2019

5/17 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Storage and Retention of Research Data (Level 1)

 

5/21 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:00 am: Completing eResearch Applications for Human Subjects Research (Level 1)

 

5/31 (Friday)

2C108-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

2:00 pm-3:00 pm: Not Regulated, Secondary Use, and “Umbrella” eResearch Applications (Level I)

June 2019

July 2019

August 2019

8/28 (Wednesday)

2813 – Medical Science Building II 
1137 Catherine St, Ann Arbor, MI 48109

9:30 am-10100 am: Not Regulated, Secondary Use, and “Umbrella” eResearch Applications (Level I) 

September 2019

9/10 (Tuesday)

2G207 - University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:30 am: The Elements of Informed Consent and HIPAA Authorization for Research (Level I) 

9/17 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

10:30 am-11:30 am: Writing Informed Consent Documents (Level I) 

9/25 (Wednesday)

3817 – Medical Science Building II 
1137 Catherine St, Ann Arbor, MI 48109

9:00 am-10:30 am: Waivers, Alterations, and Alternative Forms of Informed Consent & Waivers of HIPAA Authorization (Level II)

October 2019

10/1 (Tuesday)

2C224-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:30 am: Research Involving Drugs and Devices (Level III)

 

10/8 (Tuesday)

5303 – Taubman Health Sciences Library 
1135 E. Catherine St, Ann Arbor, MI 48109

9:00 am-10:30 am: Regulatory Requirements for Research with Children, Pregnant Women, Fetuses, Neonates and Prisoners (Level II)

 

10/15 (Tuesday)

2813 – Medical Science Building II 
1137 Catherine St, Ann Arbor, MI 48109

9:00 am-10:30 am: Reporting Adverse Events, ORIOs, and Unanticipated Problems (Level I)

November 2019

11/6 (Wednesday)

2C108-UH University Hospital 
1500 East Medical Center Drive, Medical Campus

9:00 am-10:0 am: Data Safety Monitoring Boards (DSMB) and Data Safety Monitor Plans (DSMP) (Level II)

 

11/12 (Tuesday)

3813 – Medical Science Building II 
1137 Catherine St, Ann Arbor, MI 48109

9:00 am-10:00 am: Storage and Retention of Human Subjects Research Data (Level 1)

 

11/19 (Tuesday)

3813 – Medical Science Building II 
1137 Catherine St, Ann Arbor, MI 48109

9:00 am-10:30 am: Single IRB Requirements for Multi-Site Research Involving Human Subjects

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.