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 2018: Introduction to the IRB and Human Subjects Research

1/12 (Friday)

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

2:00 pm-3:00 pm: Federal and Institutional Requirements for Human Subject Research

3:00 pm-4:00 pm: Study Team Responsibilities 

 

1/30 (Tuesday)

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

9:00 am-10:00 am: The Elements of Informed Consent (Level 1)

10:00 am-11:00 am: Waivers, Alterations, and Alternative Forms of Informed Consent (Level II) 

11:00 am-12:00 pm: Writing Informed Consent Documents (Level I)

February 2018: Completing Your eResearch Application

2/13 (Tuesday)

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

2:00 pm-3:30 pm: Completing eResearch Initial Applications for Human Subjects Research

3:30 pm-4:45 pm: Completing eResearch Scheduled Continuing Review and Amendment Submissions

 

2/27 (Tuesday)

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

2:00 pm-3:00 pm: Exempt and Not Regulated Applications

3:00 pm-4:00 pm: HIPAA Requirements and Waivers of Authorization

March 2018: Reporting, Data and Safety Monitoring, and Data Storage

3/6 (Tuesday)

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

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

10:00 am-11:00 am: Study-specific AE Reporting Plans

 

3/20 (Tuesday)

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

9:00 am-10:00 am: Data and Safety Monitoring Plans (DSMPs) and Data and Safety Monitoring Boards (DSMBs)

10:00 am-11:00 am: Storage and Retention of Data

April 2018: FDA-Regulated Research

4/24 (Thursday)

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

9:00 am-10:30 am: Research Involving Drugs and Devices

May 2018: Research with Vulnerable Populations and Completing Your eResearch Application

5/8 (Tuesday)

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

2:00 pm-3:00 pm: Completing eResearch Initial Applications for Human Subjects Research
3:00 pm-4:00 pm: Completing eResearch Scheduled Continuing Reports and Amendment Submissions

 

5/22 (Friday)

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

9:00 am-10:00 am: Research with Children 
10:00 am-11:00 am: Research with Pregnant Women, Fetuses, and Neonates

June 2018: Introduction to the IRB and Human Subjects Research

June 5 (Tuesday)

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

9:00 – 10:00 a.m.: Federal and Institutional Requirements for Human Subject Research
10:00 – 11:00 a.m.: Study Team Responsibilities

 

June 19 (Tuesday)

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

9:00 – 10:00 a.m.: The Elements of Informed Consent (Level I)
10:00 – 11:00 a.m.: Waivers, Alterations, and Alternative Forms of Informed Consent (Level II)
11:00 a.m. – 12:00 p.m.: Writing Informed Consent Documents (Level I)

July 2018: Completing your eResearch Application

July 10 (Tuesday)

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

9:00 – 10:00 a.m.: Completing eResearch Initial Applications for Human Subjects Research
10:00 – 11:00 a.m.: Completing eResearch Scheduled Continuing Reports and Amendment Submissions

 

July 31 (Tuesday)

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

9:00 – 10:00 a.m.: Reporting Adverse Events (AEs), ORIOs, and Unanticipated Problems (UAPs)
10:00 – 11:00 a.m.: Study-specific AE Reporting Plans

August 2018: HIPAA Regulations and Exempt and Not Regulated Applications

August 14 (Tuesday)

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

9:00 – 10:00 a.m.: HIPAA Requirements and Waivers of Authorization
10:00 – 11:00 a.m.: Exempt and Not Regulated Applications

 

August 28 (Tuesday)

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

9:00 – 10:00 a.m.: Data and Safety Monitoring Plans (DSMPs) and Data and Safety Monitoring Boards (DSMBs)
10:00 – 11:00 a.m.: Storage and Retention of Data

September 2018: Data and Safety Monitoring, Data Storage, and FDA-Regulated Research and Completing your eResearch Application

September 7 (Tuesday)

Room1122 NCRC, Building 520
1600 Huron Parkway, North Campus Research Complex

3:00 – 5:00 p.m.: Research Involving Drugs and Devices

 

September 18 (Tuesday)

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

1:00 – 2:00 p.m.: Completing eResearch Initial Applications for Human Subjects Research
2:00 – 3:00 p.m.: Completing eResearch Scheduled Continuing Reports and Amendment Submissions

October 2018: Research with Vulnerable Populations

October 9 (Tuesday)

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

9:00 – 10:00 a.m.: Research with Children
10:00 – 11:00 a.m.: Research with Pregnant Women, Fetuses, and Neonates

 

October 23 (Tuesday)

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

9:00 – 10:00 a.m.: Research with Special Populations

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.