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.

 

Schedule

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