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 2017: Introduction to the IRB and Human Subjects Research

1/13 (Friday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

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

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

 

1/27 (Friday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

1:00 pm-2:00 pm: The Elements of Informed Consent (Level 1)

2:00 pm-3:00 pm: Waivers, Alterations, and Alternative Forms of Informed Consent (Level II) 

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

February 2017: Completing Your eResearch Application

2/10 (Friday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

1:15 pm-2:45 pm: Completing eResearch Initial Applications for Human Subjects Research

2:45 pm-4:00 pm: Completing eResearch Scheduled Continuing Review and Amendment Submissions

 

2/21 (Tuesday)

NCRC Building 520, 520-1122 NCRC Building 520
1600 Huron Parkway, North Campus Research Complex (NCRC)

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

 

2/28 (Tuesday)

NCRC Building 520, 520-1122 NCRC Building 520 
1600 Huron Parkway, North Campus Research Complex (NCRC)

1:00 pm-2:30 pm: HIPAA Requirements and Waivers of Authorization

March 2017: Reporting, Data and Safety Monitoring, and Data Storage

3/3 (Friday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

 

2:00 pm-3:00 pm: Reporting Adverse Events (AEs), ORIOs, and Unanticipated Problems (UAPs)

3:00 pm-4:00 pm: Study-specific AE Reporting Plans

 

3/17 (Friday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

2:30 pm-3:30 pm: Data and Safety Monitoring Plans (DSMPs) and Data and Safety Monitoring Boards (DSMBs)

3:00 pm-4:00 pm: Storage and Retention of Data

April 2017: FDA-Regulated Research

4/27 (Thursday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

2:30 pm-4:00 pm: Research Involving Drugs and Devices

May 2017: Research with Vulnerable Populations and Completing Your eResearch Application

5/9 (Tuesday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

1:15 pm-2:45 pm: Completing eResearch Initial Applications for Human Subjects Research
2:45 pm-4:00 pm: Completing eResearch Scheduled Continuing Reports and Amendment Submissions

 

5/19 (Friday)

NCRC, Building 520, Room 1122
1600 Huron Parkway, North Campus Research Complex (NCRC)

2:00 pm-3:00 pm: Research with Children 
3:00 pm-4:00 pm: Research with Pregnant Women, Fetuses, and Neonates

June 2017: Introduction to the IRB and Human Subjects Research

June 9 (Friday)

2C108-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 23 (Friday)

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

1:30 – 2:30 p.m.: The Elements of Informed Consent (Level I)
2:30 – 3:30 p.m.: Waivers, Alterations, and Alternative Forms of Informed Consent (Level II)
3:30 – 4:30 p.m.: Writing Informed Consent Documents (Level I)

 

July 2017: Completing your eResearch Application

July 11 (Tuesday)

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

1:30 – 3:00 p.m.: Completing eResearch Initial Applications for Human Subjects Research
3:00 – 4:15 p.m.Completing eResearch Scheduled Continuing Reports and Amendment Submissions

 

July 25 (Tuesday)

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

2:00 – 3:00 p.m.: Reporting Adverse Events (AEs), ORIOs, and Unanticipated Problems (UAPs)
3:00 – 4:00 p.m.: Study-specific AE Reporting Plans

August 2017: HIPAA Regulations and Exempt and Not Regulated Applications

August 15 (Tuesday)

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

2:00 – 3:30 p.m.: HIPAA Requirements and Waivers of Authorization
3:30 – 4:30 p.m.: Exempt and Not Regulated Applications

September 2017: Data and Safety Monitoring, Data Storage, and FDA-Regulated Research

September 8 (Friday)

2C108-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 p.m.: Storage and Retention of Data

 

September 19 (Tuesday)

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

2:00 – 3:30 p.m.: Research Involving Drugs and Devices

October 2017: Completing your eResearch Application

October 24 (Tuesday)

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

1:30 – 3:00 p.m.: Completing eResearch Initial Applications for Human Subjects Research
3:00 – 4:15 p.m.: Completing eResearch Scheduled Continuing Reports and Amendment Submissions

November 2017: Research with Vulnerable Populations

November 14 (Tuesday)

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

1:30 – 2:30 p.m.: Research with Children
2:30 – 3:30 p.m.: Research with Pregnant Women, Fetuses, and Neonates