IRB Update Meeting

1
IRB Update Meeting

• March 18
• Babcock Auditorium

2
Agenda

• Ed Musselwhite from Investigative Associates and
  Consultants
• Finding subjects lost to follow up
• IRB Administrative Issues
• eIRB Terms
• CR in eIRB

3
IRB Staff

• Tammy Alley Administrative Assistant
• Continuing Review Applications
• Invoicing for IRB fees
• Jeannie Tullock Protocol Analyst
• Boards 2 4
• New full board, expedited and exempt
• Jeanie Baird Protocol Analyst
• Boards 1 3
• New full board, expedited and exempt

4
Role of Protocol Analyst

• Pre-Review all IRB Applications
• Responsible for knowing the federal regulations,
  state laws and local policies regarding human
  subjects research
• Review application for consistency to make sure
  it is complete
• Review consent form for required language
• Assist Board Members
• Coordinate all aspects of IRB meetings
• Review expedited and exempt applications
• Process all amendments
• Provide education to research community

5
Other IRB Admin Issues

• Board membership will change in July so new
  rosters will be posted soon after
• New Chair Margaret Harper, MD Obstetrics and
  Gynecology to Chair Board 2

6
eIRB State Transitions
Section Specialty Review
Pre-Submission Protocol is waiting for the PI to
click submit application
Board Assignment Shows up in IRB Inbox -
Protocols wait here until all Co-Is Study
Coordinator agree to participate
Full Board Review Protocol has been scheduled for
a meeting assigned to Board Reviewers (email is
sent to study team)
IRB Admin Review Application has been claimed by
an IRB Administrator perform pre-review
7
After Board meeting, studies can be in one of
several states
Minor Board Concerns
Major Board Concerns
If all concerns are addressed, it goes into a
state called Post Review
Study has been tabled so it must be reassigned to
a Board and will go back to Full Board Review
Active
8
Continuing Review in eIRB

• Implementation Plan
• IRB staff to Beta Test in May/beginning of June
• Open to a few Departments late June/July
• Open to all Departments August 1
• All protocols should be in eIRB by December 31,
  2007

9
CR in eIRB

• Dates of Training
• July 6 2-3 PM 
• July 13 2-3 PM 
• July 18 230-430 
• July 20 2-3 PM 
• July 26 930-1130 
• Register via IRB website
• All training to take place in Commons 2 3 (G
  floor Nutrition Building)