1. Christopher M. Ryan, Ph.D. IRB Director ryancm@upmc.edu
Human Subjects Research Update New CITI Training Modules Child Clearance Requirements WePay Secrets
Christopher M. Ryan, Ph.D.
IRB Director

2. Collaborative Initiative Training Institute (CITI): Why the Change?
Federal regulations mandate training in human subject protections
CITI Program: “Gold standard” for internet-based research ethics training
Accepted by virtually all institutions/agencies
Single source for all training
New courses continually developed and existing courses updated

3. General Information
Pitt/UPMC: Continue to use HSConnect authentication
Every user must have a HSConnect account
Special portal to access CITI courses
External Investigators with CITI accounts
Obtain credit for previously completed CITI modules that match Pitt requirements (if taken within 2 years)
Eliminates redundant training across institutions

4. New users required to take the CITI courses prior to conducting human subject research or to access OSIRIS
Existing users have one year to complete the CITI courses
After March 31, 2013, access to OSIRIS will be denied
Cumulative passing score of 80%
3-5 hours to complete all modules (some report 7 hours)
Re-certification every 3 years
CITI ‘Refresher Course’ plus other requirements
Reminder notifications sent out automatically

5. Designated “User Groups”
Biomedical Researcher (including all health science students)
Social & Behavioral Researcher
Undergraduate Student Researcher
Optional course for IRB Members

6. Go to

7. Create a new account or login in with your existing account
Do not create a duplicate account. If you are unsure, us

8. Creating or merging your CITI account

9. Linking your existing CITI with Pitt

11. Access the course modules Example: Student Researchers

12. Social/Behavioral Human Subjects Curriculum
Belmont Report
History and Ethical Principles
Defining Research with Human Subjects
The Regulations & Social/Behavioral Science
Assessing Risk in Social/Behavioral Research
Informed Consent
Privacy & Confidentiality
Conflicts of Interest
Two Additional Electives

13. Social/Behavioral Responsible Conduct of Research Curriculum
Responsible Mentoring
Introduction to the Responsible Conduct of Research
Research Misconduct
Data Acquisition, management & Sharing
Publication Practices and Responsible Authorship
Collaborative Research
+ 1 Elective module

14. Additional Continuing Education Requirements
Required to attend at least 3 continuing education hours (CEUs) in a 3-year period specifically related to human subject protection or ethics
Examples may include:
IRB programs (i.e., Ask the IRB)
IRB board member attendance
ACRP programs
Keep records of attendance in your file

15. FAQs
I took the VA version of CITI last year. Is that acceptable at Pitt or should I take it again?
As an administrator, how do I verify which courses have been completed by my faculty?
I conduct both biomedical and behavioral research. Do I have to complete both courses in CITI?
Will we receive reminders when our CITI courses are close to expiring?
According to the Provost, all faculty must take the Research Integrity Module and the COI module. If I’ve taken the CITI modules, is that sufficient?

16. Child Clearance Requirements

17. New Question Added to OSIRIS
It is the responsibility of the principal investigator to ensure that all research staff have these clearances prior to any interaction with children.
Act 33; Act 34; FBI Criminal Background Check
Contact Human Resources at for assistance with this process.
OGC Contact: Alan Pittler

18. FAQs
I called Human Resources and they said I was “grandfathered.” Does that mean that no clearances are required?
I have an ongoing study. Do I have to stop the study until everyone has their clearances?
We are starting a new study. Do I have to wait until all staff have these clearances?
We provide ‘babysitting’ for our subjects; does that staff member need these clearances?

19. FAQs, cont.
My secretary greets the kids when they come in but otherwise isn’t involved with the research. Clearances Required?
I am interviewing children over the telephone. Clearances Required?
I am conducting on-line surveys of children. Clearances Required?
I am doing a medical record review on children. Clearances Required?
Do these clearances ever expire?

20. WePay Facts You May Not Know
I am the ONLY person at the IRB who addresses WePay issues
SSNs must be collected unless a ‘waiver’ is requested
me with request
Subjects cannot receive more than $100 in a year
Exception: certain studies (e.g., spousal abuse) where receipt of 1099 could lead to harm

21. Gift cards ordinarily cannot be used ‘Man in the Street’ option
me for an exception (granted infrequently)
‘Man in the Street’ option
‘Petty cash’ approach
Can be used to purchase gift cards (but…)
Investigators are required to maintain records documenting who received what when
Names may not be required, but info is needed to ensure that subjects actually participated
Amazon gift codes may be possible…

22. Upcoming Education Programs
Building Bridges:
Research Around The World
National conference on international research co- sponsored by Pitt, CMU, VA Healthcare System, and the federal Office of Human Research Protections
Sheraton Station Square
Friday, June 22, 2012