1. Tips for a Successful IRB Submission
Sara Horn, IRB Program Director

2. Today’s Discussion
Short Overview of Penn State’s Office for Research Protections and IRB
Practical Tips for a Successful IRB Application
Questions

3. Office for Research Protections (ORP)
Comprised of 10+ programs focused on research compliance including but not limited to:
Human Subjects Research (IRB)
Vertebrate Animal Care and Use (IACUC)
Radioisotopes (UIC)
Regulated Biohazardous Materials (IBC)
Conflicts of Interest (COI)
Educations and Quality Management (EQM)
Research Misconduct

4. IRB Program One part of the Human Research Protections Program at PSU
Two IRB Offices
Office for Research Protections IRB Program- University Park- Serving UP and all Commonwealth Campuses except for College of Medicine
Human Subjects Protections Office- Hershey- Serving College of Medicine, Penn State Milton S. Hershey Medical Center and College of Medicine Regional Campus
Note: The two locations share the same policies and procedures (HRPP Toolkit) and the CATS IRB System

5. IRB Program Staff at the ORP
IRB Program Director: Sara Horn: or
IRB Program Coordinator: Stephanie Krout: or
IRB Analysts (Work assigned according to the first letter of the last name of PI):
Courtney Whetzel: or (A-C)
Tracie Kahler: or (D-G)
Philip Frum: or (H-K, O)
Jodi Mathieu: or (L-N)
Julie James: or (P-S)
Joyel Moeller: or (T-Z)

6. Tip #1: Know Who to Contact

7. Who Should I Call (or email)?
IRB Analyst (aka Your Best Friend at the IRB)
Provide information on how to submit, information on review process
Provide regulatory knowledge
Provide IRB policy information
Provide assistance in preparing your IRB application (regulatory knowledge, best practices, etc.)
General Inquiries (not related to a protocol that has been submitted)
Manned by our Program Coordinator who will provide you a quick response
Questions or Problems with CATS IRB
Manned by ORIS (Office for Research Information Systems) staff

8. Tip #2: Know Where to Find Information

9. IRB Website Overview of IRB process https://www.research.psu.edu/irb
Access CATS IRB
Leave us feedback

10. CATS IRB

11. What you will find In CATS IRB
Help Center
Investigator Manual (What investigators need to know/do regarding submission and conduct of research)
Study Submission Guide (How to submit)
Training Information
Video Tutorials
IRB Library
IRB SOPs
Checklists and Worksheets used by IRB Members to evaluate a submission
Templates (Protocol, Informed Consent, etc.)

12. Tip #3: Know Whether You Need to Submit

13. Human Research Definitions
RESEARCH Systematic investigation designed to develop or contribute to
generalizable knowledge* +
HUMAN SUBJECT A living individual whose information is collected
via intervention/interaction or private/identifiable data* =
IRB REVIEW
*These definitions apply to non-FDA regulated research

14. Tip #4: Identify a Faculty Advisor for the IRB Application

15. Tip #5: Complete Required Trainings Before Submitting to the IRB

16. Required Trainings Human Subjects Training
Required of all individuals listed on an IRB submission (including your advisor )
Citi.psu.edu
Complete one of the two human subjects research courses: Biomedical OR Social Science and one elective module of your choice within the course
Completion report will pull through to our system within hours and then staff confirm the training
Good Clinical Practice Training
Required ONLY for individuals listed on an NIH funded clinical trial

17. Tip #6: Obtain the Appropriate Permissions from the Research Site

18. IRB Policy
Investigators are required to obtain and retain within their research records letters of permission from sites (schools, businesses, etc.)
Research in Schools:
A specific permission letter for schools is located in the templates tab in CATS IRB
School boards may have their own review process or their own requirements, our IRB cannot override these requirements
FERPA regulations apply when obtaining student educational records- often requires signed consent for use in research

19. Tip #7: Start the IRB Process Early

20. IRB Review Timelines Typical turn around times:
Exemption Determination: approx days
Expedited Review: approx days
Full Committee Review: approx. 30 days
* These times do not necessarily reflect the amount of time it may take you to revise your application, seek additional information to provide to the IRB, etc. Review process may take longer if other committees need to review in addition to the IRB.

21. Tip #8: Don’t Start Until You Receive Approval/Determination Letter

22. Questions?