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

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

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

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

IRB Program Staff at the ORP IRB Program Director: Sara Horn: sjh246@psu.edu or 5-3696 IRB Program Coordinator: Stephanie Krout: sqk2@psu.edu or 5-2935 IRB Analysts (Work assigned according to the first letter of the last name of PI): Courtney Whetzel: cae130@psu.edu or 5-1776 (A-C) Tracie Kahler: tlk14@psu.edu or 5-7955 (D-G) Philip Frum: plf13@psu.edu or 5-7986 (H-K, O) Jodi Mathieu: zjc2@psu.edu or 5-7954 (L-N) Julie James: jag31@psu.edu or 3-6833 (P-S) Joyel Moeller: jdm35@psu.edu or 5-7957 (T-Z)

Tip #1: Know Who to Contact

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) Irb-orp@psu.edu Manned by our Program Coordinator who will provide you a quick response Questions or Problems with CATS IRB irbadmin@psu.edu Manned by ORIS (Office for Research Information Systems) staff

Tip #2: Know Where to Find Information

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

CATS IRB https://irb.psu.edu

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.)

Tip #3: Know Whether You Need to Submit

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

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

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

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 24-48 hours and then staff confirm the training Good Clinical Practice Training Required ONLY for individuals listed on an NIH funded clinical trial

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

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

Tip #7: Start the IRB Process Early

IRB Review Timelines Typical turn around times: Exemption Determination: approx. 10-12 days Expedited Review: approx. 15-20 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.

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

Questions?