1. Navigating eIRB and eIRB Submission Types
Katie Daniels Amanda Goode
IRB Coordinator IRB Coordinator
Committee C Committees A & B

2. Objectives Learn what is eIRB Understand how GHS uses eIRB
Know the functions of eIRB
Understand the different types of submissions
Observe a demonstration of how to submit in the eIRB

3. eIRB Overview electronic Institutional Review Board
HSSC- Health Sciences South Carolina
Made up of 8 Institutions:
GHS
USC
MUSC
AnMed Health
Palmetto Health
Self-Regional
Spartanburg Regional
Clemson (only HSSC institution that does not use eIRB)
IRB is committee established to protect the rights and welfare of human research subjects recruited to participate in research activities
Application used to communicate, manage IRB review and documentation
Note Clemson is different. They have access to eIRB and are included in HSSC agreements, but do not utilize eIRB at their site.

4. How to get started in eIRB?
Who needs an eIRB account?
Any person participating in research activities…
Principal Investigators
Co-Investigator(s)
Study Coordinator(s)
Other Study Team Member(s)
Regulatory staff, project assistants, students, etc.
Guest List
Read-only access
Studies collaborating with Clemson- add Clemson IRB as guest

5. How to get started in eIRB? (Cont.)
eIRB user account
HSSC affiliates visit:
Select affiliated institution
Complete registration fields, click ‘Register’
3-5 business days to activate account
Affiliated- have institutional ID and password
Outside HSSC affiliates me for instructions to obtain GHS username & PW to register for eIRB

6. Uses for eIRB Submit research proposals for IRB approval
Submit Continuing Reviews
Submit study Amendments/Changes
Submit Reportable Events

7. Submitting Studies- Research vs. Quality Improvement
“Is this project a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge?”
If Yes, Research!
i.e., Intended to publish in journals, present results at conference; anything that leaves the institution
If quality improvement- no IRB Oversight required

8. Submitting Studies- Human Subjects vs. Non-Human Subjects
“Does this project involve the investigator obtaining data about living individuals through 1) intervention or interaction with the individual; or 2) identifiable information?”
If Yes, Human Subjects Research!
i.e., prospective studies, retrospective chart reviews (with access to PHI), studies involving collection of specimens, etc.
If non-human subject research- no IRB oversight required

9. Submitting Studies- Full Board vs. Expedited vs. Exempt
Full Board: Studies involving more than minimal risk
Committee A: Non-Pediatric/Non-Oncology
Committee B: Pediatrics, Adult Studies (not adult oncology)
Committee C: Adult Oncology
Expedited: Studies involving no more than minimal risk
IRB Chairs review
Exempt: IRB oversight not required
Full Board: each committee meets once a month, all studies are reviewed by two reviewers, at the meeting the reviewer discussion any questions, finding, etc with committee, vote, deadlines for study submission is listed on the website.
Expedited: Currently 7 Expedited Review Categories (Not as heavily regulated as exempt. Categories are listed as research that may be reviewed as expedited)
Exempt: Currently 6 Exempt Categories (new common rule there are two new exempt categories applicable if institution is utilizing broad consent- GHS is not)

10. Submitting Studies- In Conclusion
Submit Everything!
Best to let IRB determine if oversight is required
IRB notice of review is required for most publications and/or conference presentations, even if research is non-human subjects, exempt, etc
Based on how you answer questions-
QI, Non-human subjects research, and exempt research have a shorted eIRB application
Only documentation required in application is a project protocol that explains the project thoroughly enough for the IRB to make the appropriate determination

11. Submitting Studies- What will I Need?
New Study Submittal Checklist
Investigator Signature Page
Consent Forms
Protocol
Data collection forms, surveys, questionnaires, etc.
CV of PI
CITI Training
For full list, visit eIRB website:

12. eIRB Study Page Study Statuses Requiring Action:
Changes Requested per IRB Staff
Contingencies Pending
Department Review
Expired
Pre Submission
Study Statuses :
Acknowledged
Approved
Assigned to IRB Meeting
Awaiting Correspondence
Changes Requested per IRB Staff
Completed
Contingencies Pending
Department Review
Disapproved
Exempt Approval
Expired
External IRB Review
In Review
IRB Staff Review
Not Human Subjects Research
Pre Submission
Suspended
Withdrawn

13. Continuing Reviews

14. Continuing Reviews
All studies require IRB review no less than once per year (i.e., 364 days or 6 months)
Current Study Status
Number of Subjects
Subjects’ Demographic Information
Interim Findings
Redacted Last Signed Consent Form
For pediatric studies: updated pediatric risk grading form
Updated COI information

15. Continuing Reviews
*this continuing review snapshot is before submission to the IRB

16. Amendments

17. Amendments Submit Amendments whenever there are changes to:
Study Personnel
Advertisements/Study Recruitment material
Informed Consent Documents
Protocol Documents
Investigator’s Brochures
Editorial/Administrative Changes
Additional Sites for Treatment/Follow-up
Modification in Subject Enrollment Goals
Location of Program Activities
Questionnaires & Assessment Tools
Risk Change(s)
Subject Confidentiality/Anonymity
Subject Population
HIPPA Authorization
Study Funding Source/ Sponsorship
Conflict of Interest (COI)
Other Changes, etc.

18. Amendments are reviewed based on:
Risk
The initial study submission review type
Amendment Requirements
Risk change assessment
Description of what is changing
Update changes in SmartForm

19. …for the people in the back
Amendments
…for the people in the back
Update the SmartForm!

20. Amendments
*this amendment snapshot is post submission to IRB

21. Reportable Events

22. Reportable Events Unanticipated Problem Adverse Event
Unexpected
Related or possibly related
Change in known or recognized risk
Adverse Event
undesirable/unintended , although typically not unexpected, result of therapy or intervention
Protocol Deviations
Other Reports/Events
Not a bad thing to submit

23. Submitting Reportable Events
Type of reportable event
Multi-study reportable event
Internal vs. External event
If only local study, always Internal
External AEs should only be reported to local IRB when event requires changes to study protocol, IB, or Informed Consent
Specific event questions

24. Reportable Event

25. eIRB Demo

26. Contact Us Office of Human Research Protection (OHRP)
701 Grove Road- Employee Services Center (ESC) Greenville, SC 29605
Matt Hudson, PhD Chris Wright, MD
OHRP Director OHRP Medical Director
Katie Daniels Amanda Goode
IRB Coordinator IRB Coordinator
Committee C Committees A & B