1. University of Charleston’s
2017 Institutional Review Board
And how it affects you.

2. Why do we need an IRB?
To ensure the institution is in compliance with the HHS Protection of Human Subjects (Federal Regulation 45 CFR part 46).
To be eligible for a Federalwide Assurance (FWA), a commitment that we will comply with this regulation.
To be eligible for grant money.

3. What is an IRB?
A review committee established to help protect the rights and welfare of human research subjects.
Research is a systematic investigation designed to contribute to generalizable knowledge.
Human subjects are those about whom an investigator obtains data, or from whom identifiable private information is obtained.

4. Authority of the IRB Approve / disapprove research Modify research
Hold continuing reviews
Observe / verify changes
Suspend / terminate approval
Observe the consent process and research procedure

5. Composition of the IRB Five members minimum Varied Professions:
Both sexes must be included
Varied Professions:
1 non-science,
1 science,
1 not affiliated with the institution.
Additionally, the board must be culturally diverse, be sensitive to community issues, and have members that understand the research being done.

6. UC’s IRB Board Rebecca Linger, Chair Annie Cardell Stephen Cook
Brad Deel
Jackie Hurt
Matt Lonam
Jennifer Pack
Jessica Jacovidis*
Jack Levin*
Nonvoting Member:
John Adkins, Assistant to the Board and Recordkeeper
* Denotes an outside representative who is not affiliated with UC

7. IRB Meetings The IRB meets quarterly to complete full reviews:
August
November
February
May
Check with John Adkins for specific dates.
The IRB may hold additional, Special Meetings, based on need.

8. Types of IRB Submissions
Application for initial review
Application for Annual Renewal/Progress Report
Amendments or modifications
Reports as indicated by the IRB
Closure Report
Reports to other agencies may also be required.

9. Forms and instructions are on the UC website (Faculty and Staff)
Faculty Information
Forms and instructions are on the UC website (Faculty and Staff)
The primary investigator for research involving human subjects must submit an IRB application.
The investigators must have the appropriate NIH training or their application will not be reviewed.

10. NIH Training – Protecting Human Research Participants
Investigators must have current Training in Protecting Human Research Participants or applications will not be reviewed.
Training is found at: phrp.nihtraining.com
PI is responsible for submitting a copy of their current certificate with EACH application.
Training is good for 3 years from the date of certification.
Plan to renew your training before it expires, to avoid delays with your project.
PI Certification Expires before project is complete, the project is suspended until:
The PI renews training certification, or
An application for change in PI to another PI who has training certification, is approved.

11. Application Preparation
Review
Instructions
Forms
Choose
(All appropriate)
Complete
Save Electronic Copy of All Completed Forms
Submit
Electronic to:
Signed Paper Copy to: Marea Dodd, SOP-304
You will NOT be issued an application numbers, until the project has been approved.
NOTE: Our process has changed for issuing application numbers.

12. Types of IRB Reviews Full Committee Review Expedited Review
Exempt Review
Annual Review

13. Full Review IRB will go over the application at a formal meeting.
Modifications may be requested by the IRB before approval is given
There must be a quorum present for the IRB to vote and each member will vote to approve or disapprove the project.

14. Expedited Review Risk Level Minimal
Falls into one of nine specific categories (Refer to Instructions for detail):
Noninvasive Sample Collection
Blood Samples
Studies with approved drugs/devices
Data that has already been collected or will be collected for non-research purposes
Review
Two IRB Members are chosen to review.

15. Falls into one of six categories:
Exempt Review
Risk Level
No Risk
Minimal Risk
Falls into one of six categories:
Educational Research
Educational Tests
Educational Research involving public officials or candidates for office
De-identified existing records
Research conducted by heads of government department
Taste and Food Quality Evaluations
Review
IRB selects one IRB Member to review

16. Exemptions Do Not Apply To
Prisoners
Surveying or Interviewing Children
Observations of public behavior when investigator participates
Exemptions Do Not Apply To

17. CAMC’s IRB actions will be accepted in lieu of UC’s IRB
Joint Studies
CAMC’s IRB actions will be accepted in lieu of UC’s IRB
Other Institutions involved in a study must have a FWA and obtain approval from UC’s IRB

18. Submission of Application
Select Application Type:
Save a Copy of All Completed Forms:
Electronic Copy of All Completed Forms to:
Print Copy & Obtain All Required Signatures:
Submit Signed Hard Copy to:
See
You will need this for the next two steps.
You will also want a copy for your records.
Primary Investigator
Other Investigator
School/Division Chair
Marea Dodd at SOP-304

19. Approval
If there are changes to the project, such as, PI, PI’s NIH Certification Expires, or Circumstances or situations arise that were not previously know. You MUST notify the IRB.
You may NOT begin your project, until you receive written approval from the IRB.
Once approved, it is good for one year from date of approval. If you wish to continue beyond one year, you must seek approval through the Renewal Process.

20. Renewals
A project must stop at the end of the approved year; unless you have applied for and received approval.
Apply at least 60 days before the expiration of your approval.
NIHTraining Certification must remain current.

21. Complete Closure Report
At Project Termination
Project Completed
Funding Ended
PI Left University
At end of Approved Year
Unless completing a Renewal Application

22. Timeline for IRB Decision
Four Weeks
Exempt
Six Weeks
Expedited
Eight Weeks
Full Review
Submit 60 days prior to expiration of the approved year.
Annual Renewal / Progress Report
No approval required, due upon the completion or termination of project or suspension of approved year; unless, applying for renewal.
Closure

23. Questions?