Please review the topics/questions below for more information.

Common Errors

Don't let these delay your application!

  • Individuals completing the wrong CITI training
  • Not signing the IRB application
  • Not emailing the IRB application and required attachments to [email protected]
  • Not clearly describing the research questions, research design and methodology, the analysis plan, data management plan, the subjects being recruited, and the desired sample size
  • The consent form is written at too high of a reading level
  • Consent form does not contain the required elements
  • The information in the informed consent form does not match the IRB application

General Questions

What exactly qualifies as human subjects research?

When an investigator conducting research obtains (1) data through intervention or interaction with a living individual, or (2) identifiable private information about a living individual.

When should I obtain IRB approval in my research process?

Prior to any research taking place. If you are utilizing materials that are normally part of the educational process for students (such as course evaluations), you should seek IRB approval as soon as the intention is to conduct research.

Do student academic research projects require IRB approval?

Yes, if a student’s research project qualifies as human subjects research, IRB approval is required.

Who do I contact if I have a question?

The IRB can be reached at 330.490.7443 or [email protected]. You can also contact the IRB administrator or any IRB member for assistance.

CITI Questions

Who is required to take CITI training?

Any faculty, staff, student and external researcher must complete a CITI course in Human Subjects Research. The CITI training replaces the NIH Conflict of Interest course formerly utilized as part of the HSR process. Any researcher outside of Walsh University working on a research protocol can complete CITI through their home institution or through Walsh University if their institution does not subscribe to CITI.

If I have taken the HSR or NIH training previously, do I still need to take CITI training?

Yes. For IRB purposes you must complete CITI training.

Which CITI training do I take?

Either the Clinical Researchers or Social-Behavioral-Educational Researchers course. If you’re not sure - Ask!

How long will it take me to complete CITI training?

1-1/2 to 2 hours

Are my quiz scores important?

Yes! 80% is the minimum passing score. You can retake a quiz to improve your score - but all scores are final on the completion report.

How long is my CITI training valid for?

3 years. Prior to expiration of your CITI training you can complete a shorter refresher course to keep your certification valid.

Application Questions

Who needs to be listed on the IRB Application?

All investigators (researchers and collaborators) and faculty advisors must be listed on the IRB application, the application must contain their signatures, as well as CITI training certificates.

Does the application need original signatures?

No. Original materials should be retained by the investigator.

What should I list as my start date for research if I want to begin right away?

You should select a start date approximately 4 weeks from submission of your IRB application.

What should be included on my bibliography/reference list?

Only references used to answer the questions within your IRB application.

What materials need to be included with the application?

  • Signed application
  • Informed consent form(s)
  • Copies of any materials given to research participants (flyers, recruitment materials, emails)
  • All data collection forms
  • Interviewers verbal scripts/instructions
  • Bibliography
  • All CITI certificates
  • If applicable, a copy of the funded grant proposal

How do I submit my IRB application?

All materials (preferably in PDF format) should be emailed to [email protected].

I have submitted my IRB application. Now what happens?

  • Initial review for completeness. If incomplete, an email is sent to the investigators detailing missing items.
  • Complete applications are forwarded to the IRB Committee for review.
    • The IRB Chair determines if the application qualifies for expedited review or requires a full board review.
      • Expedited applications are generally returned within 1-2 weeks.
      • Applications requiring a full board review must be received one week prior to the next scheduled meeting date. The researcher has the option to attend the meeting to answer any questions/concerns in order to keep the process moving forward.
  • The IRB process could range from 2–4 weeks, not including time for any requested revisions.
  • If you are conducting your research in a medical setting or prison you will likely be required to submit your protocol to their IRB as well. You will need to leave additional time (up to a month) for each external IRB you are seeking approval from.
  • IRB approvals are valid for one year.

How do I submit changes to a currently approved protocol?

Complete an Amendment or Changes to an Approved Protocol form and submit it to [email protected].

How are changes to an approved protocol reviewed?

Review and approval of changes are the same as initial application.

What is a closing report?

A Final Report/Closeout form should be submitted via email once your research is complete.

Informed Consent Questions

What should my informed consent include?

The federal government outlines what items must be included in an informed consent.

Walsh University Institutional Review Board (IRB):

[email protected] | 330.490.7443

Federalwide Assurance Number (FWA): FWA00022389

(Expiration 05/04/2028)

Institutional Review Board (IRB) # 00009923

(Expiration 05/11/2026)