Auburn University
Auburn University
Auburn University
 

Frequently Asked Questions

  1. Who must complete the CITI Human Subjects Research (HSR) training?

  2. How do I know if everyone on my research team needs to be listed in the protocol as "key personnel"?

  3. Why must I complete the CITI HSR training?

  4. Do all members of my thesis / dissertation committee need to complete CITI HSR training?

  5. What do I do if I've already completed CITI HSR training at another institution?

  6. Which CITI HSR training modules should I complete?

  7. I am not affiliated with Auburn University, and my institution does not require training. What CITI HSR training modules do I need to complete?

  8. How much time will it take?

  9. Is there a deadline for completing CITI HSR training?

  10. What is the passing score for the quizzes?

  11. How will the IRB know if I have taken this training?

  12. If my research area changes do I need to complete additional learner groups of CITI HSR training modules?

  13. Will the IRB review my protocol if all of the key personnel have not been trained?

  14. How do I access the CITI HSR training modules?

  15. How much does the training cost?

  16. Can I earn continuing education credits?

  17. When will my completion certificate expire?

  18. What if I forget my username or password?

  19. What if I have other questions?

 

 
  1. Who must complete the CITI HSR training?

All members of the research “team” must complete the appropriate CITI HSR training. This includes the primary investigator, co-investigators, the faculty advisor, and all key personnel.

[top]

  1. How do I know if everyone on my research team needs to be listed in the protocol as "key personnel"?

If members of your research team fit the definitions of key personnel listed here, they must be listed in your protocol.

[top]

  1. Why must I complete the CITI HSR training?

The Auburn University (AU) Institutional Review Board (IRB) has determined that this training will be a requirement of all AU researchers involved in human subject research to comply with federal mandates. The National Institutes of Health’s (NIH) policy requires that all proposals for contracts and grants for research involving human subjects submitted certify that all key personnel have received training on the protection of human subjects in research.  AU’s FederalWide Assurance with the Department of Health and Human Services/Office of Human Research Protections (DHHS/OHRP) mandates that AU will ensure the protection of the rights and welfare of all human research subjects, regardless of funding. This means that the same standards for education of key personnel will apply whether a study is funded or not. The AU IRB has elected to review all protocols involving human subject research.

Protocols will not be approved unless proof of CITI HSR Training completion is attached.

[top]

  1. Do all members of my thesis / dissertation committee need to complete CITI HSR training  

No, they do not, unless they are directly involved in the study. If so, they would be listed in "key personnel" in your protocol. All key personnel do need to complete CITI HSR training. (Also note that "Outside Readers" do not need to complete CITI.)

[top]

  1. What do I do if I've already completed CITI HSR training at another institution?

You will now need to complete CITI HSR training as an affiliate of Auburn University. You will need to follow enrollment instructions here.  Note that your certificate will expire in five years from the date you complete all AU modules.

[top]

  1. Which CITI HSR training modules should I complete?

If you are not affiliated with Auburn University, see question 7.

The “Learner Group” which you select determines which modules will be required. Choose the group that best fits the type of research you normally conduct – or the type of research specifically described in the protocol you will submit to the IRB. In general, there are three types of learner groups:

Group 1 - IRB Members – This includes all current and future IRB members.

Group 2- Biomedical – This will usually be research by researchers in the School of Nursing, the Harrison School of Pharmacy or the Kinesiology Department.  The research will involve medical, physiological or pharmacological studies that typically involve direct contact with research subjects.

Group 3 -Social and Behavioral – This generally describes sociological, psychological, anthropological or educational research.

In addition, members of the research team must complete any optional modules that apply to their research.

Note:  At this time, completion of the Responsible Conduct of Research training is encouraged, but is not required.

[top]

  1. I am not affiliated with Auburn University, and my institution does not require training. What CITI HSR training modules do I need to complete?

Required Modules

Group 4

Biomedical Research

Group 5

Social and Behavioral Research

Belmont Report and CITI Introduction

X

X

History and Ethical Principles

X

X

Informed Consent

X

 

Informed Consent - SBR

 

X

Choose all that are relevant to the protocol from the following:

Students in Research

X

X

Records-Based Research

X

X

Research With Protected Populations - Vulnerable Subjects: An Overview

X

X

Workers as Research Subjects – A Vulnerable Population

X

X

Social and Behavioral Research for Biomedical Researchers

X

 

Genetic Research in Human Populations

X

 

Vulnerable subjects – Research with Prisoners

X

 

Vulnerable Subjects – Research Involving Minors

X

 

Pregnant Women and Fetuses in Utero

X

 

International Research

X

 

FDA-Regulated Research

X

 

Human Subjects Research at the VA

X

 

HIPAA and Human Subjects Research

X

 

Research with Prisoners - SBR

 

X

Research with Children - SBR

 

X

Research in Public Elementary and Secondary Schools – SBR

 

X

International Research – SBR

 

X

Internet Research – SBR

 

X

 

8.     How much time will it take?

This will depend on your familiarity with human research issues. Most modules should take between 10 to 20 minutes to complete, with a total time of 3 to 6 hours. Less time will be needed if you are already familiar with the subject. You do not need to complete all of the modules at one time. CITI is designed so that you can stop and begin again at your convenience.

[top]

  1. Is there a deadline for completing CITI HSR training?

No.  There is no deadline.  However, protocols will not be approved unless proof of CITI HSR training completion is attached.

[top]

  1. What is the passing score for the quizzes?

You must receive a passing score of 80% overall. You may retake any quiz for which you did not receive a passing score, or if you just want to make a better score. Please note that your score may not change on your CITI HSR training record, but the new score will be used to determine your average score.

[top]

  1. How will the IRB know if I have taken this training?

When you have completed all of the modules, you can print a completion certificate to keep. Please make copies to attach to any protocol submitted.  CITI will also forward an electronic record of your course completion to AU's Office of Human Subject Research.

[top]

  1. If my research area changes do I need to complete additional learner groups of CITI HSR training?

Yes. You will need to complete one or more of the additional modules if your research area changes.

[top]

  1. Will the IRB review my protocol if all of the key personnel have not been trained?

The IRB will review the protocol if at least the primary investigator and faculty advisor have completed CITI HSR training (and provided copies of their certificates). The protocol will not receive final approval until all members of the research team listed in “key personnel” have completed CITI HSR training.

[top]

  1. How do I access the CITI HSR training modules?

Go to www.citiprogram.org. The first time, you will have to go through the registration procedure. For instructions, click here.   After you have already enrolled, you will log in with your AU username and created password.   You will access your modules from your “Main Menu”.

[top]

  1. How much does the training cost?

The Office of the Vice President for Research at Auburn University pays an annual fee for all AU researchers. There is no cost to an individual user to complete the CITI training.

[top]

  1. Can I earn continuing education credits?

Auburn University does not currently provide continuing education credits for this training.

(CME/CEU credits are available through the University of Miami for completion of the Human Subjects Protection Basic Course. See the information available on CITI’s website for more information: www.citiprogram.org/citidocuments/cme/index.htm. )

[top]

  1. When will my completion certificate expire?

You will need to retake the CITI HSR training course within five years from the date of your completion certificate.

[top]

  1. What if I forget my username or password?

If you have forgotten your username (which should be the same username you use at Auburn) or your password (unique to CITI), there is a link on CITI’s home page to request assistance.

[top]

  1. What if I have other questions?

Check the “Announcements and Frequently Asked Questions (FAQ)” section on the CITI web page.  On the CITI home page there is also a link to Contact the CITI Helpdesk.  Specific questions relating to AU may be directed to the Office of Human Subject Research at 334-844-5966, hsubjec@auburn.edu.