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Mandatory Human Subject Protections Training

Frequently Asked Questions (FAQ's) on Human Subject Protection (HSP) and
Other Mandatory Training for Study Personnel on IRB Research Protocols

To jump to questions grouped by topic, click on your choice in the menu below:

Initial IRB Training Requirement

Three Year Refresher HSP Training

New Study Personnel and Continuation Review

Non-UK or Community Based Study Personnel

Classroom Assignment Human Subject Course

Contacts

Responsible Conduct in Research Training

Humanitarian Use Device (HUD) Training

Other Required Trainings

UK LINK BLUE Access to CITI

Effective 2015, access to UK’s CITI Subscription is through the UK Link Blue website using the UK Link Blue ID and Password. Link Blue is the directory account assigned to all UK employees and students. It is used to connect to many campus-wide systems, including myUK, Exchange email, Blackboard, and APEX Degree Planner.

ALL CURRENT AND NEW CITI USERS SHOULD FOLLOW THE INSTRUCTIONS BELOW TO ACCESS TRAINING COURSES ON CITI.

  • CURRENT CITI USERS – Users that have an existing CITI account affiliated with UK
    Follow instructions to link your UK Link Blue account with your course history and past completion reports. 
  • NEW CITI USERS – UK employees or UK students that have never created a CITI account at UK
    Follow instructions to create your CITI account.
  • NON-UK Personnel – Follow instructions for individuals listed as study personnel on a UK protocol that are NOT UK employees or students.

Important Reminders for CITI users:

  • Do not use another person’s email when creating an account on CITI.

    Use your own Link Blue ID and your own UK email address. Using someone else’s UK email in your CITI account as it can result in loss of that individual’s account and training records.
  • Don’t call it “CITI Training”.
    The UK CITI curriculum contains a number of training categories and types of training. If asked to complete training on CITI, be sure to confirm which course by name. Faculty who require courses as part of a class assignment should indicate the desired course by name (e.g., Human Subject Protection, Responsible Conduct in Research). See the available courses FAQ for partial list of courses on the UK CITI curriculum.
  • Only HSP for the IRB.
    There are several types of courses on CITI. Initial or Refresher Human Subject Protection Training is required for any study personnel on an IRB protocol. Other courses on the UK CITI Subscription will not count as meeting the IRB training mandate.
  • Optional Course for Classroom Assignments.

    “Students in Research” is an abbreviated course available under the Optional Courses menu on UK’s CITI Subscription. It provides an introduction to human research protections and describes what students can expect when asked to participate as a research subject. This course DOES NOT meet the IRB training mandate for any type of research submitted to the IRB. Faculty may use the course as a classroom assignment although it will not qualify a student to serve as study personnel for any research reviewed by the UK IRB.

Initial IRB Training Requirement: Who, What, When

1. What training is required for the IRB to approve human research protocols? ANSWER
2. Who must complete HSP training? ANSWER
3. Must all study personnel complete HSP training prior to the IRB submission? ANSWER
4. What if an individual listed as study personnel on my initial review have not completed HSP training? ANSWER
5. Who is considered study personnel on human subject protocols? ANSWER
6. Is the faculty advisor signing the protocol assurance statement for a student’s research project required to be HSP trained? ANSWER
7. I need a description of UK's human subject protection training that I can use in my grant application. Where do I get that? ANSWER

Initial CITI HSP Training for IRB Approval

1. How do I enroll in initial (basic) human subject training for IRB approval on the CITI website? ANSWER
2. The UK curriculum on CITI offers two course menus, IRB and RCR. Which do I choose to access Human Subject Protection (HSP) training for IRB approval? ANSWER
3. Who is approved to take the Limited HSP training on CITI? ANSWER
4. I took the CITI Limited HSP training by mistake. Will I have to retake the modules I completed? ANSWER
5. I took the CITI Responsible Conduct in Research (RCR) course. Will that count for IRB approval? ANSWER
6. I took the CITI Good Clinical Practice (GCP) course. Will that count for IRB approval? ANSWER
7. I took the CITI HIPAA course. Will that count for IRB approval? ANSWER
8. Is there a paper-based alternative for initial human subject training if I do not have access to a computer to complete CITI? ANSWER

CITI User Information

1. How do I create a CITI user account? ANSWER
2. How do I find or reset my CITI login information (lost password or username)? ANSWER
3. How do I merge my CITI account from my previous insituttion into my current UK CITI account? ANSWER
4. What happens if I need to quit a course and return later? ANSWER
5. Can I view the CITI program website in other languages? ANSWER
6. How long will it take to complete a CITI Program course? ANSWER
7. How do I review the modules that I have completed? ANSWER
8. What courses are available on the UK CITI Curriculum? ANSWER
9. How can I print a copy of a certificate for my past-completed courses? ANSWER
10. How can I obtain copies of CITI human subject training certificates for a group of study personnel on my grant? ANSWER

Sponsor-Investigator CITI Training

1. Who must complete Sponsor-Investigator training on CITI? ANSWER
2. How do I complete the CITI training specifically required for Sponsor-Investigators of FDA regulated clinical research? ANSWER

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Three Year Refresher HSP Training

1. Will I receive a reminder email to let me know my HSP training will soon expire? ANSWER
2. How do I complete the 3-year refresher human subject training on CITI? ANSWER
3. What other human subject training options will the IRB accept as refresher training? ANSWER

New Study Personnel and Continuation Review

1. Do new study personnel added to a protocol have to be HSP trained? ANSWER
2. Is training status of study personnel checked at continuation review time? ANSWER
3. What if an individual listed as study personnel on the continuing review report has not maintained his/her HSP training? ANSWER

Non-UK or Community Based Study Personnel

1. What if study personnel on my University of Kentucky (UK) IRB protocol are not affiliated with UK? ANSWER
2. If my study personnel are not affiliated with UK, but they have completed human subject training elsewhere, will it count towards UK’s requirement? ANSWER
3. Are there other HSP training options specific for individuals involved in community-engaged and community-based participatory research (CBPR)? ANSWER

Classroom Assignment Human Subject Course

1. What course should I ask my students to complete as an introduction to Human Subject Research if they are NOT serving as study personnel on an IRB protocol? ANSWER

Contacts

1. Whom do I contact at ORI with questions about human subject or other IRB training requirements? ANSWER
2. Whom can I contact at ORI with general questions about CITI? ANSWER
3. Whom can I contact at CITI for technical help? ANSWER

Responsible Conduct in Research Training

Whom do I contact with questions regarding Responsible Conduct of Research (RCR) training required by funding agencies such as the National Science Foundation (NSF)? ANSWER

Humanitarian Use Device (HUD) Training

What training is available for clinicians or researchers using Humanitarian Use Devices (HUD)? ANSWER
How do I access the CITI HUD training module? ANSWER

 

Other Required Trainings

Where can I find out about other mandatory education requirements that might be applicable to my research? ANSWER

 

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