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Mandatory Human Subject Protection (HSP) 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

NON-UK Personnel – Follow instructions for individuals listed as study personnel on a UK protocol that are NOT UK employees or students.

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.

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.

Click here for free Acrobat Reader software, needed for opening PDF links. PDF links on this page are set to open a new web page.

Initial IRB Training Requirement: Who, What, When

QUESTION ANSWER

1. What training is required for the IRB to approve human research protocols?

The University of Kentucky's Human Subject Protection (HSP) training requirement, initially implemented in 2000, requires all study personnel conducting research involving living human subjects, or data or biological specimens derived there from, to be trained in the protection of human subjects initially and complete refresher training every three years. IRB policy also requires one-time mandatory sponsor-investigator training for investigators who are also serving as sponsors for an FDA regulated clinical investigation. The Collaborative Institutional Training Initiative (CITI) [www.uky.edu/UKHome/subpages/linkblue.html] is the sole source for initial HSP training and the primary source for refresher HSP and sponsor-investigator training. Brief descriptions of each are available below. Instructions for creating a user account on CITI are available on this page under CITI User Information and instructions for enrolling in the initial HSP course are available on this page under Initial CITI HSP Training.

2. Who must complete HSP training?

All study personnel listed in the IRB application must have current HSP training as a condition of IRB approval.

3. Must all study personnel complete HSP training prior to the IRB submission?

No, all personnel must be trained as a condition of IRB approval, however, you may submit the protocol for review as personnel are concurrently completing training.

4. What if an individual listed as study personnel on my initial review have not completed HSP training?

IRB approval will be withheld until documentation is submitted supporting HSP training completion or the study personnel is removed from the protocol. Once trained, the personnel may be added back to the protocol with a Modification Request.

5. Who is considered study personnel on human subject protocols?

An individual who interacts and/or intervenes with human subjects or handles personally identifiable data from a human subject. For detailed information, download “What Constitutes Study Personnel on a Protocol Involving Human Subjects?” [PDF].

6. Is the faculty advisor signing the protocol assurance statement for a student's research project required to be HSP trained?

Yes, the student's faculty advisor is accepting a supervisory role in guiding the student in conducting regulatory compliant research. Therefore, the faculty advisor is considered study personnel subject to this training requirement.

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?

The Collaborative IRB Training Initiative (CITI) web-based training platform provides initial human subject protection (HSP) training and three- year renewal HSP training courses.  The initial HSP training provides a comprehensive overview of the regulatory framework and ethical principles involved in the conduct of human research.  Learners gain an appreciation of historical events that influence the development of current regulatory requirements.  Modules outlining the role of the Institutional Review Board (IRB) and the various IRB review mechanisms prepare new investigators to navigate the review and approval process.   Additional modules cover the core fundamental tenets of research protections including informed consent, privacy and confidentiality, conflict of interest management, and data safety monitoring and reporting.  Separate modules on specific classes of vulnerable subjects prepare the learner to consider and implement safeguards and protections where applicable (i.e., children, prisoners, pregnant women, fetuses, neonates, students, vulnerable international, cultural or community groups).  Learners are able to recognize risks and benefits unique to social and behavioral research (SBR) as well as ethical considerations for common SBR research techniques such as records review or internet research. Modules specific to biomedical research cover the regulatory requirements for research regulated by the Food and Drug Administration (FDA) as well as ethical and regulatory issues involved with the conduct of genetic research.  Examples and cases throughout the course help the learner apply the core ethical principles of beneficence, respect for persons and justice to their human research.     The CITI HSP renewal courses provide a comprehensive review of core material provided in the initial HSP training.  Topical information and regulatory updates are incorporated throughout the renewal training modules.  The course serves to remind investigators of the fundamental ethical principles while informing them of regulatory changes and relevant trends in human research protections.


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Initial CITI HSP Training for IRB Approval

QUESTION ANSWER
1. How do I enroll in initial (basic) human subject training for IRB approval on the CITI website?

You may enroll initially from the UK Curriculum selection page after creating your account. From the Main Menu on the CITI web page [link to CITI portal on Link Blue web page], click "Add a Course or Update Learner Groups".

In the next window, be sure to select the “IRB” menu and not the “RCR” menu, which offers Responsible Conduct in Research training options. Neither RCR nor Good Clinical Practice (GCP) training meets the IRB HSP requirement.

Select

›IRB
Click

Select applicable human subject protection (HSP) training:

Click

›
Select either:

Click

The course will be listed under University of Kentucky Courses on your Main Menu.

Upon entering your course, the “Grade Book” will be displayed which will track progress of module completion. Before beginning the course modules, you will be prompted to complete the required "Integrity Assurance Statement". Upon completion of the full course, click “Completion Reports” to print a Course Completion Certificate.

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?

To access HSP training required for IRB approval select “IRB” and NOT “RCR” from the CITI curriculum page. RCR training does NOT meet the training requirement for IRB approval. RCR stands for Responsible Conduct in Research (RCR). RCR training is required in order to receive grant funding from select agencies.
3. Who is approved to take the Limited HSP training on CITI? Limited initial HSP training is approved for personnel employed in the UK Survey Research Center (SRC). If you are not employed by the SRC or conducting research in that capacity, the Limited initial HSP training will NOT count towards the HSP mandate. In rare cases, approval may be granted for individual(s) with a protocol specific role that limits involvement in the conduct of the research. This requires special permission from the Office of Research Integrity (ORI). Contact ORI at 859-257-9428 or 859-323-2446 with questions.
4. I took the CITI Limited HSP training by mistake. Will I have to retake the modules I completed? If you have completed the Limited HSP training, CITI records the modules you have completed. Therefore, you will not have to re-take the modules that are in both the Limited and full Initial HSP course. When you enroll in the full initial training, the modules you previously took should show up as complete.
5. I took the CITI Responsible Conduct in Research (RCR) course. Will that count for IRB approval?

No, if your intent is to complete IRB human subject protection training, be sure to select “IRB” and NOT “RCR” from the CITI curriculum page.

Responsible Conduct in Research (RCR) training covers topics integral to the preparation and development of current and future scientist in all areas of research (not just human subjects). It is a requirement of certain funding agencies such as the National Science Foundation (NSF). For information on the RCR training or requirement, see the RCR question below.

6. I took the CITI Good Clinical Practice (GCP) course. Will that count for IRB approval? No. For IRB approval, you must complete human subject protection (HSP) training. GCP training is offered as an optional course that users may choose to take in addition to HSP training. GCP is an excellent training for those involved in the conduct of clinical research trials. Some industry sponsors of clinical trials require research staff to be trained in GCP guidelines. The CITI GCP course is one option for obtaining GCP training.
7. I took the CITI HIPAA course. Will that count for IRB approval? No. For IRB approval, you must complete human subject protection (HSP) training. HIPAA training is offered as an optional course that users may choose to take in addition to HSP training. The CITI HIPAA training provides general information regarding the privacy rules and security rules. For research specific HIPAA training, you may view the ORI course, “ ORI002: Protecting Personal Health Information in Research - Understanding the HIPAA Privacy Rule” available on UK Blackboard.
8. Is there a paper-based alternative for initial human subject training if I do not have access to a computer to complete CITI? Study personnel are encouraged to complete the initial HSP training on CITI. If extenuating circumstances prohibit access to a computer, contact Belinda Smith (belinda.smith@uky.edu, 859-323-2446) to obtain an alternate paper-based course and exam.


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CITI User Information

QUESTION ANSWER

 

1. How do I create a CITI user account?

  • 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 – Instructions for individuals listed as study personnel on a UK protocol that are NOT UK employees or students.
2. How do I find or reset my CITI login information (lost password or username)?
  • UK is transitioning to the CITI Single Sign On (SSO) access through the institution, using individuals’ UK Link Blue account. This transition will improve the traceability of training records and will allow UK users’ access to CITI without having to remember an additional username and password.  If you do not remember your CITI username or password contact ORI for assistance in making the transition to the SSO using your UK Link Blue account. 
  • For help identifying, activating, or resetting your UK Link Blue ID or password go to www.uky.edu/ukat/help/linkblue
3. How do I merge my CITI account from my previous institution into my current UK CITI account?

Once you have created your UK CITI account send an email to support@citiprogram.org with the subject: Account Merge. Into body of the email enter the information below:

Please merge my account from (enter name of previous institution) into my University of Kentucky account. Thank you.
• Your first and last name.
• University of Kentucky
• University of Kentucky Username or Member ID
• Previous Institution Username or Member ID

4. What happens if I need to quit a course and return later? CITI allows you to complete the course at your own pace. You may quit and return to the course later. However, you must quit after taking the quiz for a particular module, not DURING the taking of that quiz, or your answers will not be recorded.
5. Can I view the CITI program website in other languages? CITI currently offers website content in the following languages: English, French, Japanese, Korean, Portuguese, Russian, and Spanish.
6. How long will it take to complete a CITI Program course? Each course will have a different number of modules, but the CITI program reports that the average learner spends approximately 4.5 hours to complete the Initial HSP (Basic) Course site with approximately 5 logins to complete the course. The average learner requires approximately 2 hours to complete a CITI Program HSP Refresher Course.
7. How do I review the modules that I have completed?

From the Main Menu in the CITI web page [link to CITI portal on Link Blue web page], select "View Previously Completed Coursework" under the "My Learner Tools" menu.

8. What courses are available on the UK CITI Curriculum?

IRB Courses

Human Subject Protection (HSP) Training
Initial and refresher training mandatory for all study personnel on IRB submission

Course

Group (research emphasis) /Expanded title/Stage

INITIAL HSP training

Group 1 Biomedical Investigators and Key Personnel

INITIAL HSP training

Group 2 Social/Behavioral Investigators and Key Personnel

INITIAL HSP limited to Survey Research Center Staff ONLY

Group 3 Limited

3 YR Refresher HSP training

Group 1 Biomedical Investigators and Key Personnel

3 YR Refresher HSP training

Group 2 Social/Behavioral Investigators and Key

Sponsor-Investigator Training Options
IRB requires completion of applicable drug or device course for investigator acting as sponsor of FDA regulated research.  Completion of these GCP courses may also be required by external industry sponsors.

Device Sponsor Investigator

Good Clinical Practice (GCP) Course for Clinical Trials Involving Investigational Medical Devices

Drug (or biologic) Sponsor Investigator

Good Clinical Practice (GCP)  Course for Clinical Trials Involving Investigational Drugs

RCR Courses

Responsible Conduct in Research (RCR)
Required by select funding agencies such as NSF, select NIH grants, etc.

Biomedical Responsible Conduct of Research

Basic RCR Course –Stage 1

Social and Behavioral Responsible Conduct of Research Course

Basic RCR Course –Stage 1

Physical Science Responsible Conduct of Research

Basic RCR Course –Stage 1

Humanities Responsible Conduct of Research

Basic RCR Course –Stage 1

Responsible Conduct of Research Administrators

Basic RCR Course –Stage 1

Responsible Conduct of Research Engineers

Basic RCR Course –Stage 1

9. How can I print a copy of a certificate for my past-completed courses?

From the Main Menu on the CITI web page [link to CITI portal on Link Blue web page], click "View Previously Completed Coursework"

Then on the next screen, click on the "View" link under the "Completion Report" column.

10. How can I obtain copies of CITI human subject training certificates for a group of study personnel on my grant? You may submit a request to ORI (Jennifer Hill, jen.hill@uky.edu / 859-257-2978 or Belinda Smith, belinda.smith@uky.edu / 859-323-2446). Unless specified, please allow three business days to complete the request.


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Sponsor-Investigator CITI Training

QUESTION ANSWER
1. Who must complete Sponsor-Investigator training on CITI?

IRB policy requires mandatory training for investigators who are also serving as sponsors, (e.g., holding an Investigational New Drug (IND), Investigational Device Exemption (IDE), or abbreviated IDE), for an FDA regulated clinical investigation. A Sponsor-Investigator must complete the applicable drug or device Good Clinical Practice for Sponsor-Investigator training on CITI before final IRB approval is granted. If the sponsor-investigator has documentation of completion of equivalent training, submit with the protocol application for the IRB's consideration.

Sponsor-Investigators may also choose to require completion of the training by staff who will be involved in the conduct of the study. This is encouraged for sub-investigators to whom any sponsor responsibilities will be delegated.
For additional details and FAQs see “University of Kentucky Sponsor-Investigator Mandatory Training”. [PDF]

2. How do I complete the CITI training specifically required for Sponsor-Investigators of FDA regulated clinical research?

On the Main Menu in the CITI web page [link to CITI portal on Link Blue web page] click "Add a Course or Update Learner Groups"

Select

›IRB
Human Subject Protection (HSP) Training lists courses available to meet the Institutional Review Board (IRB) training mandate at the University of Kentucky (English and Spanish)
Click

Choose applicable course:

›Drug Development for Sponsor-Investigators (good clinical practice (GCP) course required for sponsor-investigators of investigational drug trials).

or

›Device Development for Sponsor-Investigators (good clinical practice (GCP) course required for sponsor-investigators of investigational device trials).

Click

You may select "No optional courses needed" and click

The course will be listed under the Main Menu. Click the link under the "Course" column to enter and re-enter the course. Before beginning the course modules you will be prompted to complete the required Integrity Assurance Statement.


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Three Year Refresher HSP Training

QUESTION ANSWER
1. Will I receive a reminder email to let me know my HSP training will soon expire? ORI does not send HSP training reminders. However, if you complete HSP training on CITI, you will receive an automated email notification from CITI approximately 90 days prior to your expiration date. Note that CITI sends the reminder to the email you used when setting up the CITI account.
2. How do I complete the 3-year refresher human subject training on CITI?

Log into your CITI account [link to CITI portal on Link Blue web page] using the new UK Single Sign On Portal [instructions].

If the refresher course is not already listed under the "University of Kentucky Courses" column, click "Add a Course or Update Learner Groups".

Select

›IRB
Click next3

Select applicable human subject protection (HSP) training:

image

Click next2

›
Select either:
image2

Click next1

The course will be listed under the Main Menu. Click the link under the "Course" column to enter and re-enter the course. Before beginning the course modules you will be prompted to complete the required Integrity Assurance Statement.

3. What other human subject training options will the IRB accept as refresher training?

There are several additional options for renewing your human subjects protection training:

  • Attendance at the UK annual human subject protection conference held in Northern Kentucky.
  • Attendance at a human subjects protection program, (e.g., Public Responsibility in Medicine and Research Conference), within the last six (6) months, and submit the certificate from that training to ORI. This option does not include an isolated session on human subject protection as part of a conference on another subject matter.
  • The web based NIH human subjects protection program (only qualifies as a refresher course and not for initial human subject protection training).
  • Staff conducting research at both UK and the Veterans Affairs Medical Center (VAMC) may complete the combined VA Good Clinical Practice and Human Subjects Protection training course on CITI and submit the completion certificate to ORI.

NOTE: Provide documentation of training to ORI so we can update your training record in our database. If you need a letter from ORI stating the training you attended or completed met the 3 year referesher requirement, contact Belinda Smith at 859-323-2446 or belinda.smith@uky.edu.


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New Study Personnel and Continuation Review

QUESTION ANSWER
1. Do new study personnel added to a protocol have to be HSP trained? Yes. Addition of new study personnel to an IRB approved protocol will only be approved if the proposed study personnel have completed the required HSP training.
2. Is training status of study personnel checked at continuation review time? Yes. Study personnel listed on the IRB protocol, at continuation review, must have up-to-date HSP training or be removed as study personnel from the IRB protocol.
3. What if an individual listed as study personnel on the continuing review report has not maintained his/her HSP training?

Upon receipt of a Continuing Review submission, ORI staff screen the submissions and promptly notify the investigator regarding any study personnel whose training has or is close to expiring in order for the personnel to complete training while the IRB is conducting the CR review.

If the listed study personnel have not completed or renewed their HSP training at the time Continuation Review (CR) approval is issued, they will be removed from the protocol and can be added back upon completion of the training via a Modification Request. Automated reminders are sent from CITI to the individual's email listed on the CITI account, approximately 90 days prior to the expiration date.


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Non-UK or Community Based Study Personnel

QUESTION ANSWER
1. What if study personnel on my University of Kentucky (UK) IRB protocol are not affiliated with UK?

The IRB does not mandate the type of HSP training for individuals who are NOT UK employees or students, therefore there are several options to meet the training mandate.

  1. If external study personnel has completed Human subject training at another institution, simply submit documentation to Jennifer Hill at jen.hill@uky.edu.
  2. The National Institutes of Health (NIH) Protecting Human Research Participants [HTML] course is free and available to the public. Learners receive a certificate upon completing the course. Upon completion, send a copy of the certificate to Jennifer Hill at jen.hill@uky.edu.

If neither option 1 or 2 (above) is feasible, contact ORI (Jen Hill at jen.hill@uky.edu, 859-257-2978). Click here for a PDF of the instructions for individuals listed as study personnel on a UK protocol that are NOT UK employees or students.

Options specific for Community Based Participatory Research (CBPR) are described in question 3 below.

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? If non-UK study personnel have completed an equivalent HSP training outside of UK, please submit documentation to ORI for review to confirm equivalency. Submit documentation of HSP training completion to the Office of Research Integrity (ORI); Attn: Belinda Smith at belinda.smith@uky.edu or Jennifer Hill at jen.hill@uky.edu or by FAX to 859-323-9882.
3. Are there other HSP training options specific for individuals involved in community-engaged and community-based participatory research (CBPR)? Traditional Human Subjects Protection training may not be appropriate for the study personnel who are laypersons in the community. There are a number of national programs available designed to educate nonscientific/nonprofessional community-based individuals. Alternate education may apply to those individuals who are laypersons, not students or researchers. Any alternative training plan must be submitted to ORI for review. For details, see the Study Personnel section of the  Community-Engaged and Community-Based Participatory Research Frequently Asked Questions. Contact Belinda Smith, belinda.smith@uky.edu / 859-323-2446.


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Classroom Assignment Human Subject Course

QUESTION ANSWER
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? “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.

 

Contacts

QUESTION ANSWER
1. Whom do I contact at ORI with questions about human subject or other IRB training requirements?

For questions regarding IRB training or CITI:

For assistance with the UK Link Blue account-

Contact the UKAT Service Desk at (859) 218-HELP(4357) or request help online.
2. Whom can I contact at ORI with general questions about CITI? Jennifer Hill, jen.hill@uky.edu / 859-257-2978 or Belinda Smith, belinda.smith@uky.edu / 859-323-2446
3. Whom can I contact at CITI for technical help? Click here: Contact the CITI Helpdesk, or on the CITI home page click "Contact Us" in the menu at the top of the page.


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Responsible Conduct in Research Training

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

The Office of Sponsored Projects Administration (OSPA) manages the RCR training. For more information on the requirements for RCR training download OSPA's "Responsible Conduct of Research Training Requirement" document [PDF]. For questions, contact Katie Riley, Katie.Riley@uky.edu, 859-257-9420.


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Humanitarian Use Device (HUD) Training

QUESTION ANSWER
1. What training is available for clinicians or researchers using Humanitarian Use Devices (HUD)?

The UK curriculum on CITI includes an optional course on Humanitarian Use Devices (HUD). The course is designed for clinicians who seek Institutional Review Board (IRB) approval for the clinical use of a HUD and for clinical researchers who wish to use a HUD in a clinical investigation. Completion of the course may be required at the discretion of the IRB for new HUD users.

2. How do I access the CITI HUD training module?

The course is available as a stand-alone course and as an optional portion of the Good Clinical Practice (GCP) and Device Development for Sponsor-Investigators GCP courses.

The stand-alone HUD course is available under the IRB menu, Optional Courses.

On the Main Menu in the CITI web page [link to CITI portal on Link Blue web page] click "Add a Course or Update Learner Groups"

Select

http://www.research.uky.edu/ori/images/eyebullet.gifIRB
Human Subject Protection (HSP) Training lists courses available to meet the Institutional Review Board (IRB) training mandate at the University of Kentucky (English and Spanish)
Click

•  Choose Optional Courses:

Optional Courses additional courses of interest including HIPAA, Humanitarian Use Devices (HUD), and Good Clinical Practice (GCP). (English and Spanish)

Click

•  Choose Humanitarian Use Devices (HUD)

The course will be listed under University of Kentucky Courses on your Main Menu.

 

Other Required Trainings

QUESTION ANSWER
1. Where can I find out about other mandatory education requirements that might be applicable to my research? The ORI Required Research-Education web page provides descriptions and links to trainings that may apply to your protocol based on institutional policy (i.e., Conflict of Interest), funding agency requirement (i.e., Responsible Conduct in Research) or study procedure requirements (i.e., Environmental Health and Safety).


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