Certifications in Human Subjects Protections (CITI)

FAQs for Certifications in Human Subjects Protections (CITI)

  1. What is the University of Iowa’s policy on human subjects protections?
  2. Who is required to complete the human subjects protections training under this policy?
  3. Who is NOT required to obtain this training?
  4. What is good clinical practice (GCP) training and do I need to complete this? Is this the same as human subjects protections training?
  5. What is responsible conduct of research (RCR) training and do I need to complete this? Is this the same as human subjects protections training?
  6. Do I need special training for Department of Defense (DoD) research?
  7. How do I become certified in human subjects protections training?
  8. How can I tell if someone else is certified in human subjects protections training at the UI?
  9. How do I register or create a new account on the CITI website for the University of Iowa?
  10. What CITI modules are included in the University of Iowa Human Subjects Certification?
  11. How do I register or create a new account on the CITI website for the Iowa City VAHCS?
  12. How do I add a course if I’m already a registered user that is affiliated with the UI?
  13. I have completed CITI training through another institution. Will this training fulfill the University of Iowa requirements for Human Subjects Protection training?
  14. How do I affiliate myself with the University of Iowa if I have completed Human Subjects Certification under another institution?
  15. How long do these courses take to complete?
  16. I just completed the CITI tutorial. Do I need to notify the HSO about my completion? How long will it take for this information to be updated in HawkIRB?
  17. What if I need a copy of my certification?
  18. How do I obtain a HawkID for Iowa City VAMC research purposes?
  19. What about certificates for the completion of the NIH’s ‘Protecting Human Research Participants’ tutorial?
  20. I completed a workshop conducted by the HSO several years ago for my human subjects protections training and now I need proof of this completion. How do I go about getting this?
  21. I still have questions. Who should I contact?
  22. Why do I see other courses offered on the curriculum selection page?

1. What is the University of Iowa’s Policy​​ on Human Subjects Protections?

All investigators conducting human subjects research at the University of Iowa or at the Iowa City VAHCS are required to complete an education program and become "certified" in human subject protections through the Collaborative Institutional Training Initiative program (CITI).

2. Who is required to complete the human subjects protections training under this policy?

  • All members of the research team, including the principal investigator and all other individuals (faculty, staff, or student) who have contact or interactions with research subjects or with their private, identifiable information.
  • Faculty Advisors/Supervisors of student research projects.
  • Investigators who are not affiliated with the UI, who are engaged in a UI research study and whose IRB of record will be UI IRB-01 or UI IRB-02 as designated by a formal, written agreement. (An investigator at another institution is considered to be "engaged in research" as described in guidance from the Office of Human Research Protections).
  • Members of UI IRB-01, UI IRB-03, & UI IRB-02.

3. Who is NOT required to obtain this education?

  • Individuals not considered to meet the regulatory definition of “engaged in research.”  See OHRP “Engagement of Institutions in Human Subjects Research” and definitions of “Human Subject” and “Research” under 45 CFR 46.102 as a guide.
    • Example:  Technicians whose only role in the research is to perform standard clinical procedures (such as a blood draw) that are part of the research protocol.
  • Investigators not affiliated with the UI, who are collaborating with UI investigators on a UI research study, and who will be under the review of their own IRB (not UI IRB-01 or UI IRB-02).

4. What is good clinical practice (GCP) training and do I need to complete this? Is this the same as human subjects protections training?

Effective January 1, 2017: All investigators and staff who are involved in the conduct, oversight or management of NIH funded clinical trials are required to complete training in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2) and refresh this training every 3 years.  Information on this training requirement can be found here.  Investigators will be expected to retain their own documentation of completion of this training as well as their human subjects protections training.   This policy applies to all active grants and contracts, including those awarded before January 1, 2017.  The University of Iowa will require GCP training to be completed by all researchers involved in the conduct, oversight, or management of NIH funded clinical trials no later than 12/31/17. 

*NIH may require those with NIH funded studies to complete the GCP training prior to this date.  In the event this occurs, the UI will defer to their requirement.

GCP training is not the same as human subjects protections and is not covered in the basic courses in human subjects protections offered in CITI.   If you are involved in the conduct, oversight or management of an NIH funded clinical trial, you will need to complete this training in addition to any other training that is required by UI policy or your department.  For more information regarding GCP training, please refer to these FAQs.

5. What is responsible conduct of research (RCR) training and do I need to complete this?  Is this the same as human subjects protections training?

University of Iowa Responsible Conduct of Research (RCR) Plan has been created under the joint sponsorship and responsibility of the Graduate College and the Office of the Vice President for Research to ensure funded investigators are formally trained in RCR. For contact information, FAQs, a list of training requirements, and to view the UI Responsible Conduct of Research Plan, please click on the RCR link above.

RCR training is not the same as human subjects protections and is not covered in the basic courses in human subjects protections offered in CITI.   Your department will determine if you need to complete this training in addition to any other training that is required by UI policy.


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6. Do I need special training for Department of Defense (DoD) research?

The Navy requires that you take additional certification modules. These are offered in the CITI program course, which you may have already taken in order to do research at the University of Iowa. For directions on taking the new modules, see Training Requirements on this page. Check with your DoD representative to determine if you need other DoD research-related training. If you have taken DoD-related training in the past, check with your DoD representative to see if it needs to be renewed.

7. How do I become certified in human subjects protections training?  Does the current NIH tutorial in human subjects protections training count?

  • For University of Iowa researchers, complete the UI modules of the CITI on-line tutorial (IRB-01 and IRB-02 researchers)
  • For Iowa City VAHCS researchers, complete the VA modules of the CITI on-line tutorial (IRB-03 researchers).  A curriculum for the course in the protection of human subjects has been established by the VA PRIDE office to meet annual training mandates established by VAMC policy.
    • Please note that VA training requirements mandate recertification occur every two years. VA credentialing requirements are maintained and monitored by the VA Research Office. Failure to adhere to these recertification requirements could result in the VA Research Office issuing restrictions to conduct VA related research activities.
  • The NIH tutorial, “Human Participants Protection Education for Research Teams” is not accepted as fulfilling the University of Iowa requirement for human subjects protections certification. The course that fulfills the UI training requirement is called CITI and is available online. The CITI program also fulfills the NIH requirement for human subjects protections certification as well.

8. How can I tell if someone else is certified in human subjects protections training at the UI?

Investigators who meet the UI certification requirements are listed in the Certified Investigator Database. This password-protected database is official recognition that an investigator has completed the UI requirements for human subjects protection education. The HSO no longer issues hard copy "certificates" for attending the UI Lecture, nor do we keep the completion certificates from the on-line tutorial on file (see below for information about obtaining a copy of your certificate).

9. How do I register or create a new account on the CITI website for the University of Iowa?

For the University of Iowa:

  1. Go to citiprogram
  2. Click on the ’Register’ button under ‘Create an account’
  3. You will need to select the institution that you are affiliated with, in this case, the University of Iowa. In the ‘Select Your Organization Affiliation’ section, type in ‘University of Iowa’. Only the University of Iowa modules are accepted as meeting the UI requirement. (If you are a VAMC employee, see below.) Click on the ‘Continue to Step 2’ button.
  4. Enter in your personal information. All fields marked with an * are required. Click on the ‘Continue to Step 3’ button.
  5. Create a username and password, and choose a security question/answer. We encourage you to use your HawkID as your username, if it is available. Do not use your HawkID password as your CITI password, however. Choose something that is easy for you to remember but is not your HawkID password. [NOTE: Your HawkID is NOT your University of Iowa Employee Number or student ID Number. You can obtain your HawkID from your listing in the UI online directory.] Click on the ‘Continue to Step 4’ button.
  6. CITI asks for your gender, ethnicity and race. If you have questions about why this information is collected by this site, please refer to CITI website. Click on the ‘Continue to Step 5’ button.
  7. Select whether you want to receive Continuing Education credit (CEUs) for CITI Program course completion and whether CITI can contact you in the future to participate in research surveys. Click on the ‘Continue to Step 6’ button.
  8. Complete all fields that are marked with an * in Step 6 for your University of Iowa Profile. In the very last field, please enter your HawkID to receive course credit if you are a UI faculty, staff or student. Click on the ‘Continue to Step 7’ button.
  9. Select the “I am required to complete human subjects research training.” to complete the IRB required course for certification in Human Subjects Protections. Click on the ‘Next’ button.
  10. Select Group 1 – Biomedical – IRB-01 or Group 2 –Social & Behavioral – IRB-02. (For information on which projects/departments are reviewed by IRB-01 and which are reviewed by IRB-02, please click here. If you still have questions, please call Joanie Neyens(link sends e-mail) in the Human Subjects Office (384-1176). Please note that these are the courses in human subjects protection required by the IRB. Your department may have additional CITI course requirements for you to complete. Click on the ‘Next’ button.
  11. Click on the ‘Finalize registration’ link.
  12. On the Main Menu screen, under the ‘University of Iowa Courses’ tab, click on the title of the course to enter the course.
  13. Click on the ‘Complete The Integrity Assurance Statement Before Beginning the Course’s link and complete. Click on the ‘Submit’ button.
  14. Click on the title of the first module to begin.
  15. Complete all of the required modules.
  16. Use the "Main Menu | FAQ | Logoff" links at the top of the page as needed.
  17. After completing all modules, print off a completion form. Keep a copy of the form for your records. The HSO will automatically be notified of your completion of the course. Please allow 1 to 2 business days after you complete the course for this information to be entered into the Certified Investigator Database.

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10. What CITI modules are included in the University of Iowa Human Subjects Certification?

For IRB-01 Biomedical, the required modules include:

  • Introduction
  • History and Ethical Principles
  • Basic Institutional Review Board (IRB) Regulations and Review Process
  • Informed Consent
  • Social and Behavioral Research for Biomedical Researchers
  • Records-Based Research
  • Genetics Research in Human Populations
  • Research with Protected Populations - Vulnerable Subjects: An Overview
  • University of Iowa

For IRB-02 Social & Behavioral, the required modules include:

  • Introduction
  • History and Ethical Principles - SBR
  • Defining Research with Human Subjects - SBR
  • The Regulations and the Social and Behavioral Sciences - SBR
  • Assessing Risk in Social and Behavioral Sciences - SBR
  • Informed Consent - SBR
  • Privacy & Confidentiality - SBR
  • University of Iowa

11. How do I register or create a new account on the CITI website for the Iowa City VAHCS?

  1. Go to citiprogram.
  2. Click on the ’Register’ button under ‘Create an account’.
  3. You will need to select the institution that you are affiliated with; in this case, Veterans Administration Health Care System in Iowa City. In the ‘Select Your Organization Affiliation’ section, type ‘VA Iowa City, IA-584.' Click on the ‘Continue to Step 2’ button.
  4. Enter in your personal information. All fields marked with an * are required. Click on the ‘Continue to Step 3’ button.
  5. Create a username and password, and choose a security question/answer. Click on the ‘Continue to Step 4’ button.
  6. Provide your country of residence. Click on the ‘Continue to Step 5’ button.
  7. Select whether you want to receive Continuing Education credit (CEUs) for CITI Program course completion and whether CITI can contact you in the future to participate in research surveys. Click on the ‘Continue to Step 6’ button.
  8. Complete all fields that are marked with an * in Step 6 for your Iowa City VA profile. Click on the ‘Continue to Step 7’ button.
  9. On the Select Curriculum page, answer the questions to select the courses for completion (Note: your response to question #1 will select the Human Subjects Protection course. If you have not completed a VA Human Subjects Protection Course, you will be taken to the Basic Training Course. If you have completed a VA Human Subjects Protection Course, you will be taken to the Refresher Course.) Click on the ‘Complete Registration’ button.
  10. Click on the ‘Finalize registration’ link.
  11. On the Main Menu screen, under the ‘Iowa City, IA-584 Courses’ tab, click on the title of the course to enter the course.
  12. Click on the ‘Complete The Integrity Assurance Statement before beginning the course’ link and complete. Click on the ‘Submit’ button.
  13. Click on the title of the first module to begin.
  14. Complete all of the required modules and take the quiz at the end of the module. The VA has established a minimum "passing" aggregate score of 80% for all quizzes. If you want to improve a score on a quiz, you may revisit the content and repeat any quiz. The software will remember your best score.
  15. After completing all modules, print off a completion form. Keep a copy of the form for your records. The HSO will automatically be notified of your completion of the course. Please allow 1 to 2 business days after you complete the course for this information to be entered into the Certified Investigator Database. You will need to have a valid HawkID in order to enter your certification.

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12. How do I add a course if I’m already a registered user that is affiliated with the UI?

  1. Re-enter the CITI program at https://www.citiprogram.org/
  2. On the Main Menu screen, under the ‘University of Iowa Courses’ tab, in the ‘My Learner Tools for University of Iowa’ box, select the ‘Add a Course or Update Learner Groups’ link
  3. On the ‘Select Curriculum – University of Iowa’ screen, select the situation that best describes the training you are required to complete or would like to complete (choose all that apply).
  4. Click the ‘Next’ button.
  5. Select the courses/modules that you are required to complete or would like to complete, clicking on the ‘Next’ button at the bottom of each screen until you are directed to the Main Menu screen.
  6. On the Main Menu screen, under the ‘University of Iowa Courses’ tab, click on the title of the course to enter course.
  7. Click on the ‘Complete The Integrity Assurance Statement before beginning the course’ link and complete. Click on the ‘Submit’ button.
  8. Click on the title of the first module to begin.
  9. Complete all of the required modules.
  10. After completing all modules, print off a completion form. Keep a copy of the form for your records. The HSO will automatically be notified of your completion of the course. Please allow 1 to 2 business days after you complete the course for this information to be entered into the Certified Investigator Database as verification that you have completed the correct course needs to be completed before the information is entered.

13. I have completed CITI training through another institution. Will this training fulfill the University of Iowa requirements for Human Subjects Protection training?

The University of Iowa cannot accept a CITI completion certificate from another institution. The training modules in the CITI on-line course are institution specific. Although there are a limited number of modules available through CITI, each institution establishes the groups of modules that meet their requirements for certification. For this reason, completion of the CITI course for another institution does not meet the requirements for certification at the UI.

To complete the University of Iowa CITI course modules, you will need to re-enter the CITI site and complete the course as a University of Iowa learner.   If there are modules that are a part of both the UI and your previous institution’s approved modules, the completion will likely transfer.  See question #10 for a list of the University of Iowa required modules.  The CITI program will tell you which modules are INCOMPLETE for the UI course.

14. How do I affiliate myself with the University of Iowa if I have completed Human Subjects Certification under another institution?

To add an affiliation with the University of Iowa and complete the UI required modules, you will need to do the following:

  1. Re-enter the CITI course at https://www.citiprogram.org/ by logging in with the username and password previously registered with CITI (note--if you do not remember your username and/or password, you may contact the web site to obtain that information. Contact information is given on the Home Page for the site).
  2. On the Main Menu screen, click on the “Click here to affiliate with another institution” tab and link.
  3. Type in ‘University of Iowa’ in the search box and then click the ‘Next’ button.
  4. You may be asked to enter new demographic information and answer questions for this new affiliation.  When completed, click the “Next” link.
  5. On the page for the University of Iowa, select the “I am required to complete human subjects’ research training.” option to complete the IRB required course for certification in Human Subjects Protections. Click on the ‘Next’ button.
  6. Select Group 1 – Biomedical – IRB-01 or Group 2 –Social & Behavioral – IRB-02. (For information on which projects/departments are reviewed by IRB-01 and which are reviewed by IRB-02, please click here. If you still have questions, please call Joanie Neyens in the Human Subjects Office 384-1176.) Please note that these are the courses in Human Subjects Protections required by the IRB. Your department may have additional CITI course requirements for you to complete. Click on the ‘Next’ button.
  7. Click on the ‘Finalize registration’ link.
  8. On the Main Menu screen, under the ‘University of Iowa Courses’ tab, click on the title of the course.
  9. Complete all of the incomplete modules.  Your completion of this course will automatically be reported to the HSO in 1 to 2 business days.

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15. How long do these courses take to complete?

Each CITI course module requires you to read a specified amount of text and complete a quiz at the end of each module.  Since different people read at different paces, it’s difficult to provide an estimate for how long the courses will take you to complete.   The CITI website notes that the average learner spends about 4 ½ hours completing a basic course and about 2 hours completing a refresher course.   You do not have to complete the entire course in one sitting; the CITI program is set up so that you can step away from it and start again where you left off previously.

16. I just completed the CITI tutorial.  Do I need to notify the HSO about my completion?  How long will it take for this information to be updated in HawkIRB?

Within approximately 24 hours, CITI notifies the HSO of any completions of the University of Iowa CITI module.  HSO staff then enters the certifications into the HawkIRB database after verifying that you have completed the correct course.   Your completion should be reflected in HawkIRB within one to two business days, depending on when we receive the notices from CITI and how many are received.  If your certification is not entered into the database, you will receive an email from the HSO notifying you if there are any issues with your certification.

17. What if I need a copy of my certification?

Being entered into the Certified Investigators Database is proof of certification for UI offices and committees. On occasion, however, some University of Iowa researchers have been asked to produce a "paper copy" showing they have completed human subjects training.

The Human Subjects Office does not have copies of your NIH or CITI completion certificate. If you wish to print a copy of your Completion Report:

  1. Go to the CITI Course Registration page at https://www.citiprogram.org/
  2. Enter your username and password to access your files.
  3. On the Main Menu screen, under the ‘University of Iowa Courses’ tab, click on the ‘View/Print’ link under the ‘Completion Report’ column for the corresponding course.
  4. The report will open and you can print or save the report.
  5. If the corresponding course does not appear under the ‘University of Iowa Courses’ tab, click on the ‘My Reports’ tab at the top of the Main Menu screen.
  6. Find the corresponding course under the ‘University of Iowa Reports’ tab and click on the ‘View’ link under the ‘Completion Report’ column.
  7. The report and print dialog box will open and you can print the report.

18. How do I obtain a HawkID for VA research purposes?

In order to enter you into the HawkIRB Certified Investigators Database you must have a HAWKID. The HAWKID is a personal identification assigned by the University of Iowa. Some VA researchers have been assigned a HawkID because of dual appointments with the UI. If you have a HAWKID, please use this as your CITI USERNAME.

If you do not have a HAWKID, you should obtain a HAWKID by e-mailing your name, your VAHCS department/clinic, your social security number, and your date of birth to Nadine Miller (link sends email) (phone: 338-0581, VA ext: 3595). She will complete the paperwork to assign your HAWKID.

19. What about certificates for the completion of the NIH’s ‘Protecting Human Research Participants’ tutorial?

To obtain a copy of the certificate of completion for the NIH tutorial "Protecting Human Research Participants" completed after March 1, 2008, the trainee may log in to the tutorial at any time to print the certificate associated with his or her account. NIH does not provide additional copies of the certificate.

For NIH tutorials completed before March, 2008, the certificates of completion are no longer available from the NIH. Investigators who did not keep a copy of their NIH/NCI Completion Certificates for that tutorial will have to take either the new NIH course or an NIH acceptable course for proof of certification (the UI CITI courses are accepted by NIH).


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20. I completed a workshop conducted by the HSO several years ago for my human subjects protections training and now I need proof of this completion.  How do I go about getting this?

If you need a copy of the Completion Memo for the HSO Workshop, please contact Joanie Neyens (link sends e-mail).

21. I still have questions.  Who should I contact?

If you have questions regarding the IRB requirements for certification of researchers conducting human subjects researchers, please contact:

Joanie Neyens (link sends e-mail) at 319-384-1176

If you have questions about the VA human subjects protection and GCP curriculum, contact:

Michelle MacDonald(link sends e-mail) or the VA Research Office at 319-339-7151

22. Why do I see other courses offered on the curriculum selection page? 

The curriculum selection page will display other courses for the University of Iowa. UI researchers that are involved in human subjects research are required to complete the CITI Basic Course Modules for either IRB-01 (Biomedical) or IRB-02 (Social & Behavioral) listed in the Human Subjects Research Course Enrollment section on the curriculum page. Completion of courses for the Responsible Conduct of Research, and animal subjects’ research training and Export Control training are not required by the IRB.

In addition to the required modules, there are optional additional modules that cover special topics in human subjects protections that you may opt to complete as well.

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