All investigators conducting human subjects research at the University of Iowa or at the Iowa City VAMC are required to complete an education program and become "certified" in human subject protections through the Collaborative Institutional Training Initiative program (CITI). Some investigators with funding sources (e.g. NIH, NSF) may be required to complete additional training. A 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.
Who is required to obtain this education 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 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
Who is not required to obtain this education?
- 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)
How can I tell if someone is certified?
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 education. The HSO no longer issues hard copy "certificates" for attending the UI Lecture, nor do we keep on file the Completion Certificates from the on-line tutorial (see below for information about obtaining a copy of your certificate.)
How do I become certified under this policy?
Two options are available for becoming certified (click on the title to go to details about the option):
- Completing the UI modules of the CITI on-line tutorial (IRB-01 and IRB-02 researchers)
- Completing the VA modules of the CITI on-line tutorial (IRB-03 researchers)
- VA training requirements mandate recertification occur every two years. VA recredentialing 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.
Option 1 Instructions: UI On-Line Tutorial Course (CITI)
On November 7, 2005, The University of Iowa replaced the web-based tutorial developed by the NIH titled "Human Participants Protection Education for Research Teams," with another on-line course in human protections. As of December 1, 2005, the NIH tutorial is no longer accepted in our office as fulfilling the UI requirement for human subjects protections certification. The online course that fulfills the UI education requirement is called CITI and is available online. The CITI program fulfills the NIH requirement for human subjects protection certification.
- Go to citiprogram
- Click on "Register" button under 'Create an Account.'
- Under the "Participating Institutions" drop-down menu, choose "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
- Enter in your personal information. All fields marked with an * are required. Click on the ‘Continue to Step 3’ button.
- Choose a Username, Password, and a Security Question and Answer. We encourage you to use your HawkID as your Username. Do not use your HawkID password as your CITI Password. 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.
- 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.
- 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.
- 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.
- Under Question 1, 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 Wilson 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 ‘Complete registration’ button.
- Select ‘Finalize registration’ button.
- On the Main Menu screen, under the ‘University of Iowa Courses’ tab, click on the title of the course.
- Select ‘Complete The Integrity Assurance Statement before beginning the course’ link and complete. Click on the ‘Submit’ button.
- Click on the title of the first module to begin.
- Complete the required modules.
- Use the "Main Menu | FAQ | Logoff" links at the top of the page as needed.
- After completing all modules, print off a completion form. Keep 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 course completeion for this information to be entered into the UI IRB’s Certified Investigator Database.
For IRB-01 Biomedical, the required modules include:
- 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:
- 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
Please note: The curriculum selection page will display other courses for the University of Iowa. UI researchers 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 under Question 1 on the curriculum page. Completion of the courses in the section Responsible Conduct of Research (Question 2) and Lab Animal Research (Question 3) 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. For example, there is a module regarding the protection of children involved in research.
Option 2 Instructions: VA On-Line Tutorial Course (CITI)
- Go to citi program
- Click on "Register for the CITI Course"
- Under the "Veterans Affairs" drop-down menu, choose "Iowa City,IA-584
- Choose a Username, Password, and Verification Phrase. Choose something that is easy for you to remember.
- Complete the Registration Page.
- Review the information on the Iowa City, IA-584 Instructions Page.
- 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.)
- Select SUBMIT
- Select GO BACK TO LEARNER'S MAIN MENU
- Enter the course/modules list by clicking on the ENTER link in the Status column under the MY COURSES section and click on the title to begin the module.
- Complete the required modules for the VA course 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.
Upon completion of the CITI course, the CITI program will notify the HSO of your completion within 24 hours. Your certification will be entered into the Certified Investigators Database after receipt of your completion certificate from CITI and verification that you have completed the correct course. You will need to have a valid HawkID in order to enter your certification. If you have questions about this, please contact Joanie Wilson at 384-1176.
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 VAMC department/clinic, your social security number, and your date of birth to Nadine Miller (phone: 338-0581, VA ext: 3595). She will complete the paperwork to assign your HAWKID.
Whom do I contact with questions?
If you have questions regarding the IRB requirements for certification of researchers conducting human subjects researchers, please contact:
If you have questions about the VA human subjects protection and GCP curriculum, contact:
Michelle MacDonald or the VA Research Office at 319-339-7151
What if I need a copy of my certification?
Being entered into our 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.
You can access a printable completion confirmation and report through your secure log-in.
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).
If you need a copy of the Completion Memo for the HSO Workshop, please contact Joanie Wilson
UI Lecture Course
The lecture course is no longer available