Certification in Human Subject Protections
University Policy
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.
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):
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Completing the UI modules of the CITI on-line tutorial
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Completing the VA modules of the CITI on-line tutorial
What is Option 1: 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. Instructions for using the CITI program are given below.
Features of the CITI online course:
Different course options are available. One is for those conducting research under IRB-01 (Biomedical) projects and the other is for those conducting research under IRB-02 (Behavioral/Social Science) projects,. For information on which projects are reviewed by IRB-01 and which are reviewed by IRB-02, click here.
Once you have completed and passed the online course, the CITI program notifies our office of your completion. You will no longer need to send us the completion certificate! 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 Elona McLees at 335-6837or elona-mclees@uiowa.edu.
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.
The CITI program fulfills the NIH requirement for human subjects protection certification.
How do I complete the CITI Course?
The CITI program is automated and user-friendly. Instructions for how to use the CITI program for University of Iowa researchers:
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Go to https://www.citiprogram.org/default.asp
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Click on "Register for the CITI Course"
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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.
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Choose a Username, Password, and Verification Phrase. 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.]
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Complete the Registration Page.
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Click on the "Information from your Institution" link and review the information there.
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On the Completion Report Groups page, for question 1, choose "IRB-01" or "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 Elona McLees in the Human Subjects Office 384-4546.]
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Select SUBMIT
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Select GO BACK TO LEARNER”S MAIN MENU
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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.
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Complete the required modules.
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Use the "Main Menu | FAQ | Logoff" links at the top of the page as needed.
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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.
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
What is Option 2: VA On-Line Tutorial Course – CITI
A curriculum for your course in the protection of human subjects has been established by the VA PRIDE office to meet annual training mandates established by VA policy. The course is available through the on-line tutorial called CITI. To complete the VA curriculum:
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Go to https://www.citiprogram.org/default.asp
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Click on "Register for the CITI Course"
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Under the "Veterans Affairs" drop-down menu, choose "Iowa City,IA-584
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Choose a Username, Password, and Verification Phrase. Choose something that is easy for you to remember.
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Complete the Registration Page.
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Review the information on the Iowa City, IA-584 Instructions Page.
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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.)
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Select SUBMIT
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Select GO BACK TO LEARNER”S MAIN MENU
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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.
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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.
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@uiowa.edu. She will complete the paper work to assign your HAWKID. If you would rather contact her by phone, her VA extension is 3595 (338-0581).
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@uiowa.edu. She will complete the paper work to assign your HAWKID. If you would rather contact her by phone, her VA extension is 3595 (338-0581).
Whom do I contact with questions?
If you have questions regarding the CITI program or human subjects protections certification at the UI, please contact elona-mclees@uiowa.edu. If you have questions about the VA human subjects protection and GCP curriculum, contact Marisue Cody (marisue.cody@va.gov)
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.
With the CITI course, you can access a printable completion confirmation and report through your secure log-in.
If you need a paper copy of the certificate issued by the NIH online training course, direct your questions about obtaining another paper copy to the support staff of the on-line tutorial: ncioesisupport@mail.nih.gov The Human Subjects Office does not have copies of your NIH completion certificate!
If you need a copy of the Completion Memo for the HSO Workshop, please contact elona-mclees@uiowa.edu.
UI Lecture Course -- The lecture course is no longer available