CITI & IRB Training
Principal Investigators and research personnel are required to complete the Collaborative Institutional Training Initiative (CITI) Human Subjects Research training course(s) prior to approval of their study:
It is the position of the Rice IRB that all personnel on IRB protocols require both an appropriate basic training course and an appropriate course on research ethics (i.e., a course on the responsible conduct of research). Several federal funding agencies already require this for all funded trainees, but mentors require this training as well, to ensure that research involving human subjects meets the strict ethical guidelines enshrined in the Belmont Report and the oversight of the Office for Human Research Protections at the US Department of Health and Human Services.
Instructions for New Users
- Go to the CITI home page: https://about.citiprogram.org/en/homepage/
- Click “Register” in the upper right corner and fill in steps 1-7. In Step 1, choose Rice University as your institution. Continue with the registration process filling in all of the appropriate information. Please use your Rice email address as your primary email address if applicable.
- Search the institutional courses available to Rice University. Click on the “Courses” button connected to Rice University. Click on “Learner Tools” and “Add a Course.”
- For Question 1, please select “Human Subjects Research” and “Responsible Conduct of Research” to find Rice CITI courses.
- For Question 2, select the box(es) that most closely align with your research.
- For example:
i. if you are conducting behavioral research, please select “Social & Behavioral Research Investigators” and you will be assigned to complete the course “Social & Behavioral Research - Basic/Refresher,” which meets the training requirement for Social/Behavioral research at Rice University.
ii. If you are conducting research that involves taking samples (e.g., blood, tissue, saliva, DNA, etc.) directly from research participants, please select “Biomedical Research Investigators” and you will be assigned to complete the course “Biomedical Research – Basic/Refresher”.
iii. If you are conducting research that involves using samples (e.g., blood, tissue, saliva, DNA, etc.) that have already been collected from human researchers who you will not have contact with, please select “Research with data or laboratory specimens - ONLY” and you will be assigned to complete the course “Data or Specimens Only Research – Basic/Refresher”.
- Please note that it may be necessary or appropriate to select more than one training course!
- Per NIH policy, if you’re conducting NIH-funded research, please complete a GCP course that most closely aligns with your research. GCP training does not replace the standard human subject research training required by the IRB.
- For example:
- For Question 6, select the box(es) that most closely align with your research. In most cases, this will reflect the other course selected.
- If you selected, “Social & Behavioral Research Investigators” and were assigned to complete the course, “Social & Behavioral Research – Basic/Refresher,” you would choose the “Social and Behavioral Responsible Conduct of Research” course.
- If you selected, “Biomedical Research Investigators” and were assigned to complete the course, “Biomedical Research – Basic/Refresher” or “Research with data or laboratory specimens – ONLY” and were assigned to complete the course, “Data or Specimens Only Research – Basic/Refresher,” you would choose the “Biomedical Responsible Conduct of Research” course.
Documentation of this training can be uploaded as a PDF file in the training section in the IRB protocol in Cayuse IRB, or verified by the Compliance Administrator at the time of the review of the study. When you complete all of the required modules successfully, you may print your completion report through the "Print" link on the learner’s menu. The PI on the study should keep a copy of the study researchers’ training for their records.
CITI Course Renewal - Refresher Course
CITI certification is valid for 3 years. CITI will email you an automatic training reminder 60 days before your training expires and prompt you to complete a Refresher Course for recertification.
Returning CITI Users Who Are New to Rice University
- Go to the CITI home page: https://about.citiprogram.org/en/homepage/
- Log in using your username and password from your previous institution.
- Click on the link “Add Institutional Affiliation.”
- Choose Rice University as your institution.
- Fill in the required information on the next page.
- Click “next” to advance to the curriculum selection.
- Does Rice track CITI training for all research personnel?
While we do not have a database to track training statuses, we do use CITI admin access to verify training records for all personnel listed in a protocol.
- When do I need to complete CITI training?
Study personnel must complete all required CITI training prior to protocol approval, which includes new submissions, modifications, and renewals.
- How long is my CITI certificate valid?
The CITI certificate is valid for 3 years for Basic/Refresher training. There is currently no expiration for RCR training.
- How do I know when to renew my CITI certification?
CITI will email you an automatic training reminder 60 days before your training expires and prompt you to complete a Refresher Course.
- Do I need to take the GCP course(s)?
Per NIH policy effective January 1, 2017, all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials are required to be trained in Good Clinical Practice (GCP).
Rice’s CITI account currently provides the following GCP courses:
- Good Clinical Practice Course, US FDA Focus
- Good Clinical Practice Course for Clinical Trials Involving Medical Devices (international focus)
- Good Clinical Practice Course for Clinical Trials Involving Investigational Drugs (ICH / international focus)
- GCP – Social and Behavioral Research Best Practices for Clinical Research
GCP training does not replace the standard human subject research training required by the IRB.
- Does the Responsible Conduct of Research (RCR) course satisfy Rice’s requirement for human subjects research training?
No. RCR training covers research integrity and is a specific requirement for projects funded by the National Institutes of Health (NIH), National Science Foundation (NSF), and National Institute of Food and Agriculture (NIFA). Although these courses share some information, they are not interchangeable and both types of courses should be taken for the relevant type of research.
- Why do I need to take both a basic and an RCR course? Isn’t one enough?
The position of the IRB is that taking both courses is useful for several reasons. First, the materials covered in the two courses only partially overlap, and even then the focus of the guidance provided is different between the two courses. Second, RCR training is required for many trainees by federal funding agencies already. Having mentors take this training as well ensures that they have a ready answer for their trainees’ questions and that the guidance that they offer is consistent with current best practices. This helps to ensure that research is following ethical guidelines and helps avoid improper proper research practices. Finally, RCR training currently does not expire, so completing the course is likely to be a relatively small burden.
- Do I need additional training to collect or receive protected health information (PHI)?
Yes. You will need to take the “Research and HIPAA Privacy” course.
- My Sponsor requires me to take a specific CITI course that isn’t available in Rice’s listed CITI curriculum. What do I do?
Please reach out to the IRB Compliance Administrator for assistance.
For questions regarding IRB training, please contact the IRB Compliance Administrator in the Office of Sponsored Projects and Research Compliance at email@example.com or 713-348-3586.
If you are having difficulty with the CITI training course, technical support is available at firstname.lastname@example.org or 305-243-7970 (8am-5pm Eastern).
Request a Classroom or Lab Presentation
The Human Research Protection Program provides educational resources and training opportunities for those involved in human subjects’ research. Faculty can arrange for class or lab presentations to discuss ethics, the history of human subjects’ research and/or application process. To schedule a presentation, please contact the IRB Compliance Administrator at email@example.com.