Education Instructions and Frequently Asked Questions
Who needs CITI training?
In compliance with Brown’s Institutional Review Board Policy on Education and Training in the Conduct of Human Subjects Research (Education and Training Policy), all research personnel who are engaged in human subjects research are required to have appropriate education and training to protect participants in research. Research personnel include principal investigators, co-investigators, faculty advisors for student investigators (medical, graduate, and undergraduate), student investigators (medical, graduate, and undergraduate), research assistants, and any research team members who have contact with research participants and/or their research data and identifiers.
Brown uses the Collaborative Institutional Training Initiative (CITI) Program’s research ethics and compliance web-based human research courses to satisfy the requirements of the Education and Training Policy.
What are the different CITI course options?
- Initial Education Courses
- Certificate of an Initial Education Course from a Comparable Program
- Additional Initial Education Courses
- Refresher Course
How do I register with CITI and choose courses?
Frequently Asked Questions
♦
What are the different CITI course options?
Initial Education Courses
You can choose one of the Initial Education courses below to satisfy Brown’s requirement for human subjects research:
- Group 1: Social-Behavioral-Educational Researchers and Key Personnel
- Group 2: Biomedical Researchers
- Group 3: Biomedical Data or Specimens-Only Researchers
Certificate of an Initial Education Course from a Comparable Program
If you completed a comparable Initial Education course on human subjects research at another institution in the past 3 years, you will need to upload a copy of your active training certificate from the issuing institution in the Huron system. You should affiliate with Brown when your certificate from the other institution expires (unless you are still affiliated with that other institution, e.g., Lifespan). If you are still affiliated with the other institution and renew your CITI certificates through the other institution, you will be required to update each record you are listed on in the Huron system through a Study Team Member Modification.
Please note that this will be required for each study in which you are conducting human subjects research.
Additional Initial Education Courses
If you will collect or receive protected health information (PHI) as part your research, along with one of the Initial Education Courses listed above, you will also need to complete:
- Group 5: HIPAA
If your research is an NIH-funded clinical trial, along with one of the Initial Education Courses listed above, you will also need to complete one of the following modules on Good Clinical Practice (GCP):
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP - Social and Behavioral Research Best Practices for Clinical Research
(Please note that CITI may change the Group number associated with a training course, even after the course is complete. The HRPP recommends that you choose the appropriate training course using the course title, not the Group number.)
Refresher Course
CITI certification expires after 3 years. CITI will e-mail you an automatic training reminder 60 days before your training expires and prompt you complete a Refresher Course for recertification.
You can complete a Refresher Course 3 times before CITI will prompt you choose from one of the Initial Education Courses.
♦
How do I register with CITI and choose courses?
Instructions for New Users:
- Go to the CITI home page: https://about.citiprogram.org/en/homepage/.
- Click “Register” and fill in steps 1-7. In Step 1, choose Brown University as your institution. Continue with the registration process filling in all of the appropriate personal information.
- Search the institutional courses available to Brown. Be sure to click the “View Courses” button connected to Brown University. Click on “Learner Tools” and “Add a Course” for the “CITI Course Enrollment Procedure.” Please read the instructions and continue to scroll down to the “CITI Course Enrollment Questions.”
- Answering Questions 1-7 will register you for training courses. You do not need to answer all seven questions. Please note that you may register for as many courses as you like, but not all courses may be required for your research.
- Brown has created three Initial Education customized tracks to ensure that the education you receive is tailored to your research. Completion of one of the following modules is necessary to satisfy Brown’s requirement for initial human subjects training. You are required to take only one of the modules listed below but may elect to take more modules if you choose.
- Please complete the track that most closely aligns with your research or discipline.
- Once you have chosen the appropriate Group, scroll to the bottom of the page and click “Submit.” This will bring you to the main page where you can begin the correct course. You can save your progress, log out of CITI, and re-enter the course as many times as you wish.
Returning CITI Users Who Are New to Brown:
- 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 Brown University as your institution.
- Fill in the required personal information on the next page.
- Click “next” to advance to the curriculum selection.
♦
Frequently Asked Questions
Does Brown track CITI training for all research personnel?
When does human subjects research certification need to be in place?
How long does CITI certification last?
What if my training certificate does not have an expiration date?
How do I know when to renew my CITI certification?
How many times can I take a Refresher Course before completing the Initial Education Course again?
Will Brown’s HRPP know when my certification is complete?
What should I provide Brown’s HRPP if I completed certification at another institution?
Who can use Brown’s CITI modules?
How long do I have to complete a course once I start?
Does Brown track CITI training for all research personnel?
Brown tracks CITI training for all research study team members conducting human subjects research. Training conducted under a Brown affiliation will be automatically uploaded into each submission when an individual is named as the Principal Investigator or a study team member in the Huron system.
When does human subjects research training certification need to be in place?
CITI certification must be active to receive approval, exempt determination, or acceptance for new applications, amendments, and continuing review of human subjects research.
How long does CITI certification last?
Initial and continuing education certification last 3 years.
What if my training certificate does not have an expiration date?
Any training certificate without an expiration date is considered to have an expiration date of 3 years. This date will vary based on the completion date of the certificate. For example, if you completed training on 8/1/2019 and the certificate does not have an expiration date, HRPP will consider the expiration date of the training to be 8/1/2022. Before the 8/1/2022 expiration date, you will be required to complete one of the Initial Education Courses to renew your certification.
How do I know when to renew my CITI certification?
CITI will e-mail you an automatic training reminder 60 days before your training expires and prompt you complete either a Refresher Course or Initial Education Course, as applicable.
How many times can I take a Refresher Course before completing the Initial Education Course again?
You can complete a Refresher Course 3 times before you must repeat the Initial Education Course.
Will Brown’s HRPP know when my certification is complete?
Yes. If you choose Brown as your home institution and complete a Brown module, a copy of your completion record will be available for Brown’s HRPP to see. In addition, Brown CITI training completions will be automatically uploaded into each submission when an individual is named as the Principal Investigator or a study team member in the Huron system.
What should I provide Brown’s HRPP if I completed certification at another institution?
Brown will only have access to your completion record if you registered Brown as your home institution. If you completed training through another institution, you are required to upload your current certification into the Huron system for each submission you are listed on as a Principal Investigator or a Study Team Member. You should affiliate with Brown when your certificate from the other institution expires (unless you are still affiliated with that other institution, e.g., Lifespan). If you are still affiliated with the other institution and renew your CITI certificates through the other institution, you will be required to update each record you are listed on in the Huron system through a Study Team Member Modification.
After logging in to CITI, click on “Learner Tools” and “Add a Course” for the “CITI Course Enrollment Procedure.” Please read the instructions and continue to scroll down to the “CITI Course Enrollment Questions.”
Answering Questions 1-7 will register you for training courses. You do not need to answer all seven questions. Please note that you may register for as many courses as you like, but not all courses may be required for your research.
Who can use Brown’s CITI modules?
You may only use Brown’s CITI modules for human subjects research certification if you have a formal affiliation with the University. You have formal affiliation is you are a current employee, faculty member, or an enrolled student.
Does the Responsible Conduct of Research (RCR) course satisfy Brown’s requirement for human subjects research?
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). RCR training may discuss human subjects research, but it does not satisfy the requirements of human subjects research education. More information about RCR is available through the Office of Research Integrity.
How long do I have to complete a course once I start?
You have 12 months to complete a course once you start. If you do not complete a course within 12 months, the course will be deactivated. You will need to register for the course again and start it from the beginning.
If I have non-Brown, research personnel working with me who are affiliated with another institution, do they need to complete Brown’s CITI training?
No. It is the PI’s responsibility to ensure that all research personnel working on their study complies with Brown’s Education and Training Policy. Research personnel affiliated with a non-Brown institution should follow their affiliated institution’s human subjects research education and training policy.
If I have non-Brown, foreign research personnel working with me, what should I do to be sure they meet Brown’s requirements?
It is the PI's responsibility to ensure that all research personnel working on their study complies with Brown’s Education and Training Policy. Therefore, the PI should choose the most appropriate option below:
- Foreign research personnel without another affiliation may affiliate with Brown, follow the Instructions for New Users, and complete Brown CITI training;
- Foreign research personnel affiliated with a non-Brown institution should follow their affiliated institution’s human subjects research education and training policy; or
- The PI may take responsibility for the training of foreign personnel. The IRB/HRPP Application must include a description of the education plan, the topics to be covered, and a confirmation that the foreign research personnel will be trained by someone sufficiently qualified and with the applicable expertise to conduct such training. This is especially important if the foreign research personnel will be working with vulnerable populations or handling sensitive/confidential data.
For additional information regarding Brown’s training requirements, please visit our IRB Guidance & Policies page and review our “Institutional Review Board Policy on Education and Training in the Conduct of Human Subjects Research.”