PSI Research Ethics Program

HUMAN SUBJECTS RESEARCH TRAINING REQUIREMENTS FAQ and INSTRUCTIONS

Version: June 2014

Training? What is training is required?

PSI REB requires researchers to complete a web-based training program on the protection of human subjects. The program is called the Collaborative Institutional Training Initiative (CITI) and is maintained by the University of Miami. There are 11 social behavioral modules on topics such as ethical principles, history of modern research ethics, informed consent, protecting vulnerable populations, and reporting unanticipated events.

Each module ends with a short quiz. Quiz A total score of 80 percent is required to pass.

Who has to take this training?

Regional Researchers, Technical Health Advisors, Platform Researchers, and all Principal Investigators are required to take the CITI Training.

The REB encourages all PSI Staff and interns who are engaged in the development, implementation, and analysis of research with human subjects to take the CITI training.

Are Non-PSI collaborators / consultants required to complete CITI?

If PSI is collaborating with researchers/consultants for a short-term project or a specific research study who are part of established institutions and their institutions require an equivalent training (NIH, CITI, or an equivalent) and it is within the past five years, this will be accepted by the PSI REB. If PSI is hiring long-term researchers and consultants, these individuals should complete the PSI CITI Training.

Is the training available in any language other than English? And do I have to pay money?

The training is available in French, English, and Spanish. PSI has an organization-wide subscription so it is free to all PSI employees.

What if I completed CITI or NIH training for PSI or for another institution? Do I have to do it again for PSI?

Yes. All PSI staff engaged in human subjects research are required to take the CITI training in the by the end of 2014.

I don’t have time for this! Quizzes are not my thing!

When you register for CITI, you will create a login and this allows you to log in and out as many times as needed to complete the training. Quizzes are 2-5 questions long and can be repeated, if necessary.

I’ve completed the CITI Training, now what?

You should print out a copy of your completion / save a PDF to a file for your own records. When submitting to the REB, include a copy of your completion with each new submission. In addition, the Standard Operating Procedures for Research require researchers to upload training certificates to Dataverse.

Will I ever have to take CITI Training again?

Yes. PSI staff is required to refresh their human subjects research training every three years. CITI will send several email reminders starting 60 days prior to expiration date. These emails will go to the email you have provided to CITI so it is important that you keep this email address current. After certification expires, you will receive no further reminders.

Who should consider taking additional CITI modules?

If you are involved in clinical trials or clinical/bio-medical research at PSI, you should consider taking CITI’s Good Clinical Practices modules focusing on drug trials and device trials . While this is not required, it strongly encouraged as a best practice. These modules are available in English and Spanish.

What if my CITI Training certificate expires?

If you’ve failed to upload a current training certificate to Dataverse, you may impede your platform’s ability to satisfy the Standard Operating Procedures for Research.

I need some help. Where can I go for some help?

If you are having trouble with the CITI site or course, you should contact CITI directly at or 305 243-7970. If you are working outside the US and you are unable to contact CITI directly, please contact the PSI REB Manager () and the REB Manager can work as an intermediary to resolve your problem.

If you have questions about PSI REB requirements, contact the REB:

Kelly O’Keefe

skype: kellyokeefe2

202-542-7515

How do I get started with the CITI Training?

Step by Step instructions can be found here: Login Instructions.