Brown tracks CITI training for all research study team members conducting human subjects research. If you choose Brown as your home institution and complete a Brown module, a copy of your completion record will be available for the HRPP team to see. Training conducted under a Brown affiliation is automatically uploaded into each submission when an individual is named as the PI or a study team member in the Huron system.

CITI certification must be active to receive approval, exempt determination or acceptance for new applications, amendments and continuing review of human subjects research. 

All training certificates, including those without an expiration date, have an expiration date of three years. This date will vary based on the completion date of the certificate. CITI will email you an automatic training reminder 60 days before your training expires and prompt you to complete either a refresher course or initial education course, as applicable. You are required to renew your certification before the expiration date.

Training for Non-Brown and Foreign Research Personnel

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, including foreign personnel, who are affiliated with a non-Brown institution should follow their affiliated institution’s human subjects research education and training policy.

The PI may take responsibility for the training of foreign personnel who are affiliated with another institution. The research submission 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.

Foreign research personnel without another affiliation may affiliate with Brown and follow the instructions for new users to complete Brown CITI training.

Responsible Conduct of Research Training

Responsible Conduct of Research (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.

Responsible Conduct of Research Training

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 if you are a current employee, a faculty member or an enrolled student.

CITI course options include initial education courses and refresher courses that can be taken for recertification. For some types of research, including work involving protected health information and clinical trials, you will need to take additional courses along with an initial education course. 

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.

You can complete a refresher course three times before CITI will prompt you to choose from one of the initial education courses.

Please note that CITI may change the group number associated with a training course, even after the course is complete. The HRPP team recommends that you choose the appropriate training course using the course title, not the group number.

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

Brown will only have access to your completion record if you registered Brown as your home institution. If you completed a comparable initial education course on human subjects research at another institution in the past three years, you will need to upload a copy of your active training certificate from the issuing institution in the Huron system. This is required for each study on which you are listed as a PI or 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. 

Additional Courses

For Research Involving PHI

If you will collect or receive protected health information (PHI) as part your research, along with one of the initial education courses you will also need to complete:

• Group 5: HIPAA

For NIH-Funded Research Involving a Clinical Trial

Good Clinical Practice (GCP) is a standard established by the International Conference on Harmonisation for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected. The U.S. Food and Drug Administration (FDA) has adopted GCP as guidance for the ethical conduct of clinical trials in the U.S.

If your research is an NIH-funded clinical trial, along with one of the initial education courses you also need to complete one of the following modules on 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

Requirements for NIH Clinical Trials