Brown uses the Huron IRB electronic system to manage all human research protocol submissions. This centralized platform streamlines the submission, review, and tracking process for IRB applications, amendments, continuing reviews, and reportable events.

Researchers must also complete training on using the Huron IRB submission system, which is used to submit, track, and manage IRB protocols. This is a one-time training requirement; however, the training materials are designed to be repeatable and may be revisited at any time as a refresher or as needed.

Training for Huron IRB includes:

1. System navigation and user access
2. Creating and submitting new IRB applications
3. Managing amendments and continuing reviews
4. Reporting unanticipated problems or deviations
5. Understanding workflow and communication with the IRB office

Huron IRB System Training

Required Training:

• Initial IRB Submission Training
• Amendments, Continuing Reviews, and Reportable Events
• Study Team Access and Responsibilities

How to Access Training:

• Click the links below
• Register for a live or on-demand training session
• Download a research guide from the Huron Help Center.

Brown University uses the Huron Toolkit as the standardized set of operating materials for human subjects research, including forms, templates, policies, guidance, and tools. The Toolkit is designed around a specific methodology to support consistent, compliant, and efficient IRB review. New users are strongly encouraged to complete the training below to become familiar with the Toolkit’s structure and approach prior to first use. 

Huron Consulting Group routinely evaluates and updates Toolkit materials based on communications with regulatory agencies, feedback from HRPP Toolkit clients, and input from the broader research community. Updated versions of the Toolkit are released on a regular basis. When changes occur, the HRPP communicates updates and provides education and guidance to researchers as materials become available.

Training on the Huron Toolkit is a one-time requirement; however, the training materials are designed to be repeatable and may be revisited at any time as a refresher or as needed.

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

Brown, BUH and CNE uses the Collaborative Institutional Training Initiative (CITI) program’s research ethics and compliance web-based human research courses to satisfy the requirements of human subject protection training.t

All researchers involved in human subjects research must complete Human Subjects Protection (HSP) training through the Collaborative Institutional Training Initiative (CITI Program). 

Research personnel include principal investigators (PIs), 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 or their identifiable research data and/or specimens.

CITI training must be renewed every three (3) years. Lapses in up-to-date training may result in restrictions on research activities until the training requirement is satisfied and may also be considered noncompliance.

Completion of required CITI courses is automatically linked to the Huron IRB system. Users do not need to upload CITI completion certificates into the study record. Because only trainings that load directly into Huron IRB can be verified, CITI courses completed through other institutional affiliations are not accepted.

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

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