Brown University’s Education Program for the Protection of Human Research Participants (CITI)

Brown’s Education Program
Initial Education Requirement
Certification from a Comparable Program
Additional Modules that do not meet Initial Education Requirement
Good Clinical Practices (GCP) Requirement for NIH-funded Clinical Trials
Continued Education /  Recertification

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Brown’s Education Program

All research personnel who are engaged in human subjects research and all IRB members and HRPP staff must be appropriately trained in the protection of human subjects. Research personnel include principal investigators, co-investigators, faculty advisors for student investigators, research assistants, and any research team members who have contact with research participants and/or their research data and identifiers.

Brown University uses the Collaborative Institutional Training Initiative (CITI)  web-based human research course to satisfy this requirement for faculty, staff, and students involved in human subjects research.  Initial and continuing education (every 3 years) are required as explained below.  Please read these instructions to learn how to access Brown University’s CITI training modules.

Training must be completed to receive approval for new protocols, amendments, and continuing IRB review of human subjects research. 

Initial Education Requirement

Brown has created three customized tracks to ensure that the education you receive is tailored to your research.  Completion of one of the below modules is necessary to satisfy Brown’s requirement for initial human subjects training.  Please complete the track that most closely aligns with your research:

  • Group 1: Social-Behavioral-Educational Researchers

  • Group 2: Biomedical Researchers

  • Group 3: Biomedical Data or Specimens-Only Researchers

Each module contains a quiz.  You must receive a minimum score of 80% to pass.

Certification from a comparable program

Brown now accepts CITI certification, or other comparable program certification, from another institution if it has been completed within the past three years.   Please submit a copy of your completed training certificate.  You will also be required to take the following module in CITI to ensure familiarity with Brown’s policies and procedures:

  • Group 4: Individuals who have completed a basic CITI program at another institution within the past three years

Additional Modules that do not meet Initial Education Requirement

There are two modules that you may elect to complete in addition to one of the three requisite initial trainings listed above.  These include:

  • Group 5: HIPAA training for Alpert Medical Students.

  • Group 6: Good Clinical Practice (U.S. FDA focus)

Each module contains a quiz.  You must receive a minimum score of 80% to pass.

GCP Training Requirements for NIH-funded Clinical Trials

The NIH issued a new policy effective January 1, 2017 that requires NIH-funded investigators and clinical trial staff to complete acceptable Good Clinical Practice (GCP) training if engaged in an NIH-defined clinical trial.  The NIH clinical trial definition is as follows “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” (See the NIH’s FAQs here.) 

What is Good Clinical Practice?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. While human subjects protections training requirements are one part of GCP, those training requirements do not meet the full spectrum of competencies GCP training requires. 

Who does this new training requirement apply to?
Investigators and clinical trial staff, defined by the NIH as follows:

  • Investigator:  The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

  • Clinical trial staff:  Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

How can I fulfill this training requirement?

GCP courses that will fulfill this new NIH training requirement are noted below.  You may choose to take any one of these courses, regardless of the focus of your NIH funded research. The HRPP office has reviewed each of these training courses and we offer feedback on each course, which you may find helpful in making your course selection.

Please note: If you choose to complete either of the two CITI course options in #1, HRPP will automatically receive notification that the training has been completed. If you choose one of the other options, please forward a copy of your completion certificate to IRB@Brown.edu.

1. CITI offers two options, “GCP Course for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus),” or “Social & Behavioral Research Best Practices for Clinical Research” available through Brown’s CITI training portal:

HRPP feedback: The U.S. FDA Focus course is intended for research personnel involved in drug, device, or biologic studies who would benefit from a more U.S. FDA focused training.  However, it also includes basic GCP information and would be an appropriate option for studies that are not FDA regulated as well. The Social & Behavioral course provides extensive basic information on many aspects of Social and Behavioral research. It provides extensive, basic information on GCP and will be very helpful to new investigators.

2. The NIAID GCP Learning Center course:

HRPP feedback: This course allows for a brief pre-test which will determine if you can skip the actual course and still obtain the NIAID GCP Certificate of Course completion. If you do take the course, it includes a lot of helpful regulatory information and related information, including information related to FWAs, HHS, NIH, OHRP and the FDA.

3.  National Drug Abuse Treatment Clinical Trials Network, GCP course:

HRPP feedback: This course covers all the required information and includes some additional information related to NIDA funded drug trials. It is applicable to both NIDA-funded and non-NIDA funded GCP learning.

When does this requirement go into effect?

The policy is effective as of January 1, 2017. Those proposing new NIH clinical trials must complete GCP training concurrent with other required CITI Human Subject training. GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines.   

Continued Education / Recertification

Continuing education in human subject protection is required every three years.  If you previously completed your initial education in CITI, the system will automatically notify you that your training is due to expire and will prompt you to complete the required refresher course.  Brown will accept refresher course certification from another institution.

Completing a refresher course will not satisfy the initial training requirement. 

If you have any questions please contact the HRPP at (401) 863-3050 or via email.