Collaborative Institutional Training Initiative (CITI) Program

CITI Program Training

All faculty, staff and students actively engaged in human subjects research must maintain current training by completing the required course prior to starting a research project and every three (3) years thereafter. Training is available, and must be completed, online through the Collaborative Institutional Training Initiative (CITI) Program.

Principal Investigators (PI) submitting a research proposal for review to the Institutional Review Board (IRB) are responsible for ensuring all researchers  to be engaged in human subjects research under his/her supervision hold valid and current training certifications. Certifications of training completion for all research team members need to be submitted at the time of the application as a single PDF document.

Each CITI module has text to read and a quiz to complete. The average learner spends approximately 4.5 hours completing the Basic Course.

How to Complete CITI Program Registration Process

To complete online training, users need to register at the CITI Program site and affiliate their profile with the Widener University (WU). Please visit the following link to get started and complete the registration process: www.citiprogram.org.

Several training courses are available under the WU affiliation.

Registration requires the completion of 7 steps where CITI will ask a series of questions related to the registration process, which includes establishing a user ID and password.

As part of the last step in the process, you will be asked to select a curriculum and there are 8 options.  All investigators must complete the Human Subjects Research Protection Curriculum.  During the registration process, select the choice that best fits the category that corresponds to your research focus and population:

Biomedical Research Investigators: Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Biomedical research with human subjects.

Social & Behavioral Research Investigators: Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Social and Behavioral research with human subjects.

Research with data or laboratory specimens – ONLY: No direct contact with human subjects.

IRB Members: This Basic Course is appropriate for IRB or Ethics Committee members.

Not at this time.  Clicking this option will allow you to complete the registration process without enrolling in a course.

If you skip registering for a course during the sign-up process by selecting Not at this time, it is still possible to select a course later under the “Add a Course” option once registration has been finalized.

If during the registration process, you skipped selecting a course, under the “Add a Course” menu researchers will be asked to and must select the appropriate learner group for human subjects protections, depending on the research they will be involved with: Training in Human Subjects Protection (HSP).

There is no cost or fee associated with the completion of required WU training courses.

Once a learner group or curriculum is selected in the Training in Human Subjects Protection Course, a list of all the required training modules will populate and need to be completed. The program is available online 24/7. Users may stop the training at any time and return to where they left off at their convenience, as many times as needed, until the training is finished.

Each CITI module has text to read and a quiz to complete. The average learner spends approximately 4.5 hrs completing the Basic Course.

If a researcher has completed human subjects protections training in CITI Program under a different institution affiliation in the recent past, he/she/they must log in to CITI program and add their affiliation to WU. Modules previously taken that are still current will be transferred to the WU course and only required modules that have not been completed will need to be done.

A minimum overall passing grade of 80 percent is required to successfully complete the training. Once the training requirement has been fulfilled, a completion report is generated. The researcher must submit the training completion report or the CITI permanent link with the IRB application.

The completion date will be recorded as the day the last required module(s) was completed and the course was finished. In order to maintain training as current, the course must be completed before the three-year expiration window. CITI Program will send an automatic reminder 90 days before the most current completed course will expire.

Training in Human Subjects Protection (HSP) Curriculum

Training in the protection of human subjects in research is required for all university members (i.e., faculty, students, researchers, and staff), and collaborators, who will directly interact with research participants or have access to identifiable private information. Training in human subjects protections (HSP) must be completed, and the completion report obtained, prior to seeking review and approval from the IRB to conduct research.

There are 4 options for tracks or categories based on the type of research that you are conducting:

Biomedical Research Investigators: Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Biomedical research with human subjects.

Social & Behavioral Research Investigators: Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Social and Behavioral research with human subjects.

Research with data or laboratory specimens – ONLY: No direct contact with human subjects.

IRB Members: This Basic Course is appropriate for IRB or Ethics Committee members.

Not at this time.  Clicking this option will allow you to complete the registration process without enrolling in a course.

Additional optional modules are available to the University community for educational purposes and classroom use.  Completion of these modules is not required by the Widener University IRB:

Animal Care and Use

The ACU courses are designed to meet U.S. Department of Agriculture (USDA) and Office of Laboratory Animal Welfare (OLAW) requirements for basic training in the humane care and use of animals.

The courses are intended to help investigators and Institutional Animal Care and Use Committee (IACUC) members work more productively. Additional courses are available for IACUC chairs, IACUC community members, and institutional officials (IOs), as well as individuals seeking training on post-procedure care and post-approval monitoring or wildlife research. Courses on working with specific animal types are also included.

Conflict of Interest

The COI Basic course is designed to satisfy training requirements associated with the U.S. Public Health Service (PHS) regulations on financial conflicts of interest. There is also a COI Refresher course that offers retraining on key concepts and rules relating to these regulations. These courses are intended for investigators who receive funding from a PHS agency, including the National Institutes of Health (NIH), or who are required by their organization to be familiar with the PHS financial conflicts of interest regulations.

Good Clinical Practice

Good Clinical Practice (GCP) includes basic courses tailored to the different types of clinical research. These courses also include corresponding refresher courses for retraining and advanced learning. CITI Program offers several GCP courses that are acceptable GCP training for the NIH policy released on 16 September 2016.

Responsible Conduct of Research (RCR)

Ensuring the responsible conduct of research is the responsibility of every member of the research community. It is the objective of this training to provide information about the basic rules that apply to the responsible conduct of research; from ethical considerations in performing research, to the appropriate ways of investigating with human subjects or animals, to the permitted used of research funding, among many others.