Human Subject Research Training

Training in the care and use of animals is a vital component of UNC Asheville’s Human Subjects Research Protections Program and is required under a variety of regulations and guidelines. UNC Asheville uses an independent, web-based program (CITI- Collaborative Institutional Training Initiative) for the initial training for human subjects researchers. Additional training may be required for your specific type of research.

Mandatory Training for Human Subjects Researchers

At a minimum, all human subjects researchers (except undergraduate students) must complete the “Social & Behavioral Research (Basic/Refresher)” course. This training is valid for three years, at which point you will be reminded to complete the refresher course.

  1. Visit the CITI Homepage (https://www.citiprogram.org/)
  2. Select the “Register” button under ‘Create an Account’.
  3. Search for the “University of North Carolina at Asheville” as your Participating Institution and continue the registration process.
  4. When prompted to select a curriculum, select the “Social & Behavioral Research (Basic/Refresher)” course in Question 1. (For Questions 2-6 select “Not at this time”.) If you have been instructed to refresh your training, select the “Social & Behavioral Research (Basic/Refresher)”.
  5. The Learner Menu will then display the course. Click “Enter” to begin. You do not have to finish all modules at one time; CITI saves your scores each time you submit answers so you can log out and resume later.

Undergraduate student researchers may also be required to complete CITI training. If this is the case, the instructions above apply with one exception. Undergraduates will enroll in “Student” course instead of the “Social & Behavioral Research (Basic/Refresher). If an undergraduate student mistakenly completes the “Social & Behavioral Research (Basic/Refresher)” course, the IRB will accept the completion certificate as proof that the student met their training requirement.

When an individual selects UNC Asheville as their participating institution during registration, their course completion history is automatically accessible to the Office of Research and Sponsored Programs (ORSP) for verification. You may also save a copy of your completion letter for your own records. If research personnel have completed the CITI modules while working at another institution, the user can add UNC Asheville as an affiliating institution which will give ORSP access to their records.

Good Clinical Practices Training (NIH Only)

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials can learn about the requirement to be trained in Good Clinical Practice (GCP). Effective date: January 1, 2017.

What is a “clinical trial” according to NIH? If you answer “yes” to all of the following questions, you are conducting a “clinical trial” and GCP training is required.

  1. Is your study funded by the NIH?
  2. Does the study involve human participants?
  3. Are the participants prospectively assigned to an intervention?
  4. Is the study designed to evaluate the effect of the intervention on the participants?
  5. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

Options to fulfill GCP training requirement

  1. Access resources for online trainings via the Society of Behavioral Medicine.
  2. Utilize the Harvard University’s Good Clinical Practice Field Guide for Social Behavioral Researchers (paper-based). This course introduces good clinical practice (GCP) principles to clinical and/or community-based research investigations involved in social and behavioral research.
  • Please click here for a pdf version of the training.

Included with this training is a quiz, answer sheet for the quiz, as well as a training completion sheet that is to be submitted along with your IRB application to provide documentation of training. The University requires an 80% for a passing score.