All Clemson University faculty, staff and students conducting Human Subjects Research are required to have appropriate training in the protection of human subjects in research (including continuing education every two years).
The Basic Course: The requirement for training in Human Subjects Protection will be met by successfully completing the appropriate Collaborative Institutional Training Initiative (CITI) basic course at www.citiprogram.org. CITI offers the following human subjects research courses:
• Group 1: Social and Behavioral Science Research (English and Spanish)
• Group 2: Biomedical Research (English and Spanish)
• Group 3: HIPAA only
Clemson does not have Single Sign On (SSO) access with CITI. Click the "Register" button located on CITI's home page to create an account and select "Clemson University" as the affiliated institution when creating your profile. There is no fee for the courses if you are affiliated with a Clemson University project.
Most researchers have to complete the social and behavioral science research course entitled “Group 1 Investigators Conducting Social and Behavioral Science Research (SBR) at Clemson University.” A minimum passing score of 80 percent is required to meet the Clemson IRB's training requirement. The basic course may require 1-2 hours to complete depending on the curriculum selected. You do not have to complete the course in one sitting and may use multiple logon sessions to complete the modules. You will need to keep a record of your login information to return to the course site.
Steps to add a course:
Step 1: After setting up the account, the Main Menu page should display.
Step 2: Click "Add a Course" under the heading My Learner Tools for Clemson University.
Step 3: Select "Human Subjects Research (IRB)" for the course area and click next.
Step 4: Select "Researcher" as the role and click next.
Step 5: Select the appropriate course (SBR or Biomedical) and click next.
Step 6: The Main Menu page will reappear, click the course title to access the modules.
The research compliance staff has access to CITI’s online database and will verify all team members’ training before granting IRB approval. We encourage researchers to maintain a copy of the completion report for your records.
The Refresher Course: CITI training must be renewed every two years and updated training is required before new applications, amendments, continuing reviews, or requests to add research team members are approved by the IRB. The CITI program will send an automatic e-mail reminder at least 60 days before your training expires.
The Responsible Conduct of Research Course: The Responsible Conduct of Research (RCR) course is not required by Clemson but may be required by other entities. The IRB staff will explicitly notify researchers if they are required to complete the RCR course.
Optional modules: There are various optional modules that are not included in the Basic Course (e.g., research involving minors, research in public elementary and secondary schools, and internet research). Researchers may be required to complete the appropriate optional modules if a particular research protocol involves these topics and is not exempt from continuing review. IRB staff will notify researchers of these additional requirements on a case-by-case basis.
Team members not affiliated with Clemson: For exempt protocols, the IRB recommends that team members not affiliated with Clemson University complete the Human Subjects Protections training.
For expedited and full protocols, team members not covered by another institution’s IRB are required to complete Clemson’s training. They may access the training by creating an account with CITI at www.citiprogram.org and have to select “Clemson University” as their affiliated institution when creating their institution profile. You do not need a Clemson e-mail account to create an institution profile.
Team members affiliated with another institution: Researchers covered by another institution’s IRB have to complete their institutions’ required training.