Initial Training Course

Human Subject Protection Training should be completed through Collaborative Institutional Training Initiative (CITI), a web-based ethics training program for those conducting or reviewing research with human subjects.  

CITI training must be completed with a minimum score of 90 percent. Each course module may be re-taken as many times as necessary to obtain a 90 percent average overall. 

Completion Instructions for First-Time Users 

The following instructions are meant for those accessing Texas A&M CITI for the first time.  

  1. Log in to the CITI program via the Texas A&M CITI Portal using your NetID and password. Logging in via the Texas A&M CITI Portal associates your account with your NetID. 
  2. Once in your account, select “View Courses” next to Texas A&M University. 
  3. Click on the “Add a Course” link under “Learner Tools.” Complete question 1 to select either Group 1: Biomedical Research Investigators and Key Personnel or Group 2: Social and Behavioral Research Investigators and Key Personnel, and click “submit” at the bottom of the page. 
  4. Click on the “Add a Course” link under “Learner Tools”. Under question 1, select either [Group 1] or [Group 2] training. Only one course is required, so select the one that corresponds best to your research. Once a course is selected, scroll to the bottom of the page and click “submit”.  

    The following training does NOT fulfill the CITI human subjects training requirements for Investigators and Research Staff:  
    • “Responsible Conduct of Research” 
    • “IRB Reference Resources” 
    • “Group 3: IRB Member”  
  5. Once the selected course is in your account, click “Start Now” to begin the course and follow the instructions within CITI to complete your training. Successful completion requires a composite score of 90% on the quizzes. Quizzes can be repeated in order to achieve this score. If needed, the course can be completed in multiple sessions. On average, it takes 2-3 hours to complete a basic course. 

CITI Online Refresher Course 

Human subjects’ training must be renewed every five years, i.e., before the five-year anniversary of the investigator’s most recent human subjects in research training. The online refresher course provided by CITI takes approximately one hour to complete. CITI provides a 30, 60, and 90 day reminder on expiration dates. 

Follow the directions in the email to login and complete the required refresher trainings. If logging in to CITI directly, a link to the refresher training will be on your CITI home page. 

External Personnel Human Subjects Training 

The appropriate training method depends on whether the external personnel are affiliated with an institution or entity with an IRB or not.  

External Personnel Affiliated with an Institution or Entity with an IRB 

Personnel affiliated with an academic institution or other organization with an IRB or FWA must complete human protections training as required by their institution. The relying site’s HRPP is responsible for ensuring its personnel have completed the training required by their institution. Training certificates do not need to be provided to Texas A&M IRB. 

External Personnel Not Affiliated with an Institution or Entity with an IRB (Individual Investigators) 

There are three training options available. External personnel with limited roles in remote areas, foreign countries or other exceptional circumstances as determined by the IRB may complete Group 4: Educational Requirements. This training is available in both English and Spanish. All other External personnel must complete either Group 1: Biomedical Research Investigators and Key Personnel or Group 2: Social and Behavioral Research Investigators and Key Personnel.  

Texas A&M Human Subjects Protection Training via CITI 

External personnel can create an account in CITI that is affiliated with Texas A&M University and complete Texas A&M’s CITI training by following the steps below: 

  1. Navigate to the CITI Program.  
  2. Register as an affiliate:  
    1. Click on the “Register” button. 
    2. Click on “Select Your Organization Affiliation” button (Do not sign up as an Independent Learner). 
    3. Search for “Texas A&M University” and select it 
    4. Agree to the Terms of Service and affirm your affiliation 
  3. Click “Create a CITI Program Account” 
  4. Enter your first, name, last name, and email address 
  5. Create your Username and Password by filling in the following fields 
    1. User Name 
    2. Password 
    3. Security Question and Answer 
  6. Determine if Continuing Education Credits are applicable to you 
  7.  Answer residency question  
  8. Provide additional information requested by Texas A&M 
  9. Complete Question 1 and select the appropriate option (you may skip all other Questions): 
    1. Group 1: Biomedical Research Investigators and Key Personnel 
    2. Group 2: Social and Behavioral Research Investigators and Key Personnel 
    3. Group 4: Educational Requirements 

Additional Training Opportunities

Informed consent is a process, not merely a form. Information must be presented to enable individuals to decide voluntarily whether to participate in research. Informed Consent is a fundamental mechanism to ensure respect for persons through provision of thorough information about the research in which the individual is being invited to participate so that he or she can make an informed decision to participate voluntarily.

OHRP offers a variety of free online trainings for the research community on human research protections based on the principles of the Belmont Report and the requirements of the revised Common Rule (or 2018 Requirements).
Learn how to create participant-centered informed consent forms through this interactive training.

The research community has an ethical obligation to ensure that people understand the purpose and potential risks and benefits of research before they agree to join a clinical trial. FDA leaders will:

Give an update on the FDA’s efforts to help improve informed consent materials so that they are more understandable for participants.

Recommend how informed consent can be presented in a clear, comprehensible way.

Discuss how revised consent can help individuals make an informed decision on whether to join a clinical trial.

This event is free and open to the public. However, registration is required and open until the meeting starts. Registrants can submit questions for speakers on the registration page and during the event.

Request a Presentation

The Human Research Protection Program provides educational resources and training opportunities for those involved in human subjects’ research. To schedule a presentation, please contact the HRPP office at (979) 458-4067 or irb@tamu.edu.