Investigator Handbook

To see a list of required training for investigators and research staff involved in clinical studies and investigators and research staff involved in socio-behavioral studies, please consult the Investigator Handbook.

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 complete 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.

Creating a new account in CITI

New CITI accounts for TAMU personnel

  • Login TAMU NetID (via Azure AD) -> Create new CITI account (which is really only one click)

Existing CITI accounts for TAMU users 

  • Login TAMU NetID (via Azure AD) -> Nothing (account has already been linked)
  • or Login TAMU NetID (via Azure AD) -> Select existing CITI account to link to NetID

New CITI accounts for users without Texas A&M University credentials

  1. Go to www.citiprogram.org and select “Register” under Create an account.
  2. Search for/select organization “Texas A&M University” and select “Continue to step 2” to continue CITI registration (Do not sign up as an Independent Learner).
  3. Enter the following information
    • First Name
    • Last Name
    • Email address- To ensure your CITI certificate information feeds into iRIS, please enter the same email address you have provided in your “account information” in iRIS. CITI allows two email addresses to be given in case a researcher wants an additional email used.
  4. Create your Username and Password: Fill the following fields:
    • User Name
    • Password
    • Security Question and Answer
  5. Answer residency question.
  6. Determine if Continuing Education Credits are applicable to you
  7. Provide additional information requested by Texas A&M
  8. Select courses appropriate to the type of research you conduct.
    • Question 1, select either:
      • Group 1: Biomedical Research Investigators and Key Personnel
      • Group 2: Social and Behavioral Research Investigators and Key Personnel
    • Skip or Select “Not at this time” for Questions 2, 3 AND 4.
    • “Responsible Conduct of Research” training does NOT fulfill the human subjects training requirement of the Human Research Protection Program.
    • Skip Select “Not at this time” for Questions 4, 6, 7 and 8.
    • Question 9, select a Good Clinical Practice if you are conducting clinical research and FDA regulated research.

Existing accounts in CITI

  • You may add courses by selecting “Add a Course or Update Learner Groups” from your CITI home page.

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.

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.