Training and Education Requirement

WHO MUST COMPLETE TRAINING?

Binghamton University fulfills the federal mandate for initial and ongoing continuing education of all researchers and IRB members/staff involved in human subjects research by offering online courses through the Collaborative IRB Training Initiative (CITI).

Specifically, training is required for the following groups prior to IRB protocol approval:

  • All investigators and research personnel listed on an application submitted to the IRB. This includes all individuals responsible for the design or conduct human subjects research;
  • Faculty advisors; and
  • Individuals affiliated with external organizations/institutions who are study team members.

Those serving as voting members of the IRB or involved in the day-to-day operations of the IRB must also complete CITI training. It is the responsibility of the institution and the IRB to adequately train and educate researchers and IRB members in topics pertinent to the programs ongoing at their institution.

WHAT TRAINING(S) ARE REQUIRED FOR STUDY PERSONNEL?

All research personnel must complete one of the following two courses offered through CITI before study protocols will receive initial IRB approval: 

  • Group 1: Biomedical Research
  • Group 2: Social and Behavioral Researchers

In addition, verification of a current certification will be required for the approval of study modifications or continuing review submissions. Note that CITI certification for the above courses are valid for four years. 

Please contact the IRB at hsrrc@binghamton.edu if you are unsure of what course is required for IRB study approval.

CLINICAL TRIALS

In addition to Human Subject Research training, it is the policy of the NIH that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials complete training in Good Clinical Practice (GCP). The Binghamton University IRB will require any PI and study teams members engaged in clinical trial research to complete the GCP applicable course(s) regardless of whether the project is funded by the NIH or not.

CITI GCP courses available at Binghamton University are as follows:

  • GCP for Social and Behavioral Research Best Practices for Clinical Research
  • GCP for Clinical Investigations of Devices
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

If you are not certain which courses to take to comply with these requirements, please contact the IRB office at hsrrc@binghamton.edu.

DOD SUPPORTED RESEARCH

The Binghamton University IRB requires a basic level of training in protection of human subjects for all study team members, including investigators from other institutions, listed on active IRB protocols regardless of the funding source. For research supported by the DoD, components (accounting entities or branches such as the Department of the Air Force) may evaluate the educational policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research. If research involving a DoD component requires more frequent or other training requirements in addition to those that Binghamton University requires, the investigator will be responsible for ensuring that the training is completed for those involved in the conduct of the research. Researchers should contact the human research protection officer of the DoD component for their education requirements and obtain documentation confirming the requirements.

PROCEDURES FOR  COMPLETING ONLINE CITI TRAINING

Registering for a CITI account and adding a course if you HAVE a Binghamton University email:

  1. Click HERE and log in via the blue LOG IN button.
  2. Click "Register" and select "SUNY-University at Binghamton (SS0)" for your organization type (be sure to select the one with SSO).
  3. Click both boxes:
    • I agree to the Terms of Service and Privacy Policy for accessing CITI Program; and
    • I affirm that I am an affiliate of Binghamton University.
  4. Click "Continue to SSO Login / Instructions.
  5. At PODS login create your account using your Binghamton email address and your PODS account information. 

  6. Under "institutional courses" click "view courses." You will be asked to review your profile information. Update the information, or if it is correct, select "Update." You will be directed to a page displaying your previous coursework or options.

  7. Scroll down to "learner tools for SUNY - University at Binghamton" and select "add a course."

  8. For Question 1 select one of the first two modules (based on the type of research to be conducted:

    • Group 1: Biomedical Research; or 
    • Group 2: Social and Behavioral Researchers

  9. Skip Questions 2 through 5 and 7 through 14 unless you are conducting a Clinical Trial. If you are conducting a Clinical Trial, select the appropriate course.

  10. Question 6: if you are faculty you are required to take the Conflict of Interest coursework, select "Yes."

  11. You should see the course you selected listed under "Courses Ready to Begin." After selecting "Start Now" you will be directed to an assurance page where you should select "I agree" and then click "submit." 

Registering for a CITI account and adding a course if you DO NOT HAVE a Binghamton University email:

  1. Click HERE and log in via the blue LOG IN button and then click REGISTER and chose SUNY-University at Binghamton for your organization (Do NOT select independent learner).
  2. Click both boxes:
    • I agree to the Terms of Service and Privacy Policy for accessing CITI Program materials.
    • I affirm that I am an affiliate of SUNY - University at Binghamton.
  3. Select "Continue to Step 2".
  4. Enter your personal information as requested then select "Continue to Step 3."
  5. Create your username/password then select "Continue to Step 4."
  6. Enter "County of Residence" and "Contact Preference" then select "Continue to Step 5."
  7. Select "No" for the question "Are you interested in the option of receiving Continuing Education Unit (CEU) credit" and proceed to Step 6.

  8. Answer all questions notated with the red asterisk:

    • For "Institutional Email Address" if you have a SUNY issued email use that. If not, use the email address of the Binghamton affiliated individual that is asking you to create the account.
    • For "Department" indicate the department associated with the research.
    • For "Faculty Supervisor" enter "N/A."
    • Select "Continue to Step 7."
  9. For Question 1 select one of the first two modules (based on the type of research to be conducted:
    • Group 1: Biomedical Research; or 
    • Group 2: Social and Behavioral Researchers
  10. Skip Questions 2 through 14 unless you are conducting a Clinical Trial. If you are conducting a Clinical Trial, select the appropriate course.
  11. Proceed to the next step to complete your registration. You should see the course you selected listed under "Courses Ready to Begin." After selecting "Start Now" you will be directed to an assurance page where you should select "I agree" and then click "submit."

Note: You do not need to upload a course completion certificate as a supplemental document to your research protocol submission. The IRB staff can access the information via CITI.