Human Subject Protection Training

All principal investigators, co-investigators, study coordinators and key research staff must have current up-to-date human subject protection training. The IRB will accept the training certificate of most collaborating institutions, and also accepts the Collaborative IRB Training Initiative (CITI) and National Institutes of Health (NIH) training course. The IRB may also host a full day training program. See below for additional information and a link to each website.

I. CITI Human Subject Protection Training

The New York State Department of Health Institutional Review Board (IRB) has partnered with the University of Miami's Collaborative IRB Training Initiative (CITI) to provide a training program that meets the federal requirements for training in human subjects protections.

The CITI training program is recognized by the Department of Health and Human Service's Office of Human Research Protections as meeting the educational requirements of 45 CFR 46.

The purpose of the CITI program is to develop, implement and maintain a high quality Web-based educational program in the protection of human subjects in research. The current CITI Program offers two courses:

  1. for Behavioral Science Research Investigators, and
  2. for Institutional Review Board (IRB) members.

If you have questions about which Learner Group is appropriate for you please contact the IRB Office.

The CITI software will track your progress through your course in the Grade Book. You will be able to print and download a Course Completion Report when you have satisfied ALL course work requirements and have completed your chosen Learner Group. The software will archive the completion report and allow you to print another one at a later date, if necessary.

The NYSDOH IRB will automatically be sent a copy of the Completion Report by e-mail. While we print and scan a copy of the completion report for our records, it is still essential that you maintain a copy and provide one with every protocol application/submission sent before the IRB.

You do not need to complete the course in just one session. Upon completion of each module you will be directed to take a short quiz of the material. It is acceptable to use several "log-on" sessions, but you should take the quizzes immediately after completing each module. The software will grade the quizzes and collate your scores. Links to additional information are provided in many of the modules.

You must complete all required quizzes to complete the course. When you submit the quiz you will be shown the correct response and feedback to support the correct answer. If you feel you didn't score well enough on a particular quiz you will have the opportunity to review the material again and retake the quiz for a higher score. Your Grade Book and Completion Report will reflect your best scores on the quiz.

Follow the directions below to access the CITI Program:

CITI* Instructions

This type of training will provide a five-year training certificate.

  • Go to https://www.citiprogram.org/default.asp
  • Launch Register for CITI Course.
  • Under Participating Institutions: Enter NYSDOH/Health Research Inc..
  • Highlight it.
  • Agree to Terms of Service
  • Press Continue to STEP 2
  • Enter Your Name and Email Address
  • Press Continue to STEP 3
  • Pick a USER NAME, PASSWORD, VERIFY PASSWORD, SECURITY QUESTION, SECURITY ANSWER
  • Press Continue to STEP 4
  • Indicate Country of Residence
  • Press Continue to STEP 5
  • Check Optional Boxes
  • Press Continue to STEP 6
  • Complete REQUIRED FIELDS
  • Press Continue to STEP 7
  • Select CURRICULUM, Answer QUESTIONS 1 & 2 and 3 (OPTIONAL)
  • Press COMPLETE REGISTRATION

Researchers should select the Social & Behavioral Research Investigators Course.

IRB Members should select IRB Members Course.

Biomedical Researchers should select either Biomedical Research or Biomedical Data or Specimens ONLY Research

Other Biomedical Research Courses Include:

  • Good Clinical Practice Course (US FDA Focus)
  • GCP Course for Clinical Trials Involving Investigational Medical Devices (International Focus)
  • GCP Course for Clinical Trials Involving Investigational Drugs (International /ICH Focus)

Student Researchers should select Students - Class projects

*This form of training is open to ALL Department of Health, Wadsworth Center and HRI staff and collaborators who are actively engaged and/or will be engaged in research projects with the Department of Health.

II. NIH On-Line Training

NIH offers an on-line training course http://phrp.nihtraining.com/users/login.php. This training is good for FIVE YEARS.

III. IRB Annual Full Day Training

The IRB may also host an annual Full Day Training program. This program features sessions taught by IRB professionals who are experts in the fields of research, regulation, science policy, and ethics. A five-year certificate will be issued for completion of this training program. When the program date is finalized, information will be posted on DOH NEWS on NOTES. Advanced sign-up is required.