IRB Training

Personnel named on all IRB protocols must be trained in human participant research ethics

UPDATED October 10, 2022

TRAINING UPDATE: Effective October 1, 2022, all Cornell study personnel involved in Exempt research protocols are now required to complete CITI training in human participant research ethics. This is the same training required of study personnel named on Expedited and Full Board IRB protocols. See details here. For more information about Cornell IRB training requirements, visit the IRB Training webpage.

COVID-19: Cornell IRB COVID-19 guidance and FAQs have been updated (Sept. 7, 2022). Face masks are still required for in-person, on-campus human participant research activities similar to clinical exams or procedures. Review the revised guidance in its entirety here.

IRB PROTOCOLS: As of February 1, 2022, we are using the RASS-IRB system for new protocol submissions, continuing reviews, amendments, and adverse event and protocol deviation reporting. See more details about the transition to RASS-IRB here. Find how-to documentation and recordings of Zoom training sessions on the RASS Guide Site. For help or feedback about the system, contact the RASS team at: rass@research.cornell.edu. For content-related questions about your IRB protocol or other human participant research topics, email irbhp@cornell.edu per usual. You can also schedule a Zoom meeting with members of the RASS or IRB teams via Microsoft Bookings.

Learn about Cornell University's requirements for human participant research ethics (IRB) training, who needs to complete it, and how to access it.

All research personnel listed on any protocol are required to complete human participant research ethics (IRB) training every five (5) years. NIH-funded Clinical Trials also require Good Clinical Practice (GCP) training for all study personnel.

ACCESSING REQUIRED TRAINING

Cornell subscribes to the online program delivered by the Collaborative Institutional Training Initiative (CITI) to provide relevant courses in research ethics.

You can log into CITI via the Cornell Single Sign On (SSO), and can follow our Guide to Accessing CITI Training for Cornell Researchers for more detailed directions on accessing and beginning CITI training.

If you are not affiliated with Cornell but you are listed as a research team on an IRB protocol, you will either need to take Cornell's CITI IRB training or provide proof of equivalent training. To take the Cornell CITI training, you can access the CITI Program website via citiprogram.org, register to create an account, and then add an "Affiliation" with Cornell University. You can then take the IRB/Human Subjects Research training provided by Cornell. Follow our Guide to Accessing CITI Training for Cornell Researchers for more detailed directions on accessing and beginning CITI training.

Researchers can check Course Completion Records (updated every 60 minutes) to ensure personnel listed on their protocols have completed the required training through CITI. You can also log into your CITI account and access your course history in the 'My Records' tab at the top of the page.

If neither of those methods work, you can reach out to irbhp@cornell.edu and our staff can assist you.

IRB TRAINING IN CITI

All research team members named on a Cornell IRB protocol must complete online human participant research training. This training requirement has been in place for expedited and full board IRB protocols for a number of years, but as of October 1, 2022, this applies to protocols determined to be exempt, as well. The training needs to be completed every five (5) years, and a refresher is available 90 days before the due date.

The Cornell IRB runs training via the CITI program - which can be accessed here. You can follow the Guide to Accessing CITI Training to get started.

The training is simply called 'IRB Training.' We previously offered courses with different names, focused on different fields, but have combined them into the singular course with the essential information. If you take 'IRB Basic' or 'IRB - BioMedical Research', those trainings will also be accepted.

The IRB Training course consists of eight (8) modules on various research ethics topics such as the conflicts of interest, history and ethical principles, informed consent, privacy and confidentiality, and doing research with vulnerable populations. The course material is made of text and still images with each module followed by a short quiz. The training does not need to be done all in one sitting.

You need to receive an 80% or higher on the course to fulfill the IRB Training requirement.

It depends on how comparable this previous institution’s training is to Cornell University’s training. The Cornell IRB staff can review your course record or completion report to ensure that all required topics are covered to the rigor that we expect. If they decide that your previous course is not comparable to the Cornell IRB training, they will require you to take Cornell’s.

You can submit these separate institutions’ previous records via your RASS-IRB protocol (under Additional Documents > Training Documentation (from non-Cornell sources)) or send it to irbhp@cornell.edu so that a member of the IRB staff can review it.

GOOD CLINICAL PRACTICE (GCP) TRAINING

Under National Institutes of Health (NIH) requirements that became effective January 1, 2017, all personnel involved in the design, conduct, oversight, or management of an NIH clinical trial must also be trained in Good Clinical Practice (GCP).

We have multiple courses in CITI that would fulfill the GCP requirement:

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

You should choose the one that best resembles the research you are conducting.

Personnel listed on any NIH clinical trials need to have completed GCP training within the previous three (3) years.

It depends. NIH does not specify any particular GCP course to fulfill the requirements. Cornell researchers may complete GCP training online through CITI, or discuss other options with the IRB office.

ALTERNATIVES TO CITI TRAINING

The IRB understands that researchers working in the field often hire local enumerators or researchers to collect data for their studies. Since these individuals are often "engaged" in human participant research, the federal training requirements apply. Depending upon level of education, language, and web access, online CITI training may not be appropriate as a training mechanism for these data collectors.

Field Training Guides

John Hopkins offers field training guides (in various languages) in human participant research ethics. These guides are intended for a PI or co-investigator to use in the training of study team members who will (1) obtain informed consent from research participants, or (2) collect data from human subjects (e.g. enumerators). These can be used for in-person (or Zoom) trainings, and may be more appropriate than the online CITI program IRB training when language or internet access is a barrier. 

Contact IRB staff to discuss appropriate alternatives to CITI IRB training for these types of cases.

Additional Research Trainings

The Center for Cultural Humility provides a variety of research trainings based off of the principles of anti-racism and Community-Based Participatory Research. Their services include an Equitable Research Design Training, Citizen Science Training, and Community Partner Matching. While these trainings are not required for IRB protocols, we encourage researchers to consider signing up.

Weill Cornell IRB Training Requirements 

The Cornell Ithaca campus and Weill Cornell Medical campus have separate IRBs and different training requirements. For information about Weill's training requirements, visit their website.