Research Continuity Guidance for COVID-19

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IRB Training

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

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UPDATED November 10, 2021:

At this time, invited guests and visitors to the Cornell Ithaca campus--including research participants*--who are 12 years old or older must show proof of vaccination for COVID-19 or the results of a recent negative COVID-19 test. Principal Investigators are responsible for enforcing this requirement if it applies to their participant population. See the Cornell COVID-19 Visitors Webpage for more details. The Cornell Tech campus has its own visitor policy requiring proof of vaccination, which you can review on the Cornell Tech COVID-19 Visitors Webpage.

No IRB protocol amendment submission is needed to implement these participant eligibility and screening requirements, unless you are revising recruitment or informed consent materials. Please contact irbhp@cornell.edu with any questions or concerns. The IRB COVID-19 FAQs and guidance materials have been updated to reflect this university policy change.

*If you believe your participant enrollment or retention will be severely negatively impacted by this visitor requirement, please contact IRB Manager Myles Gideon at mbg223@cornell.edu.

All individuals on Cornell's campus--regardless of vaccination status--are required to wear a mask outside (when physical distancing cannot be maintained) and inside campus buildings (except in private, non-shared spaces, or when eating/drinking). As COVID-19 pandemic-related requirements on the Cornell Ithaca campuses are reevaluated and updated, the IRB and ORIA will continue to revise our human participant research-specific FAQs and guidance documents to reflect current guidelines. Thank you for your patience and cooperation, and please contact the IRB if you have any questions.

The IRB office published a newsletter on October 28, 2021. Click to read more.

Human participant research ethics (IRB) training is mandatory for all personnel listed on expedited and full board protocols, and must be renewed every 5 years. For NIH-funded clinical trials, research personnel must also complete Good Clinical Practice (GCP) training.

All research personnel listed on an expedited or full board protocol are required to complete human participant research ethics (IRB) training. In cases where the study is NIH-funded and is a "clinical trial", Good Clinical Practice (GCP) training is also required, either through CITI or another institution's ethics program.  Personnel listed on exempt protocols are strongly encouraged to take advantage of these trainings; however, the IRB staff will still grant exemptions if training is incomplete.

Collaborative Institutional Training Initiative (CITI)

Cornell subscribes to the online program delivered by Collaborative Institutional Training Initiative to provide relevant courses in research ethics. Here is general information about accessing CITI.

  • Log into CITI via this link, using your Cornell NetID and password.
  • When creating an account in CITI, use your Cornell email address (not a personal email).
  • If you already completed training at another institution, go into CITI and 'affiliate' with Cornell University to receive credit from Cornell
  • Users must receive a score of 80% or higher on each quiz to pass the IRB course.
  • After successful completion, users can download or print a completion report.

IRB Training in CITI

The "IRB training" course in CITI is intended for students, faculty, or staff engaged in research with human participants. Here is information about that course.

  • Cornell policy requires this training be renewed every 5 years, with a refresher course available 90 days prior to the expiration date.
  • The course consists of several required modules, along with optional modules, and need not be done all in one sitting.
  • Required module topics include: Populations in research requiring additional considerations and/or protections; Conflicts of interest in human subjects research; Federal Regulation - the 'Common Rule'; Informed consent; Privacy and confidentiality; Internet-based research; and History/ethical principles.

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 GCP. Here is information about GCP training requirements.

  • As a condition of approval, the Cornell IRB will require evidence that all personnel listed on the protocol have completed this training within the last 3 years.
  • NIH does not specify any particular GCP course. Cornell researchers may complete GCP training online through CITI, or discuss other options with the IRB office. When required, GCP training is in addition to the standard IRB training.

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.

John Hopkins offers field training guides (in various languages) which provide the basic information data collectors require and are intended for in-person training. These guides are intended for PI use in the training of study team members who will (1) obtain informed consent from research participants, or (2) collect data from human subjects.

Another option, if researchers are not comfortable reading long online modules, could be for the PI or members of the Cornell-based research team to conduct group in-person training for their international or non-English speaking collaborators.

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

Check CITI Training Records

Researchers can check Course Completion Records (updated every 30 minutes) to ensure personnel listed on their protocols have completed the required training through CITI.

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.