IRB Training

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

UPDATED 07/30/2020:

Cornell University has been cleared by New York state to restart research activities, in a staged, limited manner. In mid-May, the Cornell Research and Operations Reactivation Committee published a guide for the safe restart of the university's research, which includes the requirement that researchers must submit a reactivation plan to their college/unit for approval before returning to campus.

On July 1, a sub-committee on Human Subjects Research Reactivation published new guidelines for reactivating in-person human subjects research on Cornell’s Ithaca, Geneva, and Cornell Tech campuses. These guidelines provide a means for each college/unit to decide if a research reactivation plan that involves in-person, on-campus human subjects research can be approved. Any changes to IRB protocols must also be reviewed by the IRB.

On July 28, the IRB published additional guidance for investigators on conducting in-person research during the COVID-19 pandemic.

Please visit the IRB COVID-19 FAQs page for updates and contact the IRB if you have any questions.

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)

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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.

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  • 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

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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.

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  • 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

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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.

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  • 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

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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.

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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.