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, at present, the IRB staff will grant exemptions if training is incomplete. All personnel on exempt protocols will be required to complete training later in 2022, date to be announced shortly.
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. (Note: if you are not affiliated with Cornell but you would like to take our IRB 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.)
- 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 60 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.