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For an investigator to design and conduct an ethical research project, they must understand how to conduct ethical research, how to protect the rights of their human subjects, and their responsibilities as researchers.
All researchers (including student researchers) must complete the Human Subjects Research (HSR) training offered by the CITI Program in order to receive IRB approval for research projects. In this context, a “researcher” means anyone associated with the project, including:
This training must be completed at least once every three years.
There are two versions of initial HSR training offered: Biomedical (Biomed) Comprehensive and Social-Behavioral-Educational (SBE) Comprehensive.
Both the Biomed and SBE trainings typically take several hours to complete. Researchers should set aside ample time to complete the training as part of the preparation process for IRB submission. You do not have to complete the training in one sitting, but the training must be completed in full in order to receive IRB approval.
The Northwest IRB has put together the following resource to aid researchers in accessing and completing HSR training as part of the application process.
Make sure that you are completing the proper courses within the CITI Training website and that you have correctly affiliated your CITI account with Northwest. You and your team must fully complete the SBE (and possibly the Biomed) Comprehensive course prior to receiving IRB approval for your project.
CITI Training is considered expired after three years, which means you will need your ethics training re-certified at some point. Rather than completing the entire HSR training(s) again, CITI offers refresher courses for both the SBE and Biomed courses. These refresher courses are numbered. For example, when your original SBE training expires, you should complete SBE Refresher 1; after three years, Refresher 1 will have expired, and you should complete SBE Refresher 2; and so on.
Refresher courses will only be accepted as evidence of ethics training if a certificate of completion of the original SBE/Biomed course is already on file.
Upon completing a course, CITI Program provides a completion certificate stating your name, the name of the course, the completion date, and the expiration date of the training. This certificate can be accessed and downloaded from the CITI Program website under the “Completion Record” column of the “My Records” page.
Completion certificates for all researchers involved in the project must be submitted to the Northwest IRB email (IRBNWMS@bianlifan.com) along with the other components of your IRB application. If there are multiple researchers on your project, it is preferable that the principal investigator submit certificates for all researchers rather than each individual researcher submitting certificates separately.
Researchers who completed the CITI SBE and/or Biomed course at another institution may submit their completion certificate(s) to the Northwest IRB email (IRBNWMS@bianlifan.com) as long as the training was completed within the past three years. Trainings offered through other programs or websites may be accepted in lieu of CITI training on a case-by-case basis; contact the Northwest IRB through email if you would like to discuss whether a training might be accepted.
