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Review of protocol modifications can be conducted in two different ways: Expedited or Full Board. The principal investigator may be asked to provide additional information for proper IRB review. We recommend this if the majority of the research is being conducted at that institution and UNTHSC or JPS personnel are involved in a smaller role for example, data analysis.
Are there submission deadlines for new Expedited and Exempt category protocols? Principal Investigators must keep in mind that ALL protocol modifications must be reviewed and approved by the IRB before implementation. Click on the hyperlinked course name to enter the course.
- Are there submission deadlines for new Expedited and Exempt category protocols?
The Einstein IRB will not issue approval if any key personnel has not satisfied this requirement. Macklin's Research Ethics course After the expiration of initial training currently 5 years , the CITI refresher course is required. As a courtesy the Einstein IRB sends monthly reminders as the expiration of your training approaches. Collaborative Institutional Training Initiative CITI The CITI Basic course offers a broad base of educational material for all individuals who are involved in the conduct of human subject research. The Einstein IRB requirements for completion of this tutorial have been structured to offer each researcher a program that has been tailored to address issues associated with their area of study. Please note that effective March 2015, CITI will only support Internet Explorer IE 8. Users at Montefiore whose computers only have IE 7. Click on the hyperlinked course name to enter the course. Instructions for Individuals Taking the CITI Refresher Course For individuals who last completed CITI 5 years ago. Most users will be able to log into their existing CITI account and be prompted to take the refresher. Download a visual guide to registering for the CITI refresher PDF 232 KB. Click on the hyperlinked course name to enter the course. Additional Courses Offered by CITI In addition to the required courses listed above, CITI offers other courses of interest to those conducting human subjects research. This program now includes two learner tracks. Track 1 targets the international investigator International Modules while Track 2 is intended for non US investigators, involved in U. Federally funded international research US Federal Modules. From the Select Curriculum page, select the following option s : I would like to review the International Modules, designed for an international audience, which are available in English, Spanish, Portuguese, Chinese, and French. This course covers the best practices that apply to investigational drug and device studies, and has been required for all Key Personnel involved in drug or device studies since January 1, 2015. More info about this requirement is available. If you need assistance with registration for these modules, or the basic CITI course, please contact the IRB at 718-430-2237, or. To view the updated instructions click.
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