Protection of Human Subjects in Clinical Research

Any research project involving human subjects (including questionnaire studies and reviews of medical records) or use of human specimens must be reviewed and approved by the federally designated Montefiore Einstein Institutional Review Board (IRB). Students cannot apply for IRB approval directly, and as such, obtaining this approval is the responsibility of your mentor as a faculty member. However, every individual working on a given research project, including medical students, is responsible for understanding the protections researchers must guarantee human subjects and the ethical issues that underlie these protections.

Therefore, all students working on research involving human subjects or human specimens must complete the Collaborative Institutional Training Initiative (CITI) course. This is an online course that takes about 4-6 hours and is free for Einstein students and faculty. Upon successful completion, you receive a certificate from Einstein that is valid for 5 years.

It is recommended that you work with your mentor to understand which category of review your proposal falls under (i.e., Exempt Verification, Expedited Review, or Full Review) and to complete the appropriate application form. In establishing a time frame for your clinical research project, be sure to provide sufficient time to complete the IRB application and approval process. It is important that you discuss the IRB requirements of your project with your mentor in relation to the SP due dates. If there are time constraints, it is important to let the IRB office know about these time constraints and that the study involves a medical student researcher.

If you have any questions, feel free to call the IRB office, located in Belfer 1002, at 718.430.2237.

Students in the Clinical Research Training Program take a required 12-week Research Ethics course taught by Ruth Macklin PhD. This course meets the IRB requirements in lieu of the CITI course.