All human subjects research must be reviewed by the … Human subjects research. Activities that are not human subjects research (NHSR) do not fall under the purview of the ISMMS Institutional Review Board (IRB). The IRB Reviewer can make the following determinations: The activity does not meet either the definition of research as specified under 45 CFR 46.102 (l) or the definition of clinical investigation as specified in 21 CFR 56.102 (c). If the determination, based on the information provided in the form, is that the project involves human subjects research, the reviewer may then provide a preliminary assessment as to whether the project meets one of the exempt categories or might meet one of the expedited categories of research. Here we offer advice and information to help you determine whether your research is considered human subjects, and if it is, how to understand and comply with regulations at all phases of application and award, including NIAID requirements. Created a more detailed “procedures” section that outlined the process. Your research may fall under the umbrella of human subjects research even if you aren't working on humans directly. If you are relatively sure that your upcoming project meets the definition of "human subjects research," you may go ahead and submit the study in the eIRB system. The activity is research but does not involve human subjects 45 CFR 102 (e)(1) or 21 CFR 56.102 (e). 2.2, 09/17/09: 2.1, 03/10/09: Policy revised to include Department of Defense sponsored survey research requirements. If you have questions about whether an activity is human research, please contact the IRB office for guidance. For example, some basic research on biological samples would be considered human subjects research, even if they were collected for a different study.
This information for the Icahn School of Medicine at Mount Sinai (ISMMS) research community explains which activities may meet the definition of human subjects research (HSR). ; Exempt human subjects research —The project involves research on human subjects per the federal definition, but falls into one of the exemption categories listed in the regulations. Not human subjects research —The project is not research on human subjects (per the federal definitions above) and thus does not need to be reviewed by ORIA/the IRB. Not Human Subjects Research Determination Request. If, however, you are unsure whether your project needs IRB review, you should use our Non-Human Subjects Research Determination Electronic Form by clicking the button below. Human Subjects Research (HSR) Determination . Criteria for Determination of No Human Subject Research. Policy revised to include Determination of Whether an Activity Represents Human Subjects Research form and direction for investigator to submit form. Instructions: To request a written determination that an activity is not human subjects research, please submit this form to the IRB via the online IRB system (ESTR). If you are unsure if the activities you are conducting are considered Human Subjects Research, please complete a Determination of Human Research form.