All human research (including exempt research) when individuals can be readily identified. Research involving identifiable biospecimens data sources that could be used to deduce the identity of an biospecimens. individual’s Research that generates individual-level human genomic data from biospecimens, or the use of such data. Any other research that involves information about an individual that could be used to deduce the identity of an individual. For currently IRB approved studies that receive NIH funding and involve an informed consent document, the IRB recommends the PI submit an amendment to the IRB prior to the deadline for the next time of continuing review to include . NIH’s For NIH funded studies, NIH will no longer provide a paper certificate. The award itself may be used as confirmation that CoC protections are in place. The NIH CoC website has now been updated and includes on this topic. Upon request, the NIH will issue CoCs for non-NIH funded studies. For more information, visit the . Any documents related to processing of the CoC that require the IO signature should go to the Executive Director for review and processing, before they are sent to the IO. The Executive Director will confirm all information is correct, before sending to the IO. When necessary the IRB will obtain an engineering consultant to evaluate the safety of the equipment used in research that is not FDA approved. The PI must provide information in the IRB application to assess whether the investigator or sponsor determined that an IDE is required for a device study, if applicable. Additional supportive documentation is required in the application submission (e.g., letters from the FDA or sponsor). The IDE regulations (21 CFR 812) apply to all clinical investigations that evaluate the safety and effectiveness of a medical device, unless the criteria for an IDE exemption are met (see IDE exempted investigations). A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory that is: Listed in the ,
All human research (including exempt research) when individuals can be readily identified. Research involving identifiable biospecimens data sources that could be used to deduce the identity of an individual’s biospecimens. Research that generates individual-level human genomic data from biospecimens, or the use of such data. Any other research that involves information about an individual that could be used to deduce the identity of an individual. For currently IRB approved studies that receive NIH funding and involve an informed consent document, the IRB recommends the PI submit an amendment to the IRB prior to the deadline for the next time of continuing review to include NIH’s . For NIH funded studies, NIH will no longer provide a paper certificate. The award itself may be used as confirmation that CoC protections are in place. The NIH CoC website has now been updated and includes on this topic. Upon request, the NIH will issue CoCs for non-NIH funded studies. For more information, visit the . Any documents related to processing of the CoC that require the IO signature should go to the Executive Director for review and processing, before they are sent to the IO. The Executive Director will confirm all information is correct, before sending to the IO. When necessary the IRB will obtain an engineering consultant to evaluate the safety of the equipment used in research that is not FDA approved. The PI must provide information in the IRB application to assess whether the investigator or sponsor determined that an IDE is required for a device study, if applicable. Additional supportive documentation is required in the application submission (e.g., letters from the FDA or sponsor). The IDE regulations (21 CFR 812) apply to all clinical investigations that evaluate the safety and effectiveness of a medical device, unless the criteria for an IDE exemption are met (see IDE exempted investigations). A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory that is: Listed in the ,