In Specific Aim 2, we will obtain discarded de-identified blood samples from patients to validate the CBC microchip. All specimens will be de-identified and hence will be exempt from human subjects research study, according to Department of Health and Human Services regulations in 45 CFR part 46, under exemption 4.Before starting the study, an exempt human subjects protocol will be submitted to the Partners IRB committee for approval. Exemption 4 states that a research protocol is exempt if the study involves the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research that meets the criteria for Exemption 4 is not considered """"""""clinical research"""""""" as defined by NIH. Therefore, the NIH policies for inclusion of women, minorities and children in clinical research, and targeted/planned enrollment tables, do not apply to research projects covered by Exemption 4.
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