We will create a database of optical properties from various human effusions samples to develop diagnostic criteria. Middle ear fluid specimens will be provided by our clinical colleagues at the Massachusetts Eye and Ear Infirmary (MEEI). These specimens and fluids are routinely aspirated and discarded during bilateral myringotomy with tube insertion. Research specimens used in Aim 2 will be obtained from these discarded human specimens. All specimens will be de-identified and are exempt from human subjects research study, according to DHHS human subject regulation exemption 4. Prior to the start of this study, an exempt human subjects protocol will be submitted for approval by the Partners IRB. 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. Sections regarding the Protection of Human Subjects, Women &Minorities, Planned Enrollment Table, and Inclusion of Children are not included because the proposed research with human materials is not considered clinical research.
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