False NegativeWhen a test wrongly shows an effect or condition to be absent (e.g., that a woman is not pregnant when, in fact, she is).False PositiveWhen a test wrongly shows an effect or condition to be present (e.g. that is woman is pregnant when, in fact, she is not).Federal Policy (The)The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy. (Also known as the "Common Rule.")Fetal MaterialThe placenta, amniotic fluid, fetal membranes, and umbilical cord.FetusThe product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. (See also: Embryo.)FieldworkBehavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings). (See also: Ethnographic Research.)510(k) DeviceA medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device."Food and Drug Adminstration (FDA)An agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services. (www.fda.gov)Full Board ReviewReview of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting [Federal Policy §___.108].