The literature describing vitamin D content of fat tissue is extremely limited. We conducted a pilot study that measured the concentrations of vitamin D(3) in the fat tissue and serum of obese adults. These measurements were performed using a new liquid chromatography mass spectrometry (LC/MS) method. The objectives of this study were: to measure and report the vitamin D(3) concentration in serum and subcutaneous fat samples from obese individuals and to examine the association of vitamin D(3) in fat with vitamin D(3) in serum. This cross-sectional study was conducted in 17 obese men and women who were scheduled to undergo gastric bypass surgery. The mean vitamin D(3) concentration in subjects? subcutaneous fat tissue samples was 102.8 +/- 42.0 nmol/kg. The mean vitamin D(3) concentration in serum was 7.78 +/- 3.99 nmol/l. Vitamin D(3) concentrations of fat tissue and serum were positively correlated (r = 0.68, P = 0.003). Consistent with previous findings in obese subjects, subjects in this study had suboptimal vitamin D status as demonstrated by a mean 25-hydroxyvitamin D concentration of 43.3 +/- 15.4 nmol/l. In conclusion, fat tissue vitamin D(3) can be measured by LC/MS and is detectable in obese subjects with suboptimal vitamin D status. Compatible with the long-standing concept that fat tissue is a storage site for vitamin D, fat tissue and serum vitamin D(3) concentrations were positively correlated.

Genetic and other medical technology makes blood, human tissue and other bodily samples an immediate and accessible source of comprehensive personal and health information about individuals. Yet, unlike medical records, bodily samples are not subject to effective privacy protection or other regulation to ensure that individuals have rights to control the collection, use and transfer of such samples. This article examines the existing coverage of privacy legislation, arguments in favour of baseline protection for bodily samples as sources of information and possible approaches to new regulation protecting individual privacy rights in bodily samples.

The confusion regarding the application of informed consent requirements to IVD studies and concerns about unnecessary obstacles to product development have prompted FDA to issue this guidance document. The agency believes this guidance will facilitate product development in a manner consistent with the values of human subject protection. FDA intends that the exercise of enforcement discretion expressed in this guidance begin immediately. In accordance with the agency’s Good Guidance Practice regulations, 21 CFR 10.115, you may submit comments on this guidance at any time. The agency will consider your comments and determine whether to revise the guidance at a later date.

Description provided: "Colon Cancer Tissue Microarray that contains 366 primary colon cancers along with appropriate diverticulitis, adenomatous polyps and normal colon mucosa as controls. Designed by a biostatistician, it is sufficiently robust to allow for critical testing of a marker’s prevalence in colon carcinoma as well as its association with clinical outcome."