Public Policy Recommendations for Oversight of Molecular Laboratory Tests

Scientific Autonomy and Public Oversight.

When scientific research collides with social values, science's right to self-governance becomes an issue of paramount concern. In this article, I develop an account of scientific autonomy within a framework of public oversight. I argue that scientific autonomy is justified because it promotes the progress of science, which benefits society, but that restrictions on autonomy can also be justifi...

Interference in laboratory tests

Interference in clinical laboratory testing can create discrepancies in test results which can lead to patient harm.  In clinical chemistry, interference is defined as a cause of medically significant difference in the measurand test result due to another component or property of the sample. Interference by endogenous and exogenous substances with assays for clinical analytes is a common prob...

FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?

In 2010 the US Food and Drug Administration (FDA) stated that it would issue guidance on its oversight of laboratory-developed tests (LDTs), and in July of that year the FDA held a public meeting to receive feedback on a risk-based application of LDT oversight (http:// www.fda.gov/MedicalDevices/NewsEvents/Workshops Conferences/ucm212830.htm). The FDA acknowledged that LDTs have been in existen...

State biotechnology oversight: the juncture of technology, law, and public policy.

Challenges and policy recommendations for IT governance in the University of Medical Sciences: a case study

Introduction: “Information and Communication Technology (ICT) governance” was introduced in developed countries in the late 1990s and replaced ICT management. In addition to the separation of the ICT responsibilities between different units/levels, ICT governance allowed universities to develop mechanisms for monitoring ICT decisions in line with the University's vision, mission, and strategic ...