Confidence of IRB/REC Members in Their Assessments of Human Research Risk: A Study of IRB/REC Decision Making in Action.

Understanding how institutional review boards/research ethics committees (IRBs/RECs) perform risk/benefit assessment is important to help improve their function. In environmental ethics, uncertainty about potential outcomes and the precautionary principle play important roles in regulatory oversight but have received little attention in the context of human research ethics. We carried out an empirical study to gain insight into uncertainty by asking IRB/REC members about confidence in their risk assessments immediately after discussion of new protocols under review.

Abnormal melt curve profile during prothrombin 20210G --> A analysis due to the 20209C --> T variant.

The common factor II 20210G --> A mutation, located in the 3'-untranslated region, is an important risk factor for the development of thromboembolic disorders, especially in Caucasians. A number of methods are employed for clinical laboratory diagnosis of this mutation, some of which are capable of detecting adjacent 3'-end sequence variations. We present results from an African deep vein thrombosis patient tested for the 20210G --> A mutation by real-time polymerase chain reaction and melt-curve analysis using hybridization probes that incidentally detected an adjacent 3'-untranslated region variant.