Managing incidental findings in human subjects research: analysis and recommendations.

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.     

Accidental poisonings involving carbon monoxide, heating systems, and confined spaces

Eleven incidents of carbon monoxide (CO) intoxication resulting in sixteen fatalities are reported. All of the cases involved heating systems as either the source or the means of distributing the CO. Blood samples were analyzed for ethanol and CO. Elevated blood CO saturations were found in 14 of the 16 victims while none of the victims had a blood ethanol concentration greater than 0.10% (w/v).