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.

Examining mixing methods in an evaluation of a smoking cessation program.

Three different methods were used in an evaluation of a smoking cessation study: surveys, focus groups, and phenomenological interviews. The results of each method were analyzed separately and then combined using both a pragmatic and dialectic stance to examine the effects of different approaches to mixing methods. Results show that the further apart the methods are philosophically, the more diverse the findings. Comparisons of decision maker opinions and costs of the different methods are provided along with recommendations for evaluators' uses of different methods.