Limited health literacy is a pervasive and independent risk factor for poor health outcomes. Despite decades of reports exhibiting that the healthcare system is overly complex, unneeded complexity remains commonplace and endangers the lives of patients, especially those with limited health literacy. In this article, we define health literacy and describe the empirical evidence associating health literacy and poor health outcomes. We recast the issue of poor health literacy from within the ethical perspective of the least well-off and argue that (...) poor health outcomes deriving from limited health literacy ought to be understood as a fundamental injustice of the healthcare system. We offer three proposals that attempt to rectify this injustice, including: universal precautions that presume limited health literacy for all healthcare users; expanded use of technology supported communication; and clinical incentives that account for limited health literacy. (shrink)

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings, findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and (...) even the entire head; computed tomography colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings 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. (shrink)

We weigh the presumed benefts of routinely searching all research scans for incidental fndings against its substantial risks, including false-positive and false-negative fndings, and the possibility of triggering unnecessary, costly evaluations and perhaps harmful treatments. We argue that routinely searching for IFs may not maximize benefts and minimize risks to participants.

The question of how to handle incidental findings has sparked a heated debate among neuroimaging researchers and medical ethicists, a debate whose urgency stems largely from the recent explosion in the number of imaging studies being conducted and in the sheer volume of scans being acquired. Perhaps the point of greatest controversy within this debate is whether the magnetic resonance imaging scans of all research participants should be reviewed in an active search for pathology and, moreover, whether this search should (...) be performed by a radiologist. Resistance to routine readings performed by radiologists, as opposed to selective review of those scans on which investigators have spotted a possible IF, has been fueled in part by the obvious and enormous cost — financial and logistical — of engaging radiologists to read massive numbers of scans. This cost would be especially burdensome, even prohibitive, to investigators who are not affiliated with a medical center, because of their limited access to radiologists and other medical expertise. (shrink)

How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue that our (...) data supports universal reading by a neuroradiologist of all research MRI scans for incidental findings and providing full disclosure to all participants. (shrink)

Human subject research involving brain imaging is likely to reveal signifcant incidental fndings of abnormal brain morphology. Because of this fact and because of the fduciary relationship between researcher and subject, board-certi-fed or board-eligible radiologists should review the scans to look for any abnormality, the scans should be conducted in accordance with standard medical practice for reviewing the clinical status of the whole brain, and the informed consent process should disclose the possibility that incidental fndings may be revealed and what (...) consequences will follow. In the event such fndings are revealed, qualifed physicians should explain to the subject the signifcance of the fndings and the alternatives available. (shrink)

Limited health literacy is a pervasive and independent risk factor for poor health outcomes. Despite decades of reports exhibiting that the healthcare system is overly complex, unneeded complexity remains commonplace and endangers the lives of patients, especially those with limited health literacy. In this article, we define health literacy and describe the empirical evidence associating health literacy and poor health outcomes. We recast the issue of poor health literacy from within the ethical perspective of the least well-off and argue that (...) poor health outcomes deriving from limited health literacy ought to be understood as a fundamental injustice of the healthcare system. We offer three proposals that attempt to rectify this injustice, including: universal precautions that presume limited health literacy for all healthcare users; expanded use of technology supported communication; and clinical incentives that account for limited health literacy. (shrink)