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.     

Incidental findings in human subjects research: what do investigators owe research participants?

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.     

Two kinds of rule regulating human subjects research

Alan Wertheimer argues that before we promulgate some rule regarding the conduct of research on human subjects we ethically ought to consider the consequences of the rule being followed. This ethical requirement has an exception, though, Wertheimer maintains: it doesn''t apply to rules that are not motivated by considerations of outcome. I agree that there is an exception to be made to Wertheimer''s proposed ethical requirement, but not Wertheimer''s exception. The important distinction is not that between rules motivated by considerations of outcome and rules motivated otherwise, but between rules designed to enforce ethics and rules not so designed. Before we promulgate the latter kind of rule, we are ethically required to consider the consequences of doing so. This is not so for the former kind of rule. My exception, unlike Wertheimer''s, yields the conclusion that we should promulgate, regardless of the consequences of doing so, a rule requiring that the potential benefit to the subject of participation in a study outweigh the risks. This rule is motivated by considerations of outcome, so it would land on the wrong side of Wertheimer''s divide. But it''s also designed to enforce ethics, so it lands on the correct side of my divide.     

Pharmaceutical meaning-making beyond marketing: racialized subjects of generic thiazide

In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.     

Protection for subjects in human research. Final rule

With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported by EPA, by prohibiting such research if it would involve intentional exposure of human subjects who are pregnant women or children. The rule also extends new protections to adult subjects in research for pesticides conducted by others who intend to submit the research to EPA, when it involves intentional exposure of human subjects who are non-pregnant adults, and creates a new, independent Human Studies Review Board to advise the Agency on the ethical and scientific issues arising in such research. This final rule focuses on third-party intentional dosing human studies for pesticides and sets the stage for further Agency actions. In addition, in order to display the OMB control number for the information collection requirements contained in this final rule, EPA is amending the table of OMB approval numbers for EPA regulations that appears in 40 CFR part 9.