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)
Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
This article describes a model of DNA banking that incorporates appropriate consumer influence on the design and use of DNA data banks. This model values input of consumer stakeholders in key decisions, including contracts between donors, researchers and the bank.
The currently evolving debate over ethical and legal approaches to DNA data banks reflects, in part, shifting societal perceptions of dividing lines between humanity and commodity, definitions of genetic inheritance between individuals and families, and the rights of the individual versus the rights of the community. Tensions arise whether the data bank has been created for medical or for forensic purposes. The authors, through their work as community activists described more fully below, have come to realize that the key to (...) resolving these tensions and developing ethically acceptable DNA data bank practices is meaningful community engagement. Not unlike medical DNA data banks, personally identifiable DNA samples are routinely retained by states long after a convict's or arrestee's DNA profile has been derived from it and entered into the state database. The question arises, then, as to what, if any, non-forensic uses can these samples – ethically – be put. (shrink)