No consensus yet exists on how to handle incidental fnd‐ings (IFs) 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.

Research technologies can now produce so much information that there is signifcant potential for incidental fndings (IFs). These are fndings generated in research that are beyond the aims of the study. Current law and federal regulations ofer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defned set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately ofer to disclose IFs of potential clinical or reproductive signifcance to research participants when they arise.

Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies. Sixty-six initial criteria were identified from extensive literature reviews and input from our Working Group. Criteria were placed in four categories reflecting the development, attributes, evolution, and outcomes of oversight systems. Expert elicitation, consensus methods, and multidisciplinary review of the literature were used to refine a condensed, operative set of criteria. Twenty-eight criteria resulted spanning four categories: seven development criteria, 15 attribute criteria, five outcome criteria, and one evolution criterion. These criteria illuminate how oversight systems develop, operate, change, and affect society. We term our approach "integrated oversight assessment" and propose its use as a tool for analyzing relationships among features, outcomes, and tradeoffs of oversight systems. Comparisons among historical case studies of oversight using a consistent set of criteria should result in defensible and evidence-supported lessons to guide the development of oversight systems for emerging technologies, such as nanotechnology.

The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations and policy. Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnologyspecific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges. Regulatory Demands of NanotechnologyNanotechnology is research and technology development on the nanoscale (traditionally 100 nanometers (nm) or less, or one billionth of a meter) at which particles have novel properties and functions because of their size. 1 At this size, materials exhibit quantum effects, impacting fluorescence, conductivity, magnetic permeability, melting point, and reactivity. 1 The ability to control atoms and molecules at the nanoscale has significantly advanced medical science and catalyzed the field of nanomedicine, defined by the National Institutes of Health as a "highly specific medical intervention at the molecular scale for curing disease or repairing damaged tissues, such as bone, muscle, or nerve." 2 Nanomedicine also includes nanotechnology applications for "diagnosis, monitoring, and control of biological systems." 3 Cutting-edge nanomedicine applications often integrate chemical, mechanical, and biological properties to enable and enhance detection, diagnostic capabilities, and therapeutic modes of action. In the near future, it will be possible for a single nanomedicine product, once deployed in a patient's body, to be programmed to target specific organs and tissues, create images, measure vital signs, diagnose in real time, and subsequently provide tailored therapeutics.

The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Agriculture (USDA), Occupational Safety and Health Administration (OSHA), and National Institutes of Health (NIH). All can learn from assessment of the successes and failures of past oversight efforts aimed at emerging technologies. This article reports on work funded by the National Science Foundation (NSF) aimed at learning the lessons of past oversight efforts. The article offers insights that emerge from comparing five oversight case studies that examine oversight of genetically engineered organisms (GEOs) in the food supply, pharmaceuticals, medical devices, chemicals in the workplace, and gene therapy. Using quantitative and qualitative analysis, the authors present a new way of evaluating oversight.