The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an (...) occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human Subjects Research in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. (shrink)
: During the nearly 10 years since its introduction, preimplantation genetic diagnosis (PGD) has been used predominantly to avoid giving birth to a child with identified genetic disease. Recently, PGD was used by a couple not only to test IVF-created embryos for genetic disease, but also to test for a nondisease trait related to immune compatibility with a child in the family in need of an hematopoetic stem cell transplant. This article describes the case, raises some ethical and policy issues, (...) highlights gaps in U.S. policy, and finally makes some recommendations for addressing advancing genetic and reproductive technologies. (shrink)
: The supply of organs for transplant remains inadequate to meet the needs of waiting patients, in spite of many programs and approaches to increase rates of donation. Over the years there have been numerous proposals to introduce schemes that would move toward the outright sale of organs. Three articles in this issue of the Journal propose methods for increasing organ supply—two by moving toward a market approach and the third by advocating a change in social culture. All three suffer (...) from shortcomings, including the endorsement and encouragement of the exploitation of those who may offer organs. Although the shortage of organs must be addressed, the social price of a market in organs is too high, and proposals to encourage a rethinking of social responsibility are unlikely to be effective. (shrink)
Epidemiology is a core science of public health, focusing on research related to the distribution and determinants of both positive and adverse health states and events and on application of knowledge gained to improve public health. The American College of Epidemiology (ACE) is a professional organization devoted to the professional practice of epidemiology. As part of that commitment, and in response to concerns for more explicit attention to core values and duties of epidemiologists in light of emerging issues and increased (...) scrutiny of epidemiology, the College developed, adopted, and published a set of Ethics Guidelines. The structure of the ACE ethics guidelines is in four parts: (1) a brief statement of core values and duties of epidemiologists, coupled with the virtues important to professional practice; (2) concise statements of key duties and obligations; (3) exposition of the duties and obligations with more applications; and (4) a brief summary and conclusion. The Guidelines have been published on the ACE website and in the official College journal Annals of Epidemiology. The guidelines contain (and maintain) core elements that define the discipline of epidemiology and its fundamental duties, but they are also intended to be dynamic and evolving, responsive to a changing professional and social environment. (shrink)
