Scientists in earlier times considered personal research participation an essential component of their work. Exposing themselves to untested interventions was seen as the most ethical way to gauge the human response to those interventions. The practice was also educational, for it generated useful information that helped researchers plan subsequent human studies. Self-experimentation was eventually replaced by more comprehensive ethical codes governing human research. But it is time to bring back the practice of self-experimentation, albeit in modified form. Through serving as (...) a study subject, investigators and other research professionals can obtain valuable information about their work. (shrink)
Many features of the existing biomedical research enterprise rest on questionable judgments about the value of research. Policymakers and research ethicists make assumptions about research value that aren't necessarily warranted. A more balanced view of research value could contribute to more defensible decisions about research policy and practice.
Novel nanomedical interventions require human testing to evaluate their safety and effectiveness. To establish a proper evidentiary basis for human trials, nanomedical innovations must first be subjected to animal and other laboratory testing. But it is uncertain whether the traditional laboratory approaches to safety evaluation will supply adequate information on nanotechnology risks to humans. This uncertainty, together with other features of nanomedical innovation, heightens the ethical challenges in conducting FIH nanotrials.
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)
In 2006, I was diagnosed with cancer. This began a crash course in real-world medical ethics. Having cancer was awful, but it was instructive, too. The experience gave me a new understanding of what my profession is about. Individuals in the bioethics field often address topics related to cancer, such as medical decision-making, the patient-physician relationship, clinical trials, and access to health care. Yet few engaged in this work have lived with cancer themselves. Experience as a cancer patient or family (...) caregiver extends and deepens one’s thinking about serious illness and bioethics. During my time as a cancer patient, I kept in touch with several colleagues immersed in their own cancer .. (shrink)
Law enforcement officials often turn to DNA identification methods to detect—and rule out—possible offenders. Every state operates its own database of convicted offenders' DNA profiles; some states store profiles of arrested people, too. The Federal Bureau of Investigation maintains a national database of profiles submitted by laboratories across the country.A few years ago, officials came up with a new way to use DNA profiles in forensic identification. Ordinary searches require an exact match between DNA found at a crime scene and (...) a forensic DNA profile. A partial match means that the profiled individual should not be considered a suspect. But partial matches create another possibility: the crime scene DNA may .. (shrink)
Deception is an all-too-common human activity, one that succeeds because we cannot always detect it in others. It complicates all sorts of human decision-making, including attributing guilt for criminal offenses. The law relies on human fact-finders to determine whether criminal defendants claiming innocence, as well as witnesses testifying about a case, are telling the truth. But the fallibility of human lie detection has fueled the search for a more accurate replacement. Scientists have developed new approaches to lie detection that use (...) a brain scanning technique called functional magnetic resonance imaging (fMRI) to evaluate whether someone is lying. In experimental settings, researchers have found .. (shrink)
Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human embryonic stem cell (...) research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views. (shrink)
Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies’ internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical (...) companies’ ethics materials and describe shortcomings in the companies’ existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs. (shrink)