Should research administrators be regulated as carefully as researchers?

This essay assesses the rationale for regulating research administrators as carefully as they regulate researchers. The reasons for such regulation are identical: protecting scientific integrity, ensuring responsible use of public funds, addressing the lack of effective recourse for victims, creating negative consequences for misbehaving actors, and addressing high incentives for misconduct. Whereas the reasons compelling us to regulate research administrators are obvious, counterarguments to administrative oversight are based on suggestions that the incidence and prevalence of cases of administrative misconduct are too low to warrant formal regulation. I briefly describe examples of the phenomenon drawn from publicly available records. My analysis suggests that the misconduct of research administrators is both serious and worthy of better oversight. Improved oversight of research administration will help steward tax dollars appropriately and enhance the overall integrity of the scientific record and of the free pursuit of knowledge more generally.

Misconduct in research administration: What is it? How widespread is it? And what should we do about it?

Virtually all of the scholarly literature on responsible conduct in research (RCR) focuses on the integrity of scientists - including why scientists misbehave, and how to improve training and enhance compliance with institutional and federal policies and regulations to prevent research misconduct. What this literature does not yet address is the integrity of those responsible for research administration. This article explores the responsible conduct of research administration and the potential for administrative misconduct. I highlight ways in which a lack of integrity in research administration can jeopardize the progress of science, the careers of researchers, and the reputation of institutions just as much as research misconduct can. Accordingly, I call for policies and appropriate oversight of research administration that are on par with policies governing research misconduct by scientists.

Rethinking Human Embryo Research Policies.

It now seems technically feasible to culture human embryos beyond the "fourteen-day limit," which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen-day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen-day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high-quality research and public confidence in it.

Questioning the consensus: managing carrier status results generated by newborn screening.

An apparent consensus governs the management of carrier status information generated incidentally through newborn screening: results cannot be withheld from parents. This normative stance encodes the focus on autonomy and distaste for paternalism that characterize the principles of clinical bioethics. However, newborn screening is a classic public health intervention in which paternalism may trump autonomy and through which parents are-in effect-required to receive carrier information. In truth, the disposition of carrier results generates competing moral infringements: to withhold information or require its possession. Resolving this dilemma demands consideration of a distinctive body of public health ethics to highlight the moral imperatives associated with the exercise of collective authority in the pursuit of public health benefits.

Toward a better bioethics: commentary on "Forbidding science: some beginning reflections".

It has been argued that bioethicists too often tend to represent the interests of scientists and not of the broader polity. Indeed, bioethicists seem predisposed to discard the voices and viewpoints of all but the cognoscenti. Focusing particularly on human pluripotent stem cell research, this commentary explores a variety of characterizations of bioethics and bioethicists in relation to forbidding science. Rather than proselytizing or prohibiting, bioethicists should work in partnership with scientists and publics to craft scientifically well-informed and morally sophisticated debates about forbidding science.

The ethos and ethics of translational research.

Calls for the "translation" of research from bench to bedside are increasingly demanding. What is translation, and why does it matter? We sketch the recent history of outcome-oriented translational research in the United States, with a particular focus on the Roadmap Initiative of the National Institutes of Health (Bethesda, MD). Our main example of contemporary translational research is stem cell research, which has superseded genomics as the translational object of choice. We explore the nature of and obstacles to translational research and assess the ethical and biomedical challenges of embracing a translational ethos.

Rereading Frankenstein: What If Victor Frankenstein Had Actually Been Evil?

As we reread Mary Shelley's Frankenstein at two hundred years, it is evident that Victor Frankenstein is both a mad scientist (fevered, obsessive) and a bad scientist (secretive, hubristic, irresponsible). He's also not a very nice person. He's a narcissist, a liar, and a bad "parent." But he is not genuinely evil. And yet when we reimagine him as evil-as an evil scientist and as an evil person-we can learn some important lessons about science and technology, our contemporary society, and ourselves.

The science and ethics of making part-human animals in stem cell biology.

The National Academy of Sciences recently issued voluntary guidelines to govern human embryonic stem cell research. Among other restrictions, these guidelines prohibit certain kinds of combinations of human and nonhuman animal cells, and call for ethics review and oversight of any protocol involving the transfer of human embryonic stem cells into nonhuman animals. In this essay, I discuss the history of and scientific rationales for combining human cells with cells of nonhuman animals, and critically assess the most recent attempts to limit such research on moral grounds--and find them lacking. Nonetheless, as I show, this research remains scientifically and morally contested. I then explore whether and how the NAS's recommended Embryonic Stem Cell Research and Oversight committees will allow for scientifically well-informed moral assessment of this controversial, but possibly important, research.

Human embryonic stem cell research: an argument for national research review.

The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. AT the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cell research and that while there are obvious pragmatic and political reasons for the NAS to favor local research review, there are more compelling reasons for the NAS to have recommended national review of hES cell research proposals.

Ethics, biotechnology, and global health: the development of vaccines in transgenic plants.

As compared with conventional vaccine production systems, plant-made vaccines (PMVs) are said to enjoy a range of advantages including cost of production and ease of storage for distribution in developing countries. In this article, we introduce the science of PMV production, and address ethical issues associated with development and clinical testing of PMVs within three interrelated domains: PMVs as transgenic plants; PMVs as clinical research materials; and PMVs as agents of global health. We present three conclusions: first, while many of the ethical issues raised by PMVs are familiar, PMVs add a new dimension to old issues, and raise some novel issues for ethicists and policy-makers; secondly, it is premature to promise broad applicability of PMVs across the developing world without having demonstrated their feasibility; thirdly, in particular, proponents of PMVs as a solution to global health problems must, as a condition of the ethical conduct of their research, define the commercial feasibility of PMVs for distribution in the developing world.

Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing.

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.

Crossing species boundaries.

This paper critically examines the biology of species identity and the morality of crossing species boundaries in the context of emerging research that involves combining human and nonhuman animals at the genetic or cellular level. We begin with the notion of species identity, particularly focusing on the ostensible fixity of species boundaries, and we explore the general biological and philosophical problem of defining species. Against this backdrop, we survey and criticize earlier attempts to forbid crossing species boundaries in the creation of novel beings. We do not attempt to establish the immorality of crossing species boundaries, but we conclude with some thoughts about such crossings, alluding to the notion of moral confusion regarding social and ethical obligations to novel interspecies beings.