IRB practices and policies regarding the secondary research use of biospecimens.

BACKGROUND: As sharing and secondary research use of biospecimens increases, IRBs and researchers face the challenge of protecting and respecting donors without comprehensive regulations addressing the human subject protection issues posed by biobanking. Variation in IRB biobanking policies about these issues has not been well documented. METHODS: This paper reports on data from a survey of IRB Administrative Directors from 60 institutions affiliated with the Clinical and Translation Science Awards (CTSAs) about their policies and practices regarding secondary use and sharing of biospecimens. Specifically, IRB ADs were asked about consent for future use of biospecimens, assignment of risk for studies using biobanked specimens, and sharing of biospecimens/data. RESULTS: Our data indicate that IRBs take varying approaches to protocol review, risk assessment, and data sharing, especially when specimens are not anonymized. CONCLUSION: Unclear or divergent policies regarding biospecimen research among IRBs may constitute a barrier to advancing genetic studies and to inter-institutional collaboration, given different institutional requirements for human subjects protections.

Gender and Sport.

Sport faces many challenges in creating fair, interesting, and meaningful competitions that highlight and reward the qualities widely valued in sport, such as natural talents, dedication, and competitive savvy. The Paralympic Games illuminate both the challenge and a thoughtful way of responding by organizing events that group athletes with comparable levels of impairment so that raw physical discrepancies don't overwhelm differences in talent or dedication. It may be helpful to reflect on how gender is used in decisions about who competes against whom. Gender has long served as a rough proxy for differences in size and strength. For sports where size and strength matter, those are the dimensions along which competitors should be matched, not their gender identity. In that sense, gender is incidental to fair competition in sport. Because playing sports is good for people in so many ways, we should provide abundant opportunities that are widely available and enjoyable for all people.

Making sense of fairness in sports.

Cheating evolves constantly. Dozens of athletes were barred from the Winter Olympics for taking banned substances. Gene doping is on the horizon. Questions have arisen about which athletes count as "female." What does it take to keep sports fair? And what does fairness require?

Ethics, evidence, and cost in newborn screening.

When deciding what disorders to screen newborns for, we should be guided by evidence of real effectiveness, take opportunity cost into account, distribute costs and benefits fairly, and respect human rights. Current newborn screening policy does not meet these requirements.

A Moral Foundation for Anti-Doping: How Far Have We Progressed? Where Are the Limits?

Clarity about the ethical justification of anti-doping is essential. In its absence, critics multiply and confusion abounds. Three broad reasons are typically offered in anti-doping's defense: to protect athletes' health; to promote fairness; and to preserve meaning and values in sport - what the World Anti-Doping Agency (WADA) Code refers to as the spirit of sport. Protecting health is itself an important value, but many sports encourage athletes to take significant risks. The case against doping is buttressed by concern for athletes' health, but it cannot be the sole foundation. Promoting fairness is vital in all sports as the metaphor of the level playing field attests. But playing fields can be leveled by providing performance-enhancing drugs to all competitors. When doping is prohibited, fairness is aided by effective anti-doping. But the fundamental justification for anti-doping is found in the meanings and values we pursue in and through sport.

Ripples: What to Expect When You Serve on a Bioethics Commission.

Cloning was the issue that put the National Bioethics Advisory Commission on the map, but the first clue that NBAC would address cloning was a terse fax from the White House to each of us who served on the Commission. The fax noted that with the birth of the sheep named Dolly, mammalian cloning was now a reality, and it tasked NBAC with providing advice on the ethics of human cloning and how the nation should respond to it. We were given ninety days to report our findings. That's a very tight deadline for a report written by a committee, but we met it, and along the way, I learned important lessons. My goal in this essay is to share what I learned at the ramparts of what I will call, with apologies to George Lucas, the Cloning Wars and through NBAC's work on five additional reports.

Newborn screening: complexities in universal genetic testing.

Newborn screening (NBS)--in which each newborn infant is screened for up to 50 specific metabolic disorders for early detection and intervention--is the first program of populationwide genetic testing. As a public health intervention, NBS has greatly improved the lives of thousands of affected children. New technologies and new economic and social forces pose significant ethical and clinical challenges to NBS. Two primary challenges concern (1) accommodating clinical and ethical standards to rapid technological developments in NBS and (2) preparing public health systems to respond to the medical advances and social forces driving expansion of NBS programs. We describe and analyze these challenges through consideration of 3 disorders: phenylketonuria, medium-chain acyl-CoA dehydrogenase deficiency, and cystic fibrosis.

Ethical (and political) issues in research with human stem cells.

Though it is possible to discuss the ethics of research with human embryonic stem (ES) cells without any reference to politics, doing so would shed little light on the nature or intensity of the public debate, especially in the USA. Ethical arguments and scientific claims have been appropriated and offered with what appears often to be little regard for their soundness or relevance. In this paper I will discuss: (1) briefly, the history of research ethics and policy regarding human embryos in the US and the UK; (2) the decisions made by the current President of the USA regarding ES cell research, including a critical examination of the ethical arguments offered; (3) the evolution of the debate in which nuclear transplantation in stem cell research has been conflated with cloning to attempt to create a human infant; (4) the stalemate within the US Congress over legislation on cloning; (5) possible developments suggesting that the current US policy on ES cell research may become unstable; and (6) the broader context of the ethical debate and what is at stake for the major protagonists.

Infant Bioethics Committees: dispute over guidelines.

KIE: Right-to-life groups and groups representing the disabled are criticizing the "Guidelines for Infant Bioethics Committees" released by the American Academy of Pediatrics on 27 April 1984. Opponents charge that the guidelines fail to back unequivocally a "best interests of the infant" standard for decision making, that no one is authorized to act as a "special advocate for the infant," and that a "quality of life" criterion for treatment decisions is implicit in the guidelines.^ieng

What are families for? Getting to an ethics of reproductive technology.

The standard approach to the ethics of reproductive technologies starts and ends with the parents' procreative liberty. There's much more to think about. We should start with the relationship between parents and children.