Wednesday, March 31, 2010

Biobanks and the 'well-being' of humanity: integrating consent to research with the capability approach - Critical Public Health

One of my papers on biobanks and genetic research appears in the latest issue of Critical Public Health. The paper (titled 'Biobanks and the 'well-being' of humanity: integrating consent to research with the capability approach') explores if and how the capability approach--an approach proposed by political philosophers Amartya Sen and Martha Nussbaum--can help us think about ethical, legal and social questions raised by genetic research. Throughout the paper, I argue that the capability approach is a conceptual tools that proves to helpful to smoothen the demanding requirements of informed consent, which are perhaps too demanding when it comes to research tools such as biobanks that can be established and efficiently operated only if the informed consent is not narrowly construed in the sense of prohibiting all uses of collected biological samples that are not explicitly mentioned at the time the samples are collected from sample sources. The capability approach contributes by helping us think of the big picture: if we take into account the fact that research participations, biobankers and investigators all belong to a political community in which certain duties and protections are in place (as the capability approach demands), most of the red flags raised by biobanking are no longer problematic. These duties and other constraints provide sufficient protection to research participants even not all sample uses are specified in the informed consent at the time the samples are collected.

Although published in 2010, I started writing the paper in 2004. As a consequence, the paper is in part outdated and in part timely. The discussion on the merits of 'broad' consent in biobanking is not very relevant. In the past few years, consensus has emerged, in the literature and in the policy arena, that such form of consent is justified and appropriate, and that it meets the minimum requirements of informed consent.
The paper is much more relevant with regard to the quest for a theory of political science that is useful and responsive in dealing with difficult policy issues that cut deep into our assumptions of how societies are best arranged. I think, as I argue in this paper, that the capability approach is rather appealing and quite useful. In 2006, I conducted a similar analysis, and reached a similar conclusion, in the area of transnational human rights litigation (see my The Global Enforcement of Human Rights: The Unintended Consequences of Transnational Litigation in the International Journal of Human Rights).
Most recently, I read an thoughtful and persuasive application of the capability approach to the notion of property and ownership rights. In 2009, Professor Gregory Alexander, from Cornell, wrote in the Cornell Law Review about The Social-Obligation Norm in American Property Law. Prof. Alexander proposes a view of property informed by the capability approach and in alternative to the law-and-economics approach. Alexander argues that a social obligation is embedded in the recognition of an individual's right to own property. Once again, Sen and Nussbaum's analysis as political philosophers proves to be far-reaching, indeed useful to legal scholars and legal philosophers in particular.
My thinking about the relationship between political philosophy and law and the contribution of the capability approach to this debate is also the focus of a work in progress on tort law and some of its philosophical underpinnings. It turns out I am writing a paper on the topic, which I will present at a conference in Colombia at the end of April.

Friday, March 26, 2010

Washington, Bruxelles and the crisis of human rights - The Euros

I published a short piece on the role of the USA and the EU with regard to advancing human rights. The point I make is simple: during the past decade, the USA has severely damaged its credibility as human rights promoter in the eyes of the international community (and by 'community,' I primarily refer to people rather than governments and international organizations). Guantanamo, Abu Ghraib, the USA Patriot Act, Copenhagen, the ICC.

My critique of Washington's attitude towards human rights is consistent with 'Empty Promises', a piece by Kenneth Roth of Human Rights Watch, published in Foreign Affairs, as summed by Roth's statement that 'When it comes to promoting human rights at home and abroad, the [the advent of Obama] has undoubtedly been a marked improvement in presidential rhetoric. However, the translation of those words into deeds remains incomplete.'

My piece then argues that the EU has an historic opportunity to become the leading human rights promoter in the world. Yet, to do so, the EU must first shape up its internal human rights policy (primarily by making sure that the basic rights of all EU residents, and in particular those of religious minorities and immigrants, are secured) and structure its organization so that the EU speaks to other international partners with a single voice, that is a voice that is univocally representing all EU members. While this an ambitious goal, it can be realized. Slowly and patiently.

Wednesday, March 24, 2010

Human Embryonic Stem Cells: Steps Back, Steps Forward

[published with Andrea Ballabeni in the World Congress for Freedom of Scientific Research the bulletin, Number 10 (March 2010)]

The scientific and political fate of human embryonic stem cells (hESC) is unsteady. In 2010, their use is still contested, and lab research suffers from that. It is increasingly clear that researchers need them, want to use them, and plan to use them for a long time. While some hailed human induced pluripotent stem cells (hiPS) as the way forward the regenerative medicine, the belief that hiPS and hESC are truly equivalent is slowly eroding. The unequivocal title of a Science commentary on the evidence on hiPS/hESC alleged equivalence tells it all: 'Reprogrammed Cells Come Up Short, for Now.'

In the United States, researchers' expectation finds support in policy. The Obama administration did not hold back its promise to facilitate research with hESC. The restrictions imposed by the Bush administration are gone. Yet, the obstacles and uncertainties still affect investigators. The Obama policy rightfully makes it a requirement for researchers to show that the couple who donated the embryos for the lines creation was fully informed of other options. Such evidence is lacking for several cell lines that were already in existence in 2001, when Bush limited federal funding of hESC. On March 15 2010, the Washington Post reported that ''[s]o far, the NIH has approved 43 lines. But that includes only one of the original 21 'Bush' lines. An additional 115 lines are awaiting review. But that includes only two more of the original lines.'' As a consequence, researchers face uncertainty, an uncertainty that is particularly troublesome with regard to the cell lines that were funded under the Bush era. These cell lines are the bedrock of countless protocols, and the prospect of losing them would result in a significant step back as many projects would have to start from scratch with new cells as opposed to building upon the existing.

The problem is evident, and some have proposed that the NIH revises its guidelines ''to grandfather in the existing lines or give researchers a two-year grace period to continue to work with them until they get formal approval.'' To us, even more appealing, and ultimately very reasonable, would be the proposal that all Bush-era cell lines are approved without further ethical scrutiny. After all, the ethical concerns must be relatively minor as these lines had been deemed 'acceptable' by the clearly conservative gatekeepers appointed by former President Bush. Some of the answers needed by researchers may come from the proposed expansion of the definition of hESC for the purpose of NIH funding. The NIH proposes redefining hESC as:

… pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.
While the current definition limits hESC to cells taken from the inner layer of a blastocyst (5–6 days after fertilization), the new definition will also include cells taken from a morula, the developmental stage that come before a blastocyst is formed (3–4 days after fertilization). While most researchers are not currently using morula-derived cells, the tweaking of the definition of hESC may be a significant step for two reasons. First, morula-derived cells and blastocyst-derived cells are most certainly biologically different. Thus, unique data will flow from the newly funded research. Second, morula-derived hESC lines may be derived without the need to suppress the entity—the solid ball of 4-16 cells contained within the zona pellucida. This procedure is arguably 'more ethical' as Lanza recently pointed out. The new definition should take away some ammunition from the ever vigilant critics of hESC, thus making access and use to hESC less unsteady.

Monday, March 15, 2010

The EU Commission and the Eternit trial

Laszlo Andor, EU Commissioner for Employment, Social Affairs and Inclusion, indicated that the EU Commission will monitor the Eternit trial held in Torino as the implications for EU law. The EU Commission had touched upon asbestos disease several times in the recent past. Two examples are:

1) In 2003, it had issued a Recommendation 'concerning the European schedule of occupational diseases': although not binding on member states, the Commission recommended national legislatures to list the following asbestos-related diseases:
  • Asbestosis
  • Complication of asbestos in the form of bronchial cancer
  • Fibrotic diseases of the pleura, with respiratory restriction, caused by asbestos
  • Lung cancer following the inhalation of asbestos dust
  • Cancer of the larynx following the inhalation of asbestos dust; and
  • Mesothelioma following the inhalation of asbestos dust.

The decision against Belgium concerns deficiencies in the legislation for the Brussels and Walloon regions. The decision against Ireland concerns a failure to give full effect in Irish legislation to requirements concerning asbestos removal involving the release of asbestos fibres. In the decision against Belgium, both the Brussels and Walloon regions fail to adequately transpose provisions of the Directive (Council Directive 87/217/EEC on the prevention and reduction of environmental pollution by asbestos) dealing with monitoring of air emissions and water discharges from asbestos facilities and the prevention of significant asbestos environmental pollution from the working of products containing asbestos. In addition, the Brussels legislation fails to adequately deal with effluent arising in the manufacture of asbestos.