To the Barricades!

Abstract

Mark Rothstein (2010) argues that current American regulations concerning deidentified research data and biological samples, as well as common practice by researchers and researcher overseers, are unethical, as well as quite possibly against the best long-term interests of biomedical research. He's right. Rothstein urges that, as a consequence, A detailed process of public engagement, pilot projects, and careful study is needed before any type of regulatory coverage should be extended to deidentified health information and biological specimens. In the interim, responsible researchers should consider whether, in the context of their particular research, additional measures are needed to protect deidentified health information and biological specimens and demonstrate respect for the individuals from whom the information and specimens were obtained. (3) He's wrong. What we need is not a "detailed process" but a revolt, if not a revolution.The problems Rothstein points out in the research use of deidentified information and biological samples are real, but they are deeper, broader, and more serious than he argues in this paper.He identifies six risks and one ethical problem. The risks are 1. The unregulated process of deidentifying data and materials 2. The problem of possible reidentification 3. Group harms 4. Objectionable uses 5. Commercial exploitation 6. Undermining trust (hence participation in and support for research).The problem is that our treatment of deidentified information and samples completely ignores research participants' autonomy-their rights to decide whether they want to take part in any given research project.The article discusses these issues when they arise from research with deidentified information and samples. And, apparently, although this is not entirely clear from the article, Rothstein is focusing on situations where data and samples collected for non-research uses (presumably clinical) are first used for research only after they are deidentified. But this field of vision is too narrow. The issues he raises are true not only with newly deidentified data but also with the more common situation where data collected in some kind of identifiable form for one specific research project are then deidentified and used, or made available for use, in other projects with other goals. Furthermore, all of the risks except the first (the process of deidentification) also apply to "anonymous" data and samples, those collected without any personal identifying information.Although the research system's treatment of deidentified or anonymous research information and samples is egregious, this is not the only major problem with how we currently regulate human subjects research. Researchers need to pay more attention in many ways to the interests and wishes of the people who donate the information and samples essential for the researchers' work (and careers).Researchers need to use the information and samples only for purposes to which the research partici-

Genes, cells, and biobanks: Yes, there’s still a consent problem

“…The research participant suggested “there has been an over-assumption and a gross expectation of patient altruism” [33]. This kind of reaction fits well with a prediction made by Stanford law professor Hank Greely in 2010: “As more and more people find out what can be done—or is being done—with their health information, their family histories, and their DNA, the pressure for change should grow” [45]. …”

Investigating the potential for ethnic group harm in collaborative genomics research in Africa: Is ethnic stigmatisation likely?

“…When considering the relation between genomics and stigma, authors seem to locate the potential for stigma in the possibility to attribute genetic risk factors for particular diseases to identifiable population groups (Foster & Sharp, 2006; Goodman, 1996; WHO, 2002). Such an understanding seems to be concordant with views of stigma as a ‘mark’ – an understanding of stigma that has been amply criticised as being overly simplistic (Greely, 2010; Parker & Aggleton, 2003; Phelan, 2005). Moreover, genomic studies tend to focus on complex diseases, for which it is unlikely that any one genetic variant will be identified that could explain disease causation.…”

Policy Uncertainty, Sequencing, and Cell Lines

“…As thoughtfully noted by Hank Greely, “As more and more people find out what can be done—or is being done—with their health information, their family histories, and their DNA, the pressure for change should grow” (Greely 2010). …”