In honor of DNA Day, the Genomics Law Report is completing its transformation into a one stop shop for the best in blog wrangling by hosting Scientia Pro Publica #26 and Blawg Review #260 in the same week. We think it fitting that these two august reviews should appear side-by-side at the GLR, which itself sits firmly at the intersection of science and the law.
For those unfamiliar with Scientia Pro Publica, it is a traveling compilation of the best blog writing targeted to the public about science, medicine, the environment and technology. Though more recently arrived, it is to science blogging what Blawg Review is to legal blogging. Our hope is that pairing the two will encourage all of our readers, regardless of background, to explore some of the best writing from previously unknown corners of the internet.
The occasion for this 25th 26th edition of Scientia Pro Publica – DNA Day – is one that is doubtless well-known to scientists, but if you’d like to know more please see the introduction to Blawg Review #260. As for the semi-creative counting, earlier this month Scientia Pro Publica featured a pair of 24th editions: one by Andrew at 360 Degree Skeptic and another by (a different) Andrew at Southern Fried Science. Which makes this, technically, the 26th edition of Scientia Pro Publica. If there’s one thing a lawyer hosting a science blog review can contribute it’s an increased sensitivity to technicalities. On to the submissions!
New research published this week in the Proceedings of the National Academy of Sciences from Loukides et al. offers up a new method for preserving individual privacy while linking genomic and healthcare data. (“Anonymization of electronic medical records for validating genome-wide association studies.”) Daniel Cressey of Nature News and Katharine Gammon of Technology Review have concise (and free) summaries.
As we’ve written earlier (“Back to the Future: NIH to Revisit Genomic Data-Sharing Policy”), the ability to link – and to share – genotype and phenotype data (including medical records, particularly treatment and outcome data) will be essential to the development of the next generation of genomic research. One of the most common ways to link genotype and phenotype data is to combine genomic data with electronic medical records (EMRs). A particular patient’s EMR may contain everything from basic biographical information to family medical history to current diagnoses, including ICD codes. When it comes to associating genes with medical conditions, researchers rely on International Classification of Disease (ICD) codes to categorize individual patients by disease type and search for shared genetic variations that might play a causal role.
Cracking the Codes. Obviously identifying information (e.g., biographical information) is generally required to be removed pursuant to HIPAA regulations. ICD codes, however, are sometimes retained for purposes of genetic association research and, in some circumstances, a set of otherwise anonymous ICD codes pulled from an EMR can be traced backwards to identify the specific individual supplying the codes.
Is There an Obligation to Return Genetic Data to Research Participants? Kaiser Responds to 23andMe’s TEDMED Criticism
Earlier today, in the latest installment of the What ELSI is New? series, Daniel MacArthur asked a question that has cropped up repeatedly in recent weeks and months as part of the broader discourse surrounding genetic research and commerce: what rights should individuals have to gain access to their personal genetic or genomic data?
MacArthur’s position – that research participants should generally be provided with complete access to their own genetic data upon request – is one that continues to remain a minority position. It finds support in research initiatives such as the Personal Genome Project (PGP) and (to a lesser extent) the Coriell Personalized Medicine Collaborative (CPMC), but returning research results has generally been eschewed by other large-scale genetic research projects, including Kaiser Permanente’s recently announced Research Program on Genes, Environment, & Health (RPGEH).
Last month, the Genomics Law Report examined the RPGEH and its reluctance to return genetic data to a participant population that is expected to quickly grow to 100,000 or more Kaiser patients. RPGEH’s decision not to return data to its participants was under the microscope again last week at TEDMED 2009 when 23andMe co-founder Anne Wojcicki criticized Kaiser for planning to genotype RPGEH participants without offering them the ability to review their data.
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As first reported by GenomeWeb, last week the NIH issued a “Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data.” Although the title doesn’t exactly trip off of the tongue, the NIH’s announcement provides an opportunity to review where we are and where we have already been when it comes to genomic data-sharing.
At the heart of the NIH’s announcement is a desire to increase the availability of genomic datasets. From last week’s notice:
Consistent with the NIH mission to improve public health through research and the longstanding NIH policy to make data publicly available from the research activities that it funds, the NIH has concluded that the full value of sequence-based genomic data can best be realized by making the sequence, as well as other genomic and phenotype datasets derived from large-scale studies, available as broadly as possible to a wide range of scientific investigators.
For NIH-funded genomic researchers, this language should have a familiar ring. In 2007, the NIH published a policy covering data-sharing for genome-wide association studies (GWAS) that required all NIH-funded GWAS research be deposited in a central data repository. Here’s the mission statement from the 2007 policy:
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