This publication has attracted attention: Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays by Nils Homer and 9 co-authors, including David W Craig, PLoS Genet 2008( Aug 29);4(8): e1000167 [PubMed Record].
See, for example: NIH Limits Access to GWAS Databases Due to Privacy Concerns by Charles P Clayton, Alliance for Academic Internal Medicine, September 5, 2008. Excerpt:
The National Institutes of Health (NIH) announced new procedures for researchers to access previously public databases from genome-wide association studies (GWAS) in light of recently published research …
See also: NIH Tackles Privacy Concerns for GWAS, NIAID Funding News, September 17, 2008. Excerpts:
On August 25, 2008, NIH removed files of aggregate GWAS data from the public portion of its databases while keeping summary information public.
You will still be able to share and use these data. As an investigator, you must now apply for access and agree to protect confidentiality. This process matches the one NIH has required all along for individual-level data.
Read more about NIH’s new policy for accessing GWAS data at Modifications to Genome-Wide Association Studies (GWAS) Data Access.
Excerpts from NIH’s new policy:
The NIH developed a two-tiered access policy for GWAS data. The first level is the public posting (open access) of summary-level information and aggregate genotype data, including allele frequencies by case-control status, association tests odds ratios, and p values for each SNP in the scan. The second level is controlled access to individual-level data (genotypes and phenotypes). The controlled access data are available to investigators from scientific institutions who submit Data Access Request (DAR) packages that are reviewed and approved by the NIH Data Access Committees (DACs).
New statistical techniques for analyzing dense genomic information make it possible to infer the group assignment (i.e., case or control) of an individual DNA sample if one has access to high-density genomic data for that specific individual from another source and the allele frequencies for the case and control groups from publicly available aggregate datasets. …..
Two recent publications about research ethics in the genomics era:
Ethical and Practical Issues Associated with Aggregating Databases by David R Karp and 14 co-authors, PLoS Med 2008(Sep 23); 5(9): e190 [PubMed Record]. Excerpt:
Box 1. Recommendations
1. Determine whether initial consent and ethical approval will allow secondary research.
2. Ensure that there are appropriate data security mechanisms and review bodies to protect privacy interests in aggregated databases.
3. Informed consent should take into account the potential incorporation of data into aggregated databases.
4. Address special challenges of using data obtained from existing databases.
5. Pursue efforts directed at standardization of data.
6. Establish data sharing rules, including attribution of contributions.
7. Adopt “best practices” to avoid identifiability of the data.
And, Informed Consent in the Genomics Era by Deborah Mascalzoni, Andrew Hicks, Peter Pramstaller, Matthias Wjst, PLoS Med 2008(Sep 16); 5(9): e192 [PubMed Record]. Summary Points:
* Genetic cohort studies storing biological materials hold great promise for medical research, but also present new problems that are profoundly different from the classical clinical trial for which informed consent was developed.
* The classical risk/benefit analysis of physical harm doesn’t take into account new threats to the individual such as uninsurability, unemployability, genetic discrimination, or disruption of family relationships.
* Traditional informed consent may therefore no longer be appropriate when dealing with long-term studies using biological materials.
* Informed consent should be seen as an ongoing process between researcher and participant, and not just as a once-and-for-all decision.
* Research following the initial storage of samples needs to be likewise explained and may be announced using new communication methods.
The publications cited above are all in PLoS journals, and are OA.