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All samples in the Repository were collected with the understanding that they would be used not only for the projects for which they were initially collected, but also for a wide range of future studies. The samples may be used for a broad range of genetic variation research, including studies of gene expression and proteomics. Their use is not limited to the study of any particular disease. Both non-commercial and commercial entities may study them. Donors of these samples understood that the full value of the resources developed with their samples (the HapMap Project and 1000 Genomes Project resources) can be realized only if the samples remain widely available for other research that builds on these resources. Some research with these samples, however, may carry the potential for group stigmatization or other ethical concerns. For example, if a genetic variant found to be associated with a particular disease or characteristic is found to be more frequent in groups from a particular geographical location, and if this information is over-generalized to all or most members of that group or related groups, entire groups could be stigmatized. Harm could also occur when reports of the findings of genetic association studies are not placed in context to make clear that there may be significant non-genetic contributions. An overemphasis on group allele frequency differences can create the misleading impression that there are precise boundaries between groups of people, thus reinforcing racial or ethnic biases. Each community that provided new samples for the HapMap established a Community Advisory Group (CAG) to serve as a liaison between the community and the repository. Some of these CAGs still exist, while others have become inactive. Even where the CAGs are inactive, however, many of the sample donors and others in their communities are interested in how the samples collected in their communities are being used. Donors and members of the communities participating in the 1000 Genomes Project are also very interested in staying informed about the uses of their samples. In recognition of the importance of keeping the donor communities apprised of how their samples are being used, Coriell sends each donor community a quarterly report that lists the investigators who have requested their samples during that quarter and the nature of the research. The communities are also informed when major papers result from research with their samples. It is the policy of this Repository that an entire donor community, through its CAG, could decide (after careful discussion) to withdraw its samples from the Repository, if it were determined that the community's samples were being used in a manner inconsistent with the wishes of most of the members of that community. Although this would be expected to occur only rarely and after extensive discussions, it might occur based on a use of the samples that the community found unacceptable or stigmatizing. According communities a right to withdraw their samples in this manner is consistent with contemporary standards of research ethics for genetic variation research that involves identified populations (See "Integrating ethics and science in the International HapMap Project." (2004) Nat Rev Genet. 5:467-75. PMID: 15153999). Investigators who use these samples are asked to be sensitive to the possible implications of their research for the sample donors and their communities and populations. Investigators should describe their study results with care and attention to the potential broader implications of their research. Investigators should adhere to the Guidelines for Referring to Populations in Publications and Presentations. Investigators should notify Coriell (nhgri@coriell.org) of any publications resulting from the use of the samples; an annual reminder will be sent out requesting this information. These measures will help to protect not only the donor communities but also the sample collections and the integrity and long-term viability of the genetic variation research enterprise itself. |
