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What are the most oppressing legal and ethical issues facing biorepositories and what are some strategies to address them?

Biobanks and, in particular, large population studies have been built, but what now? Optimizing access and use, ensuring sustainability, and supporting personalized medicine are the major challenges. 
 
Fears of legal liability by the universities and institutions that house biobanks for possible misuse of data or samples may well impede the future use of biorepositories. Paradoxically, even where participants have consented to broad access including international research, multiple ethics reviews and extreme data security may also thwart access. Likewise, if such resources are not sustained, then cost-recovery charges imposed on researchers could include the overall costs of recruitment, maintenance, and administration of the biobank, not just the preparation of samples and data for research. Again, this will affect access and use and perhaps lead to closure and possible loss of all the data and samples. Finally, researchers using biorepositories for disease-specific studies employing whole exome/genome sequencing will discover incidental findings that have clinical, “personal” significance and raise the thorny issue of the return of results (a minefield!). 
 
Are strategies available to mitigate these issues or solve them? Not yet, but we should address them. First, we need to streamline, simplify, and customize access to such resources such that an internationally accepted approach is generally accepted in terms of policy (though local interpretation may differ). Second, such infrastructure science deserves and needs continuing public support especially if we wish to re-contact participants and update the data in these population reference maps. Third, personalized medicine can only happen if research results can be validated against these maps. So, personalized medicine ultimately depends on the population. The whole system of communication with participants must become dynamic, interactive, and ongoing. Only then will the return of results and incidental findings become “normalized.”