Improving the Quality of 'Personalized Medicine' Research and Practice

Through an Ethical Lens

George P Browman; Jochen Vollmann; Alice Virani; Jan Schildmann

Disclosures

Personalized Medicine. 2014;11(4):413-423. 

In This Article

Private (Industry)/Public Partnerships

The evolving vision of PM as an integrated system will require vast amounts of funding to develop, maintain and monitor enabling infrastructures for data collection, data sharing and analysis; for communications networks and for tissue biobanking resources; and for the linkages among them. It is unlikely that such infrastructure can be achieved without the collaboration of multiple financial stakeholders including private foundations, individual donors, governments at the regional (e.g., state) and federal levels and the participation of industry. Industry is already a key partner in PM consortia for cancer such as the ambitious Worldwide Innovative Networking (WIN) Consortium for PM.[25]

From an ethics perspective, these partnership arrangements will need to be carefully negotiated to avoid real and perceived conflicts of interest among partners and between funding bodies, evaluation programs and individual scientists. Furthermore, to meet ethical standards, such arrangements will need to be as transparent as possible, even to the public, and reference to them will need to be incorporated into consent documents for both clinical care and research. Such arrangements will need to be specific about the expected 'returns' to investors with respect to access to linked personal health and genomic information and to administrative databases that track resource utilization in order to achieve the benefits of a PM system.[26,27] While various existing recommendations on proper conduct of genetic research do include clauses on shared benefits and risks, the scale of a systems approach at an international level involving for-profit–not-for-profit partnerships with substantial investment linked to expectations of benefit may require re-examination of current ethical frameworks. Relevant issues in this respect are the balance between reasonable risks to privacy against potential benefits to individuals as well as between public and private investors and society as a whole. The international agenda for PM may indeed be a boon to accelerate drug discovery and development by the industry sector, but accompanied by risks associated with expectations for access to tissues and information, and information sharing of personal data that will require regulatory and reimbursement reform and further legislative protection for privacy.[28,29]

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