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22The DNA Donation ProjectTricia A. ThorntonEver since completion of the first sequencing of the human genome, geneticists havebeen struggling to meet the public’s hope for breakthrough discoveries. The search fora “genotype-phenotype” link in which associations are made between genetic variationsand physical traits faces at least two challenges: (1) the need for rapid ascertainment(patient consent) or ready access to study participants and their DNA, and (2)the need for rich clinical information to accompany DNA samples. These are the twochallenges that William Anderson, M.D., of Hudson University Medical Center(HUMC) decided to tackle.Dr. Anderson is the assistant director of research at HUMC, a large academicmedical center in the United States. Along with many other biomedical researchers,Dr. Anderson is interested in how genetic variations are related to human diseaseand response to pharmacological treatment. Large numbers of subjects withdetailed clinical information are crucial to the success of genetic studies, but currentmethods of subject ascertainment and chart review are labor-intensive and timeconsuming.Dr. Anderson set out to define his biomedical research project by describing amethod that would automate the process of linking clinical data with patients’ DNA.The process of collecting DNA samples for each individual research study would nolonger need traditional subject ascertainment, which required developing a patientconsent form and obtaining approval from the institutional review board (IRB) of eachindividual research study’s ascertainment process. Researchers would simply submitrequests for the use of anonymous banked DNA samples from patients who hadreceived care at HUMC and whose clinical information could be retrieved for use inany number of genetics studies approved by the medical center’s scientific advisoryboard and the IRB. De-identifying the DNA samples, such that DNA informationwould not be recorded in a patient’s record, would safeguard patient privacy, andpatients could not be identified from their DNA samples. Dr. Anderson’s concept wasnamed the “DNA donation project.”The DNA Donation Task ForceAt the beginning of the year, Dr. Anderson assembled a task force of research andadministrative faculty he considered integral to making his vision a reality. It was theconsensus of all present at the first meeting that the DNA donation project was veryambitious and would require a large, concerted effort across several individuals and214