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22. The DNA Donation Project 215departments. However, there was also recognition that the project would be very efficacious,especially in the long term, since the greater the size of the DNA bank, themore useful it would be to a wide range of HUMC researchers and their collaborators.Thus, the task force decided to investigate the matter further.Of great concern from the beginning were the legal and ethical issues surroundingthe project, such as when and how patients should be asked to participate, whetherHUMC could ever be compelled to release DNA information to a third party, andwhether a patient should be notified of a significant medical advance in treatment fora disease to which they were predisposed. In addition, there were concerns aboutwhether patients would actually be willing to participate.One task force member, Carol Evans, M.D., J.D., director of the genetics and publicpolicy center, offered direction on the legal issues, which included the patient consentprocess. She expressed the view that true “informed” patient consent could not beobtained under Dr. Anderson’s current proposal, where patients would be asked toparticipate and would be provided with the requisite patient consent form by clericalstaff at the time of admission or check-in. These staff would not have the clinical orresearch background to be able to answer detailed questions about the project, and inaddition, patients might feel pressured to participate since the request was made priorto receiving any care, particularly in the hospital setting. The recommendation wasmade that persons trained in patient ascertainment—either research nurses or geneticcounselors—be utilized in this role and that efforts be restricted to outpatient clinicsand the clinical trials center.The second recommendation Dr. Evans made was that focus groups be conductedto assess the public’s potential willingness to participate and to explore potential areasof sensitivity. In addition to the anticipated concerns about the privacy of medicalrecords and DNA information, several patients had indicated that they were uncomfortablewith the idea of donating DNA without a specific study in mind. Some patientsdid not understand how DNA from anonymous persons could be used in research.Thus, Dr. Evans recommended that a large-scale educational and public relations campaignprecede implementation of the DNA donation project.In June, a second task force meeting was held, with one important addition to thelist of attendees. Just that week Lauren Nelson, Ph.D., M.L.S., had begun work as assistantdirector of medical informatics. At this task force meeting, she offered to assemblea formal proposal for the project based on notes from the meeting, and in Octobershe disseminated the proposal for comments.Among the items suggested was the hiringof a clinical research professional to plan and direct the entire project. This personwould work with administrative and clinical leaders from the hospital and the outpatientclinics to develop a comprehensive business plan, detailing costs and phases ofimplementation. Despite this recommendation, Dr. Anderson continued to direct theproject. By the time a year had passed since the first task force meeting, the recommendationsof neither Dr. Evans nor Dr. Nelson had been heeded.In April of the following year, a third task force meeting was held to discuss the feasibilityof the proposal and to decide what the next steps in the process would be. Theproposal indicated that a DNA database would be developed that would de-identifypatient medical record numbers. Thus, samples would never be labeled with thesenumbers, and the fact that a patient had donated DNA would not be recorded anywherein their medical record, although there would be a field in the electronic medicalrecord indicating whether the patient had been approached about participating, so thatthe same person would not be approached repeatedly. The task force decided that thecenter for human genetics (CHG) was best equipped to store the DNA samples and