Reference no: EM133448106
Dr. Alberta Russo, a physician working in the Huntington's Disease Clinic at Easton Hospital, is beginning a prospective double-blind longitudinal clinical study during which she will collect DNA samples from a large group of currently healthy community volunteers who have a family member with the disease, thus putting them at risk. The study will look for early signs and symptoms of the disease in those at risk, compare them to a control group of volunteers who have no family history of Huntington's disease, and correlate these findings with the genetic test. As part of the study, the participants must agree that they will never receive the results of the genetic test.
Dr. Russo has received financial support for the study from the Fund for Huntington's Disease Research (a private foundation). Knowing the sensitivity of the information, Dr. Russo wants to protect the identities and privacy of the volunteers in her study and safeguard the Protected Health Information that she will be collecting. She consults with a colleague who suggests she apply for a Certificate of Confidentiality (CoC) from the NIH. Her colleague also mentions that she needs to first obtain Institutional Review Board (IRB) approval of her research protocol before she can apply to the NIH for a CoC. Ultimately, the IRB approves Dr. Russo's study and she is able to obtain a CoC from the NIH.
Dr. Russo intends to acquire her sample in two ways. The easiest way will be to look through the entire panel of her clinic's patient records to identify all local residents. Because these patients live in the community, they will be easy to invite in to donate the small sample of blood needed for her study. As Dr. Russo reviews charts, she records a lot of demographic data, including names, addresses, and other personal information about family members, especially highlighting those who have the disease.
Being very compulsive, Dr. Russo enters all the demographic data into her laptop computer that she carries with her back and forth to work. In addition, she makes hard copies of these data, which she keeps in her locked file cabinet as a backup, just in case something should happen to her laptop.
Despite the fact that Huntington's disease is a rare condition, Dr. Russo believes that by adding a second recruitment strategy, using random digit dialing from her office phone, she will not have trouble accruing an adequate sample. Not only will she collect data from phone conversations with Huntington's patients and family members at risk, she will also collect data on others she speaks with who are not eligible for the study because they do not have Huntington's disease in their family. She intends to use these individuals in future studies as healthy (normal) controls.
Because of Dr. Russo's busy workday in the clinic, she needs to take her office laptop home with her so she can continue her research in the evening. On one of these evenings, Lucia, her neighbor and close friend, rushes in to ask Dr. Russo for a special favor. She is desperate to borrow Dr. Russo's laptop for only a few hours because her computer isn't working and she has a vital assignment to complete for the next day. Dr. Russo agrees to help her friend, and gives her the computer. By this time, the computer is in sleep mode, with the lid closed. Therefore, Dr. Russo doesn't realize that she has neither exited her database nor shut down her computer.
When Lucia activates the computer, Dr. Russo's Huntington's disease registry appears on the screen, with the genders, ages, addresses, and diagnoses of local residents and their families (but not their names). Some of the addresses are familiar to Lucia as she works in the town hall. She is concerned because she appreciates the severity of the situation, and so she returns the computer immediately to Dr. Russo. They discuss whether Dr. Russo needs to notify the IRB that Lucia accessed the database.
On another evening, as Dr. Russo gets ready to work on her data, she is shocked to realize that she must have left the CD-ROM disk containing the latest data from the clinic in the taxi she took home. All she has now on the screen are her older data.
Word has spread that Dr. Russo has developed an unparalleled database of patients at risk for Huntington's disease. And so it comes as no surprise that a pharmaceutical-company representative, Jeff Brown, asks Dr. Russo if his company can purchase access to her database. The company would pay her a generous sum of money that in fact represents the legitimate expenses for the time and effort she has expended to gather this valuable data repository. This pharmaceutical company is planning a clinical study to test a new drug that appears to delay the onset of Huntington's disease in those at risk.
Several months later, Dr. Russo is pleased with her success in recruiting. Participants have developed a trusting relationship and are impressed with her professionalism. She has recruited a significant number of participants who have provided the needed blood samples for DNA testing. After some time has passed, several of the DNA donors have changed their minds and are now demanding to know their DNA test results. They vocally protest that they have the right to change their mind and have a right to now know the results of their DNA test. After all, they say, aren't these genes their property? Dr. Russo wonders what the implications would be if she agrees to give the participants their test results.
Should Dr. Russo provide the information requested? Why or why not according to the moral theories of Utilitarianism, Kantianism, and Ethics of Care? Has the doctor breached the privacy of her participants in her actions? Would selling the information to the drug representative be morally permissible?