»Annotated Case Studies«
Annotated Case Study 1: Clinical Case
Annotated Case Study 2: Social Sciences and Behavioral Case
»Annotated Case Study 1: Clinical Case«
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.
»Annotated Case 2: Social Sciences and Behavioral Case«
Dr. Alberto Ruiz, a sociology researcher in the Newton University HIV Center, is conducting a complex international high-risk study of HIV and illicit drug use — in this case, the use of crystal methamphetamine. The purpose of the study is to compare crystal meth use among those who are HIV-positive living in the U.S., France, and Turkey. Specifically, the researcher intends to study users who are making the drug in their homes. The researcher has colleagues doing research in HIV clinics in those countries that will make sample accrual relatively easy.
Dr. Ruiz will recruit interviewers who are gay and have access to these drug-using populations. Interviewers will be carefully trained to maintain confidentiality as that is the only means for the interviewers to gain the trust of the sample of participants. Dr. Ruiz has had a hard time getting the proposal through the IRB that is concerned about how the data, particularly identifiers, will be protected. Dr. Ruiz describes a complex password-protection plan, which the IRB accepts. In addition, a Certificate of Confidentiality will be obtained.
Dr. Ruiz has decided to collect the study sample using the Internet. He proposes to send recruitment flyers to gay Web sites and Listservs. When potential study participants reply, volunteering for the study, he will promise not to collect their names or addresses. What these men do not realize, however, is that he will be collecting their IP (Internet Protocol) addresses.
The IRB was very particular about the informed consent process, requiring that Dr. Ruiz take special measures to protect the participants‘ Protected Health Information (PHI), invoking the HIPAA protections. Dr. Ruiz claims that this is not necessary as the University is not a health-related institution. The IRB claims that this is beside the point; they are concerned with more than just compliance. Their aim is to protect the rights and welfare of all research participants.
One of the members of the IRB is a domestic violence investigator, Doris Grant. She informs Dr. Ruiz that domestic violence is often a problem for crystal meth users and their partners as this drug is associated with episodes of violent behavior, paranoia, anxiety, confusion, and insomnia that can persist for long periods. As Dr. Ruiz is especially interested in those who are making crystal meth in their homes, the likelihood of domestic violence is high. Ms. Grant asks him how he intends to instruct the interviewers to respond if they learn that one of the partners frequently beats up the other partner, especially if the interviewer notices signs of abuse (e.g., visible bruises or a secret plea for help).
Ms. Grant asks Dr. Ruiz if he knows whether the Certificate of Confidentiality is absolute or if the interviewer can breach confidentiality if there is danger of imminent harm.
After the study has been running for two years, Dr. Ruiz is surprised one day when two CIA agents enter his university office with a subpoena for his data. They are trying to break up a Turkish crystal meth smuggling ring. Dr. Ruiz feels confident that he does not have to give them access to data from the U.S. meth users. He never expected, however, that there would be an interest in the data he collected from Turkey. He strongly believes, though he has no direct knowledge, that the CIA does not have jurisdiction over data he collected from Turkey. He realizes now that the risks of the study are far higher than he had ever imagined, and that he needs a lawyer badly as he now may risk being jailed for obstructing justice.
Continue to the next section: → Foundation Text