In Studies of Family Medical Ties, Privacy May Stall Science
When Rick Curtin tore into the large, thick envelope bearing his daughter’s name on a fall day in 1998, he had no inkling he also was opening a Pandora’s box that would shake the biomedical research community and prompt a federal inquiry into protecting the privacy of patients in scientific experiments.
Inside, Curtin found a 25-page questionnaire from a Virginia Commonwealth University researcher who was building a database on the health of twins born in the state and was asking his daughter Allison, who has a twin brother, to participate. But she was off at college and had asked her father to check her mail.
When Curtin began to read, he was stunned. The questions were not only about his daughter but also about other family members, including him. And they were intensely personal.
Had her father ever suffered from depression? Did he have abnormal genitalia? Curtin, a financial manager for the Defense Department, felt they needed his permission before his daughter could answer those questions.
Federal regulators agreed and temporarily shut down the research. Now they are struggling to craft a national policy on just who beyond patients deserves privacy protection. On Monday, a Health and Human Services Department advisory panel plans to begin the task of drafting guidelines.
The notion of “informed consent”--fully explaining to patients in research experiments the potential risks of their participation--has been around since Congress made it the law in 1981. But the law does not specifically address family members or others whose privacy could be invaded, albeit unintentionally, by broadening new avenues in research, particularly in the study of genes. Entire populations and family lines--not just individuals--are now under the microscope.
“This is a new generation of privacy issues--uncharted territory,” said Mary Faith Marshall, director of the bioethics program at the University of Kansas Medical Center, who chairs the panel. “We are pushing a new envelope and need to come up with new answers.”
“This is really a Solomon-esque type of problem,” agreed Abbey Meyers, a member of the panel, which will debate and draft recommendations for the government in the coming months. “Family members need to know if information about themselves is to be used.” But, she said, if you demand that family members give consent, “research, especially genetic research, could come to a grinding halt.”
Francis S. Collins, director of the National Human Genome Research Institute, recently received an e-mail from a researcher complaining that his proposal to study the genetics of alcoholism had been rejected by a local review panel because he hadn’t obtained consent from “secondary” subjects.
“He believes his primary subjects would be extremely reluctant to involve family members in any way . . . that it would kill his project,” Collins said. “So this is not a hypothetical concern. A lot hinges on what this advisory committee decides to do. . . . Much of our hope in understanding inherited conditions lies in our being able to study families.”
On the other hand, there clearly are cases in which “private information could cause serious harm to a person’s reputation and livelihood, if disclosed,” said Greg Koski, director of the HHS office for human research protections, which ultimately will decide the policy.
“If a wife enrolls in a research study and is asked, ‘Does your husband have any health problems?’ does she have the right to disclose that he has HIV without the permission of her husband?” Koski asked.
Lana Skirboll, director of the National Institutes of Health’s office of science policy, which oversees the conduct of federally funded research, called the current dilemma “the world’s most impossible issue,” adding: “It seems simple at first. But then when you poke your finger into it, you realize that it’s far more complex than you ever thought.”
To be sure, privacy always has been an issue in health care. Patients routinely fill out forms in their doctors’ offices, answering questions about their family medical history without giving it a second thought. Yet, there are no rules to safeguard that information from abuse--only the implicit trust between doctor and patient that the information will remain confidential.
In research, the stakes are different. The information is taken not for the care of the patient but for the benefit of science, increasing the risk of disclosure and raising basic questions about who owns a patient’s family history.
There are thousands of clinical trials underway at any given time and at many places in the United States and abroad, a large number funded by the federal government.
Before an experiment can begin, it must be approved--and continued to be monitored--by a local institutional review board, an independent panel of physicians, statisticians, community representatives and others who ensure that the research is ethical and that participants’ rights are protected.
Controversy over patient rights grew after the September 1999 death of 18-year-old Jesse Gelsinger of Tucson, who had been participating in a gene therapy trial at the University of Pennsylvania. His case did not directly involve the use of secondary research subjects. But the panel formed in the furor over Gelsinger’s death has been asked to deal with a wide range of patient protection issues, including whether researchers can delve into the medical histories of their patients’ relatives.
The panel is not expected to recommend a rigid standard but rather to encourage local review boards to consider certain criteria each time they evaluate a research proposal.
This kind of blueprint should give the local boards latitude in making decisions. For example, they might decide that in a small town, where most people know each other, inadvertent disclosure of personal medical information about a patient’s relatives might be too risky, while it would pose much less of a concern in a large city.
“We’ll have to go back and do some very careful thinking in light of the new possibilities for information that we have now,” said Marshall, the panel’s chairwoman.
Marshall acknowledged that the task ahead is formidable, but “we would be remiss if we didn’t try to answer those questions and come up with the best answer we can, one that does the most good and involves the least amount of harm. Sometimes, in bioethics, that’s the best you can do.”
