By Lisa Seachrist
VIENNA, Va. ¿ In attempting to put the finishing touches on a two-and-a-half year effort to produce guidelines for using stored tissue samples for research, the President¿s National Bioethics Advisory Committee (NBAC) looked at privacy regulations being considered for medical records.
In August, under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), federal medical records privacy rules, written either by Congress or the Department of Health and Human Services (DHHS), will take effect. John Fanning, privacy advocate and senior policy analyst with the office of the assistant secretary for planning and evaluation at DHHS, pointed out the benefits of ensuring privacy protections using the existing regulatory framework and a single law.
¿The proposed protections for medical records privacy parallel the existing rules,¿ Fanning said. ¿It allows us to use the framework without instituting a whole new set of rules for certain uses or types of information. These regulations would make little change in research.¿
Much of the concern over research using the nearly 280 million samples of stored tissue has been the fact that with the advent of genetic technologies, researchers are able to retrieve much more information about a person from an unidentified sample. More to the point, however, is that most people who have had biopsies or blood drawn have no idea their tissues may be used for research purposes.
Current regulations permit research on this tissue as long as the identifiers are stripped or coded. Likewise, researchers may use information in medical records for research without additional review as long as the identifying information is removed.
NBAC View Could Put More Research Under IRBs
NBAC, however, is looking at the growing amount of information that can be obtained from the samples and considering those samples as identifiable, which would put the research under the purview of the local institutional review board.
¿In the design of privacy protections, the obligation to behave is on the person who has the information,¿ Fanning said. ¿One of the dangers of considering all information as identifiable is that it destroys the advantage of taking the identifiers off.¿
Commissioner Steve Holtzman, chief financial officer at Cambridge, Mass.-based Millennium Pharmaceuticals Inc., asked Fanning whether in assessing the medical privacy protections he paid ¿more attention to the protections of the information rather than the information itself.¿
Fanning agreed with Holtzman¿s assessment, noting that ¿the general principle is that information used for research purposes shouldn¿t be used for any other purposes.¿
Provisions in the medical records privacy regulations call for criminal and civil penalties for misuse of the information.
Commissioner Alex Capron, professor of law and medicine at the University of Southern California in Los Angeles, argued that the information that can be culled from tissue samples makes necessary a higher level of protection.
¿When people are now asked to participate in genetic research, they often refuse because they consider the information is like a black box that could be unlocked and they don¿t want that information known about them,¿ Capron said.
Holtzman challenged Capron, noting that medical records in the hospital are extremely leaky in the sense that personal medical information can be posted on the grease board in the intensive care unit and picked up at the nurses station by people who aren¿t directly involved in a patient¿s care.
¿The position you are taking, then, is that a drop of blood has more risk to the patient than a medical record, which is lying around for all to see?¿ Holtzman asked.
¿I would say yes,¿ Capron said.
The NBAC is proposing the tissue samples that are coded be referred to an institutional review board to determine whether there is more than minimal risk to the patients whose samples are being used. If so, the researchers would need to get informed consent. If not, the research would be able to go forward. n