By Lisa Seachrist
WASHINGTON — In trying to establish an ethical framework for conducting research on stored tissue, the National Bioethics Advisory Commission (NBAC) has chosen to change the framework of informed consent as is currently practiced and is exploring ways of involving the community in ethical decisions on the research conducted with the tissues.
At a meeting Tuesday, the NBAC's genetics subcommittee established that the decision on what types of informed consent were necessary to conduct research should be based on the way the researcher intended to use the tissue rather than the purpose for which the tissue was collected.
"It is not the sample we are interested in," said Ezekiel Emanuel, associate professor of medicine and social medicine at Harvard Medical School, in Boston. "It is the way in which it is to be used that concerns us. This reconceptualizes work done by others."
For decades, researchers and clinicians have amassed a tremendous store of tissues taken during diagnostic and surgical procedures. As a safeguard to patients, these tissues have been stored as a reference. In addition, the tissues also are used as the raw material for investigations of diseases such as cancer and neurological disorders.
At the time of the surgery, most patients sign a generic consent form agreeing to the risks and benefits of the procedure as well as to allowing the hospital to store the tissue and use it for research purposes. Federal law allows such research without any institutional oversight as long as those samples are kept anonymous.
The problem arises from the fact that, with the advent of genetic technologies, a gold mine of information can be retrieved from every sample. As a result, a vast number of academic and industrial research studies can be generated from nearly any stored tissue. For example, a sample take from a skin biopsy could be used to find genes associated with Alzheimer's disease.
Researchers are loath to go back and obtain consent for each and every study they intend to conduct on stored tissue because of the exorbitant time and financial costs.
The subcommittee has determined that such an undertaking is only necessary when the researchers use the sample with identifiers attached to it.
Samples that have had all identifiers stripped from them would be available for research purposes after an institutional review to guarantee that the research meets anonymity standards.
Informed Consent Considered Essential
"It is important, however, to note that the system that we put in place to anonymize these samples must be sufficiently robust to make it impossible for researchers to walk back to identify the source of a sample," said Carol Greider, senior scientist at the Cold Spring Harbor Laboratory, in Cold Spring Harbor, N.Y. "We need to be sure that we believe in the system that we put in place — it's not just the colleague down the hall that is removing the identifiers."
The subcommittee was equally adamant that the current general informed consent provided during surgery was inadequate to allow even anonymous research once its recommendations have been finalized. Because the day of surgery is an emotional time for people to give truly informed consent for the use of their tissues, one proposal was to provide the consent form prior to the surgery and allow the patient to review it and turn it in at the time of surgery.
Another proposal was to presume consent but provide patients an opt out provision. However, some committee members noted that the provision would reward poor record keeping.
"The problem with an opt-out provision is that it would encourage researchers who want to use a specific sample to lose paper," said Lawrence Miike, director of the Hawaii State Department of Health.
The committee will continue to weigh the informed consent issues at its January and February meetings. In addition, it will tackle means by which researchers can look to community leaders when research will focus on particular ethnic groups.
The commissioners recognized the need for including the community when a study may produce results that could stigmatize a community or, perhaps, result in employment or health insurance discrimination for a particular group.
"One could sit here and wish that we were in Sweden, where part of the contract in receiving national health care is that your tissue is available for research," said Steve Holtzman, chief business officer of Millennium Pharmaceuticals, in Cambridge, Mass. "Maybe that is the way it ought to be, but it isn't. We have to work with that."
The subcommittee was hesitant to propose a system that would provide community leaders veto power. Instead, it favors a consultation process that would allow community representatives to present their point of view. Nevertheless, the commissioners are struggling with how to decide who speaks for a community. *