Research using tissue taken from patients sparks new debates on privacy and property.
When a patient goes to the hospital these days to have a biopsy or operation, chances are good theyll be asked to sign more than the waiver and the bill. They might be given a form asking for permission to use tissue removed during the procedure for medical research.
On the surface, that request sounds pleasingly benign: a chance to further medical science, maybe even find a cure for your own ailment, with no extra effort beyond attending to your own health. Whats an altruistic individual not to like?
Possibly plenty. Depending on the fine print and the success of the research, giving up your cells for scientific scrutiny could open the door to a terrifying invasion of privacy and cause considerable financial and social risks to donors.
Need for permission
The power of biotechnology to unveil the secrets of the genetic code is what has changed this arena. Todays researchers are finding genes that cause a predisposition to disease and are using DNA to connect the dots between living people and their long-dead ancestors. They are also discovering treatments for illnesses at an astonishing rate. Each step forward, however, brings with it a whole new set of ethical questions that arent always immediately apparent.
A minefield of questions surrounds the unwitting tissue donor, according to Richard Lynch, professor of pathology at the University of Iowa College of Medicine. He brings up the case of researchers who find that a certain gene in a patients tissue puts them at risk for disease. As the tissue donor, you could say you dont want to know about it because you would worry. You might want to know so you could plan for it. Or you dont want anyone else to learn about it, because if the insurance company finds out, you could be discriminated against.
The danger of ones medical information falling into the wrong hands is frighteningly real. As vice president for consumers at the Alliance of Genetic Support Groups, Sharon Terry has heard numerous horror stories of people denied health insurance, life insurance, and even employmentjust because the wrong people learned of their medical history. I know of someone who actually lost her job before their employer even understood the ramifications of their disease and how it wouldnt affect her ability to work, Terry says. And in the 1970s, several insurance companies and employers discriminated against sickle cell gene carriers even though their health would not be affected by the allele.
Over the long run, this type of research is clearly worth pursuing. We want to provide researchers with a steady supply of tissue, but we want to ensure the appropriate moral limits are respected, Childress says. The two are linked because people will only contribute their tissues if they are satisfied that human subject research policies offer donors adequate protection. If you really want to go forward in this kind of research, you need the public trust, says Childress.
Federal policy already provides some safeguards for tissue donors. Scientists conducting federally funded research on tissue that can be linked to living persons must obtain specific consent for the research from subjects or the investigation must impose minimal risks to subjects. Institutional Review Boards (IRBs) made up of scientists and community representatives decide whether studies meet these criteria. Yet this system of checks and balances can be flawed. Various IRBs interpret the law differently, and members might be swayed by a personal stake in the research, such as desiring to promote the status of a colleague.
According to the NBAC, there should be a continuum of permissibility that depends on the level of risk to the donor. Part of what would make it less risky is confidentiality, Childress says. At the permissive end of the continuum are unlinked samples for which personal information cannot be obtained. At the other end are samples that can be connected directly to an individual or family and for which identifying information such as medical records can be obtained. An NBAC report suggests that researchers who wish to use identified or linked tissue must provide a high level of disclosure, whereas researchers who wish to use unlinked tissue that has been stored for decades might not need to notify patients at all.
The Web site of the National Action Plan on Breast Cancer in Washington, DC (www.napbc.org), offers a sample consent form for donating tissue excised during biopsy for research. The form discusses how tissue donation may assist research. Patients are given the option to consent to the use of their tissues for cancer or other disease research, and are asked whether researchers may contact them in the future to take part in further research. The latter option was controversial among NBAC members, including Alexander Capron, professor of law and medicine and codirector of the Pacific Center for Health Policy and Ethics at the University of Southern California. I dont think people should be able to ask others for open-ended permission to use identifiable records. I dont think people can make those choices without knowing more, Capron says.
Profiting from tissue
At the forefront of this kind of research is GeneLogic of Gaithersburg, MD, for which 18 hospitals in the United States and the United Kingdom have agreed to procure a steady stream of human tissue samples. The agreements require them to provide us with X number of samples on a regular basis, says Robert Burrows, spokesman for GeneLogic. In exchange for the tissue, which is generally donated by patients for free, GeneLogic pays the hospitals a collection fee or gives its researchers access to some of the massive genetic databases it builds with the samples. Burrows says GeneLogic takes in hundreds of tissue samples a month and eventually hopes to build gene expression profiles for a football stadium full of people.
The companys hospital contractors use a standard consent form and medical record-taking process that includes diagnosis, treatment, medical history, and other patient information. Burrows says the distance between GeneLogic and the patient helps the company avoid potentially thorny patient privacy issues. Its all anonymous. We dont know any of them, and we never can. It also allows the company to avoid the issue of whether to pay the original tissue donors.
Researchers take all
Not everyone is comfortable with the researcher take all rule. Says Capron, If its something from which you derive great value, paying something back is not a bad idea. If its from the entire city of New York, maybe not, but what about an undeveloped society without the ability to do the research themselves? Thats like strip mining their land. Lynch suggests establishing a system by which companies might pay a percentage of donor-derived profits into Social Security or another fund for public development.
The NBACs recommendations are being considered by the federal government, but it is unclear at this point how they will affect federal research policy. And only the future will tell how the nation as a whole will tackle the blessing and curse of genetic knowledge. Says Childress, Its an ongoing societal conversation that has not been settled yet.