Who owns your DNA?

The answer might not be you. In an era when the map of the human genome can be accessed by any professor with an Internet connection, the question becomes more crucial every day. Courts and lawyers and legislatures wrestle with it; people who joined medical studies wonder just what their participation means. Courts have ruled that people who donate actual tissue — pieces of organs, tumors or blood, for example — have no right to financial compensation if a drug or treatment is developed from research done on that tissue.

But DNA, which contains the genetic blueprint from which you were built, seems more personal, something whose fate you and you alone should have the right to control.

Oregon is the site of the most recent battle over the rights to DNA. The state’s 1995 genetic privacy law, one of the first in the nation, gives a person property rights to his or her own DNA. A proposed change to the law last year would have taken those rights away. An advisory committee is expected to offer recommendations to the governor next month on how to proceed.

“There are many competing agendas here,” says Gregory Fowler, executive director of Geneforum.org, an organization founded to educate people about gene related issues. He also is a member of Oregon’s advisory committee.

Experts have tried to sort out those agendas for years. This year the federal government strengthened its regulations protecting human research subjects, hoping to make more explicit the process by which patients are told what a study will entail.

The National Bioethics Advisory Commission report on which some of those recommendations were based noted the difficulty in protecting subjects no longer physically involved in a study.

In some cases, those who donated the original tissue or DNA are dead, leaving wide open the question of whether new research can be done with that material — and who has rights to it.

For example, 4,000 of the 10,000 people who have taken part in the 52-year-old Framingham Heart Study have died, and coordinators of that study don’t know who can give consent to use the information from the dead volunteers if the study becomes a commercial venture, as planned. They are trying to work that out.

“We certainly feel we’re blazing a trail here,” says Susan Paris, vice president for university relations at Boston University, which runs the Framingham study. The usual concerns also come into play when the issue is genetics. Researchers make every effort to disconnect the DNA samples from the identities of their donors, but experts still worry.

“No genetic sample can be totally anonymous,” says Lori Andrews of the Institute for Science, Law, and Technology at the Illinois Institute of Technology. “We use DNA in forensics to identify people. I could always figure out who it is.”

Complicating the issue further is money — lots of it. Biotech and genomics companies have been hot in recent years in the stock market, and even academic researchers, once seen as above the financial fray, often have start-up companies.

The federal government is balking at Framingham’s plans to go commercial; Washington underwrites the famous study, which provided the baseline for nearly everything we know about heart disease. Some of the 6,000 living participants are nervous about how their data — which includes health histories, blood, tissue samples and DNA — will be used.

“A lot of time and commitment and love have been poured into this (by the volunteers), and they’re concerned that the data isn’t exploited,” Paris says. “But we have to get over the fact that companies may make money (from the data). How do you do (research) without money?”

John Kilyk Jr., managing partner with a Chicago law firm specializing in intellectual property, says that those who believe volunteers should get a cut of any proceeds fail to understand how much money goes into the research upfront, compared with what’s earned at the other end. “There is a lot of money at stake, or at least there’s perceived to be a lot more money at stake,” he says. “But there’s no guarantee that (researchers are) going to find something … What (laypeople) don’t appreciate is the time and money involved in getting to that point, and the number of winners and losers.”

Andrews rejects that argument. “It’s an unnecessary windfall,” she says. “They’re being rewarded disproportionately to what they do. It’s a trick on the public. It’s like patenting the alphabet and charging people every time they speak.”

Some companies have found a way to compensate those who volunteer DNA without going into dollars and cents. A company called DNA Sciences, which wants to find gene-based tests and treatments for common illnesses, is building a large database of DNA from scratch by asking volunteers to donate. If a relevant test or treatment is found, any volunteer who participated in that study will be offered the test or treatment free, says chief business officer Steven Lehrer. “The whole concept of paying people for (taking part in) research is very negative,” he says. “It looks like you coerced them.”

With the trend toward the creation and use of extremely large databases such as Framingham and DNA Sciences’ Gene Trust, “the property value of any individual genome gets smaller,” says Gillian Woollett, associate vice president for biologics and biotechnology at the Pharmaceutical Research and Manufacturers of America, a drug industry trade group.

Besides, she says, what portion of your DNA is yours? The large part of the genome we share with chimpanzees? The part you share with an identical twin? “Do you own what is unique to you,” she asks, “even if you don’t know what’s unique to you?”