Advocates say, Give back to community that gives’
Study population should benefit
For more than two centuries, the small communities that make up the Canadian province of Newfoundland and Labrador, on the country’s most northeastern coast, were largely isolated from the rest of the world. Over the years, few families moved in or out. More than 90% of the inhabitants of the province, which borders the Gulf of St. Lawrence, can trace their ancestry directly back to England or Ireland.
It is this unique setting that now is drawing genetic researchers from around the globe.
"We have pockets of homogeneity around the province," explains Daryl Pullman, PhD, associate professor of medical genetics on the faculty of medicine at Memorial University of Newfound-land. "There are certain communities that have a high incidence of certain kinds of genetic disorders, so they have become very attractive from a genetic research point of view."
Unfortunately for residents, outside researchers rarely have been interested in the welfare of the people they ask to contribute DNA, or the potential impact that participation may have on them. Often, they arrive, collect samples and information, and then depart, with no agreement for following up or giving information back to the community.
In one particularly troublesome case, Pullman relates, researchers went to several different communities, rented hotel rooms, persuaded residents to come to the rooms, undergo electrocardiograms, provide blood samples and, in some cases, copies of medical records.
Repeated occurrences left provincial officials concerned that residents were being exploited — their genetic information used to further medical science or enrich pharmaceutical research — then abandoned.
They began exploring establishing a provincial research ethics board (REB), similar to an institutional review board, which would have oversight over genetic research conducted in the province or involving province residents. That mechanism, they felt, would better enable authorities to ensure subjects were given adequate informed consent and protection from harm, Pullman says.
However, ethicists also are interested in something more — whether the residents who are agreeing to allow their DNA to be studied should be able to share in the benefits of the research.
Putting a price on DNA
Discussions of benefit sharing — the view that commercial sponsors should return a portion of the profits or other in-kind benefits that accrue from this research to those who made the research possible in the first place or to humankind in general — have become more common in the spheres of human genetic research, Pullman explains.
"Historically, industry sponsors, like the pharmaceutical industry, for example, have not paid a direct benefit to subjects of clinical trials and so forth, the idea being that the market will take care of everything. If they develop a drug that is going to be beneficial to society, then everyone will benefit," he notes. "And that is the response you often get from industry representatives when you talk to them about benefit sharing. What’s different about genetics?’ Our answer is, it is one thing to take out a patent on a drug. It is another to take out a patent on a gene, or a particular string of DNA."
Human DNA, in a sense, belongs to no one and to everyone at the same time, he says. "Even if a company has a patent on genes that may come from me, but they also are in a certain sense your genes, as well, because they are part of the human genome."
Benefit sharing largely has been discussed in relation to large-scale, population-based genetic studies, but little consideration has been given to smaller genetic studies, particularly the add-on studies so common in modern pharmaceutical research, says Pullman.
He and a colleague, Andrew Latus, PhD, also at Memorial University, recently published a paper on possible benefit-sharing arrangements in these smaller contexts.
They propose that commercial sponsors who wish to come into a community and study the genes of its population work out a separate benefit-sharing arrangement before being allowed to submit a proposal.
"Of course, our model is built around the idea of health care as a public and not a private good," he notes. "The rationale here is that the people of our entire province bear the burden of disease and illness. We all pay taxes to support the health care system. Any benefits that come from commercial research should go back to the community, not to individuals per se."
Pullman and Latus do not propose that a person or family with a particular genetic disorder receive direct compensation from the commercial sponsors, for example. Because the entire community bears the burden of the family’s health care, the community should benefit.
But they do say that perhaps sponsors could agree to help fund a project at a local university or center to study diseases in the population and help find treatments.
The sponsor would then have the right to present study proposals to the provincial REB, or a university REB, for consideration.
Under their model, consideration of the benefit-sharing agreement should be separate from the REB consideration and monitoring of specific studies, he says.
Avoiding conflicts
"It just comes down to, frankly, the potential for conflicts of interest," he says. "If there is a situation where you know there is a research ethics board for an institution is looking at a protocol and, at the same time, knows that this particular pharmaceutical company is willing to provide the institution with a new gene sequencer, then we might be more inclined to say, Yeah, let’s go ahead with that one.’"
In addition to community-based benefit-sharing arrangements, Pullman points out that some smaller, subject-based agreements may be appropriate in some circumstances.
For example, in the province, a particular family has a genetic disorder that leaves them chronically insensitive to pain.
"There is a real interest, of course, in finding out what the genetic problem is that makes them insensitive to pain," he notes. "But the interest isn’t in determining whether they can help people with this condition, so that they can become sensitive to pain. The interest is in finding the genetic link — which may have all kinds of implications for developing analgesics, etc. But none of the benefits of the specific research would ever go to this family. But they are interesting research subjects because of this."
In that case, it might be appropriate for a study sponsor to work out some sort of benefit-sharing arrangement with this particular family.
Of course, care must be taken to ensure that the benefit did not serve as an inducement to participate or continue participation in a research protocol, he adds.
"We are wide open on the application of this, but the general principle is not that it will be individual people negotiating on their own, but community negotiators to take care of the community in a way that is most appropriate," he says. "Whatever benefit comes back into the system gets dispersed to the community — either to some people who are carrying a tremendous burden and will get very little benefit from the results of the research — or to the community as a whole."
Reference
1. Pullman D, Latus A. Clinical trials, genetic add-ons, and the question of benefit sharing. Lancet 2003; 362:242-244.
For more than two centuries, the small communities that make up the Canadian province of Newfoundland and Labrador, on the countrys most northeastern coast, were largely isolated from the rest of the world.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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