New legal model proposed to counter red tape, boost participation in DNA sample research

April 18, 2011

Healthy people who contribute DNA samples for medical research see their relationship with researchers as sharing a trade secret, rather than participation in traditional medical research, according to a new study.

Legal and medical experts from the University of North Carolina at Chapel Hill and Duke University studied interviews with research participants. They discovered that even though subjects had read informed consent documents which explicitly stated that their DNA contribution was not a commercial transaction, participants still perceived the exchange in that light.

The experts believe that using trade secrets as a paradigm for the contribution of DNA to research would solve several current problems that are stymieing and deterring people from taking part in research studies.

Their findings appear in a policy paper, “Genomics, Biobanks and the Trade-Secret Model,” published in the April 15, 2011, issue of the journal Science.

“If you listen to what DNA sample contributors – research subjects – say about their participation, they understand it more than anything else as a commercial transaction,” said John Conley, William Rand Kenan Jr. Professor of Law in the UNC School of Law.

Conley said the policy paper is intended to start a debate about the nature of informed consent in DNA-related research. Traditionally, informed consent for the purposes of tries to make it explicitly clear that research subjects are not entering into a commercial exchange that would in some way reward their participation.

“Why not do it differently for DNA research? DNA contributed by healthy donors is quite different from giving a liver, for example,” Conley said.

The people interviewed expressed a range of views about research using contributed DNA. About half had contributed DNA, while the other half had been asked to contribute but declined.

“Some said ‘just give me the money and I’m done.’ Others would have taken less money but with conditions such as being able to opt out of a future research project or being told if researchers find something that has a bearing on their personal health,” said Conley. He argued in favor of a tiered consent, which would give more or less control over the use of their DNA depending on their preferences.

Conley said that using as a paradigm for the contribution of DNA to research would solve several current problems, such as how to handle DNA and tissues stored in banks for research purposes. Getting informed consent from donors for each new research application also is burdensome, said Conley; with a trade secret approach, however, individuals could give blanket consent or could retain the right to opt out of future research programs.

“We are trying to fit old models onto new technologies, such as biobanking,” said paper coauthor Ryan Gladden, second-year law student and Conley’s research assistant. “This is one solution.”

Related Stories

Recommended for you

Scientists provide insight into genetic basis of neuropsychiatric disorders

July 21, 2017
A study by scientists at the Children's Medical Center Research Institute at UT Southwestern (CRI) is providing insight into the genetic basis of neuropsychiatric disorders. In this research, the first mouse model of a mutation ...

Scientists identify new way cells turn off genes

July 19, 2017
Cells have more than one trick up their sleeve for controlling certain genes that regulate fetal growth and development.

South Asian genomes could be boon for disease research, scientists say

July 18, 2017
The Indian subcontinent's massive population is nearing 1.5 billion according to recent accounts. But that population is far from monolithic; it's made up of nearly 5,000 well-defined sub-groups, making the region one of ...

Mutant yeast reveals details of the aberrant genomic machinery of children's high-grade gliomas

July 18, 2017
St. Jude Children's Research Hospital biologists have used engineered yeast cells to discover how a mutation that is frequently found in pediatric brain tumor high-grade glioma triggers a cascade of genomic malfunctions.

Late-breaking mutations may play an important role in autism

July 17, 2017
A study of nearly 6,000 families, combining three genetic sequencing technologies, finds that mutations that occur after conception play an important role in autism. A team led by investigators at Boston Children's Hospital ...

Newly identified genetic marker may help detect high-risk flu patients

July 17, 2017
Researchers have discovered an inherited genetic variation that may help identify patients at elevated risk for severe, potentially fatal influenza infections. The scientists have also linked the gene variant to a mechanism ...

1 comment

Adjust slider to filter visible comments by rank

Display comments: newest first

tjcoop3
not rated yet Apr 19, 2011
Tiered consent. Please! If they got it they will use it however they want to including, if the Supreme Court ever allows patenting it or developments as a result. Make em pay for it. Lots and lots.
If the researcher doesn't benefit the pharmaceutical company funding them will. You can believe it.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.