Harvard Scientists Say Research Subjects Should See Data

People who give blood or other tissues for research should be able to track their use through the scientific process to see the data their activities or samples generate, Harvard University scientists said.

The standard one-way flow of information creates an unequal relationship that blocks participants’ ability to hold scientists accountable for how the data is used, Harvard genetics researchers George Church and Jeantine Lunshof said in a policy paper written with Barbara Prainsack from King’s College London. The paper will be published tomorrow in the journal Science.

Biobanks hold vast stores of information about individuals’ genes, tissues, and illnesses, and research subjects should have some right to see where their data is kept and how it’s used, the authors said. The current system is like a financial bank that won’t allow customers to verify that their money is in an account, Lunshof, a visiting fellow in genetics at Harvard Medical School in Boston, said in a telephone interview.

“When you donate your data or material to a researcher, it’s actually quite logical to think you’d get an acknowledgment of it and the opportunity to see what you gave them,” Lunshof said. “But right now it is a one-way transaction, and anything you contribute goes into a black hole.”

Church and Lunshof are researchers in the Personal Genome Project, a Harvard-based program that returns the results of full-genome sequencing to individuals. The project’s website explains that participants may receive unexpected information about their health or genetic background.

Recommending Option

The authors said they weren’t recommending providing clinical analysis and findings, such as an abnormal heart rhythm or gene mutation, to subjects. Rather, they advocate giving research participants the option to access raw data that their samples generate, such as a gene sequence, with the opportunity to have it interpreted on their own.

Such access would give research subjects the freedom to decide if they want the data, a choice in who analyzes it and would inform their decision-making about participating in studies, Prainsack said in a statement. The same principles would apply in social science research and human behavior studies that don’t involve biological samples, Lunshof said.

Human research samples and data are often collected, analyzed, and maintained differently than those that are intended for medical use, said Lainie Ross, a University of Chicago professor of clinical ethics. Giving individuals access to information that may be flawed, inaccurate or out of context incurs the risk that it may lead to harmful decisions, she said.

Confusing Missions

“They’re confusing clinical care and research,” Ross said. “To bring data into the clinical setting when it was collected in the research setting is inappropriate.”

23andMe Inc. halted sales of health-related data with its DNA tests after the U.S. Food and Drug Administration said that people who don’t understand the information might react to it inappropriately. For example, people who discover they have mutations in genes related to breast cancer might get unnecessary medical treatment, the FDA said.

Even allowing research subjects to track the use of their data may be risky, Ross said. For example, individuals might make assumptions about their health simply by finding out whether their data were included in a group of subjects with a particular condition or gene mutation, she said.

“Researchers should update individuals about the research their data is being used in,” said Mark Rothstein, a professor of bioethics at the University of Louisville School of Medicine in Kentucky. Even so, “I think tracking your sample like it’s a FedEx delivery is not very valuable.”

Subjects who were able to monitor their data might help weed out research fraud that has sometimes occurred when scientists have based conclusions on fabricated findings, Lunshof said.

“People should be able to say, ‘That is my data, it’s my sample and it’s right there,’” she said. “And that’s currently totally lacking.”

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