Think Scientists Have to Get Your Consent to Study Your Blood or DNA? Think Again
Under new proposal, all scientists receiving federal funds would have had to get patients' permission before doing research
A controversial proposal requiring all federally-funded scientists to get permission from patients before using their cells, blood, tissue, or DNA for research has been dropped.
The proposal was removed from the final revision a complicated set of regulations known as the Common Rule. The Rule is designed to made sure that scientists whose medical research is federally funded carry out that research in an ethical manner. This revision—which is expected to take effect in 2018—is the first update of the Rule in 26 years.
The initial proposal requiring patient consent was the result of an attempt to make sure that what happened to Henrietta Lacks—an American who died of cervical cancer in 1951—never happened again. Some of Lacks's cancer cells were kept alive for decades and used for both research and commercial purposes even though she had not consented to such uses and her family had no idea it was happening.
Scientists opposed to the requirement have argued that it was not necessary and that it would make it harder to conduct key research.
Dr. Jerry Menikoff is the head of the Health and Human Services Office of Human Research Protections.
"That proposal received a lot of criticism," he said. "There was concern that by implementing this new rule it would be harmful to the research enterprise, because it would make it harder to do research that is very, very useful."
Scientists and universities alike applauded the decision to drop the proposal.
"We are very pleased," said Mary Sue Coleman, biochemist and Association of American Universities president. "It would have been an unworkable system. Every time you have to get consent, it adds costs and complexity to the system that would have affected millions of samples — and, we think, would have limited research."
However, not everyone was pleased with the decision. In fact, the choice greatly concerned some.
"We know that trust is a critical factor in folks participating in research," says Debra Mathews, a bioethicist at Johns Hopkins University. "And we've seen in recent years the impact of when that trust is breached. In order for the public to trust the scientific community, the scientific community has to demonstrate that it's trustworthy. And a big part of that is asking permission."
Rebecca Skloot is a journalist who wrote a popular 2010 book about Lacks, The Immortal Life of Henrietta Lacks. She says that many readers have been surprised to learn about Lacks and her family's situation.
"One of the most commonly asked questions," Skloot says, "is, 'this couldn't happen today, right? They couldn't just take cells from people without their knowledge and use it in research?' My answer to that question is, 'Yes, this happens all the time.' And people are always shocked by this."
Dr. Menikoff hopes to reassure concerned patients.
"Research has been changing in the way it takes place over the last quarter century," he says. "The type of research we do is different."
According to Dr. Menikoff, large studies involving several institutions are far more common today than they used to be, a fact that requires standardized techniques and practices. "The notion was: 'Let's change the way we protect research subjects to fit with the type of research we do now.'"
With the exception of the consent requirement, scientists approved of most of the changes involved in the revision of the Rule, including one allowing one central ethics committee to oversee studies carried out at multiple locations. Until now, each place has had to have its own separate oversight panel.
"The bottom line," Dr. Menikoff says, "is the trial has to be conducted the same way across all those sites to be scientifically valid. Therefore, the ethical analysis of the study should be consistent across all the sites — it doesn't make sense to have a separate ethical analysis at each site."
Some, however, are concerned about this change. One such scientist is Dr. Michael Carome, head of consumer watchdog group Public Citizen's Health Research Group.
"The concern is that there may be inadequate protection for the subjects of the research at a particular site," he says.
He and others believe that certain factors that vary across research participants from one location to another—such as important cultural differences—may require each location to have its own oversight committee.
"They might have unique vulnerabilities in terms of their education level," Carome says. "Or they might be non-English-speaking subjects. And if there is only an English version of the informed consent form, that could lead to the subject at a particular institution not fully understanding the risks and the benefits."
In addition, scientists' increasing use of patient blood and cells in genetic research raises the possibility that those patients' identities could inadvertently be revealed.
The new regulations will be phased in over the next several years.