Throughout history, atrocities have been committed in the name of medical research.
To protect people participating in medical research, the federal government decades ago put in place strict rules on the conduct of human experiments.
"We're in a very, very different world than when these regulations were first written," says Dr. Jerry Menikoff, who heads the HHS Office of Human Research Protections. "The goal is to modernize the rules to make sure terrible things don't happen."
Many of the revisions are long overdue and would significantly improve oversight of scientific research, say researchers, bioethicists and officials who oversee human research studies.
But many of the updates are also triggering intense debate and criticism.
The new rules are too complex and too vaguely written in many places, says Elisa Hurley, executive director of Public Responsibility in Medicine and Research, a nonprofit organization in Boston. As such, she says, they could cause confusion for volunteers and researchers. It's a "flawed attempt" to improve things, Hurley says.
After hearing such criticism and receiving numerous requests to give the public more time to study the proposed revisions, the HHS office announced Tuesday that it was extending the public comment period by 30 days — to Jan. 6.
One change that some object to would require scientists to obtain explicit consent from patients before using their blood or tissue for research. The requirement aims to prevent a repeat of what happened to Henrietta Lacks. She was an African-American woman who died of cervical cancer in 1951. Cells taken from her cervix were used without her consent to produce a research cell line that has been kept alive in labs around the world ever since.
Researchers and companies use these cells in a wide range of research, including the development of new drugs. Neither Lacks nor her family consented to this use.
Under the new rules, scientists would only be able to do research on biological specimens from people who explicitly agree to it: " 'I'm OK with that. I'm OK with future research studies taking place using the leftover portions of my tumor or blood,' " Menikoff says.
But some scientists argue that in most cases the new requirement would create unnecessary red tape that would significantly impede important research.
"It's now going to be much more onerous to get this tissue that otherwise would just go in the trash," says Dr. Luis Garza, a Johns Hopkins University dermatologist who uses foreskin from circumcisions for a variety of experiments. "It's creating barriers for working on human tissue, which is what we need to do to solve human disease."
Another revision would expand the number of studies that would have to follow the rules. All scientists who get federal funding would be required to adhere to the rules for every experiment they conduct, even those that aren't funded directly by the government.
Other changes are designed to make some research easier, such as conducting large studies involving multiple institutions. Right now, independent panels known as institutional review boards, or IRBs, oversee studies in each location where people volunteer. Under the proposed rules, one centralized IRB could run an entire multicenter study.
"It is all one study," HHS' Menikoff says. "So basically the same ethical rules apply to all of the subjects in the study."
He says the issues raised by any given study are pretty much the same at one study site compared to another site, so that duplicate ethical reviews can be eliminated. He and other researchers say the proposed change would help get new cures to patients more quickly.
But some advocates and bioethicists worry that streamlining study reviews in this way would undermine protections for volunteers, especially studies involving many sites, says Dr. Michael Carome, who heads Public Citizen's Health Research Group, a Washington, D.C.-based advocacy group.
It's unlikely one IRB can "adequately understand the local context, local ethical issues, the quality of the facilities and the credentials of the practitioners," he says. "That one IRB is unlikely to have sufficient knowledge of all those sites."
The proposal would also exempt many studies that don't pose physical risks. Examples include projects that only involve asking subjects questions and answers — things like surveys and in-depth interviews. The idea is to get rid of unnecessary bureaucratic hoops for harmless research, Menikoff says.
But this change is raising fears, too.
"I think that's a major step backwards that, as far as I'm concerned, takes us back into the dark ages," says Ruth Macklin, a bioethicist at the Albert Einstein College of Medicine in New York.
Those kinds of studies "are not physically invasive, but they may be intrusive," Macklin says. "There are forms of harm that are not just physical harm."
Probing people about sensitive subjects, such as whether they've had an abortion or have been physically or sexually abused as children, can trigger strong emotional reactions, potentially causing psychological distress, Macklin says.
Menikoff disputes whether the changes would put anyone at risk. But he says the government will consider all the feedback it gets before changing the rules.
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LINDA WERTHEIMER, HOST:
This next story is about improving trust in medical experiments. The federal government is updating rules that protect people involved in research. And as NPR health correspondent Rob Stein reports, many of the proposed changes are generating debate.
ROB STEIN, BYLINE: Throughout history, some horrible things have happened in the name of medical research. Nazi doctors experimented on concentration camp prisoners. American doctors let poor black men with syphilis go untreated in the Tuskegee study. So Jerry Menikoff, the top U.S. official protecting people in studies today, says the government has strict rules.
JERRY MENIKOFF: These regulations make sure that we don't take advantage of the people who are good enough to volunteer their time and effort and, in many cases, put their health and well-being on the line.
STEIN: But the regulations haven't been updated in nearly a quarter-century, so the government has proposed changes.
MENIKOFF: We're in a very different world than when these regulations were first written. And so the goal was to modernize the rules to make sure terrible things don't happen.
STEIN: Many of the changes are seen as big improvements, but some researchers and bioethicists complain the new rules would be much more confusing. And some of the changes get lots of criticism, like one designed to make the rules tougher in one way. Take the case of Henrietta Lacks, the African-American woman immortalized by her cells. Scientists all over the world studied them for decades. Turns out no one ever asked her or her family if that was OK. The new rules would make that kind of thing a big no-no.
MENIKOFF: What happened to Henrietta Lacks would now need consent. Under the new rules, it would only be taking place for the people who said, I'm OK with future research studies taking place using the leftover portions of my tumor or blood that you still have left from me.
STEIN: Sounds good, right? Well, this freaks out many scientists. They say, in most cases, it will create unnecessary red tape that will block important research. For example, Luis Garza uses foreskin left over from circumcisions for all sorts of experiments at Johns Hopkins.
LUIS GARZA: It's now going to be much more onerous to get this tissue that otherwise would go just go in the trash. It's creating barriers for working on human tissue, which is what we need to do to solve human disease.
STEIN: Other changes are designed to make things easier, like big studies. Right now, independent watchdogs have to keep an eye on studies at every site where people volunteer. Under the new rules, Menikoff says one ethics panel could run the whole thing.
MENIKOFF: It is all one study. So basically, the same ethical rules apply to all of the subjects in the study. There's probably not a lot of distinct issues in one site versus the other site.
STEIN: Many researchers say this will get cures to patients quicker, but it makes some people very nervous. Michael Carome runs the advocacy group Public Citizen's Health Research Group. He says independent watchdogs are needed everywhere. They're called institutional review boards, or IRBs.
MICHAEL CAROME: Think of a study that might involve several hundred institutions. To think that a single IRB can adequately understand the local context, local ethical issues, the quality of the facilities and the credentials of the practitioners, that one IRB is unlikely to have sufficient knowledge of all those sites. And this could ultimately undermine protection of human subjects.
STEIN: Another change would exempt many studies if they don't pose physical risks - things like questionnaires, surveys and in-depth interviews. The idea is to get rid of useless bureaucratic hoops for harmless research. But that also raises a red flag for some people.
RUTH MACKLIN: That, as far as I'm concerned, takes us back into the dark ages.
STEIN: Ruth Macklin is a bioethicist at Albert Einstein College of Medicine in New York.
MACKLIN: Those kinds of research are not physically invasive, but they may be intrusive. If you start asking people about their drug use, about their abortions, about being physically molested or sexually molested as a child, I think there's enough literature out there in the field of psychology to say that there are forms of harm that are not just physical harm.
STEIN: The federal official in charge of the changes, Jerry Menikoff, disputes the changes would put anyone at risk. But he says the government will consider all this feedback before changing rules that protect people who volunteer for research. Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.