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.
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