IRBs need to be reminded how even the smallest of studies based on bad science or being performed by an unethical researcher can have long-lasting dangers and impact on society, a regulatory coordinator says.

The best example is the now-discredited study that linked autism to childhood vaccination. Although the study later was found to be poorly done and inaccurate, celebrities and others who grasped it as the truth have corralled a movement that has convinced a higher percentage of parents to avoid or postpone their children’s vaccinations.

“It’s fascinating to me that one small study comes out, and the media puts out headlines, and celebrities talk about it,” says Tonya Edvalson, CCRP, regulatory coordinator for Intermountain Healthcare in Salt Lake City. Edvalson recently spoke about autism and vaccines at the global conference of the Association of Clinical Research Professionals (ACRP), held April 25-28, 2015, in Salt Lake City.

“Yet, even when the study is found to be fraudulent research, and so much is wrong with it, we still fight this battle,” she adds.

Edvalson refers to the example of the 1998 study by a British physician that reported to find a direct link between autism and the common vaccine for measles, mumps, and rubella (MMR).

Many parents panicked soon after the study was published and vaccination rates fell to dangerously low levels, leading — in the past 15 years — to multiple outbreaks of once-controllable childhood diseases.

For example, the United States went from having nearly eradicated the three diseases to having disastrous outbreaks, including the recent one in California in which measles cases were linked to an amusement park, according to an April 2015 report by the Centers for Disease Control and Prevention in Atlanta.1

Last year, the U.S. had a record number of measles cases with 668 reported cases from 27 states. That was the most cases since measles elimination was documented in the U.S. in 2000.1

The original study reported on 12 patients’ medical histories and was published in BMJ. After other scientists raised questions about the study, mistakes and misrepresentations were discovered, and BMJ retracted it. Britain took away the researcher’s medical license in 2010. In the many years since then, scientifically credible studies have disproven the connection, showing that rates of autism among non-vaccinated children are not lower than those among vaccinated children, according to various news reports.

The latest study, published in the Journal of the American Medical Association (JAMA), found that autism rates for more than 95,000 children who were vaccinated with the MMR vaccine were no higher than rates for children who were not vaccinated — even when they had older siblings with autism. About 1% of the children enrolled in the study were diagnosed with autism.2

But these later studies arrived after the major damage was done, Edvalson says.

Edvalson is in a unique position to discuss the issue, as she worked for an IRB for seven years before moving to the clinical side to work with investigators. Her current role includes reviewing all studies submitted to the IRB. And she has a son with autism.

Autism scares parents, and this fear may have fueled the irrational belief that vaccines were causing the disorder, she suggests.

IRBs should keep in mind that once bad science is out in public, it’s very hard to control what’s said, Edvalson says.

“Make sure studies are designed appropriately from the beginning, and make sure there are protections in place and it’s done according to the plan,” she adds.

The discredited vaccine researcher did not follow the rules, Edvalson notes.

“He used a specific procedure that wasn’t in any IRB submissions, a lumbar puncture,” she adds. “And when the general medical council reviewed it, they said they thought it wasn’t germane to the study at all.”

Knowing what she does about how to conduct ethical and regulatory compliant research, Edvalson says she takes it personally to see how one bad study can cause so much damage to public health.

“I have a child with autism, and it really bothered me to see all of these articles come out with misinformation about vaccines,” she says. “If our kids with autism are not protected by immunizations, then they are even more at risk.”

IRBs, researchers, and others in the human research protection community have a role to play in keeping bad science from being conducted, Edvalson says.

“Most of the people I speak to are research coordinators and study monitors, and I tell them that when they suspect something doesn’t look right, they should point it out and bring it up to whoever they think can do something about it,” she says.

“This is more than having a culture of compliance,” Edvalson notes. “It’s doing the right thing for the right reason.”

The vaccine-autism research was continuing despite not having proper ethical approval, and someone involved with it had to know this was happening, she says.

“We need to create a culture of, ‘This is how it’s done,’” she says.

IRBs can help prevent this type of lone-wolf researcher fraud by getting to know investigators and research staff. “Having a collegial relationship between an investigator and IRB goes a long way to preventing problems,” Edvalson says. “You need to have a safe place for research staff to go and to say, ‘This is not in the consent form, but he’s asking me to do this.’”

Also, IRBs should make sure there are processes in place for reporting fraud and bad research behavior.

Some IRBs conduct not-for-cause audits of studies to make sure there are no problems or disturbing trends. The idea is to be accountable and make sure the good research is what’s put out there in the public, Edvalson says.

References

  1. Measles cases and outbreaks. Report by the Centers for Disease Control and Prevention. April 27, 2015: http://www.cdc.gov/measles/cases-outbreaks.html.
  2. Jain A, Marshall J, Buikema A, et al. Autism occurrence by MMR vaccine status among US children with older siblings with and without autism. JAMA. 2015;313(15):1534-1540.