The reporter and the IRB: Should IRBs get involved in investigative journalism?

Many debate whether IRBs should have role in journalism

As the debate continues over whether journalists in academic settings are subject to IRB oversight, a newspaper journalist has taken the unusual step of voluntarily seeking out IRB review of his work.

Douglas Fischer, a reporter for The Oakland Tribune, worked with a private IRB before embarking on a project to test the blood of a Berkeley, CA, family for environmental contaminants. Fischer says that prior to this experience, he had known about IRBs, but had never considered applying to one for review of a proposed story. But the complexity of his project — blood draws from a family of four, including two children — and a suggestion from a source led him to seek out the IRB.

He says now that the process, which added months to his project and cost his newspaper $1,300, was a positive one, and he'd use it again for a similar story.

"I feel like I've found religion here," Fischer says with a laugh.

"It's a cumbersome process, no question about it, and it would be impractical for everyday stories, but for large investigative pieces, I do see benefits," he says. "I think when there is a potential significant downside to the subjects, it's very helpful to have a board that is dedicated solely to protecting the well-being of the subjects to oversee things."

Fischer's goal was to find a family, have their blood drawn, and test the blood for a number of substances — flame retardants, PCBs, metals such as mercury and lead — that are found in residential environments. He says there has been little research on this subject, especially regarding children, and Fischer wanted to know to what extent regular household contact with cleaners, solvents, and other sources affected different members of the family.

He came up with a family willing to be studied, but at that point, he said, he was stymied by how to proceed. "I realized I was in totally over my head," he says. "I was going to be drawing blood from this family and sending it to a lab to be analyzed. I was going to get back numbers that could be scary. Something could go wrong when we were drawing blood, plus with the child, I had no idea how much blood I could draw.

"The lab initially was telling me that they needed a lot of blood. I had no idea how much was safe to take out of an 18-month-old child that weighs 10 kilograms."

Seeking out an IRB

Fischer called Greg Koski, PhD, MD, former OHRP director and currently senior scientist at the Institute for Health Policy at Massachusetts General Hospital, Harvard Medical School in Boston.

Koski says that when he heard the details of Fischer's proposal, it sounded more like scientific research than simple reporting. "The more we talked about it, the clearer it became that this particular piece of [Fischer's project] was really a research study and in that manner no different than if I were doing it as a physician or a PhD were doing it in a biochemistry lab," he says. "I suggested that if he wanted to do this right, since there were privacy issues and a host of other issues that came up, that he should go through an IRB."

So Fischer went looking for a review board that would give him some guidance. IRBs at area universities turned him down because his employer was a for-profit company, but Independent Review Consulting (IRC), a Marin County, CA-based private IRB, was willing to accept his application.

Fischer filled out the same application form that any other investigator would, with help from a researcher he'd been working with on the project.

He devised a consent form that not only included information about the required blood draws but also the other aspects of his reporting on the stories.

"I'm rather proud of our consent form," he says. "It explained exactly what we were going to do in terms of the 'clinical trial' part — the testing, how much blood, what we would do with it, who would analyze it, what we would do with the samples afterward.

"Then it has another whole section on how the interviews would be conducted, that the photographer would be in their house taking pictures and it also explained that we would be publishing this in the newspaper and using photos and identifying features."

Under the terms of the informed consent, the family could withdraw from the project at any point up to publication, no questions asked, Fischer says.

One potential risk that Fischer outlined in the consent form was that because of the scarcity of research on this subject, the family could be upset by the information that the blood tests revealed.

"There was a potential for disturbing information — we told them that very clearly," he says. "In talking with various doctors and researchers, I got the clear sense that I would give them numbers that we would not be able to interpret. And we put that in the description of risks and/or discomforts: 'You should be prepared for some uncertainty.'"

IRB review — of a sort

Erica Heath, MBA, CIP, president of IRC, says her IRB determined, in looking at Fischer's proposal, that it wasn't research in the strict sense of the term. The board wondered whether they could review it at all, and worried about being able to convey risks to a non-investigator.

"The activity proposed was a case study and was not research," she says. "There was question about whether it should be reviewed or if it should be considered to be not research or not regulated research. Once accepted for review, it was not as a 'study' and the usual review formula could not be used."

She says the risks to the family were seen to be similar to subjects in a bio-monitoring study.

Since Fischer's application was voluntary, she says the board gave him a sort of 'approval,' after counseling him to make changes that would minimize risks to the family. Among those changes, Fischer says, was providing a specialist for the family to consult after receiving results from the tests to answer their questions to the extent possible.

"It was one of the best suggestions that came from the IRB," he says. "They wanted me to find a doctor that specializes in these environmental contaminants and get the family in for whatever they needed after we got the results. And we did that, and it was great."

Another issue was harder to resolve. The board was particularly concerned about the effect of the testing on the children, noting that the information gleaned would follow them for life, and possibly hurt their ability to gain insurance in the future, Heath says.

In his revised proposal, Fischer argued that the information from the children was important. It could show, for example, whether the youngest child, who was breastfeeding, was receiving contaminants via the mother's breast milk. In addition, children's smaller bodies and proximity to the ground also make it more likely that they would have higher levels of contaminants in their blood.

Eventually, he says, he and the IRB worked out a minimal amount of blood to be drawn from the children that would meet his needs.

The resulting stories, published in March, revealed surprising details about the level of the family's exposure to contaminants, including the presence of unexpected levels of flame retardants in all four family members' blood samples.

Fischer says he hopes to do a follow-up story looking at blood tests from a number of mother-and-child pairs. If he goes forward with it, he said he definitely will seek out the services of an IRB again.

"I'm probably going to get totally vilified in journalism circles, but I think it would be helpful," he says. "This added three or four months to the project, not to mention going to my editor and saying we need another $1,300. But in the end, I think it's beneficial for everybody."

Heath, too, says she'd be willing to repeat the experience, not as an official IRB review, but as a public service to provide education about how research should protect human subjects.

She says one thing that made the process work was Fischer's openness about his project and what he was hoping to accomplish. "He recognized it was not research, he saw it for what it was," she says. "Therefore, we could work with him on an open, honest basis. That counts for a whole lot."

Koski says he was happy to learn that Fischer had actually gone through with the IRB review he had recommended, noting that many legitimate researchers complain about the process.

In an op-ed piece that accompanied the newspaper articles, he wrote: "In this case, Fischer and his editors clearly did the right thing, and their work was better for it. But, more importantly, their conduct demonstrated respect for the principles and practices that characterize responsibly conducted human research."

Fischer says after the work he did on this project, he doesn't understand the reluctance of bona fide researchers to having their work reviewed by IRBs. "I don't understand, if you're involving humans, why you wouldn't want to go through this process," he says. "I know it takes time, but I felt so much more comfortable once my protocol had been vetted — that I had these guys to kind of look over my shoulder and make sure this family is being adequately protected."

Journalistic disagreement

Neil Ralston, PhD, assistant professor of journalism at Northwestern State University in Natchitoches, LA, and a member of the board of directors and a campus adviser for the national Society of Professional Journalists, says he sees no problem with what Fischer did.

"It was the reporter's choice," Ralston says. "It sounds like the reporter went out of his way to protect the people who took these tests and I think that would be a highly ethical thing to do."

But Leon Dash, a Pulitzer-Prize winning journalist and currently professor of journalism at the University of Illinois, Urbana-Champaign, IL, disagrees. "I think it's a big mistake," he says. "I would never do that. It's almost like dealing with issues of prior restraint, which the Supreme Court in the case of the Pentagon Papers found to be unconstitutional."

He says that the focus of IRBs and the focus of journalists are often in direct conflict — an IRB is concerned with protecting the subject, while a reporter is concerned with finding information from the subject, without necessarily putting the subject's needs first.

"The focus of journalism is in the public's interest, not in the interest of the people being interviewed," Dash says. "I think that's a major disconnect between IRBs and journalism."

Dash was a member of a University of Illinois panel that last year produced the Illinois White Paper, which contended that IRBs were engaging in "mission creep," delving into areas that were outside their purview rather than focusing on the research that needed their oversight most.

One example they used of IRB overreach was the suggestion that academic journalists — professors and students — might be required to submit their projects for IRB review.

"IRB purview leaves legitimate journalistic inquiry vulnerable to capricious decisions and creates confusion in the minds of students as to what is legitimately journalistic practice and what are the restraints of biomedical and even social science human subject research," the authors of the White Paper write. "Journalism is a clear example of a field that does not fit within the IRB review process."

Dash and Ralston says their institutions do not require IRB review of journalism projects. But at an another institution where Ralston taught, he learned that the IRB was considering a policy that would have required IRB approval for any research, including interviews, that were conducted by students.

"I went before the panel and told them that the First Amendment basically prohibited them from doing that, at least in terms of the journalism research," he says. "It was just prohibitive for my students to have to go to the IRB every time they wanted to do a story.

"The person who was in charge of it understood quickly and said, 'Yes, you're right, and we're not attempting to apply this to journalism students doing stories for publication.'"

Ralston does admit that there can be a gray line between what would be considered journalistic activity conducted by students or professors, and something that an IRB would consider research requiring review.

"It's quite possible where a journalist could conduct the same type of research that an academic might conduct, but the difference would be that the journalist would publish his or hers in a newspaper or broadcast outlet and the academic would publish his or hers in a journal," he says.

"The IRBs, I'm sure, would have trouble with that. This is an issue that I think is going to have to be debated more."

But as far as Dash is concerned, there is no debate. He says that anything a journalist — privately employed by a newspaper, teaching at a university or a student in a class — does is journalism, and all are protected by the First Amendment from IRB intervention.

"I didn't give up my rights as a journalist because I agreed to go into a university setting and teach," he says.

Koski says he agrees that most journalism projects are not well-suited to review by an IRB. He says Fischer's project was unusual in that it required collecting specimens from people and essentially treating them as research subjects.

"The last thing in the world that we'd want to do is to have all journalists have their stories go before some kind of committee," he says. "That would be a scary thought.

"By and large, I would say that if a journalist actually does what would constitute a scientific study — whether it's social research or something like this, which was actually toxicological — that those would appropriately be subject to IRB reviews," he says. "But what would clearly constitute traditional journalistic practice, I would say no. Wouldn't want to go there. I think it would be a serious step down a slippery slope."