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Reporting results from biomonitoring studies
What should subjects be told about exposures?
Biomonitoring—measuring levels of environmental toxins in biological samples taken from volunteers—is an important tool in public health research, providing valuable information about local exposure levels.
Some biomonitoring researchers seek to go further, including a mechanism for reporting back to participants about their individual "body burdens" (the level of contaminants in their own blood, urine, or breast milk, or in their homes). They say participants have a right to know the information, so that they can take steps, if possible, to reduce their exposure.
But this approach comes with some potentially sticky questions for researchers and IRBs. How should this information be communicated? What should participants be told, particularly about environmental exposures researchers don't fully understand yet? And how much control should IRBs exert over the individual process of communicating with participants?
Julia Green Brody, PhD, executive director of the Silent Spring Institute, Newton, MA, says that when her group studied levels of endocrine-disrupting compounds in homes and individuals in Massachusetts and California, they soon decided they should report individual results to participants.
"Our core values led us to really value the relationship between the scientific team and the community where we're doing our research," she says.
At the same time, Brody says this was a very new area of science, noting that of the 89 compounds for which participants and their homes were tested, 30 had never been looked at in an indoor environment before.
"There wasn't any off-the-shelf package for how to do this," she says. "So our team really began engaging in discussion about what was the best approach."
Researchers went to the community that was assisting in the study—residents in Cape Cod, MA, and later in Richmond, CA, as well as members of the Massachusetts Breast Cancer Coalition and the California-based Citizens for a Better Environment (CBE)—to help shape the report-back plan.
Green says community leaders strongly urged reporting back to individuals, even for contaminants about which little is known.
Phil Brown, PhD, a professor of sociology and environmental studies at Brown University, and Rachel Morello-Frosch, PhD, MPH, an assistant professor of environmental health at the University of California, Berkeley, shepherded the research collaborative's biomonitoring project through the Brown University IRB.1
Brown says that the biggest initial concern raised by the IRB regarded the involvement of the Silent Spring Institute and Communities for a Better Environment—two independent entities whom board members feared they would not be able to adequately oversee.
"An IRB can discipline its own researchers on campus," Brown says. "They didn't have any knowledge of how they could influence or control a community organization that is not part of Brown University."
Brown says his group was able to convince the IRB that Silent Spring had an extensive record of research, much of it federally funded, and that CBE was an established environmental activist group, with its own legal team. Everyone involved in the project was willing to take required human subjects protection courses, and Brown University's co-PIs would conduct checks of the organizations' recordkeeping and data storage procedures.
Brown pointed out that these types of community/institutional partnerships are becoming more common.
"We spent a lot of time detailing how widespread this new practice was, why it was important and why it would be worthwhile for them to cover it," he says. "The National Institutes of Health is the main funding source for a lot of these new partnerships, in particular the National Institute of Environmental Health Sciences."
Opportunities for taking action
In the end, the Brown University IRB agreed to cover the organizations and had few problems with the proposed protocol itself, including the report-back procedures.
Individual reports were to be presented in a graphic format, showing a participant how the household's information compared not only to EPA health guidelines, but to other homes in the study.
The charts would be accompanied by verbal summaries that distilled the key messages. Participants were told as much as researchers knew about the possible sources of the contamination, so they could take steps to reduce exposure.
"That's part of the importance of reporting—to give people the opportunity to do that," Brody says. "It makes it possible for people to take action and helps people understand why they might want to take action."
Phil Brown says the Brown IRB did emphasize that any meetings called to report back to the community shouldn't consist entirely of individuals who had contributed data. The board's concern was that an individual attending that meeting could look around and know who the other study participants were.
"We should be clear that we were sending invitations to a wide range of people who lived in the area," he says. "Some of them might be involved in the study, but there was no way anybody could know they were involved."
Brown says the collaborative had far more problems with the Massachusetts Department of Public Health's Research and Data Access Review Committee (RaDAR), which had to approve the study because it involved subjects originally drawn from the Massachusetts Cancer Registry, a government-held database.
That committee raised several concerns about the project, including the researchers' plans to provide individual reports to subjects.
"At some point, they wanted us to show them every single letter that would have gone out (to participants)," Brown says, noting that would have required the committees' approval of about 120 letters. Eventually, the committee agreed to review only a template of the letter.
The RaDAR committee also originally called for the destruction of environmental and biological samples immediately after the first chemical analyses were completed. Eventually, the committee withdrew that requirement as well, as long as the research team obtained a new consent form from the participants allowing further storage of the samples.
Brown says destroying the samples would have been devastating to future research. As an example, he points to a recent study showing that childhood exposure to the now-banned pesticide DDT was associated with breast cancer later in life.
"The researchers had discovered an incredible databank of blood samples from decades ago," Brown says. "If those samples had been destroyed, this major scientific advance would not be possible.
"We know, day to day, how much science advances," he says. "Things are developing so quickly that we owe it to people to keep samples as long as they can be protected, so we can analyze this kind of data."
Brown says IRB approval of this study was eased by the fact that the researchers did not attempt to engage participants in publicly announcing the results of their biomonitoring, as other projects have done.
In one case, an environmental group put individual results on a web site (with participants' permission), to put a human face on the problem of environmental contamination.
Brown believes that IRBs should be willing to approve research designs that include such public disclosure, as long as the informed consent makes it clear that participants can decline to reveal their own data.
"I would hope that an IRB confronted with that would say, 'Yes, people should have that right,'" Brown says. "It's a basic right of your own data."
Clarity, follow-up important
Brody and Brown say IRBs should consider several other issues in reviewing biomonitoring studies.
• Choice: Brody says the informed consent process should spell out that participants have the option either to receive their individual results or to decline them.
• Clarity: In looking at a template of the individual reports, Brody says the IRB member should be sure the information is complete, but understandable.
"Which doesn't mean dumb it down—that is key," she says. "I think there's been a kind of knee-jerk reaction that people can't understand rich scientific information and our experience has been very consistent that people want to be told in quite a bit of detail."
In particular, she says, the report should be very clear about what is and isn't known.
"You need to be cautious about making unsubstantiated recommendations, or providing unsubstantiated reassurance," she says.
• Potential follow-up: Brody says the team's experience in writing the summaries has been that giving participants an understanding of both the results and what they may mean requires a broad and deep knowledge of the science.
To help with any questions, participants receiving reports were given the phone number of the study's chief toxicologist, who read all of the individual summaries. Brody says a few participants did end up calling her.
They also were encouraged to speak with prominent community-based participants, for example a breast cancer survivor who was active in the Massachusetts Breast Cancer Coalition.
"She is very well known in the Cape Cod community," Brody says. "And she did speak to many study participants after they got their study results."
• Risks of affecting behavior: Brown says concerns about the effects of biomonitoring on people's subsequent behavior may be overstated.
In particular, there has been concern that studies revealing the presence of chemicals in breast milk samples might lead women to stop breastfeeding their children.
"All of the studies that have looked at this have been very careful to say that the evidence is overwhelming that the benefits of breastfeeding are much greater than the risks and we encourage people to breastfeed," Brown says. "In research around that, we've found that people do continue to breastfeed, that testing breast milk has not scared them away."
• Community representation: Brown says IRBs should include members who can provide perspective from the community being studied. This can help avoid "helicopter research," in which researchers swoop in and conduct studies without giving results back to the community or providing them any benefit of the knowledge gained, Brown says.
He suggests paying community members to serve on an IRB, if necessary. He says the NIH could pilot a program in which a small percentage of grants at major research institutions are set aside to pay community members for their participation.
"After a few years, look at how this affected the way the IRB operated—were there new policies as a result? Did professionals at the university learn from the community representative? Were there better protections for the community than before?"