For less than $100 and a sample of spit, you can learn about your genes, your disease susceptibility, and your ethnic heritage. Wearable sensors report on your sleep patterns, your heart rate, and what air pollutants are nearby. With Detox Me Action Kit, a crowdsourced project my team recently launched, you can find out what common hormone-disrupting chemicals are in your body, including ingredients that manufacturers don’t have to disclose. Then there’s all the data in your medical record that you can now get hold of, thanks to changes in health laws.
Between the rise in direct-to-consumer products and more transparent medical care, people today have access to myriad types of data about their personal health — and they’ve come to expect it. Yet for participants in most research studies, outdated ethical standards prevent them from learning anything at all about what was found in their blood, urine, or any other tissue they donated for research.
Thousands of Americans take part in studies and clinical trials every year to support work ranging from basic laboratory science to long-term epidemiological studies and clinical trials of new drugs and devices. Some donate biological samples like blood or saliva or tissue biopsies. Tests done during the course of this work can evaluate genes, the presence of environmental chemicals, drug responses, and normal biological functions, like hormone levels.
Study participants nearly always want their own results. But few get them.
Participants can learn the aggregate results of the study through newsletters or articles in medical or scientific journals. But that doesn’t tell them where they stand as individuals.
The ethical concern with giving an individual his or her results has been driven largely by a traditional doctor-centered model of health: results that can’t be tied directly to a medical recommendation or diagnosis are seen as not useful and might cause too much stress.
Relying on this model, institutional review boards (IRBs) frequently prohibit researchers from disclosing individual results that are not clinically relevant or that do not come from laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), a set of federal standards that apply to all U.S. facilities or sites that test human specimens for assessing health.
That may change. Last month, an expert committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) reviewed the pros and cons of sharing individual results with study participants and concluded that the old restrictions don’t make sense anymore. Research has become more collaborative, with study participants treated as partners rather than as “subjects,” and their ability to benefit from their own research results often extends beyond medical care.
Participants in a study of environmental contaminants, for example, may want to know their results for making decisions about healthier lifestyles, planning their family’s future, engaging in advocacy work, or simply to satisfy scientific curiosity. To support this shift in thinking, the NASEM committee recommended giving study participants the right to decide for themselves whether to receive their results.
Study participants nearly always want their own results. But few get them.
Previous reports have come to the same conclusion. And some efforts are already underway to give study participants their personal results. The California Environmental Contaminant Biomonitoring Program, also called Biomonitoring California, for example, is required by state law to offer access to personal results.
The NASEM consensus report is the first, though, to recommend specific steps needed to make reporting back to participants routine. It calls on funding agencies and research institutions to find ways to do this by providing leadership to develop infrastructure and training, as well as to support the development of empirically based best-practice models.
Implementing these recommendations would transform the relationship between researchers and participants. Researchers will be challenged to think through and communicate the implications of their data in new ways that relate to everyday experience, and participants will gain a better understanding of science as well as their own bodies.
I was a reviewer for the committee’s report, and found that it very much reflects my own experiences in returning study results to participants. About 15 years ago, my research group was conducting a study on Cape Cod, Massachusetts, on the links between environmental chemicals and breast cancer. We were testing 120 participants’ homes, and their urine, for about 90 hormone-disrupting chemicals, many of which are found in everyday consumer products.
At some point, participants began asking about what we were finding in their bodies and their homes. The ethics of this community-based study weighed in favor of sharing this information, so we began looking for the best ways to communicate the results of cutting-edge tests for exposure to the chemicals, even when the health implications of these exposures were uncertain.
Working in collaboration with community advisers, we developed reports that provided contextual information about the chemicals, including why we were studying them, how people are exposed to them and, when possible, how to reduce exposures. We explained what we knew and what we didn’t know about links between these chemicals and health. We summarized the results in personalized text and showed them in graphs that let participants compare themselves to others in the study, to those across the nation, and in guidelines, if they existed.
Since then, my colleagues and I have created personalized reports in studies across the country and in various demographic groups, and now advise other researchers on how to do this. To make it easier to prepare personalized reports for studies of any size, we developed the Digital Exposure Report-Back Interface.
We were warned that giving study participants their own data would yield little benefit and carry big risks. But as the NASEM report concluded, we’ve found the benefits have been understated and the risks overblown.
That doesn’t mean giving study participants their results is easy — it can pose substantial challenges. But it is worthwhile.
Over the last decade, my team has interviewed several hundred study participants, researchers, and IRB members and staff about reporting back individual study results in more than a dozen environmental health studies funded by the National Institutes of Health. Researchers told us that sharing individual results with participants strengthened their relationships with the people on whom the study depended, and also supported recruitment and retention. Study participants gave similar responses, saying that receiving their results improved their trust in the research team and made them feel respected.
That experience was particularly striking in a study of families living in public housing. They said that the collaborative approach of the study, which shared individual results with participants both midway through the study and at the end, made them comfortable allowing researchers into their homes to collect samples. This suggests that sharing results with participants can help reduce the distrust caused by past ethics abuses in vulnerable communities.
The intellectual demands of preparing reports can even lead to new scientific insights. While researchers typically focus on study-wide trends and averages, preparing reports for individual participants can bring attention to outliers. Having to tell a participant about a “high” result drives inquiry to explain what it means.
In our Household Exposure Study on Cape Cod, for example, reporting back participants’ results led us to discover that a floor finish used in the 1950s and 1960s was a previously unrecognized source of very high levels of PCBs in some homes. Unexpected individual results also made us realize that a carcinogenic flame retardant that had been long-banned from children’s pajamas was present in house dust. This finding led us to investigate a wider range of flame-retardant chemicals, discovering high levels that ultimately catalyzed changes in furniture flammability standards to reduce the use of toxic chemicals.
Critics of reporting back individual research results argue that it will cause extreme worry among participants, or that people might misunderstand their results and take actions that are unnecessary, or even counterproductive. Our research has shown just the opposite: sharing individual results with study participants improves science literacy and health literacy, and is an effective tool for translating research into better public health.
There’s no question that participants can be surprised by their results. In our research, as well as in other environmental health studies, people often express surprise at learning about chemicals in their bodies. Some experience feelings of so-called toxic trespass: “I didn’t give permission for this chemical to enter my body” and “I don’t know how it got there.” They reflect on how the chemicals might have influenced their personal or family health, even though most readily understand that science can’t make a one-to-one link between their study results and a particular illness they may have.
Surprise about unseen chemical exposures gives way to constructive brainstorming about sources and strategies to reduce exposures. People make plans to change specific behaviors. Some even become engaged in civic actions to reduce harmful exposures in their communities.
Aware of the benefits — and need — for sharing results with study participants, the National Institutes of Health is now tackling the issue on a massive scale with its All of Us Research Program, a key element of the Precision Medicine Initiative. The study aims to recruit one million Americans to share genetic, environmental, and clinical data, as well as biological samples, to advance precision medicine. The participants’ commitment will be significant and long term, so the study envisions fostering a sense of partnership with its volunteers and has promised to share their personal results with them. Research to develop these personalized reports is underway and can provide guidance for other studies, too.
The upside of returning individual results is substantial. So are the challenges of transitioning from the status quo. Much of the NASEM report focuses on the first-order challenge: that sharing novel measurements in biological samples starts with ensuring the reports are accurate and reported to the correct individual.
CLIA certification ensures that medical laboratory results are accurate, but it is expensive and ill-suited to measurements that aren’t intended for clinical care. To fill this gap, the NASEM committee asked the NIH to develop a new third-party certification for research laboratories. It also recommended that while that is happening, IRBs allow high-quality studies to report back individual results, noting that many research laboratories already have excellent quality control practices, which are necessary to meet their scientific goals.
A new certification process is just one piece of the expanded resources that will be needed before researchers routinely share results with their study participants. They will also need guidance from funding agencies, training, collaboration with communications experts, and model protocols.
As I’ve witnessed in my own environmental health research, these investments can have big payoffs, resulting in greater public participation in research, increased support for science, and ultimately better health.
Julia G. Brody, Ph.D., is executive director and senior scientist at Silent Spring Institute in Newton, Massachusetts.