Successful research requires mutual respect and trust between investigators and study participants, and adherence to the highest standards of research ethics on the part of researchers. Implicit in this premise is an obligation to communicate exposures and risks that become known as a part of the research initiative. Such expectations are grounded within the tenets of research ethics, viz., ensuring autonomy or an individual's right to know along with risks and benefits being equitably distributed to study participants [1
]. Professional societies such as the International Society for Environmental Epidemiology also encourage the broad communication of results including to affected communities [3
In the context of environmental health, much of the risk communication literature has historically focused on the release of aggregate exposure data to communities rather than the release of individual data [4
]. Even within communities, individual risk may vary and study participants may largely be interested in their risk, per se
. Scientists may be reluctant to discuss individual risks, even if such information could be accurately obtained, given the uncertainty of the information being communicated with regard to human health risks [5
]. To address these and other issues, participatory research forums have evolved and gained the interest and respect of researchers, communities and companies as evidence by the formation and work of early community advisory panels [6
]. In an attempt to minimize the "communication gap" between experts and the public [9
], researchers and industrial managers were encouraged to view themselves as partners with the public so that communication becomes an interactive dialogue and interactive process of information exchange and not strictly a one-way conversation [8
]. In fact, some industries require a communication plan for all protocols [11
Of late, an evolving avenue of research has developed conceptual frameworks for communicating results to study participants. In response to the 2006 National Academy of Sciences' Human Biomonitoring for Environmental Chemicals
report calling for more attention to communicating data [12
], Morello-Frosch and colleagues [13
] discussed three frameworks for communicating biomonitoring results to study participants. Briefly, these include: 1) a clinical ethics framework in which exposures with a known clinical action or health effect relation are reported to participants; 2) a community based participatory research framework that respects study participants right to know from study design and inception; and 3) a citizen-science data judo that encourages communicating individual or aggregate results from an advocacy or precautionary perspective. Irrespective of framework, it is important to note the longstanding social sciences literature that has long recognized the importance of appropriately disseminating innovations including ideas to target populations [14
], contrasting with the lag in addressing this issue on the part of environmental scientists. Another challenge in designing communication strategies is in deciding what to communicate and how. Suggestions include understandable language and guidance for any required action [15
]. Other investigators identified a series of questions that reflect their experience in reporting back individual levels including what and how much was found, high/low or safe values, what one should do, where exposures come from and any recommendations [16
]. Recognizably, the ideal communication strategy is developed for the study population at the design phase of research and remains an integral aspect throughout every aspect of the study. In fact, in 1995 the National Institute of Environmental Health Sciences (NIEHS) launched the Environmental Justice: Partnerships for Communication Program to promote community based participatory research and environmental justice [17
] with subsequent support from the Environmental Protection Agency and National Institute for Occupational Safety and Health. This aim of the NIEHS program was to foster greater community involvement in all aspects of research by bringing three partners together: 1) a community organization; 2) an environmental health researcher and 3) a health care professional for developing and fostering communication to increase community participation in the research process. From a pragmatic perspective, however, funding and other logistical considerations may not readily support Community Based Participatory Research (CBR) platforms for all environmental research even when desired, requiring investigators to seek other venues for communication. Another challenge is the receipt of exposure data late in the research process or even after funding timelines have ended resulting in challenges for how best to communicate exposure information once the research is completed. Essentially, the research team may have two options-to ignore the expectation to give results back or to seek strategies for communicating results upon completion of the study recognizing that the approach is less than ideal.
Empirical evaluation of the content of communication strategies is limited [16
] providing little published evidence in support of investigators' efforts to convince Institutional Review Boards (IRBs) or other entities of the need to communicate individual values in the context of uncertain health effects and risks. Altman and colleagues conducted 30 qualitative interviews with 25 women who received exposure data as a part of their participation in the Household Exposure Study [19
]. Among other key findings, the authors noted that participants reported wanting their results including technical explanations about what is or is not known. Moreover, the participants did not react with alarm. Morello-Frosch and colleagues [13
] interviewed 26 scientists, IRB officials and study participants and reported that most individuals stated it was desirable to set expectations before commencing data collection and communication protocols. Also, reporting individual levels can serve as an impetus for individual action to minimize exposures. To this end, researchers have few available data to help decide if, when and how individual concentrations should be reported to study participants, and how best to communicate the uncertainty of possible health risks. In our collective experience, IRBs have varying positions regarding whether or not to communicate individual concentrations when health effects are unclear consistent with other reports [13
]. This may reflect the uncertainty associated with what constitutes "safe" concentrations or our uncertain understanding of associated health effects. Moreover for persistent environmental toxicants, there may be little study participants can do to lower their concentrations in an effort to maximize their health. However, knowledge of their individual levels may inform partipants'decisions about future health behaviors.
Thus, the many critical data gaps underlying the relation between environmental chemicals and human health coupled with limited ways to minimize exposure are important considerations in devising a strategy for communicating individual concentrations to study participants even if delivered long after completion of the study. To this end, we designed and evaluated a strategy for communicating lead, dichloro-2,2-bisp-chlorophenyl ethylene (DDE) and select polychlorinated biphenyl (PCB) congener concentrations to women who participated in a prospective pregnancy study aimed at identifying the potential reproductive and/or developmental toxicity of these persistent environmental contaminants. We sought to communicate individual concentrations of persistent environmental contaminants to study participants in the context of little to no resources available for doing so in keeping with our original promise to deliver such information.