Abstract
BackgroundA considerable literature now supports the importance of effective communication with study participants, including how best to develop communication plans focusing on the uncertainty of health risks associated with particular environmental exposures. Strategies for communicating individual concentrations of environmental chemicals in human biological samples in the absence of clearly established safe or hazardous levels have been discussed from a conceptual basis and to a lesser extent from an empirical basis. We designed and evaluated an empirically based communication strategy for women of reproductive age who previously participated in a prospective study focusing on persistent environmental chemicals and reproductive outcomes.MethodsA cohort of women followed from preconception through pregnancy or up to 12 menstrual cycles without pregnancy was given their individual serum concentrations for lead, dichloro-2,2-bisp-chlorophenyl ethylene, and select polychlorinated biphenyl congeners. Two versions of standardized letters were prepared depending upon women's exposure status, which was characterized as low or high. Letters included an introduction, individual concentrations, population reference values and guidance for minimizing future exposures. Participants were actively monitored for any questions or concerns following receipt of letters.ResultsNinety-eight women were sent letters informing them of their individual concentrations to select study chemicals. None of the 89 (91%) participating women irrespective of exposure status contacted the research team with questions or concerns about communicated exposures despite an invitation to do so.ConclusionsOur findings suggest that study participants can be informed about their individual serum concentrations without generating unnecessary concern.
Highlights
A considerable literature supports the importance of effective communication with study participants, including how best to develop communication plans focusing on the uncertainty of health risks associated with particular environmental exposures
It was necessary to note this caution as the research team worked with the Institutional Review Board (IRB) to include this component, and given concerns at the state health department level about what could or could not be communicated to study participants
We did not follow up the 9% of women not returning questionnaires, given that our IRB approval only covered the dissemination of their laboratory data and one last querying of women about behaviors while attempting pregnancy in light of the amount of study participation throughout all aspects of the study
Summary
A considerable literature supports the importance of effective communication with study participants, including how best to develop communication plans focusing on the uncertainty of health risks associated with particular environmental exposures. 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 [1,2]. In an attempt to minimize the "communication gap" between experts and the public [9], researchers and industrial
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