The desirability and limits of including lay oversight and some level of community involvement in research protocols were recently reviewed in the National Research Council/Institute of Medicine’s report Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (NRC/IOM, 2005). Lay involvement can take many different forms, ranging from membership on IRBs to community-based participatory research, in which laypeople and investigators jointly define every aspect of the project. Including participants can improve research by identifying issues or risk factors that would not have been considered by investigators, improving recruitment and communication, and increasing transparency. Community advisory groups, which represent an intermediate level of involvement, increasingly act as conduits of research to the larger group of research participants (Coriell Institute for Medical Research, 2006). At the same time, greater lay involvement is time intensive for both investigators and laypeople. To date, little data exist regarding its efficacy.
In considering what level of lay involvement is appropriate in studies of the impact of interactions among social, behavioral, and genetic factors on health risks of the research, the practicability of inclusion should be taken into account. More active involvement may be desirable, for example, when study results have the potential to stigmatize individuals or groups, as might be the case in studies that explore genetic and environmental influences on antisocial behaviors. It is important to recognize that all types of differences—social, behavioral, and genetic—can be potential sources of stigma, and, where implicated, they may warrant greater lay involvement. The risk to individuals or groups may be even greater when the research participants are in some way vulnerable within the larger society.
One of the most vexing problems facing investigators is deciding what to do when research involving samples and clinical information collected for one purpose suggests new hypotheses. For example, researchers may have focused initially on cardiovascular disease risk, but new findings may suggest that the exploration of factors contributing to Alzheimer’s disease also may be fruitful (e.g., the work currently being conducted on apolipoprotein E isoforms). Consultation with the community may provide insight into whether this new direction is consistent with the original intent of the participants.
Lay involvement may be more obviously required when defined political structures exist within the group from which research participants are drawn. The paradigmatic example in the United States is research involving Native Americans because they are members of sovereign nations; however, in that setting, care must be taken to ensure the representativeness of the process and of those who purport to speak on behalf of the participants