The Office of Human Research Protections should issue guidance to institutional review boards on how to interpret the key regulatory terms—“minimal risk,” “minor increase over minimal risk,” “disorder or condition,” “reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations,” and “vital importance”—in the context of housing health hazard research. (Recommendation 8.2)
The Secretary’s Advisory Committee on Human Research Protections should develop guidelines for research with economically and educationally disadvantaged participants for use by the Office for Human Research Protections use in issuing guidance for researchers and institutional review boards. (Recommendation 8.3)
Community involvement in research and continued evaluation of the outcomes of this involvement will be advanced if funders require it as part of the research they fund. Meaningful community involvement requires adequate time and resources, including resources to reimburse the expenses of researchers and community residents or to compensate them for the time required; such expenses are not typically included in research grants.
Federal agencies (e.g., HUD, EPA, NIH, CDC), private foundations, and other funders of research on housing health hazards involving children should require researchers to have appropriate community involvement in the research. Funders should provide adequate funding to involve affected communities and should sponsor research to evaluate the outcomes of community involvement. (Recommendation 5.3)
Implementing the committee’s recommendations for housing health hazards research involving children can provide needed protection for child subjects and affected communities and researchers, ensure that the rights of child subjects are protected, and allow valuable research to proceed that is intended to benefit children living in poor-quality housing. Critical steps include adoption of Subpart D by all federal agencies and clarification of key terms in Subpart D and efforts by researchers, IRBs, and sponsors to ensure appropriate community involvement and thorough understanding by parents of key elements of the research. To do this successfully will require the commitment of researchers, IRBs, OHRP, sponsors, and representatives of the communities where this research will be carried out. A partnership among all these parties will help develop the scientific basis for public policies that will reduce or eliminate the housing hazards that threaten children’s health.