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Letting Them Know

The US National Academies of Sciences, Engineering, and Medicine is urging researchers to consider providing study results to participants, Stat News reports.

Typically, Stat News adds, people who participate in a research study aren't told of its results, often because researchers worry that the data might not be validated, that participants might not understand the findings, and that doing so would take time and money away from other research efforts. In addition, it notes that there are conflicting regulations: research participants can ask for some results under the Health Insurance Portability and Accountability Act of 1996, but the Clinical Laboratory Improvement Amendments of 1988 bars non-certified labs from giving back results.

In its new report, NAS recommends not only that researchers and their institutions routinely consider returning individual research results, but also that the National Institutes of Health develop a quality management system for non-CLIA certified labs. In all, the report makes a dozen recommendations, including that investigators include plans for the return of results in their research protocols, that funding agencies encourage researchers to make such plans, and that investigators communicate their plans clearly to participants during the consent process.