Grants

National Academy of Sciences

To study potential changes in how the Common Rule governs behavioral and social science research on human subjects

  • Amount $150,000
  • City Washington, DC
  • Investigator Barbara Wanchisen
  • Initiative Economic Implications of the Great Recession (EIGR)
  • Year 2014
  • Program Research
  • Sub-program Economics

This grant provides partial support for a study by the National Research Council (NRC) of the National Academy of Sciences on proposed reforms to the “Common Rule” – a set of rules governing the use of human subjects in research funded by 17 federal agencies. Untouched for two decades, the Common Rule is unarguably in need of revision to reflect changes in the way modern research is conducted in the U.S. Yet ill-advised changes to the Rule could significantly hinder the conduct of harmless research, particularly in the behavioral and social sciences. A proposed rule change by the Department of Health and Human Services, for instance, would extend the privacy guidelines in the Health Insurance Portability and Accountability Act (HIPAA) to research in all fields, even though the guidelines therein were specifically formulated to protect personal health information. If adopted, such an extension could require academic scientists of all kinds to obtain new permissions from human subjects, including survey respondents, before reusing their data for any purpose other than the one originally stated—even if those data have already been anonymized.The NRC will convene a blue ribbon committee of scientific and policy experts, study the likely impacts of proposed and hypothetical changes to the Common Rule, and issue a high-profile report on their findings, and hold a workshop with relevant stakeholders.

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