US proposes rule changes for research on human subjects


The US federal government has proposed sweeping reforms to rules governing scientific research on human subjects. The revisions aim at extending protections to a larger number of people while simultaneously minimising the oversight and paperwork demanded of scientists. The proposed changes would be the first in 20 years to the “Common Rule” that governs almost all human-subject research funded by US taxpayers.

The changes would attempt to address features of the research landscape that were rare two decades ago, such as the growth of research by drug companies, the collection of biological specimens for permanent archiving, and the proliferation of clinical experiments conducted at multiple locations. “These proposals are designed to modernize, simplify and strengthen the current system,” said Howard K. Koh, of the Department of Health and Human Services.

The changes, which can be amended after 60 days of comment by the public, received an warm welcome. The Common Rule lays out a single set of requirements for informed consent, ethical oversight and human-subject protection at 15 federal departments and agencies and recipients of Federal funding.

The rule would also demand that a single “institutional review board” oversee a study that enlists subjects at many hospitals and clinics. Currently, each hospital’s board generally reviews the experimental protocol and makes suggestions – a process that researchers have called burdensome and government supervisors find confusing. ~ Washington Post, Jul 24




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