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.
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.
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.
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