Various Federal agencies on November 25 announced that the comment period for the Common Rule Notice of Proposed Rulemaking (NPRM) has been extended to January 6, 2016. The proposal to make major changes in the regulations governing human subjects research was issued on September 8.
Faculty members from the Johns Hopkins Bloomberg School of Public Health and the Berman Institute of Bioethics published an essay in the November 6 issue of Science on the NPRM’s proposal to mandate the use of a single, central IRB of record on multicenter human subjects research. The authors contend that in some instances, a central IRB may be counterproductive. They concluded, “The Federal Government has made important first steps by issuing draft policies. In order to make informed decisions before mandates take effect, critical research gaps must be addressed. Recommendations need to be developed on the basis of the findings, and stakeholders, including investigators, must be involved.”