3 August 2012 vol 337, issue 6094, pages 497-612
Aligning Regulations and Ethics in Human Research
Government officials are revising the 1991 Common Rule regulations that govern most human research in the United States. They have already received public comments on a 2011 Advance Notice of Proposed Rulemaking (ANPRM) (1). The public will have another chance to comment when officials publish specific proposals. The revision effort’s overall goal is to remove unwarranted regulatory impediments to research while strengthening essential human subject protections. I offer three ideas for additions to the oversight system, each tied to one of the 1979 Belmont Report’s (2) three ethical principles governing human research.