Given the chorus of complaints about many aspects of the Common Rule that had become ever more audible as the years went by, one might have expected that a major redrafting of the Rule would have been welcomed. Ever since 2011, when the Office for Human Research Protections (OHRP) released an Advance Notice of Proposed Rulemaking (ANPRM) regarding the human subjects research regulations, commonly called the “Common Rule,” and then in 2015 issued a Notice of Proposed Rulemaking (NPRM)-both of which prompted a tidal wave of public comments, most of them very critical - people concerned with the governance of human subjects research have been anxiously waiting to see how the regulations, which have been around for over 35 years, might be changed. 3 Given that focus, events that took place 35, much less 70, years ago might well seem to be of little relevance compared with what was going on behind closed doors in Washington, D.C.
A Hydrologist’s Guide to Informed Consent in Researchįor the past several years, most thinking - as well as a great deal of activity and anxiety -among academics and practitioners in our field about the ethics of research with human beings has been focused on the (frustratingly complex and opaque) process through which the federal regulations on research with human subjects were being revised.
0 kommentar(er)
