Among scientists in the field of education, there are many who believe that all educational research, regardless of purpose, should be exempt from IRB processes and procedures. While the government did not approve education as a new category of excused research under the new proposed Common Rule that is currently slated to take effect in January 2018, there remain many areas of consideration that might be affected, including confidentiality, authentication of online participants, consent and assent, and questions around what constitutes research when conducting data collection activities in school settings. Read more


As the biomedical research enterprise increasingly moves to a more participatory model of research, where research participants are treated more as partners than passive subjects, we can expect greater emphasis on returning individual-level results of research to participants. A prominent example is the All of Us Research Program. Read more


This week’s Research Ethics Roundup examines why legal experts are advising against voluntary compliance of Common Rule changes, President Trump’s plan for the National Institutes of Health (NIH)’s budget, the debate over whether technology can replace animal models in research, and the reaction to President Trump’s pick for Food and Drug Administration (FDA) Commissioner. Read more


On January 28, 2017, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Published on January 19, the revised policy, or “Common Rule,” represents the first significant regulatory changes in human research oversight since 1991. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration. Read more

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