TAG ARCHIVES FOR Common Rule

28
Jun2017

PRIM&R's Regional Connections Program is designed to encourage research ethics professionals in a given geographic area to connect and build relationships. To that end, we offer support to individuals and institutions who would like to organize and host a Regional Connections event for their community. In this post, Kirstin Morningstar, MBA, CIP, CPIA, regulatory services director, Mary-Colette Lybrand, MS, CCRP, CIP, regulatory services manager, and Alyson Stearns, CIP, regulatory services specialist, in the Office of Research Administration at the University of Texas at Arlington share more about an innovative Regional Connections event initiated by their institution. Read more

27
Jun2017

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

1
Jun2017

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

27
Mar2017

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