TAG ARCHIVES FOR 21st Century Cures Act

5
Dec2017

Fall is now upon us, and with fall comes the fall Certified IRB Professional (CIP) exam season and the Advancing Ethical Research (AER) Conference. For those who took the exam, for the first time or to re-certify, I hope the process was rewarding and meaningful! For those of you who attended AER17, I hope you found it as exciting and useful as I did. Read more

29
Sep2017

This week’s Research Ethics Roundup looks at a top Food and Drug Administration (FDA) official’s speech on real world evidence, a National Academies report that highlights the lack of guidance for the research community on the security concerns around dual-use research, how and why the All of Us Research Program is working with traditionally marginalized communities, and the effectiveness of Animal and Plant Health Inspection Service (APHIS) inspections of Agricultural Research Service facilities. Read more

14
Jul2017

This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive government study is working on community engagement efforts, the Food and Drug Administration (FDA)’s plan for new patient-focused drug development guidance, and a European Union committee’s opinion that nonhuman primate research should continue in its member countries. Read more

11
Jul2017

Recently, PRIM&R submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan. Read more