The Food and Drug Administration (FDA) has issued the final guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” This guidance describes the authority of the FDA to assess civil money...

For applications with due dates on or after January 25, 2018, NIH expects that all sites participating in multi-site studies, which involve non-exempt human subjects research funded by the NIH, will use a single...

On June 8, 2017, Vice Chancellor for Research Terry Magnuson officially approved UNC's Research Code of Conduct. With his signature, UNC formalized the high standards that it expects from members of the research...

New UNC SOP guidelines effective June 2, 2017 require a change to the Join the Conquest study listing form approval for the compensation section only. Per UNC IRB SOP 2.4.10.1 "… In keeping with the DHHS and FDA...

Do you do research with human participants? If so, you play an important role in NIH initiatives to improve accountability and transparency in the human subject research we fund. This 15 minute video Overview of New NIH...

The International Committee of Medical Journal Editors will soon require data sharing statements as a consideration for publication of a clinical trial report. The International Committee of Medical Journal Editors...

NIH has issued a policy on Good Clinical Practice training for NIH Awardees involved in NIH-funded clinical trials. This policy requires that PIs and clinical trial staff involved in all new and ongoing NIH-defined...

NIH recently updated its policy for issuing Certificates of Confidentiality (CoCs) for NIH-funded and conducted research. Effective October 1, 2017, CoCs will be issued automatically for any NIH-funded project using...

The NIH definition of a clinical trial is very broad. Some investigators conducting human subjects research may not be aware that NIH considers their study to be a clinical trial. Correctly identifying whether a study is...

The NIH has recently revised existing case studies and added a few new ones to help clarify how the definition of clinical trial does or does not apply to a variety of clinical research studies. They have also added two...