Policies & Regulations

Clinical Trials Protocol Template for Phase II and III Clinical Trials Conducted Under an IND or IDE

19 February 2018

Investigators conducting phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use a NIH-FDA template with instructional and sample...

NIH Single IRB Policy for Multi-site Research

04 December 2017

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 Institutional...

Delay for Common Rule implementation date

18 January 2018

HHS and 15 Other Federal Departments and Agencies Announce an IFR That Delays the Effective Date The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final...

UNC Code and Standard of Research Conduct Policies

04 December 2017

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 community....

Definition of clinical trial: NIH refines case studies and FAQs

08 January 2018

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 new...

Good Clinical Practice training requirements for NIH researchers

04 December 2017

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 clinical...

NIH definition of a Clinical Trial

04 December 2017

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 considered...

New Video Provides Overview of New NIH Policies on Human Subjects Research and Clinical Trials

18 October 2017

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...

Major Policy Change for Certificates of Confidentiality (CoC)

04 December 2017

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 identifiable,...

New requirements for publication of a clinical trial report

17 October 2017

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 (ICMJE)...