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Policies & Regulations

NIH Single IRB Policy for Multi-site Research

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

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

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....

NIH definition of a Clinical Trial

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...

Major Policy Change for Certificates of Confidentiality (CoC)

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

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)...
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