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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 Review Board (sIRB) to conduct the ethical review required for the protection...

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 Rule (IFR) that delays by six months the effective date and general compliance...

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. "We already enact these high standards everyday," explains Magnuson, "with...

Definition of clinical trial: NIH refines case studies and FAQs

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 FAQs on standard clinical care and Phase 1 devices. Additionally, to help...

Good Clinical Practice training requirements for NIH researchers

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 trials complete Good Clinical Practice (GCP) training. GCP principles help...

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 by NIH to be a clinical trial is crucial to how investigators will: Select...

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, sensitive information that was on-going on or after December 13, 2016. The...

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) would like to see clinical trials sharing deidentified individual participant...
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