Policies & Regulations

Reporting requirements for studies listed at ClinicalTrials.gov

05 October 2020

If you have a study registered at ClinicalTrials.gov that meets the Applicable Clinical Trial (ACT) definition and/or an NIH-funded "Clinical Trial," please be aware that results reporting is required by federal law. The...

New website for Scientific Review Committee

07 May 2020

The Scientific Review Committee (SRC) has a new website at research.unc.edu. The website contains helpful information for researchers as well as a new Interventional Protocol Template for non-NIH-FDA clinical trials (.docx). The...

NIH Loan Repayment Programs 2020

14 September 2020

Release Date: September 14, 2020 The National Institutes of Health (NIH) is accepting new and renewal applications for its five (5) Loan Repayment Programs that provide support...

Consent Processes for Isolation Rooms

06 May 2020

The Office for Human Research Ethics (OHRE) has worked with the Office of Clinical Trials (OCT) and the Clinical Trial Quality Assurance (CTQA) program to create the following information when consenting subjects for a greater...

FDA releases guidance regarding civil money penalties

18 August 2020

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 penalties...

HHS Announces Exception to the Revised Common Rule Single IRB Requirements

25 November 2019

The HHS Office for Human Research Protections (OHRP) announced that research conducted or supported by HHS under the revised Common Rule may continue to use multiple IRBs in lieu of a single IRB for cooperative research if...

NIH posts new video for PHS Human Subjects & Clinical Trials Information Form

11 June 2020

NIH has updated the video walk-through of the PHS Human Subjects & Clinical Trials Information Form to align with their latest application form update (FORMS-F). In just six minutes, you'll learn how to use the form and...

NIH: Reminder to Address Inclusion of Individuals Across the Lifespan in Grant Applications

11 February 2019

Effective for due dates January 25, 2019 or later, keep in mind the following changes to NIH applications and progress reports. Applications must address the age-appropriate inclusion or exclusion of individuals in the proposed...

NIH FORMS-F application packages

07 May 2020

NIH applicants must use FORMS-F application packages for due dates on or after May 25, 2020. FORMS-F Grant Application Instructions are now posted at grants.nih.gov on the How to Apply - Application Guide page. Also,...

Implementation of the New Common Rule: Webex recording available

24 January 2019

On January 15, 2019, Mike Matamoros, Quality Assurance/Improvement Manager and Cassandra Myers, Director of The Office for Human Research Ethics discussed the changes to IRBIS and UNC processes and policies to reflect the...