Policies & Regulations

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,...

Payments to current research participants

12 December 2018

On September 10, 2018, Accounts Payable issued a memo regarding requirements for all new and updated campus vendors. In the UNC system, study subjects that receive payments for participation and reimbursement are considered...

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 (see bottom...

Guidance on ICMJE Data Sharing Statements for Investigator-Initiated Research

05 December 2018

Effective July 1, 2018 manuscripts submitted to ICMJE journal members must contain a data sharing statement. In connection with this requirement, a related field exists within ClinicalTrials.gov records (i.e., “IPD Sharing...

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...

NIH Policy Change Regarding Certificates of Confidentiality

22 May 2018

The National Institutes of Health (NIH) has updated their policy for issuing Certificates of Confidentiality (COCs) for NIH-funded and conducted research. Effective October 1, 2017, COCs will be issued automatically for...