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...

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 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...

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...

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. ...

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...

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...

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...

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...

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...