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Policies & Regulations

FDA releases guidance regarding civil money penalties

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...

NIH FORMS-F application packages

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

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

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...

Consent Processes for Isolation Rooms

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

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...
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