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, you may view all significant changes to form instructions.

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 new Common Rule. These revisions encompass the exemption category and continuing...

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 University of North Carolina at Chapel Hill has designated a Scientific...

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 an "Outside Party – Individual" and the following supporting documentation...

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 than minimal risk and FDA regulated study in isolation rooms. Consent...

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 Statement”) wherein the applicable sharing plan should be indicated. The data...

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 the IRB the research before the Jan. 20, 2020 delayed compliance date...

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 any NIH-funded project using identifiable, sensitive information that was on-going...

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 research project by including: - A description of plans for including...

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 text to help write protocols. Download the Word Version of Final Template. Investigators...