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Policies & Regulations

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, you may view all significant changes to form instructions.

Implementation of the New Common Rule: Webex recording available

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...

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 (.docx). The University of North Carolina at Chapel Hill has designated a Scientific...

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

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

Guidance on ICMJE Data Sharing Statements for Investigator-Initiated Research

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...

HHS Announces Exception to the Revised Common Rule Single IRB Requirements

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...

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