Research Involving Human Participants
Coversheet for UNC IRB Application
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Project Title:
Contact Information (reviewers will communicate via IRBNet)
Principal Investigator: Phone #:
School/Department: UNC email:
Research Advisor (Required for students): UNC email:
CERTIFICATION OF PRINCIPAL INVESTIGATOR (PI)
As Principal Investigator, I certify to the following:
• This application accurately reflects the proposed research;
• I and all researchers who will have contact with the participants or access to the data have reviewed this application and
the Guidelines of the UNC IRB and will comply with the letter and spirit of these policies;
• I have examined UNC’s Data Security Policy for Research Projects, and determined the level to be:
• If my security level is at 3, 4, or 5, or if my research is subject to a data use agreement, I will submit a data security
clearance form to Information Management and Technology, and will advise the IRB when that application is approved;
• I will adhere to all requirements of the Data Security Policy for Research Projects that are relevant for protection of my
research information;
• I understand that any changes in procedure that affect participants must be submitted to the IRB (using an
Amendment/Modification in IRBNet) for written approval prior to their implementation; and
• I further understand that any adverse events and significant changes in risk for participants must be immediately
reported in writing to the UNC IRB.
The signature of the PI must be completed in IRBNet.
CERTIFICATION OF RESEARCH ADVISOR (if applicable)
As the applicant’s Research Advisor, I certify to the following:
I have thoroughly reviewed this application, confirm its accuracy, and accept responsibility for monitoring the conduct of
this research, the maintenance of any consent documents as required by the IRB; and, in the case of expedited reviews,
the continuation review of this project in approximately one year;
The signature of the Research Advisor (if applicable) must be completed in IRBNet.
Summary Information (to be completed by the Lead Investigator)
Review Category: Exempt (2-3 weeks) Expedited (3-4 weeks) Full-Board (4-6 weeks)
(NOTE: During winter, spring, and summer breaks the review will take significantly longer.)
Research participants will be: (e.g., adults, elderly, children, healthy, unhealthy, etc.)
Type of data collected will be: (e.g., survey responses, interviews, blood samples, existing data, etc.)
Location of collected data:
Is standard consent documentation used? YES NO If NO, it must be addressed within the application.
Is permission required (e.g., school district)? YES NO If YES, include a letter (this is not consent).
Is this a funded research project? YES NO If YES, identify the funding source within the application.
4.29.16
