Effective Monday August 20, 2012, the IRB will no longer be stamping approved documents. From this point forward, you will have the opportunity to generate a list of documents included with an approved submission. Because file names will be used verbatim in this list, it is important that these file names are accurate, recognizable and distinguishable from others. In order to ensure that each document file name clearly reflects a unique document, we have created a new function that allows you to rename your current approved documents via a study modification or at renewal. This may be especially important to researchers who are subject to external monitoring or sponsor requirements. For more information, click here.
Office of Human Research Ethics
Biomedical Departments to Submit Online December 12, 2011
Beginning December 12, the IRB will accept online submissions from ALL CAMPUS DEPARTMENTS, including those that have their research reviewed by the Biomedical IRB. The OHRE website (ohre.unc.edu) will provide information and links about how to access the online system at that time.
Proposed Reforms for Human Subjects Research
A series of Town Hall Meetings were recently held to provide an overview of the proposed changes, and to solicit campus feedback toward a University response during the federal rule-making process. For those who could not attend, or are interested in more details, please see the following documents:
Public Health/Nursing Submission Now Online
Beginning June 1, 2011, we will begin accepting online submissions from the Schools of Public Health and Nursing, and other units that typically have their research studies reviewed by the PUBLIC HEALTH-NURSING IRB. The OHRE website will direct users to the online submission system as appropriate when you access IRB forms at:Â https://research.unc.edu/offices/human-research-ethics/online-submission/applications/index.htm.
Written notifications will no longer be signed
The written notifications from the IRB will no longer be signed as they are generated and delivered electronically by the IRB information system. It is important to note that signatures are not required by Federal Regulations. See the letter to University researchers and sponsors.
Coming soon…online submission of IRB applications
Phased implementation of online IRB submission (including renewals, modifications, and responses to contingencies) is underway. Phase One was initiated January 30, 2011 for investigators whose submissions have been traditionally reviewed by the Behavioral IRB; Phase Two for investigators whose submissions are reviewed by the Public Health/Nursing IRB likely will begin sometime in May, 2011. Dates for training classes, as well as online training materials will be posted here.