• OHRE Announces new IRB Quality Improvement/Assurance Manager

    Dear Colleagues, I am pleased to announce the hiring of Mike Matamoros, MS, CIP as the new IRB Quality Improvement/Assurance Manager.  Mike came to UNC from the University of Texas at San Antonio in 2013.  Mike brings a wealth of … Continued

  • NIH mandates single IRB review of multisite research

    Please see the attached announcement regarding the NIH mandate regarding single IRB review of multisite research.  This information is relevant to investigators and research teams participating in or planning multisite research funded by the NIH.

  • Revisions to Project Personnel

    Revisions to Project Personnel Section 2 of the IRBIS application has been revised to more clearly distinguish UNC staff from UNC Network Entity or Affiliate staff, and to separate staff from external institutions and independent investigators into distinct sections under … Continued

  • Preliminary Announcement re: AAHRPP site visit

    To the research community: The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has provided UNC with the dates of our site visit for renewed accreditation.  The site visit will be on Thursday, October 12th and Friday, October … Continued

  • OHRE Announces new IRB Reliance Compliance Manager

    Dear Colleagues, I am pleased to announce the hiring of John Roberts, CIP as IRB Reliance Compliance Manager.  John has eight years of experience as an IRB Analyst, coming to UNC in 2015.  John brings a wealth of IRB knowledge … Continued

  • New OHRE SOPs

    DATE: May 4, 2017 TO: UNC Research Community FROM: The UNC Office of Human Research Ethics (OHRE) The following Standard Operating Procedures (SOPs) will be effective on June 2, 2017. OHRE new Standard Operating Procedures The SOPs have been merged … Continued

  • New Safety Information SOPs

    DATE: April 3, 2017 TO: UNC Research Community FROM: The UNC Office of Human Research Ethics (OHRE) RE: New Safety Information Standard Operating Procedures (SOPs) We are pleased to announce three new OHRE Standard Operating Procedures: SOP 1401, Reporting New … Continued

  • Revisions to Section A.2 (Subjects)

    As part of the IRB’s continuous quality improvement efforts, and to ensure harmony with our revised SOPs (anticipated released date is 2/1/2017), Section A.2 (Subjects) of the IRB application has been revised to collect additional information about the inclusion of … Continued

  • The Compendium of Publicly Available Datasets

    The Office of Minority Health (OMH) at the U.S. Department of Health and Human Services (HHS) announced the release of a new resource to aid researchers, public health practitioners and policymakers with data on health and health care disparities and … Continued

  • OHRE Welcomes four new IRB Analysts

    Please join us in welcoming IRB Analysts, Celeste Cantrell, Cat Collins, Kathy Seabolt and Hsin-Lei Yao to the Office of Human Research Ethics (OHRE). Celeste Cantrell received a Bachelor of Science in Biology from UNC-CH and a Master’s in Elementary … Continued

  • Five or fewer scans/xrays do not need Radiation Safety Committee approval

    The Radiation Safety Committee (RSC) has determined that five (5) or less of the following FDA approved or cleared scans/x-rays represent no greater than minimal risk and therefore do not require review and approval by the RSC (i.e., you do … Continued

  • Scientific Review Questions Added to IRBIS to Support Scientific Review Committee Review (9/16/2016)

    As previously announced, beginning September 19, 2016 any new study submitted for IRB review will be required to have scientific review completed and documented. All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than … Continued

  • New Scientific Review Process at UNC

    Date new process begins: Monday, September 19, 2016 All clinical research conducted at the University of North Carolina at Chapel Hill involving greater than minimal risk must be submitted for review to the UNC Scientific Review Committee. Scientific review is … Continued

  • How to Request a Reliance Agreement updated 8-12-16

    The IRB guidance titled “How to Request a Reliance Agreement” has been updated August 12, 2016, as follows: Page 4 and 5 – Previously the IRB has only required a CV or resume for investigators; this requirement has been extended to … Continued

  • Updated Statement of Compliance

    The IRB has posted an updated Statement of Compliance.

  • How to Request a Reliance Agreement updated 7-1-16

    The IRB guidance titled “How to Request a Reliance Agreement” has been updated July 1, 2016, as follows: Page 5 – Previously the IRB has only required a CV or resume for individual investigators; this requirement has been extended to … Continued

  • Processing time delays

    The IRB may experience delays in processing time.  Recent changes in staffing have impacted the time it takes to review and approve submissions.  We appreciate your patience while we get through this transition.  Click here for guidance on how to … Continued

  • “How to Request a Reliance Agreement” revised

    The IRB guidance titled “How to Request a Reliance Agreement” was revised June 15, 2016, as follows: Page 1 – Fogarty Global Fellows has been added to the table specifying coverage by the UNC IRB and PI privileges. Page 2- Additional … Continued

  • Guidance document updated: How to Request a Reliance Agreement

    The IRB guidance document entitled, “How to Request a Reliance Agreement” has been updated. This document provides step-by-step instructions for requesting reliance agreements (i.e., IIA, IAA), including information about when agreements should be requested. To obtain a copy of the … Continued

  • OHRE has moved office, effective December 14

    The Office of Human Research Ethics (OHRE) has moved to a new location: the second floor of 720 Martin Luther King, Jr. Blvd, Chapel Hill. Our previous office at 105 Mason Farm Road is closed.

  • Dr. Elizabeth Kipp Campbell appointed OHRE Director

    OHRE welcomes our new Director, Elizabeth Kipp Campbell, Ph. D., CIP.  Dr. Kipp Campbell comes to us from Purdue University, where she served as Director of the Human Research Protection Program.  She received her Ph. D. from Pennsylvania State University in … Continued

  • Five or fewer scans/xrays do not need Radiation Safety Committee approval

    The Radiation Safety Committee (RSC) has determined that five (5) or less of the following scans/x-rays represent no greater than minimal risk and therefore do not require review and approval by the RSC (i.e., you do not need to complete … Continued

  • Online Submission Guide Revised

    The Online Submission Guide has been substantially updated and expanded.

  • IRBIS investigator interface revised

    We have revised the IRBIS investigator interface to provide improved search/filter functionality.  Click here to see a two-page summary of the changes.

  • Kim Brownley, Interim Director

    Effective Monday, January 26, Dr. Kim Brownley replaces Dr. Robert Lowman as OHRE Interim Director, pending completion of search for a permanent Director.

  • Cooperating with researchers at another institution?

    Researchers may now send questions about collaborating with non-UNC researchers, and inquire about the status of IRB reliance agreements, by email. Please include the IRB Number of your study in the subject line.

  • Departmental approval change

    Department approvers can once again compile a list of submissions awaiting departmental approval, at the Dashboard Routing Inbox.

  • Automatic deletion of aging draft submissions

    Effective November 1, 2014, submissions that remain in “draft” status (i.e., never submitted to the IRB) for more than six months will be automatically deleted on a monthly schedule.  To prevent deletion, simply access the submission and click the Save button … Continued

  • Processing time delays

    We continue to experience delays in processing time.  Recent changes in our computer system (IRBIS) have impacted the time it takes to review and approve submissions.  We appreciate your patience while we get through this transition.  Click here for guidance … Continued

  • Important information about event reporting

    Do not wait to submit a reportable event to the IRB until you have all the information about the event. Report the event promptly and follow-up with additional information as it becomes available. A UPIRSO (Unanticipated Problem Involving Risks to … Continued

  • Good Clinical Practices Training Required

    The CITI Good Clinical Practice (GCP) training module is now required of all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects and a drug, device or biologic is included in the … Continued

  • SOPs Revised April 24, 2014

    A new version of the IRB SOPs (dated 4/24/2014) is posted here and includes the following changes: SOP 3.2-Revised to reflect current practices regarding inter-institutional agreements (specifically, reliance on central IRBs). SOP 19-Unanticipated Problems Involving Risks to Subjects or Others … Continued

  • Changes to routing of IRB correspondence

    Two changes to the routing of IRB correspondence, effective immediately: 1) Co-Investigators will now be copied on all IRB-related correspondence automatically, in addition to Principal Investigators and Faculty Advisors. Other members of the research team (e.g., Study Coordinators, Regulatory Associates) can still … Continued

  • April 8 phone outage

    Tuesday, April 8 only, our phone lines will be down, sporadically.  When you attempt to call our office or individual staff members, you may hear a busy signal or a message stating that the phone number is not in service.  … Continued

  • Temporary processing delays

    Recent changes in our computer system (IRBIS) have led to a delay in processing time.  This is impacting the time it takes to review and approve submissions.  We appreciate your patience while we get through this transition.

  • IRBIS Down Saturday November 9

    IRBIS (UNC’s IRB online submission system) will be down for site maintenance, Saturday morning, November 16, 2013 from 6 AM until Noon.  During these hours, you will be unable to access your existing online submissions or to initiate any new submissions. 

  • Reliance on central/independent IRB

    Effective October 15, 2013, UNC will rely on the approval and oversight of the central/independent IRB already involved with an industry-sponsored, multicenter trial, provided certain criteria are met. Please CLICK HERE for a guidance document providing an overview of the process … Continued

  • CITI training website temporarily unavailable

    Starting Monday July 29 at 11 AM, the CITI Program website, hosting the human research ethics training modules, will be unavailable for two to three days (perhaps until Friday August 2) to complete a major software upgrade

  • Repeat presentation: “Central vs. Local IRB Review”

    Repeat presentation by OHRE Director, Dan Nelson: “Evolving Oversight for Multisite Research: Results of a Randomized, Controlled Trial of Central vs. Local IRB Review.”  June 13, 2013, 3:00-4:00 pm, Bondurant Hall G100.  We recently conducted a novel pilot project to … Continued

  • Unsubmitted online application drafts to be deleted May 23

    Unsubmitted online application drafts inactive for the past 9 months will be deleted May 23.  If you DO NOT wish your draft to be deleted, make any edit and click the save button.  Only unsubmitted drafts will be deleted, not … Continued

  • Alternative for Satisfying Consent Form Requirement Provided

    When completing your IRB application, you may now alternatively satisfy a full-consent form requirement by indicating either that you have requested a waiver of consent entirely (at D.3), or a waiver of written consent (at D.2).  To do so, at … Continued

  • Investigational New Drug (IND) Application Questions Revised

    The questions in the IRB application (section A.4.A; #s 4 and 5) relating to Investigational New Drug (IND) applications have been expanded and clarified.  As a reminder, the IND Exemption Checklist is available as a paper form at our website, … Continued

  • New Consent Form Process Training

    Orientation sessions were held across campus in January 2013 to introduce changes to the online process for managing INFORMED CONSENT DOCUMENTS and other attachments. One of these sessions was videotaped, and is posted on this website under Online Submission Training.

  • New Consent Form Process

    All departments have now been using the online IRB application system (IRBIS) for at least one year. One particularly complicated (and occasionally frustrating…) feature involves how INFORMED CONSENT DOCUMENTS are handled. After careful consideration of your feedback and much work … Continued

  • IRB No Longer Stamping Approved Documents

    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 … Continued

  • 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 … Continued

  • 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 … Continued

  • 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 … Continued

  • 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 … Continued

  • 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 … Continued

  • Unanticipated Problems/Adverse Events must be submitted online

    Click here for complete instructions, training, and access to the web portal.