News - UNC Research

OHRE and IRB Newsletter – Fall 2024

In This Newsletter Average Turnaround Times for Study Reviews Full Board Determinations (Jan 2024 – July 2024) Announcements Guidance Meet the Chairs Education Topic Upcoming Events Contact You can also view or download this newsletter as a PDF here. Average … Read more

Meet the IRB Chairs – Kim Brownley

Dr. Brownley is Associate Director of Policy & Initiatives in the OHRE and Adjunct Professor of Psychiatry, where she has been a faculty member since 1999. She is a Certified IRB Professional, has served as Chair of two UNC IRB … Read more

OHRE and IRB Newsletter – Summer 2024

A Message from the Director It is my pleasure to introduce you to the new OHRE newsletter. The OHRE newsletter features important news and information for the research community and will be distributed quarterly. It is hard for me to … Read more

BOT ATTACKS and Human Subjects Research

Harnessing the power of the internet and social media in research has many advantages – accessibility, a means to approach large and/or targeted audiences, and remote participation during public health emergences (e.g., COVID-19). However, while data collection instruments such as … Read more

New Submission Status in IRBIS: Pending COI Review

There is a new submission status in IRBIS called “Pending COI Review.” This new status will be used when OHRE has completed the submission review, yet the COI disclosure is still pending review by the COI Office. The COI disclosure … Read more

The OHRE and IRB have Moved

The UNC Office of Human Research Ethics and the IRB moved into a new office space on 12/15/2023. Download a change of address notice for your files. The previous address was: 720 Martin Luther King Jr. Blvd. 2nd Floor, CB# … Read more

Dr. Kim Brownley Hired as OHRE Associate Director of Policy & Initiatives

Dr. Kim Brownley has been named as OHRE’s new Associate Director of Policy & Initiatives. Kim joined the UNC faculty in 1999. She is an Adjunct Professor in the Department of Psychiatry, where she previously served as Vice Chair for … Read more

Celeste Cantrell Promoted to UNC OHRE Associate Director of Operations

Effective 9/5/2023, Celeste Cantrell was promoted to UNC OHRE Associate Director of Operations. In her new role with OHRE, Celeste is responsible for oversight of the Operations team within the Office of Human Research Ethics (OHRE). Her role entails working … Read more

Change in Pregnancy Disclosure for Adolescents 12 and Under

SOP 4801, section 2.4.2, stated that disclosure of a pregnancy to the child’s parent should occur when the adolescent is 12 years of age or younger. This is not consistent with state law or clinical practice. Section 2.4.2 of SOP … Read more

UNC Awarded “Gold Seal” of Accreditation for Human Research Protection Program

A Message from the Vice Chancellor for Research I am pleased to announce that the University of North Carolina at Chapel Hill’s Human Research Protection Program has been awarded full reaccreditation by the Association for the Accreditation of Human Research … Read more

Change in OHRE’s CITI Training Verification Procedure

The Office of Human Research Ethics (OHRE) and the Institutional Review Board (IRB) will no longer verify CITI Training for the PI or research team members at the time of Continuing Review or Administrative Review. The intent of this change … Read more

Dustin Yocum’s last day as the Associate Director of Operations and Education in the OHRE office was 4/28/23.

Celeste Cantrell has been named the Interim Associate Director of Operations and Education as of 5/8/23. Celeste has been with the OHRE at UNC for 6 ½ years in roles of Analyst and Senior Analyst. Previously, she worked with the … Read more

Kristen Katopol to serve as the UNC OHRE Associate Director of Regulatory Affairs and Compliance

Effective 11/14/2022 Kristen Katopol to serve as the UNC OHRE Associate Director of Regulatory Affairs and Compliance. Kristen Katopol comes to UNC Office of Human Research Ethics (OHRE) from Dartmouth Hitchcock Health, where she served as Director of the Human … Read more

Inside UNC Research: Ensuring the Protection of Research Participants

Carley Emerson is the director of the Office of Human Research Ethics (OHRE) within the Office of the Vice Chancellor for Research.

Emerson to serve as director of OHRE

Effective August 22, Carly Emerson will serve as director of the Office of Human Research Ethics (OHRE).

New OHRE SOPs

DATE: August 15, 2022 TO: UNC Research Community FROM: The UNC Office of Human Research Ethics (OHRE) RE: Revisions to OHRE Standard Operating Procedures OHRE has revised a number of SOPs to incorporate changes introduced with the implementation of the … Read more

Update to OHRE SOP # 1401 – Promptly Reportable Information

As of October 1, 2021, the OHRE SOP # 1401 will be updated to better reflect the types of information that require reporting, update the definitions of terms, and reformatting the text and tables. Over the next couple of weeks, … Read more

Announcement on Cassie Myers Departure

Date: June 7, 2021 To: Deans, Directors, and Department Chairs From: Terry Magnuson, Vice Chancellor for Research Subject: Announcement on Cassie Myers’ Departure It is with great sadness that I write to let you know that effective June 11, Cassandra … Read more

IRBIS Update – May 6, 2021

Beginning 5/6/2021, IRBIS will be updated to include some changes that will allow for more streamlined PI changes and personnel modifications. 1. PI Change process In order to change the PI on a study, a full study modification must be … Read more

Discontinuation of COVID Information Sheet

Date: 5/25/2021 To: UNC Research Community From: OHRE/IRB Subject: Discontinuation of COVID Information Sheet As we prepare for the June 1, 2021’s new research guidelines and moving towards normal operations with ongoing recommendations from the Office of the Vice Chancellor … Read more

OHRE/IRB Unsecure Communication Update

As of 10/26/2020 the “Transmission of Sensitive Information” standard has been updated. Although the standard is broader than communication with research subjects, it is inclusive of them as well and this revision will allow for an exception to the current … Read more

OHRE/IRB COVID 19 Update – Updated June 10, 2020

Updated June 10, 2020 (Originally posted May 25, 2020) UNC Research Community, As UNC-Chapel Hill begins to increase the volume of research conducted on campus in a phased, safe, and sustainable way as communicated in the OVCR’s May 23, 2020 communication, … Read more

OHRE/IRB COVID 19 Update

Dear Members of the UNC Research Community, As UNC-Chapel Hill is closely monitoring the spread of the coronavirus and COVID-19 and information is being shared with campus at https://www.unc.edu/coronavirus/, the UNC-Chapel Hill’s Office of Human Research Ethics wanted to update our research community with … Read more

CITI Program Training Updates

To: UNC-Chapel Hill Research Community, As of June 1, 2020, UNC-Chapel Hill Office of Human Research Ethics (OHRE) will require Human Subjects Protection (HSP) training through the Collaborative Institutional Training Initiative (CITI Program) be renewed every three years. This requirement aligns with many of UNC’s federal and industry sponsors … Read more

OHRE Associate Director Announcement

All, I am happy to announce that Mike Matamoros has been named Associate Director, Operations and Education in the Office of Human Research Ethics (OHRE) effective Monday, January 27, 2020. Mike Matamoros has been with the OHRE at UNC for 6.5 years … Read more

OHRE/UNC Winter Holiday 2019

Dear Members of the UNC Research Community, As a reminder, while operations at the University of North Carolina are closed, an emergency use of an investigational drug, biologic or device is permissible without prior IRB approval if the following criteria … Read more

Nurse Research and the Institutional Review Board

Article from American Nurse Today, Volume 14, Number 10 Nurse research and the institutional review board Learn how the IRB process works to ensure participant safety and quality research. By Amy Marzinsky, BSN, RN, OCN, and Cheryl A. Smith-Miller, PhD, … Read more

Commercial IRB Utilization and IRBIS Update

To: UNC-Chapel Hill Research Community On September 10, 2019 the UNC-Chapel Hill Office of Human Research Ethics (OHRE) will have several revisions go into effect to the OHRE/IRB Standard Operating Procedures (attached) and IRBIS updates that were identified through listening … Read more

April 9, 2019 IRBIS System Update

To: UNC Research Community, On April 9, 2019, IRBIS will undergo a system update. This system update is part of the changes discussed during the communication and education provided for the Final Revision to the “Common Rule” that went into … Read more

OHRE/UNC Winter Holiday 2018

Dear Members of the UNC Research Community, As a reminder, while operations at the University of North Carolina are closed, an emergency use of an investigational drug, biologic or device is permissible without prior IRB approval if the following criteria … Read more

OHRE Announces new Director

Good afternoon, I am happy to announce that Cassandra (Cassie) Myers has been named Director of the Office of Human Research Ethics (OHRE) effective Monday, December 3rd. Myers served as the Deputy Director of OHRE until assuming the Interim Director … Read more

IRB Changes to Reporting of Deviations at Continuing Review

The IRB is making a change to the review process of deviations that do not qualify as New Safety Information. Currently, protocol deviations qualifying as New Safety Information (NSI) are submitted via an NSI submission in IRBIS, and those that … Read more

OHRE Announces new Deputy Director

Dear Colleagues, I am thrilled to announce the hiring of Cassandra Myers, CIP as the Office of Human Research Ethics’ new Deputy Director. Cassie comes to us from Allina Health System in Minneapolis, MN where she served as IRB Manager. … Read more

NIH Policy Change Regarding Certificates of Confidentiality

NIH Policy Change Regarding Certificates of Confidentiality As communicated by TraCS in early December 2017, the National Institutes of Health (NIH) recently updated its policy for issuing Certificates of Confidentiality (COCs) for NIH-funded and conducted research. Effective October 1, 2017, … Read more

OHRE Announces new Senior IRB Analyst

Dear Colleagues, I am pleased to announce the hiring of Cat Collins, CIP as the new Senior IRB Analyst. Cat came to UNC-CH from North Carolina A&T State University in 2016, serving as an IRB Analyst. She brings over seven … Read more

NIH single IRB for multisite research mandate effective January 25, 2018

The NIH policy on the use of a single IRB (sIRB) of record for multisite research became effective on January 25, 2018. The policy applies to the domestic sites of NIH-funded multisite studies where each site will conduct the same … Read more

Human Research Protection Program receives re-accreditation

UNC’s Human Research Protection Program has been awarded full accreditation for the next five years by the Council on Accreditation of the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This important achievement reflects UNC’s commitment to protecting … Read more

UNC IRB Membership Drive

The UNC Office of Human Research Ethics/Institutional Review Board (OHRE/IRB) needs you! Presently, the OHRE/IRB is seeking to increase participation and expand membership of its four regular Biomedical IRBs and the IRB Safety Committee. Do you wish the Institutional Review … Read more

Multisite Research Personnel and Institutions

In an extension of the work done in IRBIS over the summer to better classify External Personnel, we have made the following additional changes: Site Liaison designation on the Project Personnel screen Revisions section 5, the Multi-site Study Information screen: … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

“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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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. … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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, … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more

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 … Read more