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 believe, but I am approaching two years of serving as the OHRE Director. I feel very fortunate to be a part of UNC-CH and am so appreciative of the OHRE team’s hard work, dedication, and flexibility as we continually strive to improve. These last years have been incredibly busy but also very rewarding.
Our office went through a very successful AAHRPP reaccreditation site visit in 2023 and a 2024 not-for-cause FDA inspection in which there were no findings. We have reintroduced OHRE outreach through “Coffees with the IRB” and “OHRE office hours.” We continually work to evaluate OHRE/IRB processes and procedures. We have made a lot of significant changes over the last two years, and I feel proud of all we have accomplished. That being said, there is always more to do!
I have enjoyed meeting and getting to know many of our wonderful researchers and research teams and learning more about the exciting work that is happening at UNC-CH. I have heard your feedback on where research teams feel improvements are needed and will continue to seek this feedback. Over the next year, I will prioritize meeting with and listening to feedback from the departments and researchers so OHRE can prioritize areas of focus that are most important to you.
Some of the feedback received was that OHRE needed to increase transparency and communications regarding the IRB review process, IRB metrics, and OHRE/IRB changes. This newsletter is a way of addressing that gap, along with our updated website, which will have regular updates posted.
Please feel free to contact me with concerns and to offer suggestions for future newsletter content so we can make this newsletter beneficial for you.
Thank you,
Carley Emerson
In This Newsletter
- Average Turnaround Times for Study Reviews
- Announcements
- Process Updates
- Updated Guidance
- Education Topics
- Contact
Download this newsletter as a PDF.
Average Turnaround Times for Study Reviews in 2024
Full Board Initial Review: 61 days
IRB Review: 33 days
PI Review: 28 days
Full Board Continuing Review: 25 days
IRB Review: 22 days
PI Review: 3 days
Expedited Initial Review: 19 days
IRB Review: 8 days
PI Review: 11 days
Expedited Continuing Review: 1 day
IRB Review: 1 days
PI Review: 0 days
Exempt: 12 days
IRB Review: 6 days
PI Review: 6 days
Non-Human Subject Research: 2 days
IRB Review: 2 days
PI Review: 0 days
Announcements
The OHRE and IRB have Moved
Our new physical address is:
UNC Administrative Office Building
104 Airport Drive, Suite 2100, 2nd Floor, CB# 7097
Chapel Hill, NC 27599-7097
Downloadable change of address notice.
Check Out Our Updated Website!
It’s now faster and easier to find what you need on OHRE’s website. Big, visible buttons on the home page link to our most frequently used services. Researchers,research participants,community partners, and IRB members also have their own portals to collect their most relevant resources in one place.
Some menu options have changed and some content has moved. Check out the new site and let us know what you think!
The IRB Needs Nonscientists and Unaffiliated Community Members
Our newest IRB member could be your neighbor, your community representative, or your friend! They must be a nonscientist, live in the community surrounding UNC-CH, and have no UNC-CH affiliation. Members work 6-8 hours a month to review submissions to the IRB and attend monthly meetings. OHRE will train new members and compensate them for their time.
Fill out the IRB New Member Application Form or share it with a friend.
OHRE Now Offering Research Review Training for Community Partners
CIRTification (Community Involvement in Research Training) is a human subjects research training program now available to UNC’s community research partners. Unlike other trainings, CIRTification is designed for people with no background in research. It’s free, self-paced, and takes about four hours to complete online. Training is available in English, Spanish, and Creole.
Visit OHRE’s CIRTification webpage to learn more about CIRTification or to log in and try it yourself.
Short Form Consent Form Now Available in Italian
Download the new Italian Short Form Consent or visit our Sample Consent Forms page to see other available translations.
Process Updates
New Submission Status in IRBIS: 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 may be awaiting review by COI Staff, COI Chair, or the COI Committee.
Please note the OHRE/IRB review process is NOT changing, but this new status will provide more transparency for research teams pertaining to the submission.
Read about the Pending COI Review in more detail.
New Intake Form for Reliance Agreements
OHRE has a new intake form in IRBIS for reliance agreements. The new form helps Reliance staff determine whether UNC will serve as the IRB of record for external sites. This will allow for a more efficient decision-making process for researchers.
Download the form. If you have questions, this video will show you where to find the intake form in IRBIS, how to complete it correctly, and submit it to OHRE.
New PI Separation Checklist
OHRE and the IRB have created a new PI Separation Checklist for principal investigators (PIs) who are leaving or retiring from UNC and plan to:
- Close their study,
- Transfer their study to a new PI, or
- Transfer their study to a new institution
A departing PI should complete the PI Separation Checklist and email us at least 45 days before departure.
Updated Guidance
New Guidance for Communicating with Research Participants through Email or Text
Can I email or text my study participants? What information can I include? How is communication different for HIPAA covered studies vs. non-HIPAA covered studies?
Read the new guidance in full or register for OHRE’s Zoom Town Hall on 07/11 at 2pm (EST). OHRE administration and staff will discuss the new guidance in detail and answer your questions.
Education Topics
How to Prevent Bot Attacks in Human Subjects Research
Harnessing the power of the internet and social media in research has many advantages – accessibility, a means to approach large and targeted audiences, and remote participation during public health emergencies. Collecting data online, though, puts your research at risk of bot attacks.
A bot is a software program that performs automated tasks, mimics human behavior, and can perform predictable form filling (aka, an internet robot). Bots are designed to be adaptable, smart and not easily detected. In research, a bot can be programmed to complete a lot of surveys in minutes, posing as eligible human participants. As bots are not people, they compromise the integrity of data and research.
Read the full story to keep bots out of your dataset.
New Education Video Library
OHRE is actively expanding our video training library for UNC staff, faculty, and undergraduates. Topics include IRB basics, guidance on applying federal regulations for research, IRBIS changes, and more.
If you don’t see the video training you want, you can request a topic with OHRE’s Education Request Form.
Contact Us
We’d love to hear from you! Email us or call us at 919-966-3113 for general questions or visit our contact page for specific inquiries.
Register for Upcoming Office Hours with an IRB Analyst
OHRE offers 15 minute consultations with IRB analysts from 9am – 11am, twice per month on Wednesdays. Sign up for a Zoom meeting or in-person at the Brinkhous-Bullitt Building.