Institutional Review Board
The Institutional Review Board (IRB) is in place to ensure that human subjects involved in research are adequately protected and that the institution acts in accordance with the federal regulations regarding research with human subjects. Prior to the initiation of any research efforts that involve human subjects, an IRB review is required.
- Please email ori@uncg.edu for IRB related questions or questions related to Reliance Agreements.
UNCG IRB Application
**Please allow eight weeks for IRB review
Cayuse Human Ethics
Cayuse Human Ethics is the online IRB submission system that UNCG has selected to replace the current online IRB submission system, IRBIS.
Learn more on the Cayuse Human Ethics Resource Page.
IMPORTANT INFORMATION REGARDING CAYUSE LEGACY SUBMISSIONS:
- The migration of studies from IRBIS to Cayuse is now complete. Some information was unable to be transferred over from IRBIS due to the IRBIS and Cayuse applications not being completely identical. In the sections of the legacy application where there are no check marks next to the section, the PI will need to provide the missing information – for most sections, this is simple information such as “yes/no” responses and inputting dates.
- IMPORTANT: The legacy application must be completed as the study is currently approved. Please do not incorporate any modifications into the legacy application. If you have a modification to the study, a modification application must be submitted after the legacy application is completed and submitted.
- Once the missing information has been inputted into the legacy application and each section has a check mark, the legacy application can be finalized.
- IMPORTANT: It is important to understand that legacy applications and modification and renewal submissions are separate actions. A legacy application is not a renewal or modification submission.
IRBIS
NEW INFORMATION: IRBIS Phase-Out
On April 1, 2021, the Office of Research Integrity transitioned from the IRBIS electronic submission system to the new electronic IRB system, Cayuse Human Ethics. Since then, more than 1,600 studies were migrated from IRBIS to Cayuse.
Per the federal regulations, principal investigators are required to maintain copies of study-related materials. It is highly recommended that researchers download from IRBIS the most recently approved attachments, along with a pdf of the IRBIS IRB application, for their files as soon as possible. The IRBIS link can in the sidebar located on this page.
It is important to note that the IRB electronic submission system, Cayuse Human Ethics, is not intended to be the primary storage location for study-related documents. Cayuse is an electronic system to facilitate the IRB application and study-related documents for IRB review.
Study-related documents should be securely stored by the PI in a location in addition to Cayuse. Study-related documents would include, but are not limited to, study questionnaires, the most recently approved consent form, and recruitment scripts.
Due to the transition to the Cayuse Human Ethics system, IRB submissions, including responses to stipulations, are no longer being accepted in IRBIS.
The system remains available for researchers who wish to download a copy of their study applications and any study-related attachments.
UNCG Research During the Coronavirus
- For the most recent updates regarding research at UNCG during the Coronavirus, please go to the Keep Researching webpage
Changes to the Common Rule
- For information regarding how UNCG implemented the changes to the Federal Regulations (Common Rule) that went into effect on January 21, 2019, click here.
Multi-Site Research and Single IRB of Record (sIRB)
- Both NIH and DHHS have policies requiring a Single IRB of Record (sIRB) for multi-site research. Click here for more information and to review the UNCG considerations for serving as the IRB of Record (i.e. “reviewing IRB”).
Training
The Office of Human Research Protections (OHRP), under the auspices of the Public Health Service, oversees compliance with the ethical guidelines and regulatory requirements for research involving human subjects. The OHRP has published educational materials which may be useful in answering some of the questions that arise when writing a research protocol.
UNCG IRB accepts certificates of training from the two below sources: Human Subjects In-Person Training sessions, offered by the Office of Research Integrity once a semester, and CITI Training. Certificates of completion are available at the end of the tutorial or training session.
Human Participants in Research Training Workshops
The UNCG Office of Research Integrity offers a two hour session in human research protection once a semester, covering all required categories to meet the requirements of our assurance with the Office of Research Protections (OHRP). Topics of this session are also a part of the RCR curriculum on the campus. These workshops cover areas such as confidentiality, informed consent, recruitment, and the history of human research protection and are offered as an alternative to CITI training.
Fall 2022 Workshop
Protection of Human Participants in Research Workshop – This event has been CANCELLED and will be rescheduled for Spring 2023
PLEASE NOTE: The Office of Research Integrity will also be happy to provide specifically-tailored sessions to a department or class by request. These requests can be made to ori@uncg.edu. Please note, a certificate of completion is not offered for this option.
CITI Training
IRB Consent Form Templates
- Adult Consent Form
- Parental Permission Form
- Combined Adult Consent and Parental Permission Form
- Assent Template for Minors 12-17
- Assent Form for Minors 7-11
- MRI consent form
- Information Sheet (Exempt Studies)
IRB Forms and Information
- Statement of Confidentiality
- Example Letter of Support/Site Approval (opens best in Firefox)
- International IRB questions
FDA Information
- FDA Information Sheet – Significant Risk and Nonsignificant Risk Devices
- FDA Information Sheet – Medical Device FAQ
- Investigational New Drug Information
- FDA Mobile Medical Applications Guidance
Additional IRB Resources
Federal Regulations/Guidance
- The Common Rule (45 CFR 46)
- The Belmont Report
- OHRP FAQ – Use of Electronic Informed Consent
- Helpful NSF and the Common Rule of Research with Human Subjects
- OHRP International Compilation of Human Research Standards
UNCG Policies/Guidance
- IRB Guidance on Class Projects (Is this Research?)
- Protection of Human Subjects in Research Policy
- Using Eraser to Securely Erase Data
- Recommended Elements of Recruitment
Data Sharing
Research Conducted at Cone Health
Frequently Asked Questions
- Clinical Trials & Related Requirements FAQ
- IRB FAQs
- Reportable Events
- Modification FAQs
- Informed Consent FAQs
- HIPPA FAQ
IMPORTANT NOTE: Approvals for research are valid for a time period established by the IRB which can’t exceed one year. If your research extends beyond one year, the project must be reviewed and renewed before the expiration date and prior to continuation. The IRB is directed by federal guidelines to shut down any and all research using human participants that does not have a current approval.
