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. Any issues can be directed to Melissa Beck, email@example.com or 336.256.0253.
UNCG IRB Application
**Please allow four 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.
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”).
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 Subjects 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.
- Date: Tuesday, September 28th
- Time: 9am-11am
- Location: Zoom
- Registration Required at UNCG Workshops – Search under “Office of Research Workshops”
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 firstname.lastname@example.org or by contacting Melissa Beck at email@example.com. Please note, a certificate of completion is not offered for this option.
IRB Consent Form Templates
- Adult Consent (to be used in studies qualifying for Expedited/Full Committee Review)
- Parental Permission for a Minor Consent
- Assent form for Minors 12-17
- Assent Form for Minors 7-11
- fMRI Consent Template
- Information Sheet Template (to be used in studies qualifying for Exempt Review)
IRB Forms and Information
- Statement of Confidentiality
- Example Letter of Support/Site Approval (opens best in Firefox)
- International IRB questions
- 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
- OHRP FAQ – Use of Electronic Informed Consent
- Research Conducted at Cone Health
- Protection of Human Subjects in Research Policy
- Training for Community – non-research team members
- IRB Guidance on Class Projects (Is this Research?)
- Using Eraser to Securely Erase Data
- The Common Rule (45 CFR 46)
- The Belmont Report
- Recommended Elements of Recruitment
- Reliance Agreement with Cone Health
- Helpful NSF and the Common Rule of Research with Human Subjects
- OHRP International Compilation of Human Research Standards
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.