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 will take several weeks. The migration team is steadily working on populating legacy applications for the research teams.
- If you have a renewal or modification that requires submission within the next several weeks and your legacy submission is currently incomplete, the PI or a current study team member will need to complete the legacy application. This can be done by copy/pasting from the IRBIS application into the Cayuse application. The IRBIS application can be found in the “attachments” section of the legacy application.
- The Legacy Submission Help Document has been created to aid researchers in the completion of the legacy application. Once the legacy application sections are populated, a renewal or modification submission can then be started.
- 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. The Legacy Application should be completed as the study is currently approved. Any changes to the study would need to be submitted via a modification sent once the legacy application is complete.
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.
- Fall 2021 Training Date: TBD
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
- Protocol Deviation/Violation Form
- Unanticipated Problem / Adverse Event Form
- Statement of Confidentiality
- Example Letter of Support/Site Approval
- 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
- IRBIS FAQs
- 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.