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, firstname.lastname@example.org (336) 256-0253.
**Please allow four weeks for IRB review
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.
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’s 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. This certificate must be printed and attached to your IRB application.
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 2019 Training
**NOTE: Registration for in-person training is required due to limited seating. Participants can register at: https://workshops.uncg.edu/ – search under “Office of Research Workshops”.
- Date: Tuesday, September 24, 2019
- Time: 9am-11am
- Location: MHRA 2711
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 email@example.com or by contacting Melissa Beck at firstname.lastname@example.org. Please note, a certificate of completion is not offered for this option.
IRB Consent Form Templates
- NEW – Adult Consent
- NEW Parental Permission for a Minor Consent
- Assent form for Minors 12-17
- Assent Form for Minors 7-11
- NEW fMRI Consent Template
- NEW Information Sheet Template
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
- REVISED! Application to Use PHI in Research
IRB Standard Operating Procedures (SOP’s)
- 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
- 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.