- According to the updated federal regulations 46 CFR 46, any protocol approved as expedited will no longer require continuing review as of January 2018. You are still required to submit modifications and obtain IRB approval for any changes to any aspect of the study before the changes can be implemented.
- Due to the changes to the federal regulations, you will note that the stamp on your consent form no longer has an expiration date. Consent forms will only be re-stamped in the event a modification has been submitted that required changes to the consent form.
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 NOTE: RCR TRAINING IS SEPARATE FROM IRB TRAINING. SEE HERE FOR A HELPFUL EXPLANATION.
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.
- Date: March 7, 2017
- Time: 9am-11am
- Location: MHRA 2711
- Register: http://workshops.uncg.edu/
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
- Revised! Adult Consent Form Template
- Revised! Parental Permission for a Minor Consent
- Assent form for Minors 12-17
- Assent Form for Minors 7-11
- REVISED! fMRI/MRI Consent Form Template
- Information Sheet Template
- Unanticipated Problem-Adverse Event Form
- REVISED! Statement of Confidentiality
- Example Letter of Support/Site Approval
- International IRB questions
- Application to Use PHI in Research
IRB Standard Operating Procedures (SOP’s)
Additional IRB Resources
- Revised! Research Conducted at Cone Health
- UNCG Human Subjects Research Policy
- Training for Community – non-research team members
- 2017 IRB Meeting dates
- 2015 Annual Report
- IRB Guidance on Class Projects (Is this Research?)
- Using Eraser to Securely Erase Data
- REVISED The Common Rule (45 CFR 46)
- The Belmont Report
- IRB Member Roster
- Required Elements of Recruitment
- Reliance Agreement with Cone Health
- ITS – Top 10 Safe Computing Practices
- Helpful NSF and the Common Rule of Research with Human Subjects
- 2015 International Compilation of Human Research Standard
- FDA Information Sheet – Significant Risk and Nonsignificant Risk Devices
- FDA Information Sheet – Medical Device FAQ
- Investigational New Drug Information
Frequently Asked Questions
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.