Human Research

Researchers should submit IRB applications to the ORC. Full Board reviews should be submitted according to this submission schedule.

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's IRB accepts certificates of training from three sources. 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.

Instructions for Human Subjects CITI Training
CITI Training Website
Research Using Human Subjects

Applications

Determination Application
Exempt Application
IRB Expedited/Full Application
Modification Application
Renewal Application
Closure Application
Application to Use Protected Health Information (PHI) in Research

IRB Forms/Templates

Sample Letters of Support - Student
Sample Letters of Support - Faculty
Sample Letters of Support - Faculty
Assent Template for Minors 12-16
Information Sheet Template
Long Form Consent
Short Form with Oral Presentation Script
Parental Permission Consent and Assent
Statement of Confidentiality

Guidance/Information

Informed Consent Guidance Document
The Common Rule (45 CFR 46)
The Belmont Report
Cone Health Agreement
Protection of Human Participants in Research
IRB Member list
Required Elements of Recruitment
Exemption Request Overview
IRB Determination Overview
Common Errors
IRB Authorization Agreement with Cone Health
Top 10 Safe Computing Practices

Procedures

IRB Standard Operating Procedures
IRB Renewal Process Flow Chart
IRB Application Process Flow Chart
IRB Exempt Process Flow Chart
IRB Modification Process Flow Chart

Frequently Asked Questions

IRB FAQs
Modification FAQs
HIPAA FAQs
Informed Consent FAQs

Special Situations

Adverse Event Form

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.

If you have difficulty viewing the files on the page, please contact 6-tech to assist you.