General IRB Information
In 1974, the Public Health Services (now U.S. Department of Health and Human Services (DHHS) required that all institutions conducting research create an ethics board or Institutional Review Board (IRB) to govern the research done at that institution.
- Mission statement - to ensure research with human subjects is ethically and legally responsible.
- Belmont Report
- Common Rule 45 CFR 46
- Active studies under FMC IRB (Coming soon!)
- Institutional statement regarding 21CFR Part 11: FDA Regulations related to electronic records and electronic signatures are located at 21 CFR Part 11. An institutional statement regarding Part 11 has been developed to assist study teams in responding to inquiries from sponsors and CROs.
Requirements for all research staff
- CITI training in human subject research
Completion of human subject training should be done by all staff working on a research project (all investigators and other study personnel, including all persons who are responsible for designing and/or conducting research, performing data analysis or reporting activities). The required course can be found by affiliating with "Novant Health Traid Region- Forsyth Medical Center." It is suggested you take the CITI training before submitting your IRB protocol for approval.
- Obtaining a copy of CITI Completion Report
You can view and print a copy of your completion certificate by logging into the CITI homepage. At the "Learner's Menu" screen:
- If under the status heading it says "Passed", then click on the "Print" link under Completion Reports. This will display a table. Click "Print Completion Report" to print the certificate.
- If under the status heading it says "Not Started - Enter" or "Incomplete - Re-enter", click on Previous Coursework Completed link, and then click on See Coursework Completed. When the table is displayed, click on the "Print Completion Report" link.
- PI and Sub PI - updated CV (email to IRB staff)
- Current IRB Schedule
- Current Fee Schedule
- Good to Know
Regulations and guidance:
- Getting Started
- User Manual PDF
- Troubleshooting e-protocol
- Change log