General IRB Information
- Mission statement - to ensure research with human subjects is ethically and legally responsible.
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.
- Belmont Report
- Common Rule 45 CFR 46
- Active studies under FMC IRB
- 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.
- OHRP link - "It's your decision"
- Clinical Trial.gov
- HIPAA Privacy Rule establishes national standards to protect individuals' medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically. The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients' rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.
Requirements for all research staff
- CITI complation report/equivalent in human subject training
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 responsibile for designing and/or conducting research, performing data analysis or reporting activities). 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 Roster
- Current IRB Schedule
- Current Fee Schedule
- Good to Know
Recourses: regulations and guidance:
- FWA00018652 - chart for assurances relying on FMC IRB
- Getting Started
- User Manual PDF
- Troubleshooting e-protocol
- Change log