What happens if I don't get my project approved and I do the research anyway?
Investigators who conduct research with human participants without IRB approval are putting the entire University at risk of losing our Federalwide Assurance. Our Assurance is the permission that Health and Human Services and the Office of Human Research Protections gives us to conduct human subjects research. It can be revoked at any time.
When an institution loses its Assurance, all research in progress that was approved by that institution's IRB must stop immediately. All studies in progress must be re-reviewed before they can continue. In addition, no new research may be approved.
The press frequently highlights institutions that lose their Assurance for major biomedical violations. In fact, the most common reason an institution loses its Assurance is for errors in the Informed Consent process.
An example of Bluefield State College, which lost its Assurance for 8 months for the following violations:
The Institutional Review Board:
- Conducted reviews without sufficient information
- Conducted reviews through email
- Conducted continuing reviews late or not at all
- Failed to review grant applications
- Had a chair who was not knowledgeable in IRB requirements
- Conducted research without approval
- Conducted research with verbal approval
- Used incomplete consent forms
- Used exculpatory language in consent forms
- Changed research protocols without approval
- Hadn't held meetings in person and lacked meeting minutes
- Did not have written policies or procedures
- Had poor records of investigator materials, Board correspondence, and continuing reviews
Institutions that lose their Assurance often find that it is a very costly experience. Not only does it cost tens of thousands of dollars to quickly get into compliance with the ethics and regulations, but it impacts the ability to get grant funding, faculty recruiting, and the instituion's public image. Faculty counting on a certain timeline to complete research and publish before their tenure or promotion year are often impacted.
In short, it isn't worth it. Please submit.