How do I know whether my project requires review?
If you are affiliated with MSU Denver and are doing any type of research involving living humans, your project must be reviewed. If you are not affiliated with MSU Denver and wish to do any type of research involving MSU Denver students, staff, or faculty, your project must be reviewed.
Does my project need review if I am doing it outside the United States?
Yes. If you are affiliated with MSU Denver and are doing any type of research involving living humans your project must be reviewed, regardless where data will be collected. The MSU Denver IRB will review your research protocol application based both on the regulations required for research in the United States and the standard of ethics adopted by the country in which your data collection will take place.
My project fits under one of the categories listed as exempt. Does it still have to be reviewed?
It is MSU Denver's position that the determination of level of review is made only by the IRB Chair and Committee. The OHRP states the following in response to the question "Must there be review by someone other than the investigator before a research study is determined to be exempt?"No, the regulations do not require that someone other than the investigator be involved in making a determination that a research study is exempt. What they do require is that there be accurate determinations so that non-exempt research ends up being reviewed by an IRB. Because of the potential for conflict of interest in this situation, OHRP's long-standing recommendation is that investigators not be given the authority to make an independent determination that human subjects research is exempt.
In addition to the potential for conflict of interest, making an accurate determination of exempt review requires knowledge not only of 45 CFR 46, but the hundreds of pages of guidance and precedent published by the OHRP to aid IRBs in their decision making. As a result, investigators are not authorized to make determinations on the level of review of research. The MSU Denver IRB must review all research involving human participants.
What happens if I don't get my project reviewed and 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.