IRB Review Criteria |
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What type of studies require an IRB review?
All federally-funded, human-subject research, or research into drugs and devices under the jurisdiction of the Food and Drug Administration (FDA) must go through an IRB review or be formally determined to meet a category for exemption. Exempt research may include, for example, reviews of records or surveys where the subjects can’t be identified and aren’t at risk for civil or criminal liability or damage to their reputation. However, even if IRB review is not required by regulation, review may be required by journals, and an IRB review can be helpful for ensuring the study can withstand outside scrutiny. |
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What are the requirements for the IRB process?
In order to start an IRB review, researchers must submit an IRB protocol, which is a detailed plan for the study. In addition, you’ll need to provide a sample consent form, any surveys or questions that may be used and credentials for key personnel. Evidence of training in human-subject studies is also required. Often, a formal agreement between the researcher and their institution and the IRB must be in place to ensure adherence to IRB expectations and policies. |
