Introduction to IRBs and Human Research Protections
Researchers at healthcare facilities or universities are required to obtain approval of their studies from their local Institutional Review Board (IRB), which serves to ensure research studies comply with regulatory policies and ethical standards to adequately protect research participants. In the video below, Elise Russo gives a brief history of human research protections and what the Common Rule policy means for research.
What is Research (and Quality Improvement)
Determining what activities are constituted as “research” can be somewhat confusing. In the video below, Elise discusses the specific exclusions defined by the Code of Federal Regulations (CFR) as well as the somewhat murky distinction between research and quality improvement. In general, it’s best to secure IRB approval for any project you may want to eventually present or publish in the future. The IRB will typically issue a “not research” determination letter for quality improvement projects, which is usually sufficient for journals when publishing.
Understanding Exempt Research
Not all research falls under the requirements of full IRB review. In the video below, Elise gives an overview of the types of research situations that are considered exempt, such as observational studies related to standard practice or benign behavioral interventions as long as the participants identities are protected. Notably for informatics research, another exempt category is secondary research where consent is not required. This includes analyzing clinical data in the EHR that was originally collected and stored as part of routine care.
HHS.gov info on exempt research
Demonstration of IRB Exempt Protocol Submission (part 1)
In the video below, Elise begins a demonstration of how to complete an exempt IRB protocol submission using the DiscoverE system we use here at VUMC/VU: https://irb.app.vumc.org/login. This portion of the demo includes entering key personnel as well as study type and performance site information.
Demonstration of IRB Exempt Protocol Submission (part 2)
In the video below, Elise continues the exempt IRB protocol submission in DiscoverE, including study purpose and description and, importantly, the designation of applicable categories of exemption from the 45 CFR 46.104 discussed earlier and the source of the data being used. There is some standard language available for use if your study is using data from sources like the Research Derivative (RD), which can be found in the sample protocols linked below. This portion of the demo also covers HIPAA identifiers and protection to ensure privacy of subjects. The IRB form also requests a data collection sheet with all variables/data fields required to conduct your study, an example of which can be seen here.
Sample exempt protocol 1--EHR data
Sample exempt protocol 2–low risk interview project
Demonstration of IRB Exempt Protocol Submission (part 3)
In the video below, Elise completes the demonstration of an exempt IRB protocol submission, including the uploading of required documents such as a data collection sheet within “Study Materials.” After the application is submitted, it will be automatically routed to the PI to review and submit, followed by the department chair and division chief, if applicable, before being reviewed by the IRB committee. Elise also notes that exempt studies only stay active in the DiscoverE system for one year, so there are some nuances in terms of amendments, but she’s happy to help answer any of your questions via email (elise.russo@vumc.org)
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