Expedited review is a process used by institutional review boards (IRBs) to quickly evaluate research proposals that involve minimal risk to participants. This type of review is designed to streamline the approval process for studies that do not require the same level of scrutiny as higher-risk research, allowing for faster initiation of projects while still ensuring participant protection.
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Expedited review is applicable to research that falls under specific categories defined by federal regulations, typically involving minimal risk.
The IRB chair or designated members can conduct expedited reviews without needing a full board meeting, speeding up the approval process significantly.
Examples of research eligible for expedited review include studies on educational practices, surveys, and certain behavioral interventions.
Researchers can request expedited review during their initial proposal submission, but the IRB has the final say on whether the criteria are met.
Expedited reviews still require thorough documentation and adherence to ethical guidelines, despite the reduced time frame for approval.
Review Questions
What criteria must research meet to qualify for an expedited review by an IRB?
To qualify for expedited review, research must involve minimal risk to participants and fit into specific categories outlined by federal regulations. These categories often include studies involving normal educational practices, collection of data through non-invasive means, or research that involves existing data where subjects cannot be identified. The IRB must determine that the proposed study meets these conditions before granting expedited status.
Discuss how expedited review processes differ from full board reviews and the implications for researchers.
Expedited reviews differ from full board reviews in that they involve fewer members of the IRB and are conducted more quickly due to the lower level of risk associated with the research. For researchers, this means they can initiate their projects sooner, which can be crucial for time-sensitive studies. However, despite the expedited process, it is essential for researchers to maintain rigorous ethical standards and thorough documentation to ensure participant safety and compliance with regulations.
Evaluate the potential benefits and drawbacks of utilizing expedited review processes for certain types of research.
Utilizing expedited review processes can provide significant benefits, such as faster approval times and increased flexibility for researchers working on low-risk studies. This efficiency can encourage innovative research and help address urgent public health needs. However, drawbacks may include the risk of insufficient oversight if IRBs rush through evaluations, potentially compromising participant safety or ethical standards. Striking a balance between efficiency and thoroughness is crucial for maintaining integrity in research practices.
A process by which researchers provide potential participants with comprehensive information about a study, allowing them to make an informed decision about their involvement.
Minimal Risk Research: Research where the likelihood and magnitude of harm or discomfort anticipated are not greater than those ordinarily encountered in daily life or during routine physical or psychological tests.