Expedited review

Definition

Expedited review is a process used by Institutional Review Boards (IRBs) to evaluate research proposals that involve minimal risk to participants, allowing for a faster approval timeline than standard reviews. This approach is essential for facilitating timely research while still ensuring the protection of human subjects, particularly in situations where delays might hinder important advancements or timely interventions.

5 Must Know Facts For Your Next Test

1. Expedited review can be applied to specific categories of research that involve minimal risk, as defined by federal regulations.
2. The IRB chair or a designated member usually conducts expedited reviews, streamlining the evaluation process.
3. Researchers must provide sufficient information about the study to determine eligibility for expedited review, including details about participant selection and safeguards.
4. Expedited reviews are particularly common in studies involving data collection through surveys or non-invasive procedures.
5. Although expedited review speeds up the process, it still requires adherence to ethical guidelines and federal regulations to protect participant rights.

Review Questions

• How does expedited review differ from standard IRB review processes in terms of risk assessment and timelines?
  • Expedited review differs from standard IRB processes primarily in its focus on minimal risk research proposals, allowing for quicker assessments and approvals. While standard reviews involve a more thorough evaluation of higher-risk studies, expedited reviews streamline the process by utilizing pre-defined categories that qualify for this faster track. This approach helps researchers begin their studies sooner while still ensuring ethical oversight.
• What specific criteria must research proposals meet to qualify for expedited review by an IRB?
  • To qualify for expedited review, research proposals must demonstrate that they involve minimal risk to participants and fall into specific categories outlined by federal regulations. These categories include studies using existing data, non-invasive procedures, or surveys that do not pose greater risks than those typically encountered in everyday life. Additionally, researchers need to provide clear information on how they will protect participant rights and manage any potential risks.
• Evaluate the ethical implications of utilizing expedited review processes in research involving vulnerable populations.
  • Utilizing expedited review processes in research involving vulnerable populations raises important ethical considerations regarding the protection of these individuals. While expedited reviews can accelerate critical research that may benefit these groups, there is a heightened responsibility to ensure that their rights and well-being are safeguarded. Researchers must carefully justify the use of expedited review, ensuring robust protections and informed consent processes are in place. Balancing the need for timely interventions with stringent ethical oversight is crucial to maintaining trust and integrity within vulnerable communities.

Related terms

Institutional Review Board (IRB): A group responsible for reviewing and approving research studies involving human subjects to ensure ethical standards are met.

Minimal risk: A situation in which the probability and magnitude of harm or discomfort anticipated in the research is not greater than those ordinarily encountered in daily life.

Informed consent: The process by which researchers obtain voluntary agreement from participants, ensuring they understand the nature, risks, and benefits of the research.