Title: Understanding IRB Review and the Protocols that Require it
When conducting research involving human subjects, it is important to ensure that ethical considerations are taken into account. This is where Institutional Review Boards (IRBs) come into play. IRBs are responsible for reviewing research proposals to determine if they meet ethical standards and to ensure that subjects are protected during the study. In this article, we will discuss the protocols that are most likely to require IRB review and why.
One of the most important factors that determine whether a protocol requires IRB review is whether it involves human subjects. Any research that involves living human beings or their data, tissues, or bodily fluids is considered to involve human subjects. Examples of such research include biomedical experiments, surveys, and clinical trials.
Next, the protocol in question must meet the regulatory definition of research. According to the U.S. Department of Health and Human Services, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” This means that the study must have a clear goal of contributing to scientific knowledge, rather than just serving the purposes of the investigator.
Assuming a study meets these two criteria, it is important to consider the level of risk involved. Protocols that involve greater risk, such as invasive medical procedures or interventions, are more likely to require IRB review than those with minimal risk, such as basic surveys or observational studies. The IRB will typically classify protocols according to the level of risk and determine the appropriate level of review.
Finally, some studies may be exempt from IRB review altogether. These are typically studies that involve minimal risk or do not involve human subjects. Examples of exempt studies include studies that use publicly available data, studies that involve only anonymous surveys, and studies that use previously collected data.
In conclusion, the protocols that are most likely to require IRB review are those that involve human subjects and meet the regulatory definition of research. The level of risk involved will also be taken into account. It is important for researchers to understand these factors and to work with their IRB to ensure that ethical standards are met and human subjects are protected. By doing so, we can ensure that scientific research is conducted in a responsible and ethical manner.