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The IRB Maze

I am new to the process of navigating Institutional Review Boards (IRB). I have enjoyed writing various articles but have never had to undergo the IRB process as a principle researcher. I was usually the name in the middle of the author list and assisted on a specific part of the project.

Steering through an IRB application can be intimidating, especially if you are new to the process. Radiology nurses are becoming more involved in projects to answer the complex clinical questions in our environment. This is evident with the vast array of topics presented during the poster session in Austin. Having had the opportunity to attend the excellent presentations, it is my hope that sharing some of the upcoming changes in the IRB submissions will make the path easier for others Radiology nurses.

First, we must review some background. The Federal Policy for the Protection of Human Subjects ('Common Rule') is based on the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It was last updated in 2005. The common rule outlines basic procedures, consent and the role of the IRB in protecting human subjects (Menikoff, Kaneshiro, Pritchard; 2017).

In January 2018, a revision to the common rule was published. The revision was needed due to the changing nature of research and improved information technology available. The revised regulations increase standardization of human subject protections, while decreasing costs. The revised document contains additional steps for safeguarding human subjects while streamlining regulations to allow certain research to be exempted from IRB (Menikoff, Kaneshiro, Pritchard; 2017). 

The revised regulations redefine research which makes some performance improvement activities of them based on the risk profile. With the creation of these new categories, some exempt research will not require IRB review for privacy safeguards. The revised document also removes the current requirement to conduct an Tenuate reviews on expedited studies and on studies and remain open to analysis but are close to interventions. In addition, a concise summary of research and way languages required at the beginning of the consent form (Menikoff, Kaneshiro, Pritchard; 2017).

All submissions representing risk to subjects should be reviewed by the IRB. Submissions to the IRB need to outline both the purpose and significance of the study, and the mechanisms for guaranteeing that the subjects are protected from harm and loss of privacy. The research questions must also be answerable with the proposed protocol. The IRB panel assigned to review the submission will verify congruency between the research project, recruitment materials, and the consent form. Any lack of congruency would require revision by the researcher before approval.

As Radiology nurses move towards a sharing of results through posters, publications and podium presentations, familiarity the current IRB regulations can ease the process and decrease stress. Understanding research categories necessitating IRB approval can facilitate project development. Depending on the individual IRB, approval for a simple project can be obtained in as little as a few days, while approval of a large project may take several months. Time is important in our busy lives. Before starting a project, I encourage you to reach out to your organization's IRB. They are an asset to understanding your facilities process and how to submit your work.

 

References

Menikoff, J., Kaneshiro, J., and Pritchard, I. (2017). The Common Rule, Updated. New England Journal Medicine. 376(7). 613 to 615.

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