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Classifications for Research, Essay Example

Pages: 1

Words: 313

Essay

Introduction

The Code of Federal Regulations has identified different areas of research that include exempt, expedited, and full review, depending on the nature and complexity of the study, and these reviews are provided by Institutional Review Boards (IRBs). In essence, a more complex research project that involves a high level of human subject activity is likely to require full review in order to ensure that study participants are protected from unnecessary risk or harm. IRBs are designed to protect human subjects from risk and are governed by the Office of Human Research Protections (New Hanover Regional Medical Center, 2015).

Body

In consideration of the Postpartum screening tool project, this study would likely require full IRB review in order to demonstrate that the lives of study participants are not compromised in any way. This process is critical to the overall direction of the study, its objectives, and its potential success as supported by the appropriate IRB approvals. Each type of classification is of critical importance because not all research is the same, thereby requiring different levels of review in order to determine the safety and efficacy of the study and its impact on participants. IRBs must be regulated by the federal government and must have an assurance in place in order to ensure that human subjects protection is properly governed and supports effective action in regards to research (FDA, 2015).

Conclusion

Research classifications are critical to the overall direction of research in order to determine the level of risk associate with study participants and how to manage this risk as effectively as possible. This process, therefore, requires each study protocol to be examined thoroughly by the IRB in an effort to identify possible risks and the overall impact of the study on the surrounding environment.

References

Food and Drug Administration (2015). Regulatory information. Retrieved from http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm

New Hanover Regional Medical Center (2015). What is an IRB and its purpose? Retrieved from http://www.nhrmc.org/what-is-an-irb

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