Food and Drug Administration (FDA) is a government agency that was established in the year 1906 with the passage of the Federal Food and Drugs Act mandated with overseeing organization’s obligations relating food, drugs, cosmetics, animal feeds, dietary supplements, as well as biological goods among others (Bankert & Amdur, 2006). Through its existence, various laws and rules regarding were developed all aimed at ensuring human beings are safe from harmful products. On the other hand, Institutional Review Board (IRB) is mandated with protecting the rights and welfare of individuals that are involved in research. As a result, all the institutions that consent to research funding from the Federal Government ought to have an IRB to review all research entailing human subjects (Johnson & Virgo, 2006). It is through that rationale that the paper would undertake to expound on the significance of the FDA and IRB specifically in the clinical investigation.
Importance of FDA and IRB in the clinical investigation
As mentioned exceedingly, the FDA was founded with objectives of defending and guarding the rights, safety, and welfare of individuals that take part in clinical trials of the FDA controlled products. Hence, it would without doubt be true to state that the FDA undertakes to protect persons who offer themselves for research that are always risky in order to advance public health. Moreover, FDA enables the clinical investigations to enhance knowledge not only in the public health as mentioned, but also in therapeutics and biomedical knowledge all aimed at consolidation as well as endorsing the human subject fortifications exemplified in the rules and regulations of the FDA (Robertson & Williams, 2009). An additional importance of FDA in the clinical investigation is that it ensures that the human subjects taking part in the research do so voluntary as well as in a legitimately effective and informed manner. Equivalently, it ensures that the subject volunteers for the research in an independent and ethical manner something that the FDA has done from the year 1981. However, volunteer protection in the process of clinical investigation would not be attained without the inclusion of data monitoring something that the FDA enhances (Bankert & Amdur, 2006). Through the monitoring, experts would be able to safely monitor patient’s treatment response with an aim of fulfilling those duties entailed in the FDA regulations. Worth mentioning also is the fact that even though several volunteers might wish to take part in the clinical investigation, the FDA as an agency undertakes to ensure that they are qualified for the wider use for better outcomes. Otherwise, the outcomes that might be recorded with unqualified subjects would not meet the required standards (Johnson & Virgo, 2006). Hence, FDA would categorize the results as unacceptable for clinical applications.
Under the FDA conventions, the IRB as well undertakes to analysis, evaluate, and approve the persons that accept to take part in the research in the clinical investigation. Hence, stating that the IRB fosters the protection of the rights and welfare of the human subjects taking part in the research. It fosters and protects such rights through reviewing the protocols as well as informed permissions, and proper documentations that might include recruitment plans and investigation brochures (Robertson & Williams, 2009). An additional importance that might be attributed to the IRB would be the disapproval of the research that might have been done through unstated or documented methods and procedures. A clinical investigation as well may be disapproved as a result of other reasons beyond non adherence to the stated procedures (Robertson & Williams, 2009).
For instance, unacceptable workloads at the site or limited availability of suitable subjects in the process of conducting the clinical investigation would be reasons for the disapprovals. Without doubt, they FDA and IRB has improved the clinical investigations processes while at the same time, they were given credit for developing alternative methods and techniques for inspecting the procedures. While the FDA works to ascertain and pinpoint the potential challenges that might come up in the clinical investigation process, the IRB undertakes to communicate the needed procedures that might be applied to solve the challenges that are sprouting and emerging. In the process, duplication of processes as well as efforts is reduced making the whole process of clinical investigation a success (Johnson & Virgo, 2006). The two agencies, therefore, ensures that the human subjects or volunteers are protected while the process of clinical investigation is under on, and at the same time guaranteeing better outcomes that would not be rejected.
In closing, it is evident from the elucidations given above that in the process of undertaking clinical investigations, the FDA legalizes and standardizes products, the investigators as well as the subjects all aimed at attaining better and acceptable outcomes. As a result, the FDA adopts measures that recommendations regarding the Agency’s oversight in the clinical investigations including those of IRB are effusively and completely enforced or addressed (Robertson & Williams, 2009). Concluding that the FDA and the IRB roles have resulted to better and effective approaches and opportunities would not be an understatement since it has done much in giving guidelines in clinical investigations.
Bankert, E. A., & Amdur, R. J. (2006). Institutional review board: Management and function. Sudbury, Mass: Jones and Bartlett.
Johnson, F. E., & Virgo, K. S. (2006). The bionic human: Health promotion for people with implanted prosthetic devices. Totowa, NJ: Humana Press.Bottom of Form
Robertson, D., & Williams, G. H. (2009). Clinical and translational science: Principles of human research. Amsterdam: Academic.