The Institutional Review Board (IRB) is a constituted group that has been designated to review and monitor various biomedical research that involves human subjects. The IRB was established in accordance with the FDA regulations. The main role of the IRB is thus to protect the welfare and rights of human subjects that are being used in research. IRB thus plays a critical role in assuring the public that there are appropriate steps and procedures that are taken so as to protect human beings subject to the research. IRB reviews the appropriateness of the clinical trial protocols as well as the benefits and risks of the research to the study participants. It ensures that the participants will be exposed to minimal risks when compared to the benefits that could result from the outcomes of the research.
In order to accomplish its purpose, the IRB makes use of a group process in order to review various research protocols. The agency has the mandate to approve, require modifications, disapprove, and secure approval of a research. Research that has already been reviewed and approved by the IRB will be subject to continual review. The research could be reevaluated on an annual basis or even more frequently based on the recommendations of IRB. IRB will thus review all the materials related to the research before and throughout the research process. It will also operate in accordance with the national regulations, local regulations, or in accordance with the acceptable clinical practices.
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IRB was established after there were multiple crimes committed against human beings. Throughout history, various researchers committed several crimes against humanity and this resulted in the establishment of strict rules involving human subjects (Kawar, 2016). Various laws and regulations were established in order to protect the rights and welfare of human beings. These regulations saw the creation of IRB in order to oversee that before any research is undertaken, it should abide by all the laws and regulations. In case any research undermines the rights of human beings, it will be disapproved. IRB thus grew out of a history of unethical scientific research practices and was established in order to protect human subjects.
Length of Time to Obtain IRB Approval
Once an individual makes a submission to IRB, the research first goes to a screening process. The process of screening is not an official review by the IRB. It is used to determine whether the submission is adequate and should be ready for an IRB review. The screening will be used to note whether additional information or corrections are required in the document. The screening process takes up to 5 business days from the receipt of the IRB Application.
After the application has been considered ready for an IRB review, the form is usually assigned to a reviewer designated by IRB. The reviewing process should take approximately 7 to 10 business days. In times of high volume of reviews, the time to complete the reviewing process can take longer. One should thus expect that their studies can take approximately 3 to 5 weeks from the time of submission. Submissions that will also require continual approval are usually reviewed within 4 to 6 weeks after submission (“IRB Timelines”, 2019).
The overall time spent throughout the IRB reviewing process will vary from one project to another. It will be dependent on the nature and the number of revisions that could be required. Projects that have significant feasibility and risk concerns could take additional months for one to receive an approval.
References
“ IRB Timelines”. (2019). Retrieved from https://irb.research.chop.edu/irb-timelines
Kawar, L. N., Pugh, D. M., & Scruth, E. A. (2016). Understanding the role and legal requirements of the institutional review board. Clinical Nurse Specialist , 30 (3), 137-140.
