Clinical research involves the testing of investigational products so as to determine their suitability for the purposes of approval for the greater population’s use. The articles subjected to tests include medical devices, drugs or other biologic products such as blood products and vaccines.
The Food and Drug Agency (FDA) has several responsibilities in clinical research. These responsibilities are geared towards protecting the welfare, safety and rights of the subjects. FDA has a responsibility to regulate both the initial and final approval of the clinical studies that are proposed. FDA has set regulations that compel sponsors to monitor all their investigations. This is done in order to ensure that all the studies done are according to the study protocol and the investigational plan. The FDA is also responsible for granting marketing approvals for the different drug products on the basis of their efficacy and safety data review (Gad, 2009).
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Importance of Institutional Review Boards (IRB)
Institutional Review Boards (IRBs) are essential in clinical research in ensuring clinical research is done ethically. It is the duty of IRBs to approve and monitor clinical research. IRBs have the authority to terminate or suspend clinical research even after approval if it is found to be unethical. IRBs are also responsible for making follow ups to ensure there is prompt reporting to officials of IRB of any research processes that might harm clinical research participants (Emanuel, 2008). IRBs are mandated to safeguard the rights of clinical research participants.
These safeguards include the researchers’ values throughout the research process. The IRB acts as a double check that works in the interests of the human subjects. The IRB evaluates all the research proposals and the values involved. In reviewing the human subject research, the IRB sees into it that the researchers abide by clinical research ethics and the federal regulations (Banker, 2006).
- Bankert. (2006). Institutional Review Board: Management and Function. Ontario: Jones & Bartlett Learning. Print
- Emanuel. (2008). The Oxford Textbook of Clinical Research Ethics. New York: Oxford University Press. Print
- Gad. S. (2009). Clinical Trials Handbook. New Jersey: John Wiley & Sons. Print
