The warning letter to Dr. Teasley was sent due to the unacceptable clinical research activities that were conducted by the clinical officer. In the case, Dr. Teasley failed to conduct the clinical research himself and in addition, he failed to supervise the research activities that were conducted by his clinic. In this regard, the doctor failed to obey the laws set by the government concerning conduct of clinical investigations and the regulations put in place by food and drug administration. According to the statement signed by Dr. Teasley, it was stated that the doctor would conduct the clinical investigation himself or through his supervision. However, the doctor did not do this and instead, his employees did the research and this is why there were errors in the research activities (Teasley, 2011). These employees took photographs of fundus that did not match as expected since the photographs came from the same human beings.
The reason for the regulation is that some of the specimen used during most of the clinical research activities are human beings. It is therefore important that the health of human beings is protected. In addition, the safety and welfare of the specimen used is protected. The accuracy and reliability of the data to be collected by the research is also protected. In the above case, the results of the clinical research cannot be relied on because there are observable errors already in the conduct of the research. There is a possibility that there are more errors in the research report (Skinner, 2005).
It can therefore be concluded that the statutory laws and the food and drugs regulations are very important. Clinical officers should conduct their research activities themselves or under their close supervision. This is important to avoid errors in the research activities and therefore the research results can be confidently relied upon. In addition, the safety of the specimen is ensured to facilitate future researches. Therefore the mistakes made by the clinical officer should be avoided at all costs.
References.
Teasley, L. (2011) Inspections, Compliance, Enforcement, and Criminal Investigations Retrievedfrom;http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm277338.htm
Skinner, S. (2005). Understanding clinical investigations: A quick reference manual. London: Bailliere Tindall.
Bateson, M. C., & Bouchier, I. A. D. (1997). Clinical investigations in gastroenterology. Dordrecht: Kluwer Academic.
