Question One
The increase incidence of deaths from defective and contaminated products leaves the average consumer at a disadvantage (Kufman, 2008; Woodcock, 2008 and WJLA, 2014). The consumers purchase the products unaware of the fact that they might be contaminated. Since the implicated products are produced in known countries, regulatory authorities should require the labeling of the products to include information on the country of production. Additionally, the outsourcing of the production of products for medical use should be done in countries where there are strict regulations on quality.
Question Two
Despite the presence of goo clinical practices, there is a feeling that the regard for safety, especially in the materials used in the first phase is lower compared to the subsequent phases. This is because of the incentive the get the drug approved for the subsequent stages of the clinical trials. Even though modern analytical techniques are used, the prospect of drug discontinuation due to non-compliance (Buckley & Blanks, n.d.) might lead to lax standards in the first phase.
Question One
Institutional review boards are tasked with assessing the conditions in research that make the participation dangerous. Through the evaluation of the risks in this sense, the Institution Review Boards then deliver a judgment as to whether expected benefits from the research are significant enough to justify the undertaking of the risk by the participants.
Question Two
The role of Institutional Review Boards during clinical trials is mandatory. The mandate is issued for all clinical trials that involve human subjects and are regulated by the Food and Drug Authority as provided by regulation (45 CFR 46) (Office for Human Research Protections, 1993).
Question Three
Institutional Review Boards keep various documents. For instance, the IRBs store the research files for three years after the approval for research was terminated. In studies involving children, the research files are stored for twenty-one years (Office for Human Research Protections, 1993). Files containing the complaints launched by the research subjects and the resultant actions are stored for three years after the approval for research was terminated. The IRB also keeps recorders of adverse event reports for three years after the approval for research was terminated (Office for Human Research Protections, 1993).
References
Buckley, B. and Blanks, R. (n.d.). Overview of the GxPs for the regulatory profession. Cambridge. Idenix Pharmaceuticals, Inc.,
Kufman, M. (2008). FDA raises estimate of deaths linked to blood thinner. Retrieved from http://www.washingtonpost.com/wpdyn/content/article/2008/04/08/AR2008040803032.h tml
Office for Human Research Protections (1993). IRB guidebook. Retrieved from http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
WJLA. (2014). Contaminated jerky pet treats linked to at least 1,000 canine deaths. Retrieved from http://wjla.com/news/business/contaminated-jerky-pet-treats-linked-to-at-least-1- 000-canine-deaths-many-more-illnesses-103320
Woodcock, J. (2008). FDA’s ongoing heparin investigation. Retrieved from http://www.fda.gov/NewsEvents/Testimony/ucm115242.htm
