Clinical research studies are invaluable in enhancing evidence-based medicine as well as finding a resolution to medical challenges but are the most regulated type of research. Clinical trials tend to put the lives of individuals at risk thus the necessity for their close monitoring and regulation; a role played by the Food and Drug Administration (FDA) and ICH. The development of the clinical protocol is the initial step and the basis of clinical research study thus vital. The two bodies have set out standards that have to be accounted for in the design of clinical protocols with the main purpose of safeguarding the participants. The rules and regulations are founded on a concern for people’s welfare, justice and respect hence ensures that corporations involved in clinical research do not place their interests before people’s safety and dignity. The utilization of FDA regulations and ICH guidelines consequently enhances transparency and accountability thus safety and trust.
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Clinical researchers are expected by FDA and ICH to describe clearly how the clinical trial will be carried out. The clinical design protocol is supposed to provide information regarding aspects of the research that concerns and affects the participants. For instance, they ought to indicate the trial’s goals and objectives, methodology, quality control and assurance, safety and efficiency assessment, and the selection and exclusion criteria among others. The complete disclosure of relevant information that participants hold important to their wellbeing that assists them to make informed decisions regarding participation is an ethical demonstration of respect as required by FDA. The major aim of these guidelines and rules is to protect the participants’ welfare both emotionally and physically. They do minimize exposure to exploitation and risks associated with the intake of harmful substances during the research thus ensuring safety as indicated by Gallin & Ognibene (2012).
Nwabueze (2013) claims that utilizing ICH guidelines as well as FDA regulations in the clinical protocol design is vital in ensuring the participants’ safety and wellbeing. The ICH guidelines on the basic specification that should be included in the clinical trials’ design protocols such as methodology and quality control as well as assurance enhance transparency and accountability thus aiding to gain participants’ trust consequently increasing the level of participation motivation in providing honest data. The guidelines also act as a reference during the clinical protocol designing to ensure basic aspects are not forgotten. The application of ICH and FDA regulations aid in the appropriate evaluation of possible risk thus promoting safety and avoiding a possible lawsuit in case the trial goes wrong. The incorporation of ethical standards ensures the integrity of the data collected and preserves human rights thus encouraging participation as implied by DeRenzo & Moss (2006).
In summary, clinical research is the most regulated type of research because they directly concern human health thus risky if not regulated due to the possibility of exploitation that may result in the loss of lives. Therefore, the guidelines by ICH ensure that the clinical protocol is designed appropriately with a clear description of major research elements thus helping to minimize omission of those research aspects. Similarly, FDA regulations focus on safety and ethical standards about respect for human life which if considered would enhance transparency and accountability creating trust thus improving the level of participation as well as ensuring individuals’ safety.
Canadian Institutes of Health Research. (2013). Open Access Policy.
Chow, S.-C, & Chang, M. (2007). Adaptive design methods in clinical trials. Boca Raton, FL: Chapman & Hall/CRC.
Council for International Organization of Medical Science. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva.
DeRenzo, E. G., & Moss, J. (2006). Writing clinical research protocols: Ethical considerations. Burlington, MA: Elsevier Academic.
Gallin, J.I., & Ognibene, F. P. (2012). Principles and practice of clinical research. Amsterdam: Elsevier/AP.
Harmon, D. E. (2002). The Food and Drug Administration. Philadelphia: Chelsea House Publishers.
Machin, D., & Fayers, P.M. (2010). Randomized clinical trials: Design, practice, and reporting. Chichester, West Sussex: Wiley-Blackwell.
Meinert, C. L. (2013). Clinical Trials Handbook: Design and Conduct. Baltimore, MD: Wiley.
Nwabueze, R. N. (2013). Legal and ethical regulation of biomedical research in developing countries. Farnham, Surrey: Ashgate.
World Medical Association (2008). Declaration of Helsinki-Ethical Principles of Medical Research Involving Human Subjects.
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