Abstract:

Clinical Research is a branch of medical science that experiments new drug, medical device or biological on human subjects prior to approval. For the study to be credible, unbiased and generally applicable, all ICH-GCP regulations, other international and local regulations governing ethical clinical research studies should strictly be adhered to. The current regulations for clinical research are based on a combination of ethical thoughts and history. Ethics is different from law and regulation, both of which mandate a certain way of acting. The United States regulations for the protection of human subjects and other regulatory agencies from different countries have provided minimum baseline with which everyone must comply in operating an institutional review board (IRB), obtaining informed consent from research subjects and conducting research in an ethical manner.

The challenge, especially in a practical environment such as clinical research, is to translate these regulatory documents, provisions and different ethical principles into action. In clinical research, the consent of the research participants should be received before they are enrolled for trial. Many years after the document governing ethical principles of clinical research was developed and addressing three major areas: respect for persons, beneficence and justice, abuse of informed consent process has been a major ethical problem in most clinical research conducted across the globe and especially those conducted in Africa.

Is informed consent process well administered? Do these patients have a good comprehension of the entire research process? Is informed consent a mere signing of a paper to participate in a trial, or a continuous process?. Is there a better way of administering informed consent to achieve a better research outcome that will benefit all? This review shall focus on recalling history of abuses of informed consent process and ways to correct the unethical practice shall be discussed. 

References:

[1.] Alexander Gaffney, (2013). Revised Declaration of Helsinki Published for Comment, Earning Scathing Reviews.Regulatory Focus News, October, 2013. Retrieved from www.raps.org/focus.

[2.] David Perlman, (2004). Ethics in Clinical Research A History of Human Subject Protections and Practical Implementation of Ethical Standards. Society of Clinical Research Journal, May, Pp 37-41.

[3.] Indrajit Basuaddd, (2004). India's clinical trials and tribulations. South Asia in Asia Times, July, 23.

[4.] Ketan, D. (2005). The ethics of Clinical Trial in India: An Indian perspective. Journal of Clinical Research Best Practice Vol 1, No.12

[5.] Mitscherlich, A.., Mielke, F. (1992). Epilogue: Sever Were Hanged. In: The Nazi Doctors and The Nuremberg Code - Human Rights in Human Experimentation. Edited by Annas GJ, Rodin MA. New York: Oxford University Press; pp: 105-107.

[6.] Nancy, E. K. et al (2007): The structure and function of Research Ethics Committees in Africa: A Case Study. Retrieved from www.plosmedicine.org.

[7.] Onyeaghala, A..A.,(2008). Pharmaceutical companies, clinical trial in Africa and Good Clinical Practice. Retrieved from www.ibpassociation.org/IBPA_articles/april2008.

[8.] Rothman, D.J. (1991). Strangers At The Bedside: A History of How Law And Bioethics Transformed Medical Decision Making.: Basic Books; New York ,USA, ISBN : 0-465-08210-6 .

[9.] Robert, V., Carlson, Kenneth, M., Boyd and David Webb (2004). The revision of the Declaration of Helsinki: past, present and the future. British Journal of Clinical Pharmacology, 57:6 PP 695-713.

[10.]         Shuster, E. (1997) Fifty Years later: The Significance Of The Nuremberg Code. N Engl J Med , 337, 1436-1440.

[11.]         Steinbrook,(2003). Trial design and patient safety-the debate continues. New England Journal of Medicine. 349:629-630.

[12.]         Stolberg, S. G. (1999): The biotech death of Jesse Gelsinger. New York Times Magazine, Novenmber,28.