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.
[1.] Alexander Gaffney, (2013). Revised
Declaration of Helsinki Published for Comment, Earning Scathing
Reviews.Regulatory Focus News, October, 2013. Retrieved from
[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
E. (1997) Fifty Years later: The Significance Of The Nuremberg Code. N Engl
J Med , 337, 1436-1440.
Trial design and patient safety-the debate continues. New England Journal of
S. G. (1999): The biotech death of Jesse Gelsinger. New York Times Magazine,