Informed Consent Process, the Bane of Unethical Clinical Research, a Review

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Authors : Augustine Onyeaghala


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. 


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