Ethical conduct during clinical trials

The ethical conduct of all clinical researchers is of supreme importance. Participants in all clinical trials are volunteers while the word volunteers is typically exclusively used to describe participants in human pharmacology studies, all participants in all clinical trials are, by definition, volunteers (see Turner, 2007). Individuals participate in clinical trials for the greater good, not specifically to benefit themselves. Everyone involved in clinical research has an obligation to conduct all aspects of this research to the highest ethical standards. 

Several fundamental ethical principles guide drug development research in clinical trials (see Turner, 2007)  

The topic of ethics in clinical trials is addressed again in Section 3.16.1, where we talk about ethical considerations in choosing the nature of the control treatment used in trials involving investigational antihypertensive drugs. 

It is appropriate here to highlight the additional ethical responsibilities that are shouldered by those involved in statistical aspects of clinical trials, as outlined in the operational definition of Statistics presented in Chapter 1. Derenzo and Moss (2006) addressed the importance of ethical considerations in scientific and statistical aspects of clinical studies  

Each study component has an ethical aspect. The ethical aspects of a clinical trial cannot be separated from the scientific objectives. Segregation of ethical issues from the full range of study design components demonstrates a flaw in imderstanding the fundamental nature of research involving humans. Compartmentalization of ethical issues is inconsistent with a well-run trial. Ethical and scientific considerations are intertwined. 

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Investigator site audits are probably the most frequent type of audits conducted by clinical QA departments and, therefore, deserve particular attention. The purpose of investigator site audits is to assess compliance with the GCP regulations (with a focus on the country-specific regulatory requirements) and the protocol. Further, thesafety of the trial participants, the ethical conduct of the trial and the validity, completeness and accuracy of the data collected and recorded are verified during the audit. 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

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