Informed consent ethical basis

Informed consent is in some sense the ethical cornerstone on which human subjects protection rests. It requires that individuals understand their part in a study and the potential consequences, and are free to choose to participate. As Levine has argued, the consent process should include specific elements an invitation to participate a statement of the purpose of the study the basis of participant selection and explanation of procedures, risks, and discomforts how untoward consequences will be handled the benefits of participation alternatives to participation financial consideration confidentiality opportunities for continuing disclosure and measures for ensuring that a person s decision to participate is voluntary (Levine, 1981). 

All consent documents and the entire informed consent process should be designed and implemented to be in compliance with the above-stated regulations, as well as consistent with the principles of the Declaration of Helsinki, World Medical Assembly, Revised 1996, 48th General Assembly, the accepted basis for clinical trial ethics incorporated into the ICH GCP Guideline. 

Efficacy non-inferiority trials are often conducted in situations where a placebo-controlled trial would not be ethical, for example, when there exists effective therapy for a serious or life-threatening condition. Despite this, the ethical basis for non-inferiority trial has been called into question. For example, Garattini and Bertele (2007) argue that"... it is unethical to leave to chance whether patients receive a treatment that is anticipated to provide no extra benefit, but could be less safe and less effective than existing treatment options." While their comments were in the context of efficacy non-inferiority trials, the issue could be even greater in the context of a safety non-inferiority trial. The primary objective of a safety non-inferiority trial is to determine whether or not an experimental treatment causes an important harm on this basis alone, there would be little incentive for a prospective patient to participate. Patients must be fully informed of the purpose of such a trial, including the potential benefits and harms, before they can consent to participate. 

On the basis of the available prechnical data and on predefined clinical trial plans, ethics committees will evaluate whether the anticipated benefits and risks would justify clinical testing. In addition, local regulatory authorities must be informed and may deny consent. The clinical trial product must be made in compliance with Good Manufacturing Practices with increasing demands (e.g. regarding the qualification of equipment and facihties, product specifications, and validation of methods) as the trials proceed to later phases. 

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