Informed consent doctrine

Abstract

Informed consent refers to an ethical and legal doctrine based on the understanding that all interventions (diagnostic, therapeutic, preventive, or related to scientific studies) in the medical field should only be performed after a participant has been informed about the purpose, nature, consequences, and risks of the intervention and has freely consented to it. The primary focus of consent should be on informing and protecting research subjects, through disclosure and discussion of relevant information, meaningful efforts to promote participants’ understanding, and by ensuring that decisions to participate, or to continue participating, are always made voluntarily. Informed consent is the ethical cornerstone of randomized clinical trials (RCT), where volunteers are given the option to participate in a trial that includes randomization or to remain outside the trial and receive traditional medical treatment. Mandatory condition for an informed consent include; provision of detailed information to a subject; adequate understanding of the information provided; expression of consent and/or authorization of the intervention. The researcher's primary moral responsibility is to design a clinical trial that will answer a research question without exposing human subjects to undue risks in the process. When fully informed subjects give their consent, acknowledge their role as research participants and take responsibility for their designated roles. Assuming that the research question is significant, the trial is well structured, and the risks to the individual patient are justified, the tension between collective ethics and individual ethics is obviated when individual subjects give their informed consent. This holds true if the primary intent of the investigator is to compare two treatments, not to provide better overall care to the subject. Implementation of informed consent can be considered as a sign of the growing patients’ welfare and rights movement, protecting various dimensions of their integrity, safety, and confidentiality. Obtaining consent does not necessarily employ disclosing the information; rather it demands comprehension of the information ensuring that the subject is, in fact, amicably informed. However the problems in attaining fully informed consent are well documented. In some situations, despite researcher's sincere efforts, subjects often fail to understand the nature or rationale for the research and hence are incapable of providing an informed consent. This reflects an important understanding that genomic research presents challenges for traditional models of informed consent, and provides opportunities for new models of consent and communication.