Responsibility Of Parties To Informed Consent

It is the responsibility of all parties to the informed consent that all parties remain within its ethical and practical constraints. The Informed Consent document is essentially an agreement between Ethics Committee, investigator and patient. However, for example, an investigator is also responsible for the patient's role in the informed consent; if the investigator suspects that the patient is not truly informed, even in the absence of any deficiency on the part of the investigator, then the investigator should nonetheless police the patient's part of the agreement. This is entirely different from the notion of a contract, where each party to the contract is responsible only for fulfilling its own commitments.

Audit and policing of some of the elements listed above may also form part of the duty of a regulatory authority. For example, in the USA, the Food and Drug Administration (FDA) will audit institutional review boards (IRBs) and issue citations if the IRB is not ensuring that written informed consent documents are complete and appropriate. FDA will also audit study sites, and discipline investigators (including prosecution) who do not ensure that appropriate informed consent procedures are being followed.

Although under law it is not the primary responsibility of the typical pharmaceutical company, it nonetheless behooves pharmaceutical physicians to ensure that appropriate informed consent is being obtained in all company-sponsored studies. Many companies recognize this within their own Standard Operating Procedures, and create patient files that require a copy of the signed informed consent. Investigators will often be grateful if the company will draft an informed consent document that complies with the guidelines, which the investigator can submit to the ethics committee or IRB.

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