Informed consent: A tool for patient education; Not merely a regulatory requirement

Abstract

Informed consent is an ethical and legal requirement for medical treatment. Informed consent is the process by which a blood center educates a donor and patient regarding their safety, benefits, and adverse effects using the twin tools of blood donor consent and blood transfusion consent. In case of other patient procedures, the health-care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. Consent by the patient may be implied (where a patient passively cooperates in a process without a formal consent), verbal (where the health-care professional provides information to patient regarding the procedure and its relevance through effective communication), or written. It is important for medical practitioners to have written and signed informed consent from their patients before performing any invasive or irreversible procedures. Informed written consent is also needed to publish scientific data regarding patient and incorporating images of the patients while publishing case reports. Written consent may have fixed formats or may be personalized adapting to the needs of the patient and the practitioner. The purpose of obtaining consent must be to make the patient understand the procedure planned and give him/her an opportunity to make a decision about whether to undergo the procedure or intervention. Informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision-maker is available. The process of informed consent is shifting-focusing more on communication and less on obtaining signatures. No matter how well worded the consent form is, if the patient does not understand what is being communicated, the purpose of it lost, and it does not stand well in the court of law. The present review addresses some of the vital issues and nuances regarding informed consent when providing medical care. Literature search for the present article was conducted using databases such as PubMed, Medline, and relevant articles published in peer-reviewed journals.

Keywords

• ethical
• informed consent
• legal
• tool