Informed Consent, Research Paper Example

Before undergoing any procedure, an individual has the right to completely understand their treatment.  By providing informed consent, patients are able to acknowledge that they agree with the recommendations of their healthcare provider and that they understand completely what the procedure or treatment will entail.  Having an individual’s informed consent is important in a healthcare environment to protect dignity and provide autonomy over the direction of their healthcare.

Informed consent is one aspect of a patient’s bill of rights, as it allows patients to direct the outcome of their healthcare.  This process helps to ensure that a patient is fully educated, aware of their options, and able to participate in their healthcare decisions.  It is the ethical and legal responsibility of healthcare providers to make sure that patients understand the nature of their decisions; this includes the risks, benefits, and the reasonable alternatives available.  The informed consent document must acknowledge the patient’s acceptance and comprehension and be in a language that is understood by the patient.  Though the document is designed to protect the healthcare providers, it cannot waive or appear to waive the healthcare provider from negligent behavior.

Informed consent as a legal process originated in 1979 when the Belmont Report was issued in the United States.  The Belmont Report summarized the ethical principles defined by the National Commission for the protection of Human Subjects of Biomedical and Behavioral Research. This allowed for three major principles to emerge: beneficence, justice, and respect for patients.  According to Smith-Tyler (2007), there are two sets of regulations regarding informed consent and they are “found in the Code of Federal Regulations Titles 21 and 45: 21 CFR 50 and 56, the Food and Drug Administration (FDA) regulations, and 45 CFR Part 46, where applicable, the Department of Health and Human Services (DHHS) Regulations.”  However, informed consent is one aspect in a patient’s bills of rights.  There is no set standard for a patient’s bill of rights; the American Hospital Association developed the first patient bill of rights in 1973 to ensure patients the right to privacy, information about their treatment and prognosis, care with dignity, and the right to refuse treatment.  A bill of rights helps to provide patients with complete information, fair treatment, and autonomy over medical decisions.

It is important to realize that informed consent should consist of not only a piece of paper, but a verbal discussion as well.  Healthcare providers may intentionally or unintentionally make patients and their families feel vulnerable in order to perform the treatment which they feel is best, regardless of the patient’s wishes.  Documents may be presented rapidly in medical and legal language and the patient may sign them without full understanding.  Though the healthcare provider may be legally protected, having a patient undergo a treatment or procedure without a verbal acknowledgement from them or their legal representatives violates their rights.

According to O’Neill (2005), a patient’s rights are violated as informed consent cannot be given by the very young, mentally impaired, unconscious, or confused.  O’Neill points out that people are usually unable to give informed consent in emergency treatment.  Fatigue and malaise from an illness can interfere with the ability to fully comprehend fully the treatment or procedure recommendation, even if the patient is in full possession of their mental facilities.  Prisoners, soldiers, and those who are dependent have their rights to informed consent violated because they are unable to refuse selected procedures or treatments, even though they are fully competent.

Advance directives are legal documents that enable patients to dictate their decisions about end-of-life care while they are in complete possession of their mental facilities.  Confusion is avoided because family, friends, and healthcare providers have documentation of the patient’s final wishes.  These directions involve important issues such as breathing and dialysis machines, resuscitation, tube feeding, and organ and tissue donation.

Keeping patients informed of their healthcare and medical decisions is the legal and ethical responsibility of all health care providers.  A patient’s bill of rights covers both informed consent and advanced directives to ensure as much patient autonomy as possible.  By respecting the patient’s wishes, healthcare providers can help patients receive the care which they desire and still maintain their dignity.


O’Neill, O. (2005). Some limits of informed consent. Journal of Medical Ethics, 29(1), 4-7. doi:10.1136/jme.29.1.4

Smith-Tyler, J. (2007). Informed consent, confidentiality, and subject rights in clinical trials. Proceedings of the American Thoracic Society, 4(2), 183-193. Retrieved from