In many circumstances, before doctors and other medical professionals can provide patients with a course of treatment or other procedure, it is necessary (even required) to obtain the informed consent of the patients. One common way for medical professionals to obtain and document that the patient's consent has been given for the procedure is by having the patient sign or fill out a consent form.

But do patients truly understand exactly what they are consenting to? A new study indicates that often patients may not. Patients who do not fully understand the risks involved in a study or medical procedure and are subsequently injured, may look for help from attorneys experienced in medical malpractice law.

Not Fully Informed Consent?

A recent study by the New England Journal of Medicine suggests that many of the consent forms used in medical research studies are written at a level too high for the average participant to understand. The study found that the reviewed consent forms were written three reading levels above what institutional review boards (IRB) recommend. IRBs recommend consent forms be written at a grade-8 level and the reviewed forms were written at a grade-11 level.

Conducted by Madhav Swaminathan, MD, the director of perioperative echocardiography in the Division of Cardiothoracic Anesthesiology and Critical Care Medicine and an associate professor of anesthesiology at Duke University School of Medicine, the study analyzed 15 consent forms using "five validated, standardized readability tests."

Discussing the results of the study with Anesthesiology News, William Tremaine, MD, director of the Office of Human Research Protection at Mayo Clinic, said that consent forms need to be only part of the process of obtaining informed consent. He said: "Potential participants need to have an opportunity to ask questions, including questions about the meaning of words and phrases in the written consent documents. They need to get answers in lay language they can understand so that they are fully informed about the details of the study."

In addition to being beneficial to patients, Dr. Swaminathan said that the results of the study could positively affect medical research studies: "Subjects who do not fully understand a consent form may initially consent to participate, but withdraw after realizing they are receiving an intervention or procedure they did not understand or agree with at the outset of the study."

While this study of consent forms only looked at documents used for medical studies, the results raise possible questions and concerns about the process of obtaining informed consent in other aspects of medical care and treatment, specifically in patient care.

Informed Consent

Generally speaking, informed consent is the process of discussing the potential benefits and risks of a course of treatment, surgical procedure or other care, along with any alternative treatment or procedures that may exist, with patients so that they can make a fully informed decision about their medical care. Patients ultimately provide their consent or authorization for a medical procedure by signing a document that acknowledges they were provided with the information necessary to make the decision.

The process of obtaining informed consent from patients should be more than just signing a document, but actually be a conversation between physician and patient. This is especially important with surgical procedures, which inherently carry many risks. A conversation with the patient not only clarifies the dangers involved, but may also help the physician avoid surgical mistakes.

To help ensure that patients provide informed consent, the American Medical Association (AMA) suggests that medical professionals discuss and disclose certain information with their patients, including:

  • Patient's diagnosis;
  • The proposed treatment or procedure's nature and purpose;
  • The proposed treatments or procedure's risks and benefits;
  • Any alternative treatments or procedures that may be available;
  • The alternative treatments' risks and benefits; and
  • The risks and benefits of foregoing any treatments or procedures.

The AMA notes that the treating physician should speak to patients when seeking consent for a procedure, this should not be delegated to a nurse or other medical professional.

The informed consent process is not just a one-way street. Both the AMA and Dr. Tremaine state that patients, whether about to participate in medical research or undergo a procedure or treatment, should be afforded the opportunity to have any questions or concerns clarified and answered before providing consent.

Informed consent may be necessary in many instances - and absolutely necessary in some instances, like medical trials - but it is not needed in every instance. For example, routing "procedures" during an exam or check up and emergency situations will not require doctors to obtain informed consent.

If you believe you were not fully informed of the entire situation before undergoing a medical treatment or procedure, speak with a medical malpractice attorney. An attorney can help you get to the truth of the situation, did the doctor not personally speak with your about the procedure or treatment or answer your questions? Was the document you were asked to sign too complicated to understand? Or was there another reason that you were not able to provide informed consent?


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