Informed consent is the process in which a patient is given information to make an informed decision about whether he or she will pursue a particular treatment or procedure. Informed consent is essential for the patient to understand how a particular treatment, surgery, pharmaceutical drug, or implanted device will affect his or her body. Because the standards of informed consent vary from state to state, physicians are governed only by their ethical code, state regulatory authorities, and the nebulous “standard of care” applicable to all medical professionals. However, doctors seldom provide sufficient information for a patient to make a genuinely informed decision about invasive procedures. Furthermore, the concept of informed consent must be expanded to the prescribing of drugs and implants. Drugs and implanted devices can be viewed as an invasion to one’s body and are no less significant and dangerous than surgical procedures.

Types of Informed Consent

There are two basic types of informed consent. These are provider-centered informed consent and patient-centered informed consent. Provider-centered informed consent is generally for the protection of the medical provider from liability for failure to “inform” the patient before invading his or her body. Patient-centered informed consent is intended to deliver sufficient information to the patient that he or she can make an intelligent decision, in cooperation with the doctor, about the best way to proceed.

State Laws Governing Informed Consent

There are two ways laws are applied to informed decision. One is a standard built around what a “responsible body of physicians deems important.” The other is built around what a “reasonable patient” would want to know. In the U.S., states are almost evenly split on which standard has legal standing. These are directly parallel to the types of informed consent described above. The “reasonable patient” standard seems to be defined only after the fact when a patient alleges that he or she was not informed of the consequences of an invasive procedure. The jury in such a case then decides whether a “reasonable patient” would have wanted to know the missing information.

Decision Aids

The old complaint from doctors that they do not have enough time to give genuine informed consent has fallen away as high-quality decision aids have become available. Reputable decision-aid sources are shown in the box below.

Decision Aid Sources

• Mayo Clinic
• Kaiser Permanente
• The Ottawa Hospital Research Institute (AHRQ makes reference to this source)
• http://www.med-decs.org/en/reliability (huge database of decision aids, read reliability first)

Expanding Informed Consent to Medications and Implanted Devices

It is common for patients to be surprised by the side effects of drugs or devices used in their treatment Serious side effects are more common if a drug is prescribed off-label, but even on-label prescribing can cause serious harm or death. A drug is off-label if the FDA did not approve it for the patient’s specific condition or age group. For example, some drugs approved for adults are off-label for children, adolescents and the elderly. There is a major push by the pharmaceutical industry to promote off label use of drugs or devices if there is evidence of effectiveness.

An additional risk comes from use of drugs that have a “black-box” warning. These are drugs that just missed being removed from marketing by the FDA based on data accumulated after FDA approval. Black box warnings are the strictest labeling requirements that the FDA can mandate. First implemented in 1979, black box warnings highlight serious and sometimes life-threatening side effects. The general supposition is that the patient will read the drug label and insert, and thereby determine if it is a black-box drug. This is insufficient. There must be a discussion about side effects, initiated by the prescriber well before the patient is handed the drug and its insert at a pharmacy. Michelle Llamas, senior writer at Drugwatch reports that “We get many patients writing to us about tendon problems with a class of antibiotics called fluoroquinolones (Cipro, Levaquin). The FDA placed a black box on these drugs in 2008. But, many patients still tell us they were not made aware of these issues by their physicians or were told they were so rare it would not happen to them.”

Report drug side effects at: https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm. All of the above issues surrounding prescription drugs apply to devices that are implanted in the body.

The Empowered Patient and Informed Consent

A patient that knows about the informed consent process is better able to make informed choices. A checklist to use during the informed consent process can be very helpful. Presenting the checklist to the clinician before discussion of whether to accept the recommended medication or procedure enables patients to make a more informed decision. The box below contains such a checklist. You may need to adapt the checklist to your specific situation.

Reasonable Patient’s Informed Consent Checklist

• What are all my options for treatment of my condition or illness, and what are the risks and benefits of each? Please be specific concerning risks and benefits of each choice I may have.
• If an invasive diagnostic procedure is recommended, how will the results of the procedure change my treatment plan?
• Will the recommended invasive procedure be according to evidence-based guidelines? If not, then please explain in detail why not.
• What harm might I experience if I choose watchful waiting? Please be specific about known risks of doing this.
• May I view objective decision aids for my disease or illness.
• Who will perform the recommended invasive procedure and how will trainees be involved?
• If I choose an invasive procedure, what will my recovery be like? Will I have restrictions on my lifestyle during or after recovery? What are the chances I’ll have lasting pain?
• Will any drugs prescribed to me be off-label or have a black-box warning? If so, please characterize the risks of those drugs and explain why a less-risky drug cannot be prescribed.

KNOW YOUR RIGHTS as a PATIENT, provided by The Joint Commission, an independent, not-for-profit organization that accredits and certifies nearly 21000 health care organizations and programs.

​What is Informed Consent? Conformed consent is a PROCESS that can make a life or death difference for patients.

​Pre-Procedural checklist. for TRUE Informed Consent, an Empowered Patient fact sheet

​Code of Federal Regulations, MEDICARE CONDITIONS OF PARTICIPATION FOR HOSPITALS. Section 482.13 applies specifically to Patients Rights.