HPSO 2007 Webflash

Failing to obtain informed consent is a common secondary issue cited in professional liability complaints; how to avoid such complaints is the subject of an article in the 2007 HPSO Risk Advisor. You may think that only surgeons, physicians and nurse practitioners really need to worry about informed consent. But think again.

These days, any healthcare provider who directly treats patients may be considered responsible in one way or another for educating them and ensuring that they've consented to treatment. Even when you're not legally required to obtain consent, skipping this important process can increase your odds of being sued, the amount of damages a plaintiff seeks, or both.

What consent entails

In a nutshell, informed consent means you provide enough information to allow a patient to make an informed decision. You should explain your assessment of the problem and the proposed treatment. Also, outline the intended benefits, the potential risks, and what could happen if the patient refuses the treatment. If someone else is to perform the intervention or if any alternative approaches are available, clarify those points, too. Invite the patient to ask questions, and make sure you answer them. You may consider using handout materials for certain treatment options or directing the patient to a book, journal, or trusted Web site where he or she could learn more about the subject.

It's equally important to ensure that the patient really understands what you've explained. Nearly half of American adults have trouble understanding and acting on health information, according to a 2004 report from the Institute of Medicine.1 Language barriers or illiteracy can limit a patient's comprehension. So, too, can using routine medical jargon, so whenever possible use plain-language substitutions. Instead of saying or writing "oral," for instance, consider using "by mouth."

Competency is another issue you may need to consider. If a patient is elderly, mentally ill, or has other impairments that may affect his or her ability to make informed healthcare decisions, find out whether that person could be considered incompetent under state law. If so, you may need to get consent from a family member or legal guardian. Routine procedures (like taking a patient's blood pressure) usually require only implied consent (for instance, the patient raises his arm so you can put on the cuff). But, for anything involving some level of risk, the patient must explicitly permit you to proceed. The law may not always require that consent be given in writing, but having patients routinely sign informed consent forms is a simple way to document that the patient was informed about the treatment and agreed to it.

If a patient is just too nervous or squeamish to discuss medical issues, he or she may tell you to skip the informed consent discussion and just go ahead with your proposed treatment. Before you do that, ask him if you can bring in one or more family members whom he trusts, so they can hear about the treatment, ask questions, and help him make the decision that's best for him. Carefully document his response and all other details of the encounter. If the patient still insists on avoiding the discussion, have him sign an informed consent waiver.

Know the details for your state and profession

To protect yourself, you must find out what, if any, specific requirements your state's statutes or common law impose and follow any policies or procedures your employer has instituted. It's also wise to abide by any ethical standards recommended by professional organizations in your field.

And speaking of your field, be sure you are aware of informed consent issues that are particularly relevant to what you do. For counselors, taped or recorded sessions may call for consent in writing that explicitly addresses how the tapes will be stored and for how long, and how they may be used. Similarly, consent may also be required in situations involving healthcare or counseling conducted through electronic means.

For the pharmacist, informed consent means more than just dispensing drugs and information about them, such as potential side effects. Pharmacists' legal and ethical obligation to counsel patients means they must ensure that patients understand the disclosed information. If a pharmacist senses that a patient is reluctant to take a prescribed medication, it's important to find out why, in case the decision is based on flawed information or unreliable sources, or to contact the prescribing physician to see if an alternative may better suit the individual. That way, if the patient still refuses treatment it will be an informed decision.2 In a case like this, be sure to document the refusal. You may even consider having the patient sign something stating that he or she refused treatment.

Physical therapists, for their part, need to take extra precautions before proceeding with heat treatments because burns resulting from therapeutic heat commonly trigger malpractice suits. Make sure you carefully explain the treatment, get the patient's consent (preferably written), and emphasize that he or she should immediately alert you to any discomfort. During the treatment, be sure to monitor the patient and the equipment. And, above all, document, document, document.

Getting help

Professional organizations in your field of practice may offer guidance in preparing informed consent forms and your role in educating patients and obtaining consent. The American Physical Therapy Association and the National Association of Emergency Medical Technicians, for example, both provide form templates on their Web sites that members can use as written or adapt to their own needs. The American Psychological Association offers a HIPAA compliance product that includes a psychotherapist-patient agreement specifically designed for each jurisdiction and customizable to suit the therapist's practice. The American Counseling Association doesn't provide form templates but does offer informational articles and guidelines about informed consent.

Whatever your area of practice, always keep the doctrine of informed consent firmly in mind to minimize your chances of a professional liability claim. It's one of the best ways to protect your patients--and yourself.


  1. Institute of Medicine. Health literacy: a prescription to end confusion. Report brief. www.iom.edu. (Oct. 10, 2006).
  2. Wick JY, Zannie GR. Informed consent: what every pharmacist should know. J Am Pharm Assoc. 2001; 41:523-527.