Medicolegal Issues

Informed consent: The more you know, the more you and your patient are protected

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The clinical opportunity of informed consent

More than a technical legal doctrine, informed consent provides ObGyns an important opportunity for better communications with patients, and is a chance to create reasonable expectations and a more therapeutic relationship that involves the patient in care and decision making. It is likely that engaging the patient in good informed consent processes can set the stage for improved outcomes.

Interactive dialogue with the patient is one advised approach.10 This undertaking in part reflects that, as patients have more ready access to information in the digital age, they are positioned to play a more active role in health care decision making.

The benefits of informed consent are likely to be greatest if you view the process not as a technical legal requirement but as an excellent opportunity to engage the patient in her own care and treatment. Planning, intervention, and evaluation of care options as well as education regarding the medical problem at hand are integral to the informed consent process. And, of course, the right to consent is a “basic patient right” that in a sense guarantees that he/she has the right to make informed decisions regarding one’s care.6

Special considerations

Informed consent most often is associated with but not limited to surgical procedures (often performed with the use of surgical instruments and/or devices). It applies to diagnostic interventions as well as treatment. The more invasive or risky an intervention, the more important it is that the information is thorough.14,15

Pharmaceuticals have informed consent issues. The theory has been that pharmaceutical companies inform physicians of the risks and instructions for the use of pharmaceuticals and the physicians inform the patients. Indeed, traditionally pharmaceutical companies have gained immunity for “failure to warn” patients because the physicians were the “learned intermediaries” providing information to the public. Patient package inserts and pharmacists have taken over the informational role, but informed consent does apply to pharmaceuticals.

It is also worth noting that informed consent in any formal research study or the trial of new techniques, compounds, or devices requires a special process of approval by an institutional review board.

Set the stage for best outcomes

The main objective of informed consent is promoting the autonomy of your patient. That requires that she understand the risks, benefits, and alternatives associated with the procedure and the risks associated with a refusal of treatment. Done properly, this can result in your patient gaining confidence and trust in you as her provider.

Informed consent is a process that reflects our interactions with our patients. It is part of the broader commitment by the medical profession to “first do no harm.”

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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