Informed Consent – Back to Basics

July 10, 2014

The Department of Health and Human Services’ Agency for Healthcare Research and Quality recently published notice of its intention to request that the Office of Management and Budget approve a proposed information collection project entitled “Improving Hospital Informed Consent with an Informed Consent Toolkit.” The Agency for Healthcare Research and Quality is concerned about the effectiveness of hospitals’ informed consent policies and processes. However, the issue of informed consent also affects other health care providers.

Whether you operate a hospital, long term care facility, physician practice, or other type of health care facility, you should be asking yourself the following questions about informed consent:

  • When is the last time you reviewed and updated your informed consent forms?
  • Does the informed consent form advise the patient of the risks and benefits of the proposed treatments or procedures?
  • Does the informed consent form advise the patient of alternative treatments and the risks and benefits of the alternative treatments?
  • Is the informed consent form easy to understand?
  • If your patient population has limited English proficiency, do you provide informed consent forms in other languages representative of your patient population or do you provide interpreter services?
  • Do you regularly review and update your informed consent forms to reflect new alternative treatments or newly discovered risks and/or benefits of existing treatments?
  • If you operate a long term care facility, do you have an informed consent form to obtain written consent from a resident who is competent prior to administering psychotropic medication?
  • Have you provided the patient with the opportunity to ask questions and have you adequately answered those questions?
  • Are your informed consent forms written in a way that minimizes liability?
  • Is the patient legally competent? If not, is the person signing the informed consent form the patient’s legally authorized representative?

If you have any questions about informed consent or would like assistance in updating your informed consent forms, please contact Rochelle H. Zapol, a partner in Prince Lobel’s Health Care Practice Group and the author of this alert. You can reach Rochelle at 617 456 8036 or

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