	Toolkit Contents

	Introduction What is Informed Consent? Why Do We Need to Improve It? How Can This Guide Help You? Background Requirements for Informed Consent Understanding the Barriers to Informed Consent Understanding the Impact of Health Literacy on Informed Consent Evolving Best Practices in Informed Consent How to Improve Your Informed Consent [1] Gain Organizational Consensus [TOOL 1A] Staff Training Slides [2] Assess Status & Prioritize Needs Survey and Questionnaire Mini-Study, Audit, or Inventory [TOOL 2A] Survey to Assess the Status [TOOL 2B] Audit for Measuring Compliance [3] Improve Your Written Consent Forms and Other Educational Materials [TOOL 3A] Style Guide [TOOL 3B] Checklist For Assessing the Informed Consent Form [TOOL 3C] Patient Pretest [4] Improve Your Consent Process [TOOL 4A] Checklist for Patients Appendicies [A] Evidence Review: Informed Consent in Practice [B] Barriers to Effective Informed Consent [C] Sample Consent Forms References Resources Authors/Reviewers

Background:

Requirements for Informed Consent

Informed consent is an ethical concept—that all patients should understand and agree to the potential consequences of their care—that has become codified in the law and in daily practice at every medical institution. One of the earliest legal precedents in this area was established in 1914 when a physician removed a tumor from the abdomen of a patient who had consented to only a diagnostic procedure (Schloendorff vs. Society of New York Hospital). The judge in this case ruled that the physician was liable for battery because he violated an “individual’s fundamental right to decide what is being done with his or her body.” [Edwards 1998, Wescott 2005] The first case actually defining the elements of informed consent occurred in the late 1950s and involved a question of potential negligence and whether a patient was given sufficient information to make a decision.

The case law and rules pertaining to informed consent have changed over the years and all 50 states now have legislation that requires some level of informed consent. [Pape T 1997] Although the details of these laws vary from state to state, the bottom line is that failure to obtain informed consent renders any U.S. physician liable for negligence or battery and constitutes medical malpractice. [Pizzi 2001] Exceptions are made for emergencies or legally adjudicated mental incompetency or physical incapacity. Several of the common elements required for full disclosure have been summarized by the American Medical Association (Table 1) and other groups representing specialists or quality assurance organizations. [AMA 1998] For example, federal regulations spell out the minimum requirements for a properly executed informed consent form (Table 2) and state that this form must be in the patient’s chart before surgery. [CFR Title 42] These regulations also stipulate that the information must be given in a language or means of communication that the patient understands. The U.S. government requires interpretation and translation services for individuals with limited English proficiency at institutions that receive federal funding; these regulations also state that informed consent forms must be translated into languages spoken by 5% or 1,000 of a provider’s patients—whichever is less. [Executive Order 13166]


	[Table 1] The Basic Features of Everyday Informed Consent
	The physician (not a delegated representative) should disclose and discuss:
	The diagnosis, if known The nature and purpose of a proposed treatment or procedure The risks and benefits of proposed treatment or procedures Alternatives (regardless of costs or extent covered by insurance) The risks and benefits of alternatives The risks and benefits of not receiving treatments or undergoing procedures Source: AMA 1998

	[Table 2] What’s Needed on the Informed Consent Form
	Name and signature of the patient, or if appropriate, legal representative Name of the hospital Name of procedure(s) Name of all practitioners performing the procedure and individual significant tasks if more than one practitioner Risks Benefits Alternative procedures and treatments and their risks Date and time consent is obtained Statement that procedure was explained to patient or guardian Signature of person witnessing the consent Name and signature of person who explained the procedure to the patient or guardian Source: Federal Code (Title 42 C.F.R. § 482.51 (b) (2)) Interpretive Guideline A-0392

Which procedures require informed consent? Unfortunately there is no continually updated national list describing exactly when informed consent is required. Again, it varies from state to state and is also influenced by clinician or hospital interpretation of recommendations from professional and specialty groups.

For example:

Pennsylvania state law specifically requires that consent be obtained for blood transfusions, chemotherapy, and methadone use as part of a narcotics treatment program. [PA Law Code]

Many states have developed specific laws governing breast cancer diagnosis and treatment. [ACS 2007]

The American College of Obstetrics and Gynecology has developed detailed guidelines for informed consent issues related to sterilization and carrier testing for cystic fibrosis. [ACOG 2004]

Increased levels of institutional quality (e.g., compliance with accreditation standards)

Potential time and money savings (or offsets) related to reduced litigation

Thus, based on guidance from staff and counsel, each institution generally develops its own list of surgeries, procedures, or situations where full informed consent is needed. [Manthous 2003] In fact, the Joint Commission (formerly known as the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) has set a standard that hospitals must establish and follow policies that describe which procedures or care, treatment, or services require informed consent. [Joint Commission 2005] One of the first steps recommended in the next section is to clarify your institution's policies about when informed consent is required.

Another area subject to local interpretation is exactly how much to disclose. How many potential risks must be described, for example, and how many alternatives must be mentioned? While many states rely on a standard of what a “reasonable physician” would provide or what a “reasonable patient” would need, this still leaves room for interpretation. [ACS 2007, Westcott 2005] Most laws describe the need to cover all “material” (i.e., significant) risks. But common sense suggests that not every potential risk can be described in detail and that only the most prevalent and/or serious risks and side effects would be covered. [Wescott 2005] The number and type of complications also may vary widely depending on the severity of the patient’s underlying conditions or comorbidities (e.g., pneumothorax following central vein catheterization may not be life-threatening in a patient admitted for a soft-tissue abscess but could be extremely risky in a patient receiving mechanical ventilation for severe acute respiratory distress syndrome). [Manthous 2003] How can a single form cover both situations? Further complicating the issue, of course, is the fact that there are limitations and variations in the capacity of individual patients to comprehend many of these details—and therefore the information needs to be tailored for each individual.

It is precisely these gray areas in the requirements for informed consent—When is it needed? How much is needed? And how can I make sure the patient understands?—that have opened the door for many of the documented failures of informed consent in everyday practice. (See below: “Informed Consent in Practice” and Appendix A) One common defensive response to the uncertainties about how much to disclose, for example, is use of “blanket” informed consent forms that contain only boiler-plate generalities that “all potential risks and side effects and alternatives have been explained and understood by the patient.” If such a generic consent form is accompanied by genuine documented education involving appropriate explanation and printed material, this may work. (Attorneys also usually advise clinicians to document the details of this interchange in the patient’s record. [Wescott 2005, AMA 1998]) But on its own, an overly generic consent form without any significant accompanying education and interchange—that is, a quick request for a signature while the patient is on the gurney—is not adequate. On the other hand, an exhaustive list of all the potential risks may be difficult for patients to understand. (Attorneys reviewing such a list would also likely point out that any omission from such a long and seemingly comprehensive list might be a red flag, and that such a form would therefore need to state that the list is not inclusive. [AMA 1998])


	[See Appendix A]
	Informed Consent in Practice
	How often does informed consent work as intended? How do your practices match up to the national norms for informed consent? How does one even begin to measure the “success” of informed consent? These are complex questions that have been tackled by clinicians and researchers from different settings and perspectives. Many studies have focused on one therapeutic area of interest. Others have analyzed the consent process only in the research setting. And some have evaluated the process in targeted patient groups such as those with low literacy. Reviewing the results from such studies provides a sense of the problems that must still be overcome in planning for and delivering informed consent in everyday clinical practice. See Appendix A for a review of the clinical literature evaluating what works and what doesn't work in informed consent. While much of this data comes out of the clinical research setting, many of the broader “lessons learned” in these studies are highly applicable to the setting of everyday informed consent.

Thus, even a brief review of the requirements for informed consent reveals the complexity at multiple levels of ethics, law, and effective medical communications. This guide is meant to help you, in partnership with your legal staff and clinical team, navigate these gray areas and, at the end of the day, be set to provide consistently high-quality informed consent. A key part of the solution that will be repeated throughout this publication is that informed consent requires more than just a good written form—it also requires preparation for a full discussion with the patient and a check to ensure that the messages have been received.