Quick Safety Issue 21: Informed consent: More than getting a signature (Updated April 2022)

February 11, 2016

Updated: April 2022

Issue:

There are numerous challenges to implementing an effective informed consent process – that is, one in which the patient fully understands the health care treatment or surgical procedure they are agreeing to undergo. Even after signing a consent form, patients frequently do not understand the risks, benefits and alternatives involved in their course of treatment or surgical procedure – all of which are imperative for a patient to provide valid authorization.¹ 

Stated simply, informed consent in medical care is a process of communication between a clinician and a patient that results in the patient’s authorization or agreement to undergo a specific medical intervention (see sidebar box for The Joint Commission’s glossary definition). In addition to the process of communicating to their patients, clinicians are concerned with obtaining the evidence of consent that serves to document their legal and ethical responsibility.

Unfortunately, the emphasis on obtaining a patient’s signature as documentation of informed consent results in varying effectiveness of the communication between a clinician and a patient.^1,2 The process of obtaining informed consent is an essential aspect of patient-centered care and remains central to patient safety. The Joint Commission’s Sentinel Event database includes 49 reports of informed consent-related sentinel events over the 2010-2021 timeframe; 36 of the reports were specifically related to wrong site surgery, and six were related to operative or post-operative complication. Other reports were related to elopement, falls, medication errors, unintended retentions, and suicide.

Barriers to Understanding

There are many barriers that contribute to a lack of understanding on the part of the patient, including:

• A lack of basic information on the consent form. One research study found that four basic elements of informed consent – nature of the procedure, risks, benefits and alternatives – were included on the consent forms only 26.4% of the time.³
• Ineffective provider-patient communication and lack of shared decision-making between patient and provider. Effective provider communication and shared decision making have been shown to improve the adequacy of the informed consent process.^1,2,4,5,6,7 Improved communication of information to patients and families enhances their trust – even in situations where caregivers have unwillingly harmed patients through system failures and predictable human error.^8,9
• Lack of consideration of the health literacy of patients when developing informed consent communication forms and other materials.^10,11 One study highlights how adoption of a new health literacy-based consent form and process stimulated patient provider communication, enhanced patient comfort in asking questions and influenced the use of teach back (a health literacy-based technique) in the perioperative setting.¹²
• Lack of consideration of cultural issues of patients when developing informed consent communication forms and other materials.^12,13 Cultural sensitivity is paramount to obtaining informed consent. In some cultures, the decision-maker is designated by the group; a signature on a piece of paper as opposed to verbal consent may convey a lack of trust; illegal immigrants may be reluctant to sign for fear of deportation; and in some Asian immigrants, the patriarch or a male designated by the family must be consulted.^13,14,15,16

Safety Actions to Consider:

Health care organizations can improve the process of informed consent and enhance the safety of their patients by doing the following:

• Promote the notion of informed consent as a process of effective communication between a provider and patient and not a signature on a form.^17,18
• Have clear written policy on informed consent for care, including:
  • Procedures requiring written consent
  • Professional roles in the informed consent process
  • Use of qualified medical interpreters
  • The role of patients’ substitute decision makers
  • Timing of informed consent
  • Nature of a complete informed consent process
  • Documentation and verification process
  • Related tools and resources available for provider use to enhance the informed consent process
• Provide a formal training program to physicians on effective provider-patient communication and shared decision-making and the impact on informed consent and patient safety.
• Simplify the content, length and language of informed consent documents and patient education materials.
• Implement policy and interventions for patients with limited health literacy, limited English proficiency, or visual or hearing impairments, and emphasize the use of qualified medical interpreters.
• Make available appropriate communication tools and materials based on patient’s cultural and language preferences.
• Provide tools to improve shared decision-making between patients and providers.
• Provide communication models for physicians to evaluate patient understanding and make follow-up conversations to address miscommunications.

Providers can improve the process of informed consent and enhance the safety of their patients by doing the following:

• Ensure that informed consent is truly informed by making sure that the patient understands what they are consenting to undergo.
• Do not assume that patients understand the medical terms in the consent form. A consent form alone is not sufficient for informed consent. Make use of decision aids, interactive media, graphical tools and other aids to enhance shared decision making and effectively asses and present risks during shared decision making.
• Make use of everyday language instead of medical jargon in communicating with patients or substitute decision makers.
• Make use of appropriate communication materials based on the patient’s cultural or language preferences and allow patients time to consider the information provided.
• Overcome language barriers by making use of health literacy screening tools and medical interpreter services for patients with limited health literacy and/or limited English proficiency.
• To enhance active patient participation, employ patient engagement techniques and use more open-ended questions to elicit information regarding patients’ needs and preferences, and encourage patients to ask questions.
• Use tools such as the teach-back method to determine whether patients understand the risks, benefits, and alternatives to treatment. Teach-back can help to focus patients and clinicians on what’s important.

Resources:

1. Kinnersley P, Phillips K, Savage K, et al. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane’s Review. The Cochrane Library. 2013 July 6;(7):CD009445. doi: 10.0112/14651858.CD009445.pub2.
2. Matiasek J, and Wynia, MK. Reconceptualizing the informed consent process at eight innovative hospitals. Joint Commission Journal on Quality and Patient Safety. Mar. 2008;34(3):127-37.
3. Bottrell MM, et al. Hospital informed consent for procedure forms: Facilitating quality patient-physician interaction. Archives of Surgery. January 2000;Vol. 135.
4. Elwyn G, et al. Shared decision making: A model for clinical practice. Journal of General Internal Medicine. Oct. 2012;27(10):1361–1367.
5. Bilimoria KY, et al. Development and evaluation of the universal ACS NSQIP surgical risk calculator: A decision aid and informed consent tool for patients and surgeons. Journal of the American College of Surgeons. Nov. 2013;217(5):833-42.
6. Schenker Y, et al. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: A systematic review. Medical Decision Making. Jan.-Feb. 2011;31(1):151-73.
7. Schenker Y, and Meisel A. Informed consent in clinical care: Practical considerations in the effort to achieve ethical goals. Journal of the American Medical Association. Mar. 16, 2011;305(11):1130-1.
8. National Quality Forum (NQF). Safe practices for better healthcare – 2010 update: A consensus report. Washington, DC: NQF; 2010.
9. Schyve PM. Language differences as a barrier to quality and safety in health care: The Joint Commission perspective. Journal of General Internal Medicine. Nov. 2007;22(Supplement 2):360-1.
10. d_Spanish-Speaking_Women">Patient predictors of colposcopy comprehension of consent among English- and Spanish-speaking women. Women's Health Issues. Feb. 2011;21(1):80-5.
11. Mystakidou K, et al. Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries. Journal of Social Aspects of HIV/AIDS. Sept. 2009;6(2):46-57.
12. Miller MJ, et al. Improving patient-provider communication for patients having surgery: Patient perceptions of a revised health literacy-based consent process. Journal of Patient Safety. March 2011;7(1):30-8.
13. Chittem M and Butow P. Responding to family requests for nondisclosure: The impact of oncologists’ cultural background. Journal of Cancer Research & Therapeutics. 2015;11(1)174-180.
14. Hanssen I. An intercultural nursing perspective on autonomy. Nursing Ethics. 2004;11(1)28-41.
15. Piamjariyakul U, et al. End-of-life preferences and presence of advance directives among ethnic populations with severe chronic cardiovascular illnesses. Journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology. 2014;13(2)185-189.
16. Ruiz-Casares M. Research ethics in global mental health: Advancing culturally responsive mental health research. Transcultural Psychiatry. 2014;51(6)790-805.
17. Balfour D. Frequent questions on informed consent. OR Manager. April 2009;25(4):23-5.
18. Childers R, et al. Informed consent and the surgeon. Journal of the American College of Surgeons. April 2009;208(4):627-34.

Note: This is not an all-inclusive list.

Legal disclaimer: This material is meant as an information piece only; it is not a standard or a Sentinel Event Alert. The intent of Quick Safety is to raise awareness and to be helpful to Joint Commission-accredited organizations. The information in this publication is derived from actual events that occur in health care.