Informed procedural consent
- Marsha Ryan, MD, JD, FACS
Marsha Ryan, MD, JD, FACS
- Adjunct Professor, School of Law
- Southern Illinois University
- Michael S Sinha, MD, JD, MPH
Michael S Sinha, MD, JD, MPH
- Postdoctoral Fellow
- Program On Regulation, Therapeutics, And Law (PORTAL)
- Division of Pharmacoepidemiology & Pharmacoeconomics
- Department of Medicine
- Brigham and Women's Hospital
Physicians have a legal and ethical responsibility to provide adequate information to the patient so that he or she is able to process the information and make appropriate decisions . An educated patient also benefits the physician, both in terms of cooperation in the planned intervention and in reducing acrimony in case of complications . The physician who teaches and responds carefully brings the patient into the medical decision making process, addresses the patient’s concerns, and creates reasonable expectations regarding outcomes.
This topic focuses on the informed consent session. Additional information regarding the consent process and related ethical issues for adolescent health care, gynecologic care, the intensive care unit, and end of life care is presented elsewhere. (See "Consent in adolescent health care" and "Overview of preoperative evaluation and preparation for gynecologic surgery", section on 'Informed consent and patient expectations' and "Ethics in the intensive care unit: Informed consent" and "Legal aspects in palliative and end of life care in the United States".)
BENEFITS OF INFORMED CONSENT
The benefits of obtaining informed consent extend beyond the simple transmission of information from someone who has knowledge (the physician) to someone who does not (the patient). The benefits of truly informed consent include :
●Protecting the patient’s right of self-determination
●Engaging the patient in his or her health care
- Berg JW, Appelbaum PS, Lidz CW, et al. Informed Consent: Legal Theory and Clinical Practice, 2nd edition, Oxford University Press, New York 2001.
- Benak LD, Applegate S. Informed consent and issues surrounding lack of capacity vs. incompetence. J Forensic Nurs 2006; 2:48, 45.
- Black's Law Dictionary, 9th ed, Garner BA. (Ed), West Group, St. Paul, MN 2009.
- Canterbury v. Spence, 464 F.2d 772, 782 (C.A.D.C. 1972).
- Jandre v. Wisconsin Injured Patients and Families Compensation Fund, 813 N.W.2d 627 (Wis. 2012).
- Cobbs v. Grant, 502 P.2d 1, 12 (Cal. 1972).
- See 25 Tex. Admin. Code § 601.2 (2011).
- Johnson v. Kokemoor 545 N.W.2d 495 (Wis. 1996).
- Hales v. Pittman, 576 P.2d 493 (1978).
- Duttry v. Patterson, 771 A.2d 1255 (Pa. 2001).
- Howard v. Univ. of Med. & Dentistry of N.J., 800 A.2d 73,83 (N.J. 2002).
- See, eg, Tennessee Code § 63-6-502 (2009).
- Moore v. Regents of the University of California, 793 P.2d 479, 483 (Cal 1990).
- Albany Urology Clinic, P.C. v. Cleveland, 528 S.E.2d 777, 782 at n.19 (Ga., 2000).
- Hidding v. Williams, 578 So.2d 1192 (La.App. 5 Cir., 1991).
- Doe v. Noe, 690 N.E.2d 1012 (Ill.App. 1 Dist., 1997).
- Faya v. Almaraz, 620 A.2d 327 (Md. 1993).
- Mau v. Wisconsin Patients Compensation Fund, 668 N.W.2d 562 (Wis.App., 2003).
- Murphy v. Implicito, 920 A.2d 678 (N.J.Super.App., 2007).
- Tipton v. Isaacs, 17 N.E.3d 292 (Ind. 2014).
- Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 129 (1914).
- Nishi v. Hartwell, 473 P.2d 116 (Hawaii, 1970).
- Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014; :CD001431.
- Smith HK, Manjaly JG, Yousri T, et al. Informed consent in trauma: does written information improve patient recall of risks? A prospective randomised study. Injury 2012; 43:1534.
- Kinnersley P, Phillips K, Savage K, et al. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database Syst Rev 2013; :CD009445.
- Karliner LS, Jacobs EA, Chen AH, Mutha S. Do professional interpreters improve clinical care for patients with limited English proficiency? A systematic review of the literature. Health Serv Res 2007; 42:727.
- Schenker Y, Wang F, Selig SJ, et al. The impact of language barriers on documentation of informed consent at a hospital with on-site interpreter services. J Gen Intern Med 2007; 22 Suppl 2:294.
- Joint Commission "What Did the Doctor Say?": Improving Health Literacy to Protect Patient Safety, Executive Summary http://www.jointcommission.org/assets/1/18/improving_health_literacy.pdf (Accessed on April 12, 2011).
- Institute of Medicine report. Health Literacy: A Prescription to End Confusion, National Academies Press, 2004.
- Dewes v. Indian Health Service, 504 F.Supp 203 (D. S.D. 1980).
- Appelbaum PS. Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med 2007; 357:1834.
- Hanes v. Ambrose, 80 A.D.2d 963 (3d Dep’t 1981).
- Schreiber v. Physicians Insurance Company of Wisconsin. 588 N.W.2d 26 (Wis. 1999).
- Robinson G, Merav A. Informed consent: recall by patients tested postoperatively. Ann Thorac Surg 1976; 22:209.
- Herz DA, Looman JE, Lewis SK. Informed consent: is it a myth? Neurosurgery 1992; 30:453.
- See Jamison v. Kilgore, 905 So. 2d 610 (Miss. Ct. App. 2004)
- Panea v. Isdaner, 773 A.2d 782 (2001).
- Goss v. Oklahoma Blood Institute, 856 P.2d 998 (1990).
- Morvillo v. Shenandoah Memorial Hosp., 547 F.Supp.2d 528 (W.D.Va. 2008).
- Shetter v. Rochelle, 409 P.2d 74, 82 (1965).
- Paden v. Rudd, 669 S.E.2d 548 (Ga.App.,2008).
- Ey RM. "Cause of Action Against Physician for Failure to Obtain Patient's Informed Consent," 5 Causes Of Action § 1 (Updated September 2010).
- Miller-McGee v. Washington Hosp. Center, 920 A.2d 430, 440 (D.C. 2007).
- Aiken v. Clary, 396 S.W.2d 668 (Mo. 1965).
- Spatz ES, Krumholz HM, Moulton BW. The New Era of Informed Consent: Getting to a Reasonable-Patient Standard Through Shared Decision Making. JAMA 2016; 315:2063.
- Canterbury v. Spence, 464 F.2d 772, 791 (1972).
- Bloskas v. Murray, 646 P.2d 907 (Colo. 1982).
- Scott v. Bradford, 606 P.2d 554,559 (Okl. 1980).
- BENEFITS OF INFORMED CONSENT
- INFORMED DECISION MAKING
- Material facts
- Physician disclosure
- Additional procedures
- EFFECTIVE COMMUNICATION
- Focus on the patient
- Comprehensible language
- - Educational material
- - Interpreters
- Emergency situations
- Comatose or incompetent patients
- WITHDRAWAL OF CONSENT
- FAILURE TO OBTAIN CONSENT
- Battery action
- Negligent nondisclosure
- THE DUTY TO INFORM
- Professional standard
- Patient-centered standards
- SUMMARY AND RECOMMENDATIONS