Update on informed consent

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].