Frequent questions on informed consent

Ethics

he principles of informed consent are well known—patients have the

right to make informed decisions about their care, including surgery.

The primary purpose of informed consent is to ensure that the patient

has the information necessary to make a decision before agreeing to any treat-

ment.

The responsibility for informed consent is the physician’s. Informed con-

sent is a dialog between the patient and physician in which the patient

learns and understands about the proposed treatment, including the risks,

benefits, and alternatives. The patient also has an opportunity to ask ques-

tions and agree about what is to be done.

Though these principles may be understood, the details of informed con-

sent raise a lot of questions.

OR Manager asked David Balfour, an attorney

with DiCaro, Coppo & Popcke, APLC, Carlsbad, California, a law firm that

specializes in medical and health care law, to respond to frequently asked

questions from readers.

How critical is the physician’s signature on the consent form?

We sign the surgery consents with a nurse witness and the

patient. This is a convenience and customer service issue for the

surgeons. The physician is required to document risks, benefits, and

alternatives on the history and physical or dictated note. Do we need

to change our process?

Balfour: While the physician’s signature is not required on the informed

consent form, requiring the physician’s signature serves as an important

double-check for the facility. The patient and a qualified, competent health

care provider must personally interact for the requisite exchange of ques-

tions and answers. A physician is required to obtain consent from the

patient for a sur

gical pr

ocedure after informing the patient about the proce-

dur

Informed consent is a process, not a signature on a form. The informed

consent discussion cannot be delegated to the staff. Staff can assist in the

process by providing educational materials such as pamphlets, brochures,

videos, and online materials about the procedure generally (materials pro-

vided should be documented). But a physician must conduct the discussion

with the patient about the expectations of risks, benefits, and alternatives for

the procedure for that specific patient. Inappropriate assurances (or even

guarantees) made by staf

f members may subject the doctor and facility to

additional liability based on the inappr

opriate information given.

Informing the patient

Whatever format the informed consent form takes, it should not be

OR Manager

Vol. 25 No. 4

April 2009

Frequent questions

on informed consent

igned before the physician’s discussion with the patient. A patient should

be informed verbally, in nontechnical terms, about all of the following:

• a description of treatment procedures/products/devices/medications to

be used

• a description of any attendant discomfort and risks to patient that can rea-

sonably be expected from such treatment

• an explanation of any benefits to the patient that can reasonably be expect-

• an explanation of any appropriate alternatives to procedures/

products/devices/medications that might be advantageous to the patient,

and their relative risks and benefits

• an offer to answer any inquiries concerning the treatment involved.

Documenting the consent

The physician should document the consent discussion in notes separate

from the consent form. The more ironclad the documentation, the more like-

ly the consent will be confirmed by anyone reviewing the case, including

the patient’s attorney should anything go wrong unexpectedly. In litigation,

the adequacy of a written consent is a factual issue to be determined by a

jury, and the mere existence of a signed written informed consent is not con-

clusive proof that informed consent was given.

Countless surveys and articles relating to medical malpractice actions have

shown the majority of lawsuits arise due to poor communication between

physicians and patients. The informed consent discussion is one of the most

important conversations between doctor and patient and should not be mini-

mized. In both the short and the long runs, improved patient-physician-facili-

ty communication minimizes the likelihood of medical errors and liability

exposure. In the long run, the surgeons will thank you.

Do nurses witness the signature only or give their signature to

verify patients’ understanding? (Nurses never seem to get this

right.)

Balfour: At a minimum, nurses or other care providers witnessing the sig-

nature should be confident the patient himself or herself is signing the consent,

and the patient is competent to sign. The nurse should make sure the patient

is not impaired by medications in agreeing to the procedure. Competency can

also r

elate to age; for example, the nurse should ensure minor patients’ con-

sents are signed by the responsible parent(s) or guardian.

While the responsibility for informing the patient and obtaining consent

ests with the physician, witnessing the patient’s signature on the consent is

the optimum time to ensur

e the patient has had all questions answer

ed about

the procedure. While the nurse may not be, the doctor is required to verify the

patient’s understanding and consent. (Sometimes doctors don’t get this right.)

The nurse asking, “Has the doctor answered all of your questions about the

procedure?” is a good step. If not, the consent process is not complete, and the

doctor should be sought out befor

e the sur

gery to get the questions answer

ed.

Nurses should be car

eful, though, not to of

fer advice about the risk/benefit cal

culations; such calculations and advice should be left to the doctors.

The contemporaneous signature of a witness serves 2 purposes. First, it

impresses upon the patient the importance of the document the patient is sign

ing. Second, it documents a part of the informed consent process, namely the

patient’s agreement to undergo the procedure. The facility benefits from the

OR Manager

Vol. 25 No. 4

April 2009

urse assuring the patient’s comprehension. The nurse is not required to veri-

fy the patient’s comprehension of and consent to the procedure to protect his

or her own liability, but the nurse’s doing so helps to protect the facility from

liability, both by assuring that the patient has consented and continuing good

open communication with the patient.

Who can witness an informed consent (family member, surgical

team member, housekeeper, etc)? This is a debate among

physicians and nurses.

Balfour: Any adult may sign as a witness on the consent form. Given that

consent forms are typically predrafted forms with handwritten entries describ-

ing the procedure and the name of the physician(s), the form will generally be

interpreted in favor of the patient’s interpretation and against the interpreta-

tion of the facility. For this reason, it is preferred that the witness to a consent

be either a noninterested employee of the facility or a family member, friend,

or escort of the patient.

Because informed consent is a process, the best person to witness the

patient’s signing of the informed consent form is the person who has wit-

nessed the most of the informed consent process. If at all possible, it is help-

ful to have someone who has heard the physician discuss the risks, benefits,

and alternatives with the patient.

‘Reasonable patient’ standard

In some states, the adequacy of the consent is determined using a “rea-

sonable patient” standard. In those states, whether the consent is valid is

determined by whether the patient was informed of all a reasonable patient

would expect to be told, and in a way a reasonable patient could under-

stand to assess the relative risks and benefits of undergoing the procedure.

In these “reasonable patient” states, the physician must explain the proce-

dure using nontechnical terms the patient can understand. In these states,

having a family member or friend of the patient witness the consent can

help to support the comprehensibility of the information given in the con-

sent process. Inquiry should be made of the family member or friend to

ensure all of their questions have been answered as well as those of the

patient.

‘Reasonable physician’ standar

In other states, the standard for determining whether informed consent

is appr

opriate is the “reasonable physician” standard, which looks at

whether the physician gave all information a “reasonable physician” would

have provided. In these states, it might be preferable to have a witness who

is familiar with the pr

ocess and who might note if all the parts of the pr

oce

dure were covered in the informed consent discussion.

Failure to advise of risks

The failure to fully and adequately advise of the risks of a surgery to

which the patient has consented is generally categorized as negligence. But

performing a surgery that the patient has not consented to, or which is sub-

stantially different than what was consented to, is battery

, an intentional

tort. Intentional torts are, by their nature, uninsurable, so malpractice cov-

erage will typically not cover the exposure created. Moreover, in states with

malpractice litigation protection statutes, battery will destroy the protec-

tions of the statutes for the offending physician.

OR Manager

Vol. 25 No. 4

April 2009

ithout regard to the standard used in your state, prudent practice

requires that the patient undergoing this procedure has been fully informed

about the procedure and has freely made the choice to proceed, and the

informed consent process was witnessed and documented.

Should we have separate

surgical and anesthesia consent forms?

Balfour: Anesthesiologists should be having a conversation about the

risks of anesthesia with the patient apart from the conversation of the risks

and benefits from the surgical perspective. While the surgery consent

should be obtained prior to the day of surgery, frequently the anesthesiolo-

gist’s discussion with the patient takes place the same day as surgery.

Anesthesia risks should be discussed generally in any discussion of the risks

and benefits of surgeries involving anesthesia. Requiring the anesthesiolo-

gist to obtain informed consent for the anesthesia specifically is good prac-

tice because it helps to ensure that the process happens.

In our ambulatory surgery center (ASC), not all physicians have

seen the patient in the office and had an informed consent

discussion. This is especially true for GI endoscopy and pain

management. The ASC staff must then present the informed consent

form to the patient and get the signature. Rules do not allow the

patient to be brought into the procedure room until the form is

signed. So the physician must either come out to have the discussion

with the patient, or the rules must be broken to allow the discussion

to take place in the procedure room. Either way, this is not the best

time to have an informed consent discussion. Do you have any

suggestions?

Balfour: A consent obtained in the operating room could be later found

invalid. It would at least face severe questioning on review. As with most

contracts, the patient might be excused from having signed the form

because of the pressure, known legally as duress, of the situation. The sur-

geon, the surgery team, and the facility could all be viewed as counting on

the patient to undergo the procedure, and the patient could not want to

“disappoint” them. The patient might fear, for example, that he or she

would have to pay for the setup time for the surgeon and the facility if he

or she wer

e not to under

go the pr

ocedur

e. The patient’s decision to consent

to the procedure must be freely made without such pressures.

Consent should be obtained after the surgeon discusses the risks, bene-

fits, and alternatives with the patient, and prior to the patient making the

final decision to undergo the procedure. The earlier the consent discussion

and the less the pressure during the consent discussion, the better. Given

that most of the procedures performed in ASCs are elective, at least in their

timing, the facility would be wise to require the informed consent discus-

sion to take place before the patient arrives at the facility on the day of the

sur

gery

Surgery centers frequently have the referring physician’s office complete

a surgery scheduling sheet with patient demographics, type of procedure,

equipment to be used, etc. This sheet could r

equire physicians’ offices to

indicate whether the patient has given consent for the pr

ocedur

e, and the

surgery center could require a copy of the signed consent to be forwarded

to the surgery center before the surgery date.

OR Manager

Vol. 25 No. 4

April 2009

f the same-day consent is all that is practicable, the surgeon must go out

and have the informed consent discussion with the patient before the patient

signs the consent.

DiCaro, Coppo & Popcke is a law firm serving the medical and health care communi-

ties with services including malpractice defense, peer review, and medical board and

hospital board issues.

OR Manager

Vol. 25 No. 4

April 2009