The process of informed consent is an excellent risk management technique. Every endoscopist should understand and use it well. The two major advantages of informed consent are:
- The informed consent process offers an outstanding opportunity to communicate with your patient. Such communication strengthens the physician-patient relationship. It gives your patient in opportunity to see that you are reasonable and caring physician. Trust and mutual respect develops. Remember that if you are able to develop a relationship of mutual trust and understanding, the patient is less likely to sue you.
- During the disclosure process of informed consent you effectively shift the risk and burden of potential complications to the patient-consumer. Once the patient bears the risks, you indemnify yourself against liability arising from realized complications. (You are not indemnified from complications that arise from practices performed below a reasonable standard of care. Nor are you indemnified if you failed to recognize complications, or if you failed to treat them.)
Informed consent is a concept and not a document. Consent dictates that a choice has been made, free from coercion and influence. The tenants of informed consent demand that an explanation of the suggested action (usually a procedure) is accurately and fairly provided, and that the potential alternatives and consequences of the action or inaction are clearly understood. In essence, information provided should allow the patient to request the action necessary to assist in their care. Informed consent is not convincing the patient to accept an action, but giving the information that a reasonable person would require when making a decision about a particular action.
The theory of informed consent is based upon the ethical concept of the right of self-determination or autonomy. Over the last 35 years, courts and legislatures in all 50 states have recognized the legal notion of informed consent as a means to confirm this right. Endoscopist's not only have an ethical and moral duty to obtain informed consent prior to procedures, but a legal one as well. Failure to adequately inform a patient prior to an invasive procedure can also be interpreted as battery. Using this construct, a plaintiff can argue that any physical contact was unwanted, and if injury results, the defendant can be held liable for damages that are generally not covered by malpractice insurance companies. Although there is no single, absolute prescribed way of obtaining informed consent, the purpose of this section is to present a reasonable and effective means to obtained informed consent with an eye towards medical malpractice prevention.
The crux of informed consent is disclosure of the substantive information necessary to make a reasoned decision. The disclosure requirements as defined legally are of two basic types. The first is the professional standard of disclosure. It is used in the majority of jurisdictions. Under it an endoscopist is required to disclose that information to a patient, which a reasonable physician would disclose under the same or similar circumstances. The second standard is the lay or reasonable person standard. Under this standard, an endoscopist must disclose that information that a reasonable person would require prior to making informed decision about proposed procedure. It is probably best to consider this the preferred standard, but it is recommended that each endoscopist learn the applicable disclosure standard in his/her state. This in no way implies that the standards are permanent, and the courts may change the standards at any time.
The essential elements of disclosure under either standard include the following:
- The nature of the proposed procedure (s);
- The reason the procedure(s) is being suggested;
- The benefits of the procedure (s);
- The risks and complications of the procedure (s) including their relative incidence and severity;
- The alternatives to the procedure (s), including those which may be more hazardous than the one proposed.
The endoscopist should be certain to explain the procedure to the patient including what will occur before, during and after it is completed. The nature of the procedure should be described and benefits outlined. The risks and complications must be detailed. Not every possible complication needs to be underscored, but the substantive risks that would influence a reasonable person when making a choice are required. In general, those risks that occur most commonly and those that are most serious should be discussed. For example, a reasonable person might not hesitate to have a diagnostic procedure that carries a 1 in 10,000 mortality, but might balk at a purely diagnostic procedure that carries a 33% risk of pancreatitis. In general, all information that would affect a person’s choice to accept or refuse a procedure, as defined by a jury of their peers, needs to be disclosed. If the endoscopist’s complication rate is substantially different from accepted national standards, this should be disclosed to the patient. All reasonable alternatives to the proposed procedure should be presented, even if they may be more hazardous.4For example, the alternative to colonoscopic polypectomy is surgical polypectomy and in obtaining informed consent for the former, the latter should be presented. If no alternatives exist, the patient should be so informed. If you administer sedation or other medications before or during your endoscopy, be sure to include a discussion of them and their potential side effects in the informed consent process. Finally, fiduciary interest in the Ambulatory Endoscopy Center where the procedure will be performed, if any exists, should also be disclosed.
It is your personal duty to obtain informed consent. The use of preprinted materials, diagrams and other audiovisual materials may be useful adjuncts to the patient’s decision-making, but they are not substitutes for the physician-patient interaction. Documenting the use of adjuvant material may be of value if questions of adequate disclosure subsequently arise. It is reasonable for you to allow the patient adequate time to deliberate in making an informed consent decision. Likewise, you should solicit and answer any of the patient’s questions regarding the procedure. Be aware of the concept that “duress” may color a patient’s choice and every effort should be made to present the options for treatment in as fair and unbiased a manner as possible. The thought that informed consent is assumed must never be relied upon, even in the case of open access endoscopy.
Most hospitals require a formal writing, such as an informed consent form, to satisfy their informed consent policies. Some states also require by statute the formal writing. Forms notwithstanding, informed consent is not the form. It is a process of disclosure, information sharing and deliberation in which the endoscopist and the patient interact to allow that patient the reasoned decision regarding his or her welfare.
A written consent for may serve some useful future evidentiary purpose, but cannot be relied upon to confirm informed consent. In order to document the informed consent process, you may consider a specific consent form for a specific procedure, which defines the nature, benefits, risks and alternatives to that procedure with particularity. Forms should be written in a simple, lay language. An appropriate note in the hospital or office record mirroring the consent process is desirable. A witness to the informed consent process (not a witness to the patient actually signing the form!) may be valuable should the question arise.10 Tape recordings and videotapes of the consent process may be useful in certain high-risk patients or dangerous procedures.2,10
There are no differences in the need to provide informed consent in situations where patients are entered into experimental protocols. It is the investigator’s responsibility to be certain that the experimental subject is given full and adequate disclosure about the nature of the experiment, the reasons for the trial, the risks, benefits and alternatives to the study. In addition, the subject is able to stop the study at anytime without penalty or repercussion.
There are five exceptions to the informed consent process. They are:
- Therapeutic privilege;
- Waiver; and,
- Legal mandate.
When there is a genuine threat to life and there is too little time or opportunity to obtain informed consent, a physician may take that action necessary to save a patient’s life using the construct of implied consent. Before invoking this exception, you must be certain that the emergency is truly life threatening. Again, the defense’s position will be that a reasonable person given the same set of circumstances as confronting the patient would have made the same choice.
Incompetence is defined as the inability to act and is not actually an exception to informed consent. Although you cannot obtain adequate informed consent from an incompetent, you must still obtain it from the next-of-kin or legal guardian.
There are times when the disclosure of informed consent might be detrimental to the welfare of certain patients. The law recognizes this and has fashioned the exception of therapeutic privilege. If you believe that the informed consent disclosure would, on balance, be more harmful to a patient, you may delete it citing this exception. In reality, the law looks with a critical eye toward the use of therapeutic privilege, so in the event that you choose to invoke it be certain to document the circumstances carefully. Consider incorporating other opinions such as those of a family member or fellow professional. In general, physicians over estimate the degree to which patients dislike the disclosure that occurs during informed consent. Indeed studies indicate patients appreciate and wanted this information.
A patient may elect to waive his right to informed consent. Before invoking this exception, you must be certain that such waiver is knowing and voluntary. The patient must know that he has a right to information about the proposed procedure and that he must decline that information without coercion.
A judge’s order or statute may supersede the process of informed consent. For example the judge may order you to remove certain evidentiary material from patient’s stomach. You may proceed without obtaining the patient’s informed consent. In situations like these, the public welfare and interest may overshadow the patient’s right to informed consent.
You must be assiduous in documenting the circumstances whenever you choose to use any of the exceptions to informed consent. Be certain your records reflect your thinking and actions as well as those of the patient. For example, in applying the exception of waiver, be precise in stating that the waiver was both knowing and voluntary on the part of the patient.
The flip side of informed consent is informed refusal. The essence of this doctrine is that the patient, who refuses a procedure or any medical treatment, must have the opportunity to decline in a knowing way. In the process of recommending an endoscopic procedure to a patient, you must be certain to explain to them the reasons the procedure is necessary. (This is really informed consent.) In the event that the patient declines the procedure your notes must reflect that the patient was told the indications for the procedure so that you can show that his refusal was informed. For example, in the records of a patient who declines a colonoscopy and polypectomy for a 2 cm. sigmoid colon lesion, your documentation must include your discussion about the possibility of carcinoma and its potential cure. Simply state saying the patient refused is inadequate.
The process of informed consent is allowing the patient to become an advocate in their health care. The physician shifts some of the responsibility away from themselves to the patient, who will be given an opportunity to select the type of treatment they desire based upon a reasoned explanation of the indications, risks, benefits and alternatives to the procedure. The use its use as a risk management tool cannot be overstated. In addition, the exceptions to informed consent as well as the notion of informed refusal are discussed.
- President’s Commission for the study of Ethical Problems in Medical and Biomedical and Behavioral Research: Making Health Care Decisions, 1982.
- Salis vs U.S. 522 F Supp. 989 (MD Pa 1982)
- Harwell vs Pitman 428. So 2d 1049 (La Appl J Cir 1983)
- Logan vs Greenwich Hospital Association 191 Conv 282, 465 2d 294 (1983)
- Plumeri PA. Informed consent: Beware. J Clin Gastroenterol 1984;6:471-5.
- Natausan vs Kline 186 Kan 560, 350 p3d, 1093 (1960)
- Canterbury vs Spence 464 E 2d 772, (DC Cir 1972), Cert denied 409 US 1064 (1972)
- Agre P, McKee K, Gargon N, Kurtz, RC. Patient satisfaction with an informed consent process. Cancer Practice 1997;5:162-7.
- Cobb vs Grant & Cal 3d 229, 104 Cal Rptr 505, 402 p2d (1972)
- Plumeri PA Informed consent J Clin Gastroenterol 1983;5:185-7.
- Moore RM Consent form: how or whether they should be used. Mayo Clin Proc 1978;53:393-6.
- Moorow G. How readable are subject consent forms. JAMA 1980;244:56-8.
- Barbour G, Blumenkrantz M. Videotape aids in informed consent decisions. JAMA 1978;249:2741-2.
- Dunham vs Wright, 423 F 2d 940 (3d Cir 1940)
- Sullivan vs Montgomery, 155 Misc 448, 279, NYS 575 (NY City Ct 1935)
- Alfidi R. Informed consent: study of patient reactions. JAMA 1971;216:1325-9.
- Roling GT. An appraisal of patients; reactions to “informed consent” to personal endoscopy. Gastrointest Endosc 1977;23:69-70.
- Fadeis RR, Beauchamp TL. Decision making and informed consent: a study of the impact of disclosed information. Soc Indication Res 1980;7:313-5.
- Truman V Thomas, 165 Cal. Rptr. 308, 611 P. 2d 902 (Cal. 1980)
The preceding information is intended only to provide general information and not as a definitive basis for diagnosis or treatment in any particular case. It is very important that you consult your doctor about your specific condition.