Informed consent is necessary prior to the performance of any diagnostic and therapeutic interventions which are physically intrusive. *
Informed Consent should represent an ongoing communication process between the patient and his/her health care professionals. There are three key factors in informed consent:
- information
- understanding
and
- free, voluntary consent.
The first two elements enable the patient with decisional capacity or the patient's substitute decision-maker to decide whether or not to consent to the procedure in question. Each of these three elements can be used to remind you of some of the key elements of a valid informed consent.
Information - There are certain basic things that must be communicated in any informed consent process. These are:
a. The identity of the individual who will perform or supervise the treatment or procedure. If a resident or student is to participate in the procedure under the direction of an attending physician or health care professional, this must be revealed to the patient;
b. A description of the proposed treatment or procedure in language that the patient can understand;
c. A description of the possible risks and complications which a reasonable person would consider material in reaching a decision about whether to allow the treatment or procedure;
d. A discussion of the potential benefits which the health care professional recommending the treatment or procedure believes may result;
e. A discussion of other available alternative treatments or procedures that are accepted by the health care community; and
f. the consequences of foregoing treatment. (Adapted from Hahnemann University Hospital, Tenent, Informed Consent Policy, p. 3 of 6.)
Like any other educational process, the information provided should be adequate to the task at hand. The general rule of thumb is, "what would a reasonable person want to know in order to make this decision?" The importance of a risk can be expressed by multiplying the probability of it occurring by the significance of the risk for the patient. So, for example, A patient may request information about the HIV status of his/her hospital roommate. The probability of a patient getting AIDS from sharing a room with a patient who is HIV-+ is zero. The significance of the risk of getting AIDS is fairly high (say 9 on a scale of 1-10). But, 0 * 9 = 0. Therefore, the importance of the patient being informed of this risk is zero. This calculation is simply a rule of thumb to help clarify what information ought to be included.
It is important to note that the importance of information may vary depending on the particular patient. For example, the possibility of a few days of work missed may be a great burden for the owner of a small business. Bed rest can be a great burden and risk for the single parent of young children. So it is important for the information to flow both ways, from health care professional to patient and vice versa.
Understanding - It is not sufficient for you to relay this information to the patient or the patient's substitute decision- maker. The individual making the decision should understand the information you provide. This involves using language that the patient can understand. It also involves presenting the information in a manner that is conducive to understanding. This might involve things like taking into account medication schedules, avoiding the appearance of being rushed, or allowing for a number of meetings with the patient or substitute decision-maker in order to give him/her time to process and consider the information presented, for example.
Consent - The patient's or substitute decision-maker's decision to consent or refuse treatment should be free of undue, coercive influence. This includes that information was not presented in a biased manner. This does not mean that the physician should not make known his/her recommendations. Neither does it mean that the person making the decision should be isolated or cut off from individuals who might provide support when making a difficult decision. Rule of thumb - ask yourself if the patient or substitute decision-maker is making a free, voluntary choice given an honest accounting of the relevant facts.
A patient must have the capacity to make the decision in question. If there is a question about the patient's ability to understand the information communicated and the consequences of accepting or refusing treatment, a psychiatric consult should be considered to determine the patient's decisional capacity.
Decisional Capacity & Competence - Decisional capacity is the ability to comprehend and process information communicated and to understand the consequences of accepting or foregoing recommended treatment. The legal term for this is competence. An individual is presumed to be competent unless he/she has been declared incompetent by a court. A patient may lack decisional capacity without being declared incompetent either because the patient's condition is temporary or because a court has not yet declared the patient to be incompetent.
Substituted Decision-Maker - A competent adult who is responsible for making health care decisions on behalf of the decisionally incapacitated patient. This person may have been designated by the patient through a Durable Power of Attorney, be a close relative or friend, or be designated to be the patient's guardian by a court of law.
* Implied Consent - In an emergency, when the patient is unable to consent and a delay for the purpose of obtaining consent would expose the patient to a significant risk of death or serious bodily harm, necessary care may be provided without obtaining informed consent. However, the responsible physician must document in the medical record the nature of the emergency, the consequences of delay in treatment and the treatment provided. All efforts to reach a substitute decision-maker to obtain consent should also be documented. (Hahnemann University Hospital, Tenent, Informed Consent Policy, p. 4 of 6.)
Constance K. Perry, PhD
Assistant Professor, Department of Arts & Sciences
MCP Hahnemann University
constance.perry@drexel.edu
Last modified 6-22-99