Understanding Informed Consent

Introduction

Patients have the legal and ethical right to direct what happens to them, and physicians have the ethical duty to involve patients in their health care. The concept of "informed consent" is an important way in which you participate actively in choices about your health care. While such consent may be informal in day-to-day medical care, it becomes more important if you are having a procedure such as surgery - and critically important if you are participating in research.

The concept of informed consent evolved after World War II, during which experiments were performed on prisoners without their consent. The war crimes tribunal established the Nuremberg Code, now accepted worldwide, with ten standards to which physicians must conform when carrying out experiments on humans. The requirements include voluntary informed consent, which protects your right to control your own body. The code also recognizes that you need the opportunity to weigh the risks of a procedure against the expected benefits. Finally, it requires that unnecessary pain and suffering be avoided.

Although the concept of informed consent was developed for research participants, it is now generally considered to be an important component of all aspects of health care.

What You Should Expect

Generally, the complete informed consent process includes the following:

• The physician explains the proposed decision/procedure to you;
• The physician presents reasonable alternatives to the proposed procedure;
• The physician summarizes the risks, benefits, and uncertainties related to each alternative;
• You are encouraged to ask questions and the physician evaluates your understanding of the procedure and risks;
• If you decide to approve the procedure, you provide oral or written consent, depending on the situation.

Once you have consented to a procedure, the physician can only perform the procedure you gave consent for, and only the physician you provided the consent to can perform the procedure.

In order for the consent to be valid, you must be competent to make the decision and your consent must be voluntary. Since you should actively participate in the decision-making process, the physician should explain the procedure in terms you can understand. Ultimately, the decision is yours, not the physician's.

Oral vs. Written Consent

Most health care institutions have policies that state which health interventions require a signed consent form. These include surgery, anesthesia, and other invasive procedures. Signed consent forms are really the culmination of a dialogue required to help assure your informed participation in the clinical decision.

For a wide range of decisions, such as what medicine will be prescribed and drawing blood for lab tests, written consent is neither required nor needed; however, some meaningful discussion is still needed. Basic consent for such procedures entails physicians telling patients what they would like to do and asking patients if they agree.

When You Are Unable to Participate in Decisions

In most cases, it is clear whether or not patients are competent to make their own decisions. Occasionally, it is not so clear. Patients are under an unusual amount of stress during illness and can experience anxiety, fear, and depression. The stress associated with illness should not necessarily preclude patients from participating in their own care. There are several different standards of decision-making capacity. A patient should be able to:

• Understand his or her situation;
• Understand the risks associated with the decision at hand;
• Communicate a decision based on that understanding.

When this is unclear, a psychiatric consultation can be helpful. If a patient refuses a treatment, the physician cannot assume the patient is incompetent. Competent patients have the right to refuse treatment, including those treatments that may be life-saving. However, refusing treatment may indicate the need to pursue further the patient's understanding of the risks and benefits of the procedure.

When You Cannot Give Informed Consent

If it is determined that a patient is incompetent to make the health care decision, a surrogate decision-maker must speak for him or her. There is a specific hierarchy of appropriate decision-makers defined by state law. If no appropriate surrogate decision-maker is available, physicians are expected to act in the best interest of the patient until a surrogate is found or appointed.

The Federal Patient Self-determination Act of 1991 and the New York State Healthcare Proxy Act of 1990 provide patients with the opportunity to designate an agent to act as their healthcare proxy in the event that they are no longer capable of making decisions in their own behalf.

Implied Consent

The patient's consent should only be "presumed," rather than explicitly obtained, in emergency situations when a patient is unconscious or incompetent and no surrogate decision maker is available. In general, the patient's presence a hospital or clinic does not represent implied consent for all treatment and procedures. The patient's wishes and values may be quite different than the values of the physician's.

Informed Consent in the Context of Research

Informed consent in the research context is similar to informed consent in the clinical treatment setting, but more structured and detailed. Clinical (human subject) research is guided by federal regulations established by the U.S. Food and Drug Administration, including “The Privacy Rule,” known as HIPAA, the “Health Insurance Portability and Accountability Act.” More information about these regulations can be found on the HSS Clinical Trials page. The Hospital for Special Surgery Institutional Review Board (IRB) reviews, approves, and monitors all clinical research at HSS, with the primary responsibility of assuring that in the conduct of meaningful clinical research, the highest ethical standards and scientific integrity are maintained. And furthermore, that the rights, safety, and privacy of our research participants are protected at all times and without compromise.

The physician investigators must provide potential subjects (patients) with a clear written statement of the risks and benefits of the research - in language you can understand - and discuss those risks and benefits with you. You must have the ability to understand this information and evaluate it within the context of your own values. Your consent must be given voluntarily, without coercion or inappropriate inducement. You should understand that if you choose not to participate in the research, this will not affect the medical care you receive.

Because research is conducted over a period of time (as opposed to a one-time procedure) and because patient perceptions and external conditions may change over that time, there are additional ground rules for informed consent beyond those of typical medical and surgical care. It is important for subjects to know that they have the right to withdraw from any research study at any point in the process. Physicians should explain to you their role in the research, i.e., whether they are acting as a health care provider or as an investigator.

According to federal regulations, these are the basic elements of informed consent for human subject research:

• A statement that the study involves research;
• An explanation of the purposes of the research and the expected duration of the subject's participation;
• A description of the procedures to be followed and identification of any procedures that are experimental;
• A description of any reasonably foreseeable risks or discomforts you may face;
• A description of any benefits to you or others that may reasonably be expected from the research;
• Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to you;
• A statement describing the extent, if any, to which confidentiality of records identifying you will be maintained and, if appropriate, that the FDA may inspect the records of the study;
• For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be sought;
• Contact information for answers to pertinent questions about the research and your rights as a research subject, and whom to contact if you experience a research-related injury;
• A statement that participation is voluntary and that refusal to participate or subsequent withdrawal, after consent, will involve no penalty or loss of benefits to which you are otherwise entitled.

When appropriate, one or more of the following elements of information must also be provided to each research participant:

• A statement that a particular treatment or procedure may involve risks to you (or to the embryo or fetus if you are or may become pregnant) that are currently unforeseeable;
• An explanation of the circumstances under which your participation in the research may be ended by the investigator without regard to your consent;
• Any additional costs to you that may result from participation in the research;
• An explanation of the consequences if you should decide to withdraw from the research and procedures for orderly withdrawal;
• A statement that significant new findings developed during the course of the research that may relate to your willingness to continue participation will be provided to you;
• The approximate number of participants involved in the research study;
• The source and terms of research funding.

Considering Research Participation

If you are considering participation in a research study, be sure to discuss it with your primary care physician. Find out from the researchers whether your day-to-day medical care will be provided by the study's physicians or whether you will continue in the care of your own physicians - and how the researchers will communicate and coordinate your care with your physicians. Understanding these issues also should be part of informed consent.

Participating in a research study may benefit you directly and immediately but it may not; indeed, it may pose risks to you. However, the findings from the research will be used to help future patients. Research helps improve the scientific understanding of your disease so that other studies can be done and new ideas for treatment developed.

Updated: 6/30/2009

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