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Informed consent

December 22, 2011

What questions should I ask during informed consent? – “…You will, of course, have your own questions, especially once the doctor starts sharing information. But some basic questions you might ask include:

  • What is my diagnosis (the medical name for the illness I have) and what does that mean?
  • How serious is my diagnosis?
  • What treatments are recommended?
  • Are there other treatment options? What are they?
  • What benefits would you expect from the recommended treatments and other options?
  • What are the risks or complications of the recommended treatment and the other treatment options?
  • Are there problems or side effects that may be caused by the treatments?
  • What methods will be used to prevent or relieve these problems or side effects?
  • What are the side effects of the treatment — immediate, short-term, and long-term?
  • How will having treatment affect my normal functions and everyday activities?
  • How would not having treatment affect my normal functions and everyday activities?
  • How long will treatment last?
  • How long will it be before I can go back to my normal activities?
  • How much does the treatment cost?
  • Will my insurance cover it?

It’s a good idea to write down your questions and bring the list to your appointments, take notes on the responses, or bring a tape recorder to record the discussion. (You will want to check with the doctor before you record him or her.) Good health providers usually appreciate a patient’s efforts to understand the challenges they face and to make informed decisions…” (Informed Consent)

the right to stop treatment or withdraw – “…You can change your mind at any time, even if you’ve already started the treatment. Most consent forms mention that you also have the right to stop treatment or withdraw from a study even after you have signed a consent form. Even if the form does not mention it, you still have this right. You would need to contact the doctor in charge of your treatment or of the clinical trial to make your wishes known. You may be asked to sign a form refusing further treatment so that the doctor or facility will have a legal record (see the next section, “What if I don’t want the treatment that is being offered?”)…” (Informed Consent)

competent patients have the right to refuse treatment – “…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 one from participating in one’s own care. However, precautions should be taken to ensure the patient does have the capacity to make good decisions. There are several different standards of decision making capacity. Generally you should assess the patient’s ability to: understand his or her situation, understand the risks associated with the decision at hand, and communicate a decision based on that understanding. When this is unclear, a psychiatric consultation can be helpful. Of course, just because a patient refuses a treatment does not in itself mean the patient is incompetent. Competent patients have the right to refuse treatment, even those treatments that may be life-saving. Treatment refusal may, however, be a flag to pursue further the patient’s beliefs and understanding about the decision, as well as your own…” (Informed Consent)

ask questions – The patient should then have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he/she can make an informed decision to proceed or to refuse a particular medical intervention. This process is both an ethical obligation and a legal requirement in all 50 states. Problems with Traditional Informed Consent: (1) Written consent is often technical and incompletely understood by the patient; (2) Verbal explanations are dependent on the time, experience and communication skills of the explainer; (3) In-office explanations do not allow the patient sufficient time to review and ask questions about their procedure; (4) There is no clear way to ensure that the patient truly understands that to which they are consenting. The Ideal Consent Solution – Ideal Consent is a novel, computer-based informed consent process that combines informative videos and the written consent form for optimal patient understanding prior to a medical procedure…” (Informed consent)

communications process – “…The first case defining informed consent appeared in the late 1950’s. Earlier consent cases were based in the tort of battery, under which liability is imposed for unpermitted touching. Though battery claims occasionally occur when treatment is provided without consent, most consent cases generally center around whether the consent was “informed”, i.e., whether the patient was given sufficient information to make a decision regarding his or her body and health care. Because informed consent claims, unlike battery claims, are based in negligence, they generally are covered by liability insurance. To protect yourself in litigation, in addition to carrying adequate liability insurance, it is important that the communications process itself be documented. Good documentation can serve as evidence in a court of the law that the process indeed took place. A timely and thorough documentation in the patient’s chart by the physician providing the treatment and/or performing the procedure can be a strong piece of evidence that the physician engaged the patient in an appropriate discussion. A well-designed, signed informed consent form may also be useful, but an overly broad or highly detailed form actually can work against you. Forms that serve mainly to satisfy all legal requirements (stating for example that “all material risks have been explained to me”) may not preclude a patient from asserting that the actual disclosure did not include risks that the patient unfortunately discovered after treatment. At the other extreme, listing all of the risks may not be wise either. A comprehensive listing will be difficult for the patient to understand and any omission from the list will likely be presumed undisclosed. If you are using a form that contains a list, consider, with your attorney, inserting language indicating that the list is not exclusive (such as “included, but not limited to”) before the list begins. Medicare participating physicians must also be cognizant of CMS’s requirements for informed consent…” (Patient Physician Relationship Topics)

Myth and Reality – “…Before you start exploring this section of the site, you may find it helpful to confront some of the most common misperceptions about informed consent and clinical trials. Even if these do not represent your thinking about informed consent, they can serve as a helpful reminder of what the process is really about before you go through it.

  • Myth: Informed consent is designed primarily to protect the legal interests of the research team.
  • Reality: The purpose of the process is to protect you and other participants by providing access to information that can help you make an informed choice. It also is designed to make you aware of your rights as a participant.
  • Myth: The most important part of this process is signing the informed consent document.
  • Reality: Actually, the heart of this process is your ongoing interaction and discussions with the research team and other medical personnel–before, during, and after the trial. The document is designed to get this conversation started.
  • Myth: My doctor knows best; he or she can tell me whether or not I should consent to participate.
  • Reality: Your doctor is likely to be a valuable source of advice and information, but only you can make this decision. No one–not even medical experts–can predict whether a treatment, screening, prevention, or supportive care method under evaluation in a trial will prove successful. The informed consent process is designed to help you weigh all of the information and make the right choice for you or your child.
  • Myth: Once I sign the consent form, I have to enroll and stay enrolled in the trial.
  • Reality: That’s not true. Even after you sign the form, you are free to change your mind and decide not to participate. You also have the right to leave a clinical trial at any time for any reason, without forfeiting access to other treatment.
  • Myth: Medical personnel are busy, so I can’t really expect them to keep me informed as the trial progresses or listen to my questions.
  • Reality: The research team has a duty to keep you informed, make sure that you understand the information they provide, and answer your questions. If you ever feel that you are not getting what you need, do not hesitate to speak up. You will be given the name and phone number of a key contact person who can answer your questions throughout the course of the trial. Keep in mind that people like you are making this research possible through their willingness to participate (Conducting Clinical Trials).

Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the facts, implications, and future consequences of an action. In order to give informed consent, the individual concerned must have adequate reasoning faculties and be in possession of all relevant facts at the time consent is given. Impairments to reasoning and judgment which may make it impossible for someone to give informed consent include such factors as basic intellectual or emotional immaturity, high levels of stress such as PTSD or as severe mental retardation, severe mental illness, intoxication, severe sleep deprivation, Alzheimer’s disease, or being in a coma. This term was first used in a 1957 medical malpractice case by Paul G. Gebhard. Some acts cannot legally take place because of a lack of informed consent. In cases where an individual is considered unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., parents or legal guardians of a child and caregivers for the mentally ill. However, if a severely injured person is brought to a hospital in an unconscious state and no-one is available to give informed consent, doctors will give whatever treatment is necessary to save their life (according to the Hippocratic oath), which might involve major surgery, e.g., amputation. In cases where an individual is provided insufficient information to form a reasoned decision, serious ethical issues arise. Such cases in a clinical trial in medical research are anticipated and prevented by an ethics committee or Institutional Review Board. …Informed consent is also important in social research. For example in survey research, people need to give informed consent before they participate in the survey. In medical research the Nuremberg Code set a base international standard in 1947, and research proposals involving human subjects have developed since then. Most modern research is overseen by an ethics committee that also oversees the informed consent process (Wikepedia).


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