Requirements for Informed Consent The legal duty of informed consent requires that physicians disclose: a.The nature of the procedure or test b.The benefits, risks, and consequences of the intervention c.Alternatives and their benefits, risks, and consequences
A narrow vision of informed consent, while meeting legal standards, may result in suboptimal patient care decisions.
Informed Refusal Another view of informed consent is that patients have an ethical and legal right to be free of unwanted medical interventions and bodily invasions. Competent patients must be informed of the risks of the proposed plan of care and have the power to reject their physicians’ recommendations.
This right to refuse is now extended to noninvasive care, such as diagnostic tests and medications. In a broader view, patients have the right to choose among medically feasible options, in addition to the negative right to refuse unwanted interventions.
Obstacles to Informed Consent –* Patients do not understand the medical information – * Patients are compromised by illness, anxiety, etc. – * Language of probabilities is unfamiliar to lay-persons – * Takes too much time – * Some patients just don't want to know
NOTE 1.Ethically and legally, informed consent requires discussions of pertinent information, obtaining the patient’s agreement to the plan of care, and freedom from coercion.
2. In particular, the alternative of no intervention needs to be discussed. 3. The Competence of the doctor, team, institution should also be discussed because increased volume is associated with significantly better outcomes.
4. Consent should be given by the person performing the procedure. Discussions about the proposed test or treatment and the alternatives should be conducted by the attending physician or by the physician performing the intervention.
Such discussions should not be delegated to nurses, medical students, or house officers. 5. Consent is required for each specific procedure.
Informed consent for those lacking the capacity. When patients lack the capacity to make informed decisions, Advanced directives or appropriate surrogates should guide decisions. Oral directives are valid but they are difficult to prove.
Consent obtained over the phone is valid. For consent obtained over the phone, the physician may need to use another member of the healthcare team ( e.g. a nurse ) to act as a witness as it may be difficult to prove.
Pregnant women The general consensus is that fetus is not considered a person until birth. A pregnant woman has a right to informed consent as well as informed refusal even if the life of the fetus may be at risk. The father of the fetus can’t give consent.
Exceptions To Seeking Informed Consent. 1. Emergencies- if the patient is not competent and no surrogate is available and his or her advance wishes are unknown and there is danger to life or danger of serious impairment to health, and immediate treatment is necessary to avert these dangers, then the obligation to seek informed consent is waived.
2. Therapeutic privilege- If there is a reason to believe that information given to a specific patient will result in an adverse effect on the patient’s condition or health, the information may be withheld pending evaluation of the patient.
Case 1 Ms. B was a 58- year old woman who was found to have a small breast cancer, stage T1N0M0. Her surgeon recommends mastectomy and informs her of the benefits and risks of the operation, including side effects such as lymphedema of the arm. The surgeon says that a less extensive operation may not remove all the tumor. Ms. B’s daughter searched the internet for information about breast cancer and learned that her mother’s cancer could be treated with lumpectomy plus radiation therapy, which would avoid disfiguration and lymphedema.
Case 2 A 52 year old man sees you in follow-up after a radical prostatectomy. He had been fully informed about the risk of the procedure such as incontinence and impotence. Neither of these adverse effects occurs. While searching on the web he finds that there is treatment without surgery involving the implantation of radioactive seeds or pellets in the prostate. He files suit against you because of an improper informed consent. What will be the most likely outcome of the suit? A. he will lose cos there was no adverse effect. B. he will lose cos all the risks of the surgery were explained to him before he signed consent. C. he will lose cos radical prostatectomy is a standard procedure D. he will win cos radioactive seeds are the superior form of therapy. E. he will win cos you did not inform him of the risks and benefits of alternative therapy to surgery.
Case 3 A 54-YEAR OLD Spanish-speaking woman has arrived for the first of a clinical trial of chemotherapy for breast cancer. You suddenly remember the need for signing a consent form. You ask a medical student to “get the consent”. He walks up to the pt and says in English, “sign this”, and she signs. She completes the trial but her hair falls out and she files suits against you for an improper informed consent. Why will this lawsuit be successful? A. the risk of the treatment were not explained. B. she experienced harm from the study medication. C. the explanation was not in a language you were sure she could understand. D. someone who didn’t understand the study obtained the consent. E. all of the above.