Chapter II.
Your Right to Informed Consent
Your Right to Informed Consent
SUMMARY OF YOUR RIGHTS
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WHAT IS INFORMED CONSENT?
Informed consent is more than merely your agreement to a particular treatment or procedure. Informed consent is your agreement to a proposed course of treatment based on receiving clear, understandable information about the treatment's potential benefits and risks.1 You must also be informed about all treatments available for your health condition, and the risks of receiving no treatment.
WHY IS INFORMED CONSENT IMPORTANT TO ME?
| The decision to accept (consent to) or reject (refuse to consent to) a treatment, therapy or medication is ultimately yours to make -- not your doctor's or other health care provider's. |
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You must take an active role in order to receive high quality health care. The first step is having the appropriate information about your medical condition. Once you know about all the risks, benefits and treatment alternatives, you may decide the risks are too great or the benefits too few to justify undergoing the treatment. With this kind of information, you may choose to refuse the treatment by withholding your consent.
IS MY INFORMED CONSENT ALWAYS REQUIRED FOR ALL MEDICAL TESTS OR PROCEDURES?
Most of the time, yes. While your informed consent is usually required, there are two exceptions where your doctor does not need to have your informed consent before beginning treatment.
Simple and Common Exception:
The first occurs when a "simple and common" procedure, such as a typical blood screening is performed. When risks from such procedures are commonly understood to be remote, your doctor need not discuss the risks, benefits or alternatives to the procedure with you.2 You must still agree to the procedure, however, before it is done.
| If you are incapable of giving informed consent, the law presumes that you would consent to life-saving treatment, and the physician is authorized by law to provide it.5 |
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The second situation is in a life-threatening emergency. This is known as the Emergency Exception.3
An "emergency" is defined for purposes of this exception as a situation requiring immediate treatment of a medical condition that would otherwise lead to serious disability or death.4
There are two specific limitations on the Emergency Exception:
- If the patient is unable to give consent, the physician must make a reasonable effort to locate a family member or legally authorized representative who can give informed consent on behalf of the patient before treatment.6
- No treatment can be given if the doctor knows or has reason to know that the patient has previously executed a Durable Power of Attorney for Health Care or a Declaration under the Natural Death Act that expressly refuses life saving treatment.
IS THE DOCTOR REQUIRED TO TAKE THE TIME TO TALK TO ME ABOUT INFORMED CONSENT?
Yes. Your doctor has a duty to fully inform you about all of the risks and benefits of suggested treatments in terms you can understand.
HOW DO I GIVE THE DOCTOR INFORMED CONSENT?
Informally
Often, your informed consent comes informally in the course of discussion with your doctor during a routine office visit or similar situation.
Formally
Informed consent can also be given formally, by signing a document that states your doctor has fully discussed a treatment or procedure with you and that you have acknowledged and agreed to the risks. In a formal consent, you are usually asked to sign a form titled "Informed Consent to Treatment," or something similar. This is especially true in situations involving hospitalization, surgery or invasive testing.
California law requires that your consent be obtained in writing for several specific procedures and treatments for specific types of conditions, including:
- sterilizations,7
- hysterectomy,8
- breast cancer,9
- prostate cancer,10
- gynecological cancers,11
- psychosurgery,12 and
- electroconvulsive therapy.13
Another circumstance in which specific disclosures and obligation of physicians to you are mandated by law is the area of human experimentation and research.15 Federal law has established extensive regulations governing federally funded biomedical and behavioral research.16
WHEN SHOULD MY DOCTOR DISCUSS THE RISKS AND BENEFITS OF A PROPOSED COURSE OF TREATMENT AND ANY TREATMENT ALTERNATIVES WITH ME?
Any discussion of a proposed course of treatment must take place BEFORE the treatment is given.17
You are sometimes asked, as a routine part of filling out medical history and personal information forms, to sign an informed consent document. This sometimes happens before you see the doctor or care provider and before you have had the treatment and/or any alternatives explained and before there has been any chance to ask any questions.
Never sign any such document until AFTER there has been a full opportunity to have all of your questions answered and concerns discussed.
WHAT KINDS OF QUESTIONS SHOULD I ASK SO I CAN GIVE "INFORMED CONSENT?"
The key here is to ask for the information you need to decide whether or not you want to agree to treatment. Below are some examples of questions that will help you. This is not intended to be a complete list, as appropriate questions will differ depending on the medical condition or treatment being considered. These questions will help begin a discussion with your physician or care provider in order to make a truly "informed" decision about your body and health care:
- What is the condition, disease, or problem called?
- How do you recommend treating it?
- What are the risks of this type of treatment?
- What are the benefits?
- What is the complication (morbidity) rate for this treatment?
- What is the mortality (death) rate for patients in my condition using this treatment?
- What other treatments are available? Why are those not recommended?
- What will happen if I don't do anything?
- How many patients have you cared for with this problem? How many patients have you performed this surgery or this test on?
- What is your success rate in treating this problem?
- If I undergo this treatment, will it prevent me from using an alternative treatment if needed?
- Are you board certified in the specialty that treats this disease or condition?
- What can I expect if I undergo this treatment?
- Will I be able to work and/or care for myself?
- Will my activities be restricted?
- How much pain or discomfort will I be in?
- Will this treatment cause other problems?
- What kind of side effects should I expect?
- What should I do if I experience side effects?
- Will you personally perform the surgery, test, or procedure?18
- Is anesthesia necessary?
- Who will be the anesthesiologist?
- Will I be able to work and/or care for myself?
- What can I expect if I don't undergo this treatment?
- What are the alternatives to this treatment?
- What are the potential risks, complications or side affects associated with the alternative treatment?
IS THE DOCTOR LIMITED BY MY INFORMED CONSENT?
Yes. The doctor is limited by the scope of your informed consent. This means that the doctor cannot perform any procedure or treatment other than those discussed with you to which you agree.19
This is also true under the Emergency Exception previously discussed.20 Your doctor may only do what is necessary to stabilize you and eliminate the emergency situation. If a procedure can safely be postponed until informed consent is obtained, then it must be postponed. If the doctor does not postpone the procedure when it is safe to do so, you may sue him for battery if you would have refused to give consent.
WHAT ARE MY RIGHTS IF THE DOCTOR DOESN'T GET MY CONSENT, OR PERFORMS SERVICES BEYOND THE SCOPE OF MY INFORMED CONSENT?
You may be able to sue the doctor for battery and recover damages for any injury to you caused by the doctor's failure to get your informed consent, or by the doctor's performance of procedures or treatments beyond those to which you agreed.21
If your physician fails to get proper informed consent, this is considered negligence, and may be the basis for a medical malpractice lawsuit. If you think that this has happened to you, immediately consult an attorney who specializes in medical malpractice. The statute of limitations (the time within which the law allows lawsuits to be filed) for medical malpractice is one year from the time you knew or should have known that malpractice had been committed.22
WHERE CAN I GO FOR HELP?
You should report any health care provider who fails to get your informed consent for treatment to the appropriate regulatory agency. These agencies will conduct an investigation that may result in disciplinary action against the physician, care provider, or medical organization.
http://www.medbd.ca.gov
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phone: (800) 633-2322
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Phone: (916) 263-3100 or (916) 263-3117
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Phone: (916) 322-3350
(916) 322-1700 TDY
Fax: (916) 327-4402
http://www.dmhc.ca.gov
email: helpline@dmhc.ca.gov
California HMO Help Center
980 Ninth Street, Suite 500
Sacramento, CA 95814-2725
Phone: (888) HMO-2219 or (800) 400-0815
Fax: (916) 229-0465
(877) 688-9891 TDD
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Phone: (916) 263-2680
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Fax: (916) 263-2654
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Sacramento, CA 95825
Phone: (916) 263-2300
http://www.comda.ca.gov/
1428 Howe Ave., Ste. 58
Sacramento, CA 95825
Phone: (916) 263-2595
Fax: (916) 263-2709
http://www.dca.ca.gov/psych/
1422 Howe Avenue, Suite 22
Sacramento, CA 95825-3200
Phone: (916) 263-2699
Medical Board of California
E-mail: pacommittee@medbd.ca.gov
http://www.physicianassistant.ca.gov/
1424 Howe Avenue, Suite 35
Sacramento, CA 95825-3237
Phone: (916) 263-2323
(800) 555-8038
Fax: (916) 263-2671
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1420 Howe Avenue, Suite 8
Sacramento, CA 95825-3229
Phone: (916) 263-2647
Fax: (916) 263-2651
FOOTNOTES
- While a statutory definition of "Informed Consent" has never been written into California law, it has been extensively discussed in case law and is well understood within the medical and legal communities to mean that a patient "receive sufficient information to make a meaningful decision" regarding their own healthcare. Cobbs v. Grant (1972) 8 Cal.3d 229
- Cobbs v. Grant (1972) 8 Cal.3d 229.
- Cal. Business & Professions Code § 2397(a)(2).
- California Business & Professions Code § 2397(c)(2) and (c)(3).
- Cobbs v. Grant (1972) 8 Cal.3d 229, 243-244.
- Cal. Business & Professions Code § 2397(a)(3).
- Cal. Admin. Code §§ 51305.1 - 51305.4.
- Cal. Health & Safety Code § 1690.
- Cal. Health & Safety Code § 109275.
- Cal. Health & Safety Code § 109280 and § 109282.
- Cal. Health & Safety Code § 109278.
- Cal. Welfare & Institutions Code § 5326.6.
- Cal. Welfare & Institutions Code § 5326.5.
- Moore v. Regents of the University of California (1990) 51 Cal. 3d 120.
- Cal. Health & Safety Code § 24173 & § 24175.
- See 45 C.F.R. Part 46.
- Cobbs v. Grant (1972) 8 Cal.3d 229.
- If a physician obtains consent for treatment based on a particular condition and the physician fails to fulfill that condition, then the physician may be liable for battery; for example the patient consents to surgery if it is performed by a particular surgeon, and another surgeon performs the procedure. Ashcraft v. King (1991) 228 Cal.App.3d 604.
- Ashcroft v.King (1991) 228 Cal.App.3d 604.
- California Business & Professions Code § 2397.
- If a doctor obtains consent for a treatment based on a particular condition and the doctor fails to fulfill that condtion, then the doctor may still be liable for battery. For example, if you consent to surgery to be performed by a particular surgeon, but another surgeon performs the procedure, you may be able to sue the original surgeon for battery. Ashcroft v.King (1991) 228 Cal.App.3d 604.
- California Code of Civil Procedure § 340.5.