Informed Consent

We must be proactive when it comes to receiving the best medical care and as an organization we strive to provide quality information to consumers in order to receive informed consent prior to making a healthcare decision. We are responsible for asking enough questions to make an informed decision; however, healthcare professionals are also required to provide informed consent. Court cases from across the country and at various levels of the court have acknowledged and established what it means to receive informed consent. So what constitutes informed consent and what happens if you don’t receive it?

What is informed consent?

Informed consent is the right to receive clear and understandable information about a procedure or treatment’s potential benefits or risks BEFORE providing your consent. Additionally, you must receive all treatment options available for the condition and what the risks would be if deciding on not using the treatment. Informed consent should always happen BEFORE treatment. Consent can be provided verbally or in writing depending on the type of treatment or procedure that is to occur. Never sign an informed consent document until seeing the doctor and having all questions answered. For example, consent to treat forms are often thrown into the electronic health registration forms at hospitals or doctor’s offices even before meeting with the doctor.

4 Basic tenets of informed consent:

Benefits of treatment
Risks of treatment
Alternatives of the treatment
Must be voluntary, without coercion.

When is informed consent required?

Generally speaking any treatment, procedure, test, or prescription requires your consent with a few limited exceptions. Informed consent may not be required for simple, common procedures such as blood screenings. Meaning they may not have to go over the benefits and risks of the blood screening itself but DO have to receive your consent to take your blood. Another exception is in the case of an emergency, which 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. Your doctor may only do what is necessary to stabilize you and eliminate the emergency situation. If a procedure or treatment can safely be postponed until informed consent is obtained, then it must be postponed or the doctor is at risk of being sued for battery. Once you are stabilized then the doctor must receive your consent or the consent of your power of attorney for further treatment.

Questions to ask for informed consent

We often forget what questions we should be asking at a doctor’s appointment, especially if we are given a diagnosis that is overwhelming. In order to receive informed consent we must ask the right questions and be provided with the information needed to decide whether to agree to a treatment or procedure. 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 death (mortality) rate for patients in my condition using this treatment?
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?

Are you board certified in the specialty that treats this disease or condition?
If I undergo this treatment, will it prevent me from using an alternative treatment if needed?

What can I expect if I undergo this treatment?
- Will I be able to work and/or care for myself?
- Will it prevent me from breastfeeding or is it contraindicated to do this treatment with other supplements, treatments, or therapies?
- How much pain or discomfort will I be in?
- Will this treatment cause other problems?
- What kind of side effects should I expect?
- What kind of side effects are rare but possible?
- What should I do if I experience side effects?
- Can you provide the insert for the drug, treatment or biologic you are recommending?
- Will you personally perform the surgery, test, or procedure?
- Is anesthesia necessary?
- Who will be the anesthesiologist?

What can I expect if I don't undergo this treatment?

What other alternative treatments or options are available? Why are those not recommended?

What are the potential risks, complications or side effects associated with the alternative treatment?

What are my rights if the doctor doesn’t get my consent:

If your physician fails to provide 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 2 years from the time you knew or should have known that malpractice had been committed, Iowa statute 614.1.

If your doctor performs a procedure or treatment without your consent, you may also 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.

For vaccine related injuries doctors, healthcare facilities, and pharmaceutical manufacturers are immune from such lawsuits. There are two places to file claims with the Federal government for injuries due to vaccines, vaccine injury compensation program (VICP) and countermeasures injury compensation program (CICP) for emergency use authorized products only. A doctor is still required to provide you with informed consent before administering a vaccine (42 USC 300aa 26.d) and could be disciplined by their board or employer for not providing informed consent prior to giving a vaccine. While there are no specific tort actions listed in the Federal law, you could also consult with an attorney as to whether you can file a lawsuit for negligence due to not being provided informed consent.

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.

The boards of medicine, pharmacy, osteopathic medicine, registered nursing, chiropractic, dental, psychology, podiatric medicine, physician assistant, acupuncture, mental health, midwifery, etc are all regulated and overseen by DIAL.

Contact info:

Dept of Inspections, Appeals, and Licensing (DIAL)

6200 Park Ave, Suite 100, Des Moines, IA 50321

ibmcomplaints@iowa.gov

515-281-5171

To find the complaint form or process for each healthcare provider specialty visit:

https://dial.iowa.gov/ineed/complaints#:~:text=Complete%20the%20online%20complaint%20form%20for%20physicians%2C%20acupuncturists%2C%20or%20genetic,to%20ibmcomplaints@iowa.gov.

For vaccine related injuries, report the injury to the vaccine adverse event reporting system (VAERS) or ask your healthcare provider to help you file this report as required by Federal law. (42 USC 300aa.25) https://www.govinfo.gov/app/details/USCODE-2016-title42/USCODE-2016-title42-chap6A-subchapXIX-part2-subpartc-sec300aa-25

To file a claim and seek compensation for vaccine injuries:

VICP: https://www.hrsa.gov/vaccine-compensation

CICP: https://www.hrsa.gov/cicp

*note there is a statute of limitations of 3 years after symptom onset for all VICP claims and a 1 year statute of limitations after the countermeasure has been given to you for CICP claims.

Legal case citations for informed consent:

Canterbury v. Spence (1972)

Shinal v. Toms (2017)

Hope v. Samson (1966, Iowa)

Runge v. McDonald (1987, Iowa Supreme Court)

Parental rights case citations concerning parental consent:

Mcdermott vs wyatt (2012)

Frazier v. Frazier (Iowa, 2024)

Parham v. J.R., 224 US. 584 (1979)

Troxel v. Granville, 530 US 57 (2000)

Washington v. Glucksberg, 521 US 702 (1997)