Better Communication With Health Professionals

What Does "Informed Consent" Mean?

Among the various patients' rights (listed on this webpage) are these two important ones:

• Get complete information about diagnosis, treatment, and prognosis in terms that are easily understood; and
• Be asked for permission to be treated (informed consent).

Those two rights are linked. In most cases patients have the right to decide whether to accept any course of action that their health care team recommends. In order to make those decisions wisely, patients should get full and complete information, so they can give informed consent or make an informed rejection.

As the National Library of Medicine (NLM) explains, there are actually 3 aspects to informed consent:

1. You are informed. You have received information about your health condition and treatment options.
2. You understand your health condition and treatment options.
3. You are able to decide what health care treatment you want to receive and give your consent to receive it. 

The flip side of asking patients to give permission means that patients also have the right to refuse permission. As the NLM states:

"You have the right to refuse treatment if you are able to understand your health condition, your treatment options, and the risks and benefits of each option. Your doctor or other health care provider may tell you they do not think this is the best choice for you. But, your providers should not try to force you to have a treatment you do not want to have."

Consent for Treatment

The National Library of Medicine goes on to state that when asking for informed consent to treatment, someone in your health care team must explain:

• Your health problem and the reason for the treatment;
• What happens during the treatment;
• The risks of the treatment and how likely they are to occur;
• How likely the treatment is to work;
• If treatment is necessary now or if it can wait and the consequences of waiting [and also the consequences of not doing anything to treat];
• Other options for treating your health problem;
• Risks or possible side effects that may happen later on.

You may need to give informed consent in writing for some serious illnesses, or when surgery or another risky treatment is suggested, or when genetic testing is offered (in some cases, also for tests of sexually-transmitted diseases).

When Someone Cannot Give Consent

Generally, children under 18 cannot consent  - their parent(s) or guardian(s) must make decisions for them. The ethical issues can get tricky when considering teens and older children who may have different opinions from their parents about, for example getting braces on their teeth, or taking a medication they dislike. In those cases, it would be wise to talk with the health care team to find the best solution.

Adults can become temporarily incapacitated, unable to give consent (ex., if they're unconscious, or in shock, or cannot communicate).

In emergency situations, medical personnel will "presume your consent to save your life. They will attempt to obtain your explicit consent as soon as you are able to give it, and they will strive to keep you informed going forward," (quoting the Cleveland Clinic). For one example, unless they have clearly-marked Do Not Resuscitate directions, EMTs will perform CPR and other life-saving measures without asking for consent first. Another example is when childbirth emergency measures may be needed to protect both mother and baby. In that situation the healthcare team will try to get verbal informed consent if possible but will act according to their best judgement if they cannot.

When someone has a mental illness, dementia, or a cognitive deficit, it can be difficult to decide if they can make a fully informed consent for treatment, or to participate in a research study or clinical trial. Also, their ability to give informed consent may change over time. For example, early-stage Alzheimer patients may be able to participate in some research studies but their ability to consent may decline over time. There are no clear regulations in the U.S., only judgement calls - and it is best to consult with the healthcare team if there are concerns.

In California law there is a provision for people who are in grave danger of harming themselves or other people, or are "gravely disabled (unable to provide ... basic personal needs for food, clothing or shelter)" to be treated without their informed consent. Only mental health professionals licensed by the county, or an official crisis team, or police can authorize this Involuntary Treatment Hold (also called 5150) for 72 hours. When that time is up, if that person does not consent to additional treatment they must either be released or in severe cases, put on additional involuntary hold for 14 days (5250, "certification for intensive treatment"). While in practice these holds are used most often when someone is suicidal or in a mental health crisis, in theory they could be invoked in dire circumstances for any dangerous health condition.

Informed Consent for Research Studies and Clinical Trials

Why sign up for a research study or clinical trial in the first place? There are many reasons. 

Many people participate in research studies to find out more about themselves, especially if they have been diagnosed with a condition or illness and are looking for treatments or interventions that would help, or improve their quality of life. Some are concerned about health problems that run in families. Clinical trials are the last steps in approving new tests, medications, or treatment - so it can be a way to get the benefits of the latest research, as well as expert care.  Some are drawn to the chance to make other people's lives better, especially if they can help improve medicine for diverse groups of people.

If the idea of participating in a clinical trial is appealing, start here; to find research studies, check the registry listing for relevant diseases here.

The National Institutes of Health's All of Us research program looks to collect data for precision medicine, that is, to figure out which treatments work best for people of different backgrounds, to connect people with the right clinical studies for their needs, and discover whether it is possible to tailor treatment to individuals. If interested, click here find out more.

Informed consent is critical to make sure that research is done in a respectful, beneficial, and ethical way.

Children in research studies or clinical trials: as explained above, people under the age of 18 cannot give informed consent. However, when children participate in a clinical trial or in research, they may be asked if they give assent (that is, if they agree with what their parent or guardian has consented).

There are also other protective restrictions on what kinds of research can include children. While it is important to study how children grow, how medications that were approved for adults  effect children of different ages, and how to improve the lives of children with disabilities, at the same time everyone wants to protect kids in research studies as much as possible. The video for parents below is meant to help them make the best decision for their children.

The California State Informed Consent Form Guidelines include a section on patients' rights and privileges whenever participating in a research study: