What you should know about ‘informed consent’

The case of Henrietta Lacks became a cause célèbre when it was revealed that the doctors treating her for cancer at Johns Hopkins in Baltimore more than 70 years ago harvested some of her cervical cells without her knowledge or consent.

HeLa cells, as they were called, were continuously grown and reproduced, and they went on to become a cornerstone of modern medicine, enabling countless scientific and medical innovations, including the development of the polio vaccine, genetic mapping and even COVID-19 vaccines.

Science writer Rebecca Skloot turned Lacks’ story into a bestseller, “The Immortal Life of Henrietta Lacks,” in 2011, and it became an Emmy-nominated HBO film starring Oprah Winfrey. In 2021, Lacks’ descendants filed suit against Thermo Fisher Scientific Inc., of Waltham, Massachusetts, arguing that it unjustly benefited from the cell line long after its origin became well known. The biotech company and the family reached a confidential settlement in 2023.

What the doctors did in 1951 was not illegal, but it did breach the bounds of medical ethics. Today, however, informed consent is enforced by medical ethics, administrative process and the law. Although laws vary somewhat from state to state, general principles apply across the board, and if you’re going to be undergoing a medical procedure, you should know what these are.

Informed consent is the basis for a trusting relationship between patient and provider while maintaining the patient’s autonomy. It helps avoid misunderstandings and lapses in communication and ensures the patient knows what to expect.

In Illinois, physicians acting in nonemergency situations first must obtain their patients’ “informed consent” prior to performing surgical or operative procedures. The doctrine of informed consent requires that a physician disclose to each patient the risks, complications and alternatives to surgery that should reasonably be considered.

Informed consent is required for most surgeries, blood transfusions, anesthesia, radiation, chemotherapy, biopsy, some blood tests (such as for HIV) and most vaccinations — which you know if you’ve filled out the forms for a flu or COVID shot.

In general, there are three elements, or pillars, of informed consent:

1. Decision capacity

You must be able to understand what the doctor is proposing, evaluate options and make an independent decision, free of coercion. Decision capacity doesn’t necessarily mean that you will make a “good” or a “bad” decision, just that you are capable of understanding information and making a decision. If you are caring for a loved one with diminished cognition, it’s important to have a power of attorney (POA) for health care allowing you to act on your loved one’s behalf.

2. Documentation

For routine procedures such as X-rays and blood tests, consent is implied. For invasive tests, surgery or for treatments with significant risk, you should be given a written consent form and a verbal explanation in your native language. The document should include what medical condition warrants the test or procedure; what the benefits and risks are; what the consequences may be of not going ahead; and who will be performing the procedure. In a teaching hospital, an attending physician may plan to hand you off to a resident. If you don’t want that to happen, be clear about your wishes.

When you sign a consent form, you are acknowledging that you received all the relevant information, that you understand it, that you used the information to decide whether you want the procedure and that you agree to all or some of the treatment options. Retain a copy for your records.

3. Disclosure

Any questions or concerns you have should be answered in language you can understand. It doesn’t require that you are told every single detail of the test or procedure, but it does require that you are given enough information that would allow a reasonable person to make an informed decision.

So what happens in emergencies? When a decision must be made right now, the patient isn’t able to participate and the patient’s representative or advocate is unavailable, doctors can start treatment without prior informed consent. However, the doctor should tell you or your representative what happened and obtain consent for any further treatments as soon as possible.

Being on the receiving end of all this information may be overwhelming, so if you’re facing a situation like this, a medically trained patient advocate may be a useful ally who can understand the medical language, translate it into lay terms and discuss alternatives. A patient advocate can also hold the physicians accountable for meeting all the terms of informed consent.

In its simplest form, informed consent puts you in the driver’s seat, but it’s important to know the rules of the road.

• Teri (Dreher) Frykenberg, a registered nurse, board-certified patient advocate and author, is the founder of Nurse Advocate Entrepreneur, which prepares medical professionals to become private patient advocates. Reach her at Teri@NurseAdvocateEntrepreneur.com. Readers with questions about patient advocacy may contact Margo Marasa, owner of Allegiance Patient Advocacy, for a free consultation. Contact her at margo@allegiancepa.org or (773) 732-0762.