Early in my training, I learned to get patients to quickly sign consent forms without reading them. I didn’t have time to read them either. I didn’t know enough to explain risks or answer questions. Like my peers, I reassured patients that what we were giving them was safe. We just needed a signature to inject IV contrast or give medication. I gave Spanish-speaking moms multiple consent forms in English. They signed on behalf of their children. They trusted me.
I was trained to be deceptive.
In my final year of training, I was told to prescribe Premarin (Pregnant-Mares’-Urine-derived estrogen) to all menopausal women—without explaining alternatives or risks. I refused. I was reprimanded. I went to the medical library. I did my own research rather than rely on the drug company or my training program (that received money for their involvement in the Women’s Health Initiative study on Premarin in menopausal women).
Beyond the cruelty to pregnant mares, I discovered risks to my patients (for which the Premarin study was eventually halted). Since I had no time in clinic to share drug risks and alternatives, I held free public library lectures for my patients and community where I reviewed all menopause hormone therapies (including non-drug options) and shared simple, yet comprehensive handouts.
Here’s the training I wish I’d received on informed consent.
What is informed consent?
Informed consent is a medicolegal conversation between a patient and trusted health professional who recommends a procedure, reviews its alternatives, risks and benefits, then answers questions.
Who is legally capable of giving consent?
Patients must be at least 18 years old and competent to voluntarily—under no duress—consent or refuse proposed medical interventions.
Can children give informed consent?
Children under 17 cannot generally provide informed consent. Parents must be consulted for all treatments or interventions on minors.
What does “PARQ conference held” mean in the medical record?
The PARQ acronym is Procedure, Alternatives, Risks/Benefits, Questions— minimum requirements for informed consent. “PARQ done” means a meeting was held to establish consent for a procedure in which alternatives, risks (including potential risks) and benefits were discussed and patient had all their questions answered.
What alternatives must be discussed?
Viable alternative procedures and treatments must be disclosed, including the option of no treatment and potential risks of non-treatment.
What risks and benefits must be reviewed?
Risks and benefits of proposed intervention and all alternative interventions must be reviewed—including serious and life-threatening injuries such as organ damage, disfigurement, sexual dysfunction, irreversible impairment, and death. An exhaustive list of minor remote risks need not be shared.
How long can patients ask questions?
Patients can ask as many questions as needed to make a decision. Patients can be sent home with educational materials and return at a later date to ask follow-up questions as needed and should never be pressured into an elective procedure urgently.
What if a patient is unable to give informed consent?
If unable to make independent decisions, patients may need a psychiatric competency evaluation and a surrogate decision-maker or court-appointed guardian.
When is informed consent not required?
If incapacitated with a life-threatening emergency, “implied consent” is assumed unless a do not resuscitate order is present. A signed consent is not required for simple procedures such as checking blood pressure. In rare cases, court-ordered treatments for incarcerated persons may be mandated by law.
Who can obtain informed consent?
The duty is generally the responsibility of the patient’s physician. Qualified health professionals with adequate knowledge of PARQ elements of proposed intervention can obtain consent. A qualified professional must not delegate informed consent to an unqualified professional such as a new physician, medical trainee, or ancillary staff unable to educate patient. Note: consent given to one health professional is not transferrable to another—unless patient agrees to a substitute to perform intervention.
Must informed consent be documented in medical record? Is a signed form required?
For surgeries and invasive procedures, a consent form is signed by patient and health professional and placed in the medical record. For less invasive tests and drugs with known safety profiles, consent is summarized in chart note with no signed form.
Does a patient signature on a consent form guarantee informed consent?
No. A signature does not prove effective communication. In fact, patients have been pressured to sign consent forms in non-native languages with poor health literacy while naked on a gurney just minutes before procedure is performed.
How can the informed consent process be improved?
At minimum, thirty minutes should be allotted at least one week prior to intervention (depending on procedure complexity) for consent conversations delivered at a fourth-grade level with visual tools (videos or image-rich pamphlets) and interpreter if patient is a non-native speaker.
How can consent forms be improved?
Non-industry experts with no conflict of interest should create unbiased informed consent materials. If intervention is experimental with risk of serious injury or death, multi-page informed consent forms should be provided for patient review ahead of experimental procedure with a signed copy given to patient upon consent.
Why is informed consent important?
Informed consent is a fundamental human right of patient—and health professional—that honors the principle of body autonomy and prevents human experimentation.
Have patients been subjected to experiments without consent?
Yes. Due to human experiments by Nazi physicians and the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male” that continued nearly forty years, the Institutional Review Board now regulates human research. Informed consent for research requires full disclosure of information, competency evaluation, and voluntary participation. Research subjects must understand they are enrolling in an experiment and human safety and effectiveness of treatment is unknown. Yet even in modern times patients may be unaware they are taking new experimental medications with unknown safety and unclear long-term risks.
What is shared decision making?
A collaborative communication process between health professionals and patients in which best scientific evidence is shared and patients’ decisions are supported with all parties actively involved in medical decision-making.
What is informed refusal?
A medicolegal informed refusal conversation requires a health professional to disclose possible risks of refusing care and then document patient refusal of test or procedure in chart—without antagonizing the relationship.
Can health professionals’ subjective views impact informed consent?
Yes. Employer-driven productivity requirements and protocols, insurance drug formularies, medical board sanctions, financial kickbacks, education and specialty training, knowledge base, religious views, and cultural norms can all impact flow of information from health professionals to patients. Consent conversations may vary significantly depending on who is obtaining consent.
What are examples of lack of informed consent?
Staff misrepresentation: Nonphysicians failing to identify credentials and introducing self as doctor; failure to inform patient of midlevel anesthesia (CRNA & AA); failure to accept refusal of nonphysician care by NP, PA; surgical/anesthesia consent obtained by unqualified office staff. Trainee refusal: Threatening to cancel surgery if patient refuses trainee participation; failure to inform patient of medical trainees in surgery; failure to inform patient of student genital exams under anesthesia; failure to ask and/or document patient refusal of trainees’ care. Time issues: Attempting to obtain consent in a 10-minute visit for an experimental drug; multipage micro-font forms given to naked patient (without reading glasses) on gurney en route to procedure. Form issues: Patients told to accept entire document without changes or strike through; consent forms signed by patients with developmental delay, acute mental health issues, or dementia. Coercion/threats: Offering gift cards or financial awards for medical intervention; enticing children with ice cream or prizes to submit to medical intervention (without parental consent); threatening job loss for refusing medical procedure/intervention.
What happens if a patient lacks informed consent and suffers serious injury?
Physicians may be held liable in a malpractice case. Without proper documentation, there’s no proof of patient consent. Violence toward health professionals, including physician homicide may be carried out by a patient such as recent case of a man with post-op pain killing his orthopedic surgeon.
Are physicians trained in educational settings that honor informed consent?
Trainees are often left without supervision in production-driven clinics/hospitals with inadequate knowledge to obtain informed consent. Trainees are not protected by labor laws and may work > 24-hour shifts, unable to care for their own physiologic needs. Sleep deprivation is more dangerous than working under the influence of alcohol. In fact, being awake for at least 24 hours is like having a blood alcohol content of 0.10% (higher than legal limit) and would interfere with one’s ability to obtain informed consent—or perform any medical procedure safely. Trainees lack informed consent of mental/physical health risks of a medical education—including DNA aging six times faster than their non-medical peers and are uninformed of high-risk specialties for suicide (anesthesia, surgery). Groomed in training environments that negate their own human rights to informed consent, physicians are at high occupational risk of performing subpar informed consent on patients.
Any tips for health professionals on improving informed consent?
Converse at eye level with patient fully dressed to decrease power differential. Provide step-by-step description of procedure (videos are helpful). Research beyond industry-supported data when providing information to patients. Avoid consent forms with medicolegal jargon or include list of medical definitions written at a fourth-grade level. Use teach-back questions to ensure patient understands and feels empowered to consent or refuse.
How can patients get more information before consenting to medications or procedures?
Before taking a new medicine, read drug insert online or through pharmacies. Join discussion groups for specific drugs, procedures, and illnesses. Do your research. Medical sites may overemphasize benefits and minimize risks, while injured patients will focus on life-altering adverse effects. For example, radiologists might minimize IV contrast risks, while a subset of patients who lacked informed consent for MRI gadolinium contrast are in a Facebook support group suffering debilitating effects of gadolinium deposition disease. To learn more about psychiatric drugs, patients may join a Facebook Benzodiazepine Withdrawal Support Group and even Psychedelic Assisted Therapy to learn about Ketamine, if recommended by their physician.
Can patients initiate informed consent discussions with doctors?
Certainly. Be proactive with your physician about PARQ—procedures, alternatives, risks/benefits, and questions—before all medical interventions, tests, and medications. Always request cheaper generic drugs with known safety profiles. Avoid experimental procedures and new drugs unless benefit-risk ratio is in your favor. When in doubt, ask more questions or get a second opinion. Informed consent is your responsibility (Addendum: actually your right to receive and you should demand to have the information you need). Never agree to anything unless you feel comfortable. You should never be coerced or threatened to accept a medical intervention.
I wish to thank all the patients and health professionals who shared their experiences with informed consent for this article.