When Is Informed Consent Required?
Today, Pennsylvania Supreme Court judgments obligate medical professionals to secure patient consent before conducting eight forms of treatment:
- Surgical procedures
- Anesthesia during surgery
- Radiation therapy
- Blood transfusions
- Inserting a surgical device or appliance
- Experimental medications or medical devices
- Using an approved medication or device in an experimental manner
In all other cases, informed consent is not a requirement.
What Medical Information Must Be Disclosed?
In line with the Medical Care Availability and Reduction of Error (MCARE) Act of 2002, Pennsylvania’s courts use a “reasonable patient standard” in deciding informed consent issues.
This legal doctrine does not require that doctors disclose “all known information” about a diagnostic test or treatment. Instead, physicians are bound to disclose “all those facts, risks and alternatives that a reasonable patient in the same or similar situation would want to know before deciding whether to proceed with the proposed treatment” (in the words of the 1971 Pennsylvania Supreme Court decision Cooper v. Roberts).
What information would give a reasonable person pause, or change their mind, about a treatment?
- the patient’s diagnosis
- the nature and goal of the proposed treatment
- the benefits and risks of the proposed treatment
- alternatives to the proposed treatment (regardless of cost or health insurance coverage)
- the benefits and risks of alternative treatments
- the benefits and risks of not receiving any treatment
Those are the kind of details physicians must disclose; in the words of a more recent Supreme Court decision, Gouse v. Cassel, “material facts, risks, complications and alternatives.”
Who Is Responsible For Obtaining Patient Consent?
While some states allow nurses to stand in as surrogates for doctors, the Pennsylvania Supreme Court held in 2017 that physicians, and physicians alone, have the legal duty to obtain informed consent from their patients. “The duty to obtain the patient’s informed consent,” Justice David Wecht wrote in a 4 to 3 decision, “belongs solely to the physician.”
To secure informed consent legally, doctors are not allowed to use nurses or other non-MD medical professionals as proxies: “Informed consent requires direct communication between physician and patient, […] a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent.”
Who Can Consent To Medical Treatment For A Child?
State law usually considers minors, people under the age of 18, to be legally incapable of providing consent to medical treatments. As a result, the task of giving consent often shifts to a parent or legal guardian.
That isn’t always the case, though. Under the 1970 Minors’ Consent Act, a Pennsylvania state law, some minors are allowed to consent to medical, dental and other health services on their own, without the intervention of a parent or legal guardian:
- a minor who has graduated from high school
- a minor who has been pregnant
- a minor who is married
- a minor who has received a court’s decree of emancipation (from the Court of Common Pleas where he or she lives)
Beyond these categories, the Minors’ Consent Act allows any person under the age of 18 to provide informed consent for diagnostic tests and treatment related to a “reportable disease,” a surprisingly-long list of disorders and conditions that can be found at the Pennsylvania Department of Health. Minors in Pennsylvania are also allowed to consent, on their own, to certain medical services:
- contraception, pregnancy and STD testing, health services to “treat” pregnancy (not including abortion) and STDs and prenatal care
- inpatient mental health treatment (minors 14 years or older who believe they are in need of treatment and substantially understand the nature of treatment; consent must be voluntary and in writing)
- outpatient mental health treatment (any minor 14 or over)
- substance abuse treatment
- emergency situations
Is Consent Obtained In Accidents & Emergencies?
Most state courts recognize that, in order to save someone’s life, the lengthy process of obtaining informed consent can hinder a physician’s efforts. When emergency medical treatment is necessary to prevent severe harm, doctors aren’t usually required to obtain a patient’s consent. This is generally how Pennsylvania’s courts view the issue. In less-immediate emergency situations, judges may also take a patient’s level of consciousness into account, the general rule being that a patient who is conscious and able to make decisions about their own healthcare should be allowed to do so whenever possible.
What Happens When Informed Consent Is Not Obtained?
When a physician administers medical care without securing informed consent beforehand, patients may have the right to secure financial compensation in a civil lawsuit. Importantly, lawsuits that revolve around a failure to obtain consent are not considered medical malpractice cases. Instead, Pennsylvania places these claims in the realm of “battery” (as in “assault and battery”) – unwarranted or unwanted forms of touching.
In essence, patients who were treated without providing informed consent were “touched” in an illegal way. Generally, physical injuries are not required to secure compensation; the unwarranted “touching” is the problem, not any direct physical harm that “touching” may have caused.
What Does A Signed Consent Form Prove?
A signed consent form does not, in itself, prove that informed consent was given. Some patients sign consent documents without having been adequately informed. The key question, at least for legal analysis, is whether or not a doctor provided the patient with accurate and sufficiently-exhaustive information before the patient made their decision. A signed consent document doesn’t necessarily prove that.
At most, a signed document demonstrates that a patient, at the time, thought they had been adequately informed. Within the broader realm of medical malpractice, informed consent doesn’t usually matter. Cases arising from medical negligence are, as the name implies, about negligence – a medical professional’s failure to provide care in accordance with accepted medical standards. No patient ever consents to receive negligent medical care.
The Pennsylvania Supreme Court elaborated on this point in 2015, holding in Brady v. Urbas, that “assent to treatment does not amount to consent to negligence, regardless of the enumerated risks and complications of which the patient was made aware.” In medical malpractice cases based on allegations of negligence, informed consent is irrelevant.
Is Informed Consent Different For Clinical Trials?
Informed consent requirements are usually more stringent for clinical trials and experimental new therapies, since the risks posed by unproven treatments are, in general, poorly-understood. Thus patients who participate in clinical trials (both for new drugs and new procedures) are normally entitled to more information, allowing them to make better-informed decisions before taking part in the study:
- what the clinical trial aims to find out
- what will be expected of patients
- how long patients will be expected to participate
- what benefits are expected from the drug or procedure
- all known risks to patient health
- your primary contact in the research team – who you should call with questions or concerns
- alternative treatment methods that may be available
- your rights as a trial participant – that you can stop at any time and receive standard treatments instead
In most cases, the informed consent document that you receive upon your first meeting with the research team will detail all of these points. Again, informed consent requires that you actually understand the information being presented. This is a dual responsibility; researchers have to explain the study in an intelligible way and patients have to seek out more information, or clarification, when they are confused. If you don’t understand something, or the scientific language is too technical, let the research team know. A physician won’t know that you don’t understand until you tell them.
Will I Have Time To Consider The Treatment Before Consenting?
Consent documents are only the beginning of a much wider conversation. Want more trusted voices in the room? Ask the research team to include your own specialist, primary care physician and / or nurse in the initial meeting. Many clinical trials will have their own social workers or psychologists sit in to help patients think deeply about their options. Bring family members or other loved ones for support – people you know and love can help clarify your feelings and concerns.
You should be given time to process the information and come to a decision on your own. Most clinical trial teams will send you home with a copy of the consent document to review and discuss with loved ones, faith leaders, therapists and friends. If the research team doesn’t offer you a copy of the consent form, ask for one. Also request a copy of the study’s protocol, the full plan for the trial, which you can review on your time, maybe with the help of a trusted medical professional.
Keep a list of questions and concerns to bring up when you meet with the research team again. Ask every question you can think of, including the ones that you think are stupid or pointless. Some research teams will administer little “tests” to make sure that you understand the trial’s goals and risks. You might have to explain the study in your own words or fill out a questionnaire. Again, don’t wait for a researcher to explain something that you don’t understand; take an active role in getting answers.
Patients are also entitled to ongoing updates throughout a clinical trial. In other words, informed consent is a precondition both for starting a clinical trial and staying in the trial. Full and complete disclosure, along with a patient’s consent to continue, are fundamental aspects of every clinical trial. Informed consent should be folded into the research program – a function of your daily interactions with researchers and medical professionals.