What is an informed consent and why is it important?
Informed consent is a process in which patients are given important information, including possible risks and benefits, and potential alternatives about a medical procedure or treatment, genetic testing, or a clinical trial. There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency. It is a process that documents the communications between a patient and their health care provider or research study participant and their researchers. Documentation of the communications is important for a number of reasons:
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Patient protection
Informed consent ensures that patients understand their condition, treatment options, and risks, benefits and alternatives of those options. It also gives them the opportunity to understand if and how medical students and/or trainees will be involved in their care and provides patient’s the option to decline their participation in their care. Lastly, it creates a venue where patients and/or their support resources can ask questions and make informed decisions about their care.
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Trust
Informed consent can help build trust and confidence between patients and medical professionals.
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Respect
Informed consent shows respect for patients and their autonomy. It involves respecting their cultures and making sure they understand how trainees may be involved in their care.
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Legal protection
Informed consent can reduce the risk of unnecessary legal claims based on incorrect assumptions about medical care.
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Research
Informed consent ensures that research participants understand what the study entails and can voluntarily consent to participate.
Now that we have the definition and reasons why an informed consent is important, we need to ensure that the informed consent is completed properly to avoid placing the provider/organization in a position where a treatment or procedure would be questioned and potentially lead to a litigious situation.
During medical record audits, I have found that informed consents are not being completed properly or completely. Consents should have the following information completed.
- Patient name, date of birth, medical record number, physician name, room number – on the patient label.
- The practitioner performing the procedure should document on the consent form:
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- Name of the patient on the consent.
- Procedure(s) being performed described in laymen’s terms.
- Risk, benefits and alternatives of the procedure(s) and the risks and benefits of the alternatives.
- Name of any assistants in the operating room and their role, if applicable.
- Patient signature, date and time.
- Physician signature, date and time.
- Witness signature, date, and time.
- The use of an interpreter or translator with their identification number.
- Anesthesia consent should include all of the above with the type of anesthesia to be administered.
- Chemotherapy consents need to list the medications to be administered to the patient and their potential side effects.
- Equipment representatives need consent from the patient to be in the Operating Room with the patient.
- Consent should be obtained if pictures or videotaping are being performed during a surgical procedure.
The Joint Commission’s survey process related to informed consent has been updated to align with revised guidance for hospitals from the US Centers for Medicare & Medicaid Services (CMS) memo, QSO-24-10-Hospitals.
The updates clarify that informed consent is obtained when practitioners other than the operating practitioner— including but not limited to other physicians, residents, advanced practice providers (such as nurse practitioners and physician assistants), and medical and other applicable students—will be participating in and/or performing important tasks related to the surgery or an intimate/ sensitive examination (such as breast, pelvic, prostate, and rectal exams) or invasive procedure for educational and training purposes. When the patient is receiving sedation or anesthesia, this is included in the written consent form. When the patient is not receiving sedation or anesthesia, only verbal consent documentation in the medical record is required.
In summary, after explaining what will happen, physicians complete the informed consent form. All sections of the form are to be completed prior to administration of any sedating medications and prior to the initiation of the procedure. Patients should have the opportunity to ask questions and voice any concerns prior to signing the informed consent.
Well-informed patients, are cooperative, happy patients!
Reference
- US Centers for Medicare & Medicaid Services (CMS) memo, QSO-24-10-Hospitals, published on April 1, 2024
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