The law defines the relationship between the patient and physician as consensual. Informed Consent is a process which provides for open, factual dialogue between physician and patient ending with an informed decision by the patient to have or not have a given procedure, treatment, or surgery. One of the primary functions is to acknowledge the risks and benefits of the procedure and of the alternatives, including not doing anything at all.  The consent form merely documents that the process has taken place and both parties acknowledge that information was provided and there was opportunity to ask questions and have them answered. 

The elements of an Informed Consent include:

• Description of the patient’s diagnosis/medical condition or disease.
• Description of the proposed surgery or procedure (including laterality, if applicable).
• Description of the type of anesthesia that will be used during the proposed surgery or procedure
• Indications for the proposed surgery or procedure.
• Description of anticipated material risks and benefits (short and long term) of the procedure, including likelihood of each, based on available clinical evidence and the practitioner’s clinical judgment.
• Description of treatment alternatives, including material risks and benefits associated with the treatment alternatives.
• Names of persons who will perform the surgery or procedure and anesthesia.
• Information about whether physicians other than operating practitioner will be performing important tasks related to the surgery or anesthesia.
• Information about qualified medical practitioners, who are not physicians, who will be performing important tasks related to the surgery or anesthesia.
• Opportunity to ask questions.   

Pennsylvania Law specifically requires physicians to obtain Informed Consent for: HIV testing, performing surgery (including related administration of anesthesia), administering radiation, chemotherapy, blood transfusion, inserting a surgical device or appliance, administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner. 

The consent form memorializing the consent process must be incorporated into the medical record. It is also a patient safety tool as it is used during Universal Protocol to ensure the correct patient, correct procedure, and correct laterality. 

While the patient may give permission for a given procedure the patient can, at any point in time, rescind authorization, despite signature on a given form. Certainly, if the revocation or refusal to a given procedure is informed then it should be honored and documented. 

Patients 18 years of age or older provide consent; however, in a scenario when an adult patient is incapacitated then we look towards a legal guardian to be the decision maker. If there is no legal guardian, then Act 169 provides guidelines for who can give consent when the patient is unable/incapacitated to make healthcare decisions and there is no legal guardian. The first option for decision making is an identified Power of Attorney (POA).  Unfortunately, there is not always a POA identified. The pecking order to next approach in absence of a POA includes: Spouse (unless action for divorce is pending) and adult children who are not the children of the spouse, adult children, parents, adult brothers/sisters, adult grandchildren, adult who has knowledge of the patient’s preference and values. For minors, there are some exceptions as to when they are able to give consent or not. The administrative manual outlines various exceptions. 

While many physicians believe that the patients may not want of lot of information or that more information may make the patient anxious, it is prudent that the patient be provided as much information as possible to make an informed decision. This includes the information being presented in terms the patient can appreciate.  Healthcare literacy is an important piece of the process. The verbal and written communication must be in the language the patient understands, even if it requires providing a professional interpreter. Additionally, the communication must be on a level the patient can comprehend, even if it requires providing video, pictures, or materials in primary grade readability level.

The relationship between the patient and physician is always evolving. The consent process done well helps to secure that relationship and build trust and respect. A patient who takes responsibility and ownership in his/her care and decision making is less likely to blame his/her physician if there is a complication. Obtaining consent is not just a formality, it’s part of the continuum of care and a patient right.  Remember, it is not a signature, but a process.

If questions regarding consent, please contact Risk Management.