See case study “Failure to obtain informed consent"
In Texas, informed consent is governed by statute and is overseen by the Texas Medical Disclosure Panel (TMDP).
The panel includes six physicians and three attorneys who review all treatments and procedures to determine which procedures require informed consent and which do not. Procedures and treatments are then assigned to a list. Those requiring disclosure of risks and benefits are put on List A. Those that do not require disclosure of specific risks are identified in List B. (1)
The TMDP periodically examines new treatments or procedures and assigns them to one of the lists. The lists, TMDP rules, and forms can be viewed here.
When offering any treatment or procedure to a patient, the physician must make these determinations:
- if the treatment or procedure appears on List A, then disclosure specified by the panel must be followed;
- if the treatment or procedure appears on List B, no specified disclosure is legally required;
- if the treatment or procedure does not appear on either List A or List B, the physician must then disclose all material and inherent risks that could influence a patient in making decisions. (1)
It is the duty of the physician performing a procedure to obtain informed consent from the patient. The discussion should include the patient’s condition, procedure being performed, risks and potential complications of the procedure, benefits, and alternatives. There should be adequate time in the discussion for the patient to ask questions, and the physician should respond to all questions as accurately as possible. (1)
Others may help with administering informed consent documents, witnessing the patient’s signing, and reinforcing instructions; however, it is the treating physician’s responsibility to explain the procedure(s), ensure that all questions and concerns are addressed, and the patient’s understanding and willingness to proceed is documented. (1)
By statute, the TMDP may not require disclosure of the risks of certain surgeries, procedures, or medications. However, it is best to disclose those risks that a reasonable person would want to know in making the decision.
Documentation of the informed consent discussion — including the risks, benefits, and alternatives to the surgery — should be included in the medical record.
1. Texas Administrative Code. Title 25, Texas Administrative Code, Part 7, Chapter 601. Available at https://texreg.sos.state.tx.us/public/readtac$ext.ViewTAC?tac_view=4&ti=25&pt=7&ch=601&rl=Y .