The following is intended to explain the duties of the Texas Medical Disclosure Panel, the purpose of the guidelines and use of the consent forms, and to address some of the frequently asked questions. Unless otherwise provided, the term "provider" refers to a physician or other health care provider identified in the Consent Statute. This information is not intended as legal advice or to supersede the Consent Statute and regulations promulgated by the panel, but as general guidance only. Please note that the panel does not provide expert testimony in litigation or opinions on the adequacy of consent to medical treatment or surgical procedures other than as provided in the Consent Statute and implementing regulations.
1. General
1.1. What is informed consent?
Informed consent is the permission given by a patient to perform a medical treatment or surgical procedure after the patient has been advised of the risks or hazards that could influence a reasonable person in deciding whether or not to give permission. In order for the patient to make an informed decision about whether to give his or her permission, the patient needs information about the treatment or procedure and the risks associated with it. Informed consent deals with the information provided to the patient and how it is provided when obtaining the patient's permission to perform the treatment or procedure.
1.2. What is the Informed Consent Statute?
The Informed Consent Statute is Subchapter C of Chapter 74 of the Texas Civil Practice and Remedies Code, Sections 74.101-74.107. The Informed Consent Statute provides that, for a patient to recover against a provider for lack of informed consent, the patient must show that the provider was negligent in failing to disclose the risks or hazards that could have influenced a reasonable person in making a decision to give or withhold consent. Informed Consent Statute, Sec. 74.101 of the Texas Civil Practice and Remedies Code.
2. About the Panel
2.1. What is the purpose of the panel?
The purpose of the panel is to determine what risks and hazards related to medical treatments and surgical procedures must be disclosed by a provider to the patient in obtaining informed consent, the substance of the disclosure, and the form in which disclosure should be made. Informed Consent Statute, Sec. 74.102(a) of the Texas Civil Practice and Remedies Code.
2.2. Who serves on the panel and how are the members appointed?
The panel is composed of six physicians and three attorneys, appointed for six-year terms by the Executive Commissioner of the Texas Health and Human Services Commission. Informed Consent Statute, Sec. 74.102(c) of the Texas Civil Practice and Remedies Code.
3. The Work of the Panel
3.1. What is a List A procedure?
The panel is required to prepare separate lists of medical treatments and surgical procedures that require disclosure of risks and hazards and those treatments and procedures that do not. Informed Consent Statute, Sec. 74.103(b) of the Texas Civil Practice and Remedies Code. List A Procedures are those for which the panel has determined the risks or hazards would influence a reasonable person in giving or withholding consent, and, therefore, require written consent to be compliant with the Informed Consent Statute. For each List A treatment or procedure, the panel has identified the risks and hazards that should be disclosed in obtaining informed consent for that treatment or procedure. The List A procedures are set out in the panel's regulations at 25 Texas Administrative Code Section 601.2.
3.1. What is a List B procedure?
List B Procedures are those for which the panel has determined the risks and hazards would not influence a reasonable person in giving or withholding consent and therefore do not require written consent to be compliant with the Informed Consent Statute. The List B treatments and procedures are set out in the panel's regulations at 25 Texas Administrative Code Section 601.3.
3.3. How does the panel obtain information about medical treatments and surgical procedures and the associated risks?
The panel relies on the expertise of its physician members as well as input from professional medical societies and associations in determining whether there should be a disclosure of risks and hazards in connection with a particular medical treatment or surgical procedure. Any additions or changes to either List A or List B that are being proposed by the panel are published in draft form in the Texas Register and anyone may provide comments to the panel on the proposed addition or change during the 30 days following publication of the proposal. The panel then reviews the comments and publishes the final addition or change in the Texas Register with the date that the addition or change is effective.
4. Legal Protections Afforded by Statute
4.1. If a provider discloses the risks and hazards identified by the panel for a List A medical treatment or surgical procedure and uses the panel's consent form, can the provider be liable for negligence in obtaining informed consent?
If the provider complies with the procedures established by the panel, the Informed Consent Statute provides a "rebuttable presumption" that the provider was not negligent in obtaining informed consent. In a health care liability claim by a patient against a provider alleging negligent failure to disclose the risks and hazards of a medical treatment or surgical procedure, if the provider disclosed the risks identified by the panel for a List A procedure, there is a rebuttable presumption that the provider was not negligent and the jury will be so informed. The patient must then present evidence to overcome or "rebut" the presumption that the provider fulfilled his or her duty to disclose risks and hazards to recover on the claim. If the panel has determined that a disclosure of risks and hazards is not required for a certain treatment or procedure (or a List B procedure) and the provider does not disclose any risks or hazards to the patient, there is the same rebuttable presumption that the provider met the requirements of the statute and was not negligent. Informed Consent Statute, Sec. 74.106 of the Texas Civil Practice and Remedies Code.
4.2. Is a provider required to disclose the risks identified by the panel for a List A procedure or to use the panel's consent forms?
No (except in the case of a hysterectomy---see discussion below), but if the provider fails to disclose the risks and hazards identified by the panel for a List A procedure or to use the panel's form, in the event of a health care liability claim on the issue of informed consent there will be a rebuttable presumption that the provider was negligent and failed to fulfill the duty of disclosure. The jury will be so informed, and the provider must then present evidence to rebut the presumption of negligence. Informed Consent Statute, Sec. 74.106 of the Texas Civil Practice and Remedies Code.
4.3. Are there any exceptions to the rebuttable presumption if the provider fails to disclose the List A risks or use the panel's form?
The Informed Consent Statute provides that the provider may not be found negligent for failure to disclose if there was an emergency or a reason it was not medically feasible to make the disclosure. Informed Consent Statute, Sec. 74.106 of the Texas Civil Practice and Remedies Code.
4.4. What are the provider's responsibilities if the proposed medical treatment or surgical procedure is not on List A or List B?
The Informed Consent Statute provides that if a medical treatment or surgical procedure is performed for which the panel has not made a determination as to the duty of disclosure of risks and hazards, the provider is "under the duty otherwise imposed by law." Informed Consent Statute, Sec. 74.106(b) of the Texas Civil Practice and Remedies Code. The Texas Supreme Court has held that the duty is as stated in Section 74.101 of the Informed Consent Statute: the provider must disclose the risks and hazards that could influence a reasonable person in making a decision to give or withhold consent. Barclay v. Campbell, 704 S.W.2d 8 (Tex. 1986); Petersen v. Shields, 652 S.W.2d 929 (Tex. 1983).
5. The Panel's Consent Forms
5.1. Does the panel publish a consent form to be used for the medical treatments and surgical procedures on List A?
The statute requires the panel to establish the "form" in which the disclosure of risks and hazards for treatments and procedures identified by the panel must be made. Informed Consent Statute, Sec. 74.103(b) of the Texas Civil Practice and Remedies Code. The consent forms established by the panel are set out in the panel's regulations at 25 Texas Administrative Code Sections 601.4, 601.5, 601.8, and 601.9.
5.2. What consent forms have been established by the panel?
There are four separate consent forms:
- Sec. 601.4, Disclosure and Consent - Medical Care and Surgical Procedures
- Sec. 601.5, Disclosure and Consent for Radiation Therapy
- Sec. 601.8, Disclosure and Consent for Hysterectomy
- Sec. 601.9, Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia)
Each form is listed on our Disclosure and Consent Forms section. The consent forms also are available in Spanish.
5.3. What grade level of comprehension are the panels’ forms designed for?
The panel has not obtained a formal designation of grade level for the forms it has produced. The current forms were drafted to move the forms toward a junior high school reading level. The panel notes that the consent form includes an attestation that the patient has had the opportunity to ask their provider any questions they have. The provider may use the additional space on the form to clarify any of these questions from the patient at whatever grade level is necessary for patient comprehension. Providers should consult their legal counsel regarding any additional documentation.
6. Uses or Changes to the Panel's Consent Form
6.1. Is the provider required to use the consent forms promulgated by the panel?
If a provider wants to be able to assert the rebuttable presumption that he or she has complied with the duty of disclosure of risks and hazards established by the Informed Consent Statute (see discussion above under "Legal Protections"), the provider must make the disclosure "in the form and to the degree required by the disclosure panel under Section 74.103." Informed Consent Statute, Sec. 74.105 of the Texas Civil Practice and Remedies Code. Therefore, in obtaining consent for a List A procedure, the provider should disclose the risks and hazards identified by the panel for that List A procedure and use the panel's consent form.
6.2. Can a provider use the panel's Disclosure and Consent – Medical and Surgical Procedures form to obtain consent to perform a hysterectomy?
The Informed Consent Statute provides that the form specifically established for hysterectomy, Disclosure and Consent for Hysterectomy (25 Texas Administrative Code Sec. 601.8) is to be used for that procedure, unless the hysterectomy must be performed in a life-threatening situation in which the physician determines obtaining informed consent is not reasonably possible. Informed Consent Statute, Sec. 74.107 of the Texas Civil Practice and Remedies Code.
6.3. Since the statutory consent form includes consent to the administration of blood, which is a List A procedure with identified risks, does the provider need to list those risks on the panel’s form under the section dealing with consent to blood?
No. The risks identified by the panel for the administration of blood and blood products are included on the form. If the provider determines there are additional risks that should be disclosed, the provider should list those additional risks.
6.4. Does a provider need to use the panel's consent form when obtaining consent to a medical treatment or surgical procedure that is on List B (meaning the panel has determined that disclosure of risks and hazards is not required)?
No, the provider does no need to use the panel’s consent form in this instance because there is no written disclosure required. However, should a provider choose to obtain written consent for a procedure on List B the panel recommends that the provider use its Disclosure and Consent - Medical Care and Surgical Procedures form.
6.5. If the provider uses the panel's Disclosure and Consent---Medical and Surgical Procedures form to obtain consent for a List B procedure, what would the provider put on the form under the section for the listing of risks since the panel has determined there are no specific risks that need to be disclosed?
Neither the Informed Consent Statute nor the panel requires that any specific information be placed on the consent form when used for a List B procedure (or even that the panel's form be used). The provider is responsible for deciding what information to put on the consent form, but may want to provide under the section for listing of risks a statement to the effect that "no disclosure of specific risks is required by the Texas Medical Disclosure Panel," rather than leaving blank spaces on the form.
6.6. What if the provider believes there are risks that should be disclosed for a List B procedure?
This is not addressed by the Informed Consent Statute and the provider may list those risks on the panel's consent form in the appropriate space. This information could be listed by itself or along with a statement to the effect that no disclosure of specific risks is required by the panel.
6.7. What if a provider believes that there are additional risks and hazards associated with a List A procedure that should be disclosed beyond those identified by the panel? Can the provider add those risks to the risks identified by the panel?
Nothing in the Informed Consent Statute prohibits a provider from listing additional risks that he or she has identified along with the panel's listing of the risks and hazards for the List A procedure. Those additional risks may be listed in the appropriate space on the panel's consent form after the listing of the risks identified by the panel and should not conflict with the information already on the panel's form.
6.8. May a provider add information or text to the panel's consent forms other than risks and hazards, such as consent to photographs?
The Informed Consent Statute does not prohibit the inclusion of additional information on the consent form. There is always the possibility that an alteration of the form, depending on the nature and extent of the alteration, may jeopardize the legal protections that are afforded by the Informed Consent Statute for using the panel's form. Any addition should be consistent with the existing text of the panel's form.
6.9. Can the provider delete information or text from the panel's consent forms?
Deleting information or text from the panel's consent form may jeopardize the legal protections available under the statute. Rather than deleting information from the panel's consent form, if there is information that is not applicable to a particular patient or treatment or procedure, the provider and patient may want to consider lining through that information and initialing the line through.
6.10. Can the information in the panel's consent form be incorporated into the provider's own consent form and is it permissible for the provider to use electronic or digitized versions of the consent form to obtain informed consent?
This is not addressed by the Informed Consent Statute or the panel. Although it may be acceptable to a court if challenged, modification of the panel's consent forms or of the recommended disclosures may jeopardize the legal protections under the Informed Consent Statute. If electronic or digitized versions of the panel's consent forms are utilized by a provider to obtain a patient’s informed consent, the panel recommends that the provider ensures that the patient has an opportunity to review the electronic medium containing the panel's consent form information during the consent discussion as well as be provided the option to obtain a copy of the executed document. The provider may want to consult with information technology experts and legal counsel to ensure their electronic consent document system includes a means of demonstrating the electronic version contains all of the information in the panel's existing consent form, the patient had the opportunity to review the electronic version, and any electronic or digital signatures are authenticated in accordance with applicable state or federal electronic signature laws. The provider should consult with legal counsel to ensure the provider does not lose the legal protections provided under the Informed Consent Statute.
6.11. Can more than one List A procedure be included on a single Disclosure and Consent – Medical Care and Surgical Procedures form or does the provider need to use a separate form for each List A procedure?
As long as the names of each List A procedure and the risks for each of those procedures are included on the form, one Disclosure and Consent – Medical Care and Surgical Procedures form can be used to obtain consent for more than one procedure. However, procedures should not be added to the Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia) form.
6.12. Does the consent form require a signature from the provider performing the procedure or the anesthetic?
In the State of Texas, the physician/practitioner is not required to sign the consent form. However, some facilities choose to have the practitioner sign. That decision is up to the facility and may be part of their policies and procedures; however, it is not a state requirement. The TMDP cannot give advice as to whether or not the facility can require the practitioner to sign.
6.13. When the same procedure is repeated more than once in close temporal proximity does a single completed form suffice?
This question is not addressed in the state code or statute, and the TMDP does not make such determinations. Providers should consult their legal counsel for guidance.
7. ECT
7.1. What does the panel require for consent to electroconvulsive therapy or ECT?
The panel has determined that electroconvulsive therapy or ECT is a List A procedure and identified those risks and hazards that should be disclosed for this procedure. Texas Health and Human Services Commission (HHSC) has a standard consent form for ECT (see 25 Texas Administrative Code Sec. 405.117) which is required for ECT. The panel does not require a provider who uses the HHSC consent form for the ECT to also use the panel's Disclosure and Consent---Medical Care and Surgical Procedures form if the HHSC form includes the panel's risks for ECT.
Please note that, if List A anesthesia is being used with the administration of the ECT, the panel recommends that the provider use the panel's Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia) form since the information and risks and hazards identified by the panel and set out in the panel's form is not currently included on the HHSC ECT consent form.
8. Other
8.1. How long is the consent form valid after having been signed?
This is not addressed by the Informed Consent Statute.
8.2. Is the provider performing the medical treatment or surgical procedure required to obtain the consent or can the provider assign the responsibility to another individual?
The Informed Consent Statute does not address this issue.
8.3. Who is responsible to complete the consent form, i.e., fill in the blanks on the form?
The Informed Consent Statute addresses disclosure involved in "medical care or surgical procedures rendered by the physician or health care provider" (emphasis added). Case law places the responsibility for obtaining informed consent with the physician or health care provider rendering the medical care or surgical procedure. The Informed Consent Statute does not address who is responsible to insert the information on the panel's consent forms.
8.4. Whose address information is intended to be inserted at the end of the consent forms?
The name and address of the witness.
8.5. How do providers obtain the lists and consent forms?
List A and List B medical treatments and surgical procedures are located in our Rules and Regulations section. Consent forms may be obtained from our Disclosure and Consent Forms section.
8.6. How do providers learn of changes by the panel or procedures that are added to the lists?
These are published in the Texas Register, which can be accessed at the Secretary of State website under 25 Texas Administrative Code Part 7. Once enacted, the changes are incorporated to the documents available on the Texas Health and Human Services’ website.
8.7. What is the relationship between the panel and the Texas Health and Human Services?
The panel is entirely separate from the Texas Health and Human Services, but the staff of the Texas Health and Human Services provides administrative support for the panel.
8.8. May a Registered Nurse use the Disclosure and Consent – Medical Care and Surgical Procedures form to obtain informed consent for insertion of a PICC (Peripherally Inserted Central Catheter) ordered by a physician?
Generally, the duty to obtain informed consent rests with the provider ordering the treatment or procedure even though other health care providers may assist in delivering the treatment or procedure. If the insertion of the PICC and the explanation of the risks and hazards associated with the procedure are within the scope of practice of the Registered Nurse, and obtaining informed consent for insertion of the PICC is permitted by the hospital or ambulatory surgery center and the ordering physician, the Registered Nurse may use the form to document informed consent for insertion of the PICC. Note that insertion of a PICC is a List A procedure (Sec. 601.2(b)(2)(K) Vascular access – nontunneled catheters, tunneled catheters, implanted access).
9. Recent Specific Questions
9.1. List A, (n) Radiology, includes “Procedures utilizing prolonged fluoroscopy” as a List A procedure. What constitutes “prolonged fluoroscopy”?
What constitutes prolonged fluoroscopy must be determined by the provider since there are several variables to consider and the determination may vary by patient.
10. Separate Anesthesia and/or Perioperative Pain Management (Analgesia) Consent Form
10.1. Why did the panel develop a separate consent form for anesthesia and/or perioperative pain management (anesthesia)?
The panel consulted with several sources on the benefits and limitations of a separate consent form, including the Texas Society of Anesthesiologists. The prior method of addressing anesthesia in the Disclosure and Consent – Medical Care and Surgical Procedures and Disclosure and Consent for Hysterectomy did not allow for designation of the identity of the anesthesia provider, information which the panel determined would be in the patient’s interests. A separate consent form also emphasizes the separate responsibilities of the anesthesia provider as compared to the operating practitioner.
10.2. How is the separate anesthesia consent form intended to be used?
The anesthesia consent form is intended for use when anesthesia or analgesia is administered in conjunction with other procedures. If anesthesia or perioperative pain management is being provided in conjunction with another List A procedure, then the patient would be presented with both the Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia) form for the anesthesia and the Disclosure and Consent – Medical and Surgical Procedures for the operative procedure (or the Disclosure and Consent for Hysterectomy form in the case of a hysterectomy).
10.3. What form should the provider use if the provider is administering anesthesia or analgesia solely for purposes of pain management, and not in conjunction with another procedure?
If the pain management procedure is a List A procedure, such as one listed under Section 601.2(t), the provider would use the panel's Disclosure and Consent – Medical and Surgical Procedures consent form. If the pain management is procedure is not a List A procedure and is being used to facilitate a List B procedure or procedure unaddressed by the panel, then the form Disclosure and Consent form for Anesthesia and/or Perioperative Pain Management (Analgesia) should be used (e.g., Labor Epidural for vaginal delivery).
10.4. If the same provider is performing a List A procedure and administering List A anesthesia or analgesia, can the provider use only the Disclosure and Consent – Medical and Surgical Procedures form to obtain consent for both the procedure and the anesthesia or analgesia?
If the provider is performing a regional block as part of his or her procedure, then this can be included on the Disclosure and Consent - Medical and Surgical Procedures. If the provider is delegating or performing any level of List A sedation (moderate sedation, deep sedation, general anesthesia) or neuraxial anesthesia (spinal, epidural) then to assert the rebuttable presumption that he or she has complied with the duty of disclosure of risks and hazards established by the Informed Consent Statute (see discussion above under “Legal Protections”), then both forms should be used.
10.5. Can dentists use the Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia) when administering nitrous oxide?
Nitrous Oxide used on its own is considered minimal sedation and therefore, is not on List A. If a provider anticipates reaching an anesthetic level of moderate sedation or deeper through the use of additional pharmacologic intervention, then the provider is administering List A anesthesia and should use the form Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia).
10.6. Can more than one type of anesthesia or analgesia be checked on the Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia)?
Yes.
10.7. If the provider already has an anesthesia consent form, can the provider modify that form to include the information from the panel's anesthesia consent form and keep using its existing form?
If a provider wants to be able to assert the rebuttable presumption that he or she has complied with the duty of disclosure of risks and hazards established by the Informed Consent Statute, the provider must make the disclosure "in the form and to the degree required by the disclosure panel under Section 74.103." Informed Consent Statute, Sec. 74.105. Therefore, in obtaining consent for a List A procedure (of which anesthesia is one), the provider should disclose the risks and hazards identified by the panel for that List A procedure and use the panel's consent form (in this case the panel's anesthesia consent form). The Informed Consent Statute does not prohibit the inclusion of additional information on the consent form. There is always the possibility that an alteration of the form, depending on the nature and extent of the alteration, may jeopardize the legal protections that are afforded by the Informed Consent Statute for using the panel's form. See FAQs #6.1 and 6.8 above.
10.8. May a Certified Registered Nurse Anesthetist (CRNA) use the Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia) for administering anesthesia or analgesia?
The anesthesiologist or operating physician or dentist performing the procedure who is delegating the medical act of anesthesia or analgesia may involve other individuals or resources to provide information to a patient, but the anesthesiologist or other delegating physician or dentist is responsible for ensuring that informed consent has been obtained for the administration of anesthesia or analgesia.
10.9 Can a facility/physician/provider put a generic name in the field for physician such as “Member of the UT Anesthesiology Department”? or, Can a facility/physician/provider put a generic name in the field for the CRNA, CAA, or Physician in Training such as “Member of the UT Anesthesiology Department”?
No. A specific provider’s name is the intention as the informed consent process is meant to occur between a specific provider and the patient. It may be reasonable to also add “…or another member of the UT Anesthesiology Department” after the specific name listed. And indeed, the forms already state the possibility of others being involved: “note that the provider listed may change depending on the length of the procedure or other circumstances”. But a specific provider’s name was the intention of the form as developed.
10.10. The form denotes additional risk for childhood anesthesia. What age qualifies a patient for this additional risk category?
Studies looking at developmental risk of Anesthetics in young children examined effects of anesthesia prior to age 3. However, the panel feels information on this question continues to evolve. As such the panel recommends each provider make their own determination, based on the most recent evidence, for what age children they disclose the additional risk of early childhood anesthetics.
10.11. There are scenarios in anesthesia care where only minimal sedation is required, such as cataract surgery. Is this covered by the form?
Minimal sedation is not a List A procedure and therefore does not require use of a form produced by the panel. However, if you foresee the potential for minimal sedation to become moderate sedation or deeper these are List A procedures, and you should use the form Disclosure and Consent for Anesthesia and/or Perioperative Pain Management (Analgesia).
10.12. What if the designated physician or dentist will not be present for the entirety of the procedure; in other words, what if they change?
The form already accounts for the possibility of others being involved: “note that the provider listed may change depending on the length of the procedure or other circumstances”. A specific provider’s name was the intention of the form as developed. It may be reasonable to also add “…or another member of the [specific department]” after the specific name listed, but a specific provider’s name is the intention as the informed consent process is meant to occur between a specific provider and the patient.
10.13. Should the name of a sedation nurse be added to the form when a surgeon, physician, or dentist is using a sedation nurse to provide moderate sedation?
The anesthesia consent form was designed to inform the patient about those participating providers with liability for medical decision making during their anesthetic. Those individuals listed on the form are responsible for the formulation and clinically appropriate modification of an anesthesia plan to facilitate a procedure. A sedation nurse is not a qualified anesthesia provider by either state statute or Medicare conditions of participation. While a sedation nurse can administer sedatives at the direct instructions of a physically present physician, they should not be developing or modifying the anesthetic plan on their own. It is not the intended purpose of the consent form to name every participant in the patient's care. Modifying the panel's consent form should only be done in consultation with legal counsel.