Texas Medical Disclosure Panel - Frequently Asked Questions

The Texas Medical Disclosure Panel (Panel) was established in 1977 to provide physicians and other health care providers with guidelines for informed consent, both as to the risks and hazards that should be disclosed to the patient and the form of the disclosure.  Chapter 74, Subchapter C, Sections 74.101-74.107, of the Texas Civil Practices and Remedies Code (Consent Statute) set out the specific requirements as to the Panel and the duty of disclosure for informed consent.  The regulations promulgated by the Panel in implementing the statute are set out at 25 Texas Administrative Code Sections 601.1-601.8.

The following is intended to explain the duties of the 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 supercede 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.

List of Frequently Asked Questions

1. What is informed consent?
2. What information does the Consent Statute require be disclosed? 
3. What is the purpose of the Panel?
4. Who serves on the Panel and how are the members appointed?
5. What is a List A procedure?
6. What is a List B procedure?
7. How does the Panel obtain information about medical treatments and surgical procedures and the associated risks?
8. 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? 
9. 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? 
10. Are there any exceptions to the rebuttable presumption if the provider fails to disclose the List A risks or use the Panel’s form?
11. Since the statutory consent form includes consent to the administration of blood, which is a List A procedure with identified risks, can the provider preprint those risks on the Panel’s form under the section dealing with consent to blood?
12. What are the provider’s responsibilities if the proposed medical treatment or surgical procedure is not on List A or List B?
13. Does the Panel publish a consent form to be used for the medical treatments and surgical procedures on List A? 
14. What consent forms have been established by the Panel?Is the provider required to use the consent forms promulgated by the Panel? 
15. Is the provider required to use the consent forms promulgated by the Panel?
16. Can a provider use the Panel’s Disclosure and Consent---Medical and Surgical Procedures form to obtain consent to perform a hysterectomy? 
17. 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 specific risks and hazards is not required)? 
18. 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 form under the section for the listing of risks since the Panel has determined there are no specific risks that need to be disclosed?
19. What if the provider believes there are risks that should be disclosed for a List B procedure? 
20. 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?
21. May a proider add information or text to the Panel’s consent forms other than risks and hazards, such as consent to photographs? 
22. Can the provider delete information or text from the Panel’s consent forms?
23. How long is the consent form valid after having been signed?
24. 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? 
25. How do providers obtain the lists and consent forms? 
26. How do providers learn of changes by the Panel or procedures that are added to the lists?
27. What is the relationship between the Panel and the Texas Department of State Health Services? 
28. What does the Panel require for consent to electroconvulsive therapy or ECT? 

Answers to Frequently Asked Questions

General

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 consent.  In order for the patient to make an informed decision about whether to consent, 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.

2. What information does the Consent Statute require be disclosed?  The 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.  Consent Statute, Sec. 74.101. 

To Questions

Panel

3. 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.  Consent Statute, Sec. 74.102(a).

4. 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 Commissioner of the Texas Department of State Health Services.  Consent Statute, Sec. 74.102(c).

5. What is a List A procedure?  The Panel is required to prepare separate lists of medical treatments and surgical procedures that require disclosure of specific risks and hazards and those treatments and procedures that do not.  Consent Statute, Sec. 74.103(b).  List A sets out the treatments and procedures that the Panel has determined require a disclosure of specific risks and hazards when obtaining informed consent.  For each List A treatment or procedure, the Panel has identified the specific 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.

6. What is a List B procedure?  List B treatments and procedures are those that the Panel has determined do not require any disclosure of specific risks or hazards associated with the treatment or procedure.  The List B treatments and procedures are also set out in the Panel’s regulations at 25 Texas Administrative Code Section 601.3.

To Questions

7. 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. 

8. 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 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 specific 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.  Consent Statute, Sec. 74.106.

9. 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 specific 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.

To Questions

10. 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 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. Consent Statute, Sec. 74.106.

11. Since the statutory consent form includes consent to the administration of blood, which is a List A procedure with identified risks, can the provider preprint those risks on the Panel’s form under the section dealing with consent to blood?  Yes.  As long as the risks listed for the administration of blood include those identified by the Panel, their inclusion should not jeopardize the availability of the legal protections afforded by the Consent Statute.

12. What are the provider’s responsibilities if the proposed medical treatment or surgical procedure is not on List A or List B?  The Consent Statute provides that if a medical treatment or surgical procedure is performed for which the Panel has not make a determination as to the duty of disclosure of risks and hazards, the provider is “under the duty otherwise imposed by law.” Consent Statute, Sec. 74.106(b).  The Texas Supreme Court has held that the duty is as stated in Section 74.101 of the 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).

To Questions

Consent Forms

13. 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.  Consent Statute, Sec. 74.103(b).  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, and 601.8.

14. What consent forms have been established by the Panel?  There are three separate consent forms:
Sec. 601.4     Disclosure and Consent - Medical and Surgical Procedures
Sec. 601.5     Disclosure and Consent for Radiation Therapy
Sec. 601.8     Disclosure and Consent for Hysterectomy

Each form is listed on our Applications/Forms page.

15. 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 Consent Statute (see discussion above under “Legal Protections”), the provider must make the disclosure “in the form and to the degree required by the panel.”  Consent Statute, Sec. 74.106.  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.

To Questions

16. Can a provider use the Panel’s Disclosure and Consent---Medical and Surgical Procedures form to obtain consent to perform a hysterectomy?  The Consent Statute provides that the form specifically established 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.  Consent Statute, Sec. 74.107(d).

To Questions

17. 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 specific risks and hazards is not required)?  No, since there is no specific disclosure required.  In obtaining consent for the treatment or procedure, however, the Panel recommends that the provider use its consent form.

18. 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 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 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 to decide 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.

19. What if the provider believes there are risks that should be disclosed for a List B procedure?  This is not addressed by the 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.

To Questions

20. 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 Consent Statute prohibits a provider from listing additional risks that he or she has identified along with the Panel’s listing of specific 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.

21. May a provider add information or text to the Panel’s consent forms other than risks and hazards, such as consent to photographs?  The 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 Consent Statute for using the Panel’s form.  Any addition should be consistent with the existing text of the Panel’s form.

22. 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.

To Questions

Other

23. How long is the consent form valid after having been signed?  This is not addressed by the Consent Statute.

24. 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 Consent Statute does not address this issue.

25. How do providers obtain the lists and consent forms?  The List A and List B medical treatments and surgical procedures are located on our Rules/Regulations page and the consent forms may be obtained from on our Applications/Forms page.

26. 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 Sections 601.1 to 601.8.

Once enacted, the changes are incorporated to the documents available on the Texas Department of State Health Services’ web site. 

27. What is the relationship between the Panel and the Texas Department of State Health Services?  The Panel is entirely separate from the Texas Department of State Health Services, but the staff of the Texas Department of State Health Services’, Facility Licensing Group provides administrative support for the Panel. 

28. What does the Panel require for consent to electroconvulsive therapy or ECT?  The Panel has determined that ECT is a List A procedure and identified those risks and hazards that should be disclosed using the Panel’s Disclosure and Consent---Medical and Surgical Procedures form. The anesthesia used in conjunction with administration of the ECT may also be a List A procedure, depending on the type of anesthesia. The Texas Department of State Health Services (“DSHS”) has published a standard consent form for ECT (see 25 Texas Administrative Code Sec. 601.7) as required by the Texas Health & Safety Code Section 578.003, which must be used by a provider. A provider mayuse both the DSHS consent form for the ECT and the Panel’s Disclosure and Consent---Medical and Surgical Procedures form. The Panel has also provided by regulation that the provider may use just the DSHS form as long as that form has the specific risks and hazards for ECT and any List A anesthesia that the Panel has determined should be disclosed. The DSHS ECT form does not currently contain the List A anesthesia risks adopted by the Panel and effective March 4, 2007. Those risks may be attached to the DSHS ECT form or the provider may use the Panel’s Disclosure and Consent---Medical and Surgical Procedures form to obtain consent for any List A anesthesia.

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Last Updated October 8, 2007